Device Classification Name



Device Classification Name |electrocardiograph | |

|510(k) Number |K972991 |

|Device Name |MONITOR ONE NDX |

|Applicant |QMED, INC. |

| | |

| |60 bay st. |

| | |

| |sag harbor,  NY  11963 |

| | |

|Contact |joseph hanna |

|Regulation Number |870.2340 |

|Classification Product Code |DPS   |

| | |

|Date Received |08/12/1997 |

|Decision Date |12/03/1998 |

|Decision |substantially equivalent (SE) |

|Classification Advisory Committee |Cardiovascular |

|Review Advisory Committee |Anesthesiology |

|Statement/Summary/Purged Status |Summary/purged 510(k) |

|summary |summary |

|Type |Traditional |

|Reviewed by Third Party |No |

|Expedited Review |No |

[pic][pic][pic][pic]

[pic][pic]

|Code of Federal Regulations] |[pic] |

| | |

|[Title 21, Volume 8] | |

| | |

|[Revised as of April 1, 2008] | |

| | |

|[CITE: 21CFR870.2340] | |

| | |

|TITLE 21--FOOD AND DRUGS |

| |

|CHAPTER I--FOOD AND DRUG ADMINISTRATION |

|DEPARTMENT OF HEALTH AND HUMAN SERVICES |

| |

|SUBCHAPTER H--MEDICAL DEVICES |

| |

PART 870 -- CARDIOVASCULAR DEVICES

Subpart C--Cardiovascular Monitoring Devices

|Sec. 870.2340 Electrocardiograph. |

|(a)Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more |

|electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart. |

|(b)Classification. Class II (performance standards). |

|Device |electrocardiograph |

|Regulation Description |Electrocardiograph. |

|Regulation Medical Specialty |Cardiovascular |

|Review Panel |Cardiovascular |

|Product Code |DPS |

|Submission Type |510(k) |

|Regulation Number |870.2340 |

|Device Class |2 |

|GMP Exempt? |No |

|Recognized Consensus Standards |

| |

| |

| |

| |

| |

|IEC60601-2-25 Amendment 1 (1999) Medical |

|electrical equipment, Part 2: Particular requirements for the safety of |

|electrocardiographs |

| |

|IECEC53/(R) 2001 ECG cables |

|and leadwires |

| |

|IEC60601-2-27: (2005-08) Medical |

|electrical equipment -- Part 2-27: Particular requirements for the safety, |

|including essential performance, of electrocardiographic monitoring |

|equipment |

| |

|IECEC11:1991/(R)2007 Diagnostic |

|electrocardiographic devices |

| |

|IECEC57 1998/(R) 2003 Testing and |

|reporting performance results of cardiac rhythm and ST-segment measurement |

|algorithms |

| |

|Guidance Document |

| |

| |

| |

| |

| |

|Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement); |

|Final |

| |

|Third Party Review |

|Eligible for Mutual Recognition Agreement Program |

|Eligible for Accredited Persons Program |

| |

|Accredited Persons |

|british standards institution |

|center for measurement standards of industrial |

|citech |

|intertek testing services |

|kema quality b.v. |

|regulatory technology services, llc |

|tuv rheinland of north america, inc. |

|tuv sud america inc. |

|underwriters laboratories, inc. |

| |

| |

| |

| |

|Recognition List Number: |

|004 Effective Date: 07/25/2000  |

| |

|Part B: |

|SUPPLEMENTARY INFORMATION |

| |

|Recognition Number 3-30: |

|IEC 60601-2-25 Amendment 1 (1999), Medical electrical |

|equipment, Part 2: Particular requirements for the safety of |

|electrocardiographs. (Cardiovascular) |

| |

|Date of |

|Standard: 1999.  |

| |

| |

| |

|Address of Standards |

|Organization: |

| |

| |

| |

| |

|  INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC) |

| |

|  3, RUE DE VAREMBE' |

| |

|  P.O. BOX 131 |

| |

|  CH-1211 GENEVA 20, |

| |

|  SWITZERLAND |

| |

| |

| |

| |

| |

| |

| |

|CDRH Office and |

|Division Associated with Recognized Standards: |

| |

| |

| |

| |

| |

|OFFICE OF DEVICE EVALUATION (ODE) |

| |

| |

|DIVISION OF CARDIOVASCULAR DEVICES (DCD) |

| |

| |

| |

| |

| |

| |

| |

|Devices |

|Affected: |

| |

| |

| |

| |

|Electrocardiographs |

| |

| |

| |

| |

| |

|Processes |

|Affected: |

| |

| |

| |

| |

|510(k), PMA, IDE, PDP, HDE |

| |

| |

| |

| |

| |

|Type of |

|Standard: |

| |

| |

| |

| International, Vertical |

| |

| |

| |

|Extent of |

|Recognition: |

| |

| |

| |

| |

|Complete Standard for SAFETY ONLY (Including Protection Against Electric Shock Hazards) for Type CF EQUIPMENT or APPLIED PART |

| |

|(Note: Standard is NOT applicable for equipment labeled and tested as Type B or BF EQUIPMENT or APPLIED PART). |

| |

|Therefore, Clause 19.3 of the particular standard applies to only type CF electrocardiographs, not Types B or BF. |

| |

|Clause 5.6 in the particular standard is not recognized. |

| |

|Clause 51.101.1 of the particular standard is not recognized. |

| |

|Clause 56.3 of the particular standard is not recognized (SEE 21 CFR 898). |

| |

|NOTE: FDA may request performance data since the IEC particular standard only deals with safety. |

| |

| |

| |

| |

| |

|Related CFR Citations |

|and Product Codes: |

| |

| |

| |

| |

|Regulation |

|Number |

|Device Name |

|Device |

|Class |

|Product |

|Code |

| |

|§870.2340 |

|Electrocardiograph |

|Class 2 |

|DPS |

| |

|  |

| |

| |

| |

| |

| |

| |

| |

| |

|Relevant |

|Guidance: |

| |

| |

| |

| |

|Draft Guidance for Industry on 510(k) Submissions for Class II Electrocardiographic Devices [under development] |

| |

| |

| |

| |

| |

|FDA Technical |

|Contacts: |

| |

| |

| |

| |

| |

|  Charles Ho, Ph.D. |

| |

|  FDA/CDRH/ODE |

| |

|  9200 Corporate Blvd, HFZ-450 |

| |

|  Rockville MD 20850 |

| |

|                 240/276-4077         |

| |

|  Email: charles.ho@fda. |

| |

| |

|  Frank Lacy |

| |

|  FDA/CDRH/ODE |

| |

|  9200 CORPORATE BLVD, HFZ-450 |

| |

|  Rockville MD 20850 |

| |

|                 240/276-4095         |

| |

|  Email: frank.lacy@fda. |

| |

| |

| |

| |

| |

| |

|* In the United States, copies of this standard can be obtained from: |

|  AMERICAN NATIONAL STANDARDS INSTITUTE (ANSI)* | |

| | |

|  11 WEST 42ND STREET | |

| | |

|  NEW YORK, NY 10036 | |

| | |

| |

| |

| |

|Recognition List Number: |

|020 Effective Date: 09/09/2008  |

| |

|Part B: |

|SUPPLEMENTARY INFORMATION |

| |

|Recognition Number 3-2: |

|AAMI EC53/(R) 2001, ECG cables and |

|leadwires. (Cardiovascular) |

| |

|Date of Standard: |

|2001.  |

| |

|Address of Standards |

|Organization: |

| | | |

| | | |

|  ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION (AAMI) | | |

| | | |

|  1110 N. GLEBE ROAD | | |

| | | |

|  SUITE 220 | | |

| | | |

|  ARLINGTON, VA 22201-5762 | | |

| | | |

|  | | |

| | | |

| | | |

| |

|CDRH Office and |

|Division Associated with Recognized Standards: |

| |

| |

| |

|OFFICE OF DEVICE EVALUATION (ODE) |

| |

| |

|DIVISION OF CARDIOVASCULAR DEVICES (DCD) |

| |

| |

| |

| |

| |

|Devices |

|Affected: |

| |

| |

|Electrode Leadwires and Patient Cables intended for use with the following devices: Electrocardiographs (ECGS), |

|Cardiac Monitors, Arrhythmia Detectors and Alarms, DC Defibrillators, Multiparameter Physiological Monitors, Breathing Frequency |

|Monitors, Ventilatory Effort Monitors (Apnea Detectors), Other devices that use patient cables |

| |

| |

| |

|Processes |

|Affected: |

| |

| |

|510(k), PMA, IDE, PDP, HDE |

| |

| |

| |

|Type of |

|Standard: |

| |

| National, Horizontal |

| |

|Extent of |

|Recognition: |

| |

| |

|Complete Standard (including proposed changes, January 1998). |

| |

|NOTE: This standard covers cables and patient leadwires used for surface electrocardiographic (ECG) monitoring in cardiac monitors as |

|defined in ANSI/AAMI EC13-1992, Cardiac monitors, heart rate meters, and alarms. It covers both disposable and reusable leadwires, with|

|certain sections applicable to both, and certain sections applicable only to one. |

| |

|This standard defines a safe (no exposed metal pins) common interface at the cable yoke and leadwire connector. Specified in the |

|standard are the following: Labeling requirements; Construction requirements; Cleaning disinfection and chemical resistance |

|requirements; Sterilization exposure requirements; and Performance requirements (trunk cable and patient leadwires). The parameters |

|specifically addressed by the performance requirements include the following: Dielectric withstand voltage; Sink current; |

|Defibrillation withstand; Cable and leadwire noise; Flex life of instrument connector, cable yoke, patient leadwire connector, and |

|patient end termination flex relief; Tensile strength of cable connections; Number of connector mate/unmate cycles; Contact resistance;|

|Connector retention force and Patient leadwire resistance. |

| |

|ADDITIONAL NOTES: |

| |

|1. This standard also incorporates by reference the DIN 42-802 standard (Connector, touch proof, for electromedical application, 1990).|

| |

|2. Devices that comply with this standard also meet the FDA mandatory standard 21 CFR Part 898, "Medical Devices; Establishment of a |

|Performance Standard for Electrode Lead Wires and Patient Cables." |

| |

|3. Exclusions: The scope of EC53 excludes ECG cables and leadwires that are used in applications that may require special |

|characteristics, such as ambulatory ECG devices, telemetry units, the operating room and the cardiac catheterization lab. The cables |

|and patient leadwires included in the scope of EC53 may supply other functions in addition to ECG monitoring, such as respiration |

|monitoring by impedance pneumography. In this case, the cable and patient leadwires should meet all of the requirements of this |

|standard, unless a requirement is specifically excluded for that device by the standard. |

| |

|Caution: A device manufacturer who claims to meet subclause 1.2 (Exclusions) of EC53 does not attest compliance to EC53. |

| |

| |

| |

|Related CFR Citations |

|and Product Codes: |

| |

| |

|Regulation |

|Number |

|Device Name |

|Device |

|Class |

|Product |

|Code |

| |

|Unclassified |

|System, Ecg Analysis |

|Class U |

|LOS |

| |

|  |

| |

| |

| |

| |

|  |

| |

| |

| |

| |

|Regulation |

|Number |

|Device Name |

|Device |

|Class |

|Product |

|Code |

| |

|§868.2375 |

|Monitor, Breathing Frequency |

|Class 2 |

|BZQ |

| |

|§868.2377 |

|Monitor, Apnea, Facility Use |

|Class 2 |

|FLS |

| |

|  |

| |

| |

| |

| |

|Regulation |

|Number |

|Device Name |

|Device |

|Class |

|Product |

|Code |

| |

|§870.1025 |

|Detector And Alarm, Arrhythmia |

|Class 2 |

|DSI |

| |

|  |

| |

| |

| |

| |

|Regulation |

|Number |

|Device Name |

|Device |

|Class |

|Product |

|Code |

| |

|§870.2300 |

|Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) |

|Class 2 |

|DRT |

| |

|  |

| |

| |

| |

| |

|Regulation |

|Number |

|Device Name |

|Device |

|Class |

|Product |

|Code |

| |

|§870.2340 |

|Electrocardiograph |

|Class 2 |

|DPS |

| |

|  |

| |

| |

| |

| |

|Regulation |

|Number |

|Device Name |

|Device |

|Class |

|Product |

|Code |

| |

|§870.5300 |

|Dc-Defibrillator, Low-Energy, (Including Paddles) |

|Class 2 |

|LDD |

| |

|§870.5310 |

|Automated External Defibrillators (Non-Wearable) |

|Class 3 |

|MKJ |

| |

|  |

| |

| |

| |

| |

|Regulation |

|Number |

|Device Name |

|Device |

|Class |

|Product |

|Code |

| |

|§878.4040 |

|Respirator,Surgical |

|Class 2 |

|MSH |

| |

|  |

| |

| |

| |

| |

| |

| |

| |

| |

|Recognition List Number: |

|020 Effective Date: 09/09/2008  |

| |

|Part B: |

|SUPPLEMENTARY INFORMATION |

| |

|Recognition Number 3-61: |

|IEC 60601-2-27: (2005-08), Medical electrical equipment -- Part |

|2-27: Particular requirements for the safety, including essential performance, |

|of electrocardiographic monitoring |

|equipment. (Cardiovascular) |

| |

|Date of Standard: |

|2005.  |

| |

|Address of Standards |

|Organization: |

| | | |

| | | |

|  INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC) | | |

| | | |

|  3, RUE DE VAREMBE' | | |

| | | |

|  P.O. BOX 131 | | |

| | | |

|  CH-1211 GENEVA 20, | | |

| | | |

|  SWITZERLAND | | |

| | | |

| | | |

| |

|CDRH Office and |

|Division Associated with Recognized Standards: |

| |

| |

| |

|OFFICE OF DEVICE EVALUATION (ODE) |

| |

| |

|DIVISION OF CARDIOVASCULAR DEVICES (DCD) |

| |

| |

| |

| |

| |

|Devices |

|Affected: |

| |

| |

|Electrocardiographs |

| |

| |

| |

|Processes |

|Affected: |

| |

| |

|510(k), PMA, IDE, HDE, PDP, Quality System Regulation |

| |

| |

| |

|Type of |

|Standard: |

| |

| Vertical, International |

| |

|Extent of |

|Recognition: |

| |

| |

|Complete Standard for SAFETY ONLY (Including Protection Against Electric Shock Hazards) |

| |

|Standard written to ONLY apply to Type CF EQUIPMENT or APPLIED PART. |

| |

|Clause 51.101.1 of the particular standard is not recognized. |

| |

|NOTE: FDA may request performance data since the IEC particular standard only deals with safety. |

| |

| |

| |

|Related CFR Citations |

|and Product Codes: |

| |

| |

|Regulation |

|Number |

|Device Name |

|Device |

|Class |

|Product |

|Code |

| |

|§870.2340 |

|Electrocardiograph |

|Class 2 |

|DPS |

| |

|  |

| |

| |

| |

| |

| |

| |

|Relevant |

|Guidance: |

| |

| |

|Draft Guidance for Industry on 510(k) Submissions for Class II Electrocardiographic Devices [under development] |

| |

| |

| | |

|FDA Technical | |

|Contact: | |

| | |

| | |

|  Charles Ho, Ph.D. | |

| | |

|  FDA/CDRH/ODE | |

| | |

|  9200 Corporate Blvd, HFZ-450 | |

| | |

|  Rockville MD 20850 | |

| | |

|                 240/276-4077         | |

| | |

|  Email: charles.ho@fda. | |

| | |

| | |

| | |

| | |

| |

| |

| |

|Recognition List Number: |

|020 Effective Date: 09/09/2008  |

| |

|Part B: |

|SUPPLEMENTARY INFORMATION |

| |

|Recognition Number 3-41: |

|AAMI / ANSI EC11:1991/(R)2007, Diagnostic electrocardiographic |

|devices. (Cardiovascular) |

| |

|Date of Standard: |

|2007.  |

| |

|Addresses of Standards |

|Organizations: |

| | | |

| | | |

|  ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION (AAMI) | | |

| | | |

|  1110 N. GLEBE ROAD | | |

| | | |

|  SUITE 220 | | |

| | | |

|  ARLINGTON, VA 22201-5762 | | |

| | | |

|  | | |

| | | |

|  AMERICAN NATIONAL STANDARDS INSTITUTE (ANSI) | | |

| | | |

|  11 WEST 42ND STREET | | |

| | | |

|  NEW YORK, NY 10036 | | |

| | | |

|  | | |

| | | |

| | | |

| |

|CDRH Office and |

|Division Associated with Recognized Standards: |

| |

| |

| |

|OFFICE OF DEVICE EVALUATION (ODE) |

| |

| |

|DIVISION OF CARDIOVASCULAR DEVICES (DCD) |

| |

| |

| |

| |

| |

|Devices |

|Affected: |

| |

| |

|ELECTROCARDIOGRAPHIC (ECG) SYSTEMS WITH DIRECT WRITING DEVICES |

| |

| |

| |

|Processes |

|Affected: |

| |

| |

|510(K), IDE, PMA, PDP, HDE |

| |

| |

| |

|Type of |

|Standard: |

| |

| Test Method & Device Specification, National, |

|Vertical |

| |

|Extent of |

|Recognition: |

| |

| |

|Complete Standard, except the following: |

| |

|Method D of clause 3.2.7.2 Frequency and impulse response is not recognized. |

| |

|Method D of clause 4.2.7.2 Frequency and impulse response is not recognized. |

| |

|This standard includes design, testing, and labeling requirements. Recommendations in the "Relevant Guidance" listed below are not |

|superseded by this standard. |

| |

|NOTE: Cables and leadwires must meet the FDA mandatory standard 21 CFR 898.12. |

| |

| |

| |

|Related CFR Citations |

|and Product Codes: |

| |

| |

|Regulation |

|Number |

|Device Name |

|Device |

|Class |

|Product |

|Code |

| |

|§870.2340 |

|Electrocardiograph |

|Class 2 |

|DPS |

| |

|  |

| |

| |

| |

| |

| |

| |

|Relevant |

|Guidance: |

| |

| |

|Guidance for Industry -- Diagnostic ECG Guidance (including Non-Alarming ST Segment Measurement) issued by Pacing Devices Branch (now |

|assigned to the CEMB Branch) of CDRH/ODE/DCD on November 5, 1998 |

| |

| |

| |

| |

| |

|Recognition List Number: |

|020 Effective Date: 09/09/2008  |

| |

|Part B: |

|SUPPLEMENTARY INFORMATION |

| |

|Recognition Number 3-41: |

|AAMI / ANSI EC11:1991/(R)2007, Diagnostic electrocardiographic |

|devices. (Cardiovascular) |

| |

|Date of Standard: |

|2007.  |

| |

|Addresses of Standards |

|Organizations: |

| | | |

| | | |

|  ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION (AAMI) | | |

| | | |

|  1110 N. GLEBE ROAD | | |

| | | |

|  SUITE 220 | | |

| | | |

|  ARLINGTON, VA 22201-5762 | | |

| | | |

|  | | |

| | | |

|  AMERICAN NATIONAL STANDARDS INSTITUTE (ANSI) | | |

| | | |

|  11 WEST 42ND STREET | | |

| | | |

|  NEW YORK, NY 10036 | | |

| | | |

|  | | |

| | | |

| | | |

| |

|CDRH Office and |

|Division Associated with Recognized Standards: |

| |

| |

| |

|OFFICE OF DEVICE EVALUATION (ODE) |

| |

| |

|DIVISION OF CARDIOVASCULAR DEVICES (DCD) |

| |

| |

| |

| |

| |

|Devices |

|Affected: |

| |

| |

|ELECTROCARDIOGRAPHIC (ECG) SYSTEMS WITH DIRECT WRITING DEVICES |

| |

| |

| |

|Processes |

|Affected: |

| |

| |

|510(K), IDE, PMA, PDP, HDE |

| |

| |

| |

|Type of |

|Standard: |

| |

| Test Method & Device Specification, National, |

|Vertical |

| |

|Extent of |

|Recognition: |

| |

| |

|Complete Standard, except the following: |

| |

|Method D of clause 3.2.7.2 Frequency and impulse response is not recognized. |

| |

|Method D of clause 4.2.7.2 Frequency and impulse response is not recognized. |

| |

|This standard includes design, testing, and labeling requirements. Recommendations in the "Relevant Guidance" listed below are not |

|superseded by this standard. |

| |

|NOTE: Cables and leadwires must meet the FDA mandatory standard 21 CFR 898.12. |

| |

| |

| |

|Related CFR Citations |

|and Product Codes: |

| |

| |

|Regulation |

|Number |

|Device Name |

|Device |

|Class |

|Product |

|Code |

| |

|§870.2340 |

|Electrocardiograph |

|Class 2 |

|DPS |

| |

|  |

| |

| |

| |

| |

| |

| |

|Relevant |

|Guidance: |

| |

| |

|Guidance for Industry -- Diagnostic ECG Guidance (including Non-Alarming ST Segment Measurement) issued by Pacing Devices Branch (now |

|assigned to the CEMB Branch) of CDRH/ODE/DCD on November 5, 1998 |

| |

| |

| |

| |

| |

|Recognition List Number: |

|020 Effective Date: 09/09/2008  |

| |

|Part B: |

|SUPPLEMENTARY INFORMATION |

| |

|Recognition Number 3-41: |

|AAMI / ANSI EC11:1991/(R)2007, Diagnostic electrocardiographic |

|devices. (Cardiovascular) |

| |

|Date of Standard: |

|2007.  |

| |

|Addresses of Standards |

|Organizations: |

| | | |

| | | |

|  ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION (AAMI) | | |

| | | |

|  1110 N. GLEBE ROAD | | |

| | | |

|  SUITE 220 | | |

| | | |

|  ARLINGTON, VA 22201-5762 | | |

| | | |

|  | | |

| | | |

|  AMERICAN NATIONAL STANDARDS INSTITUTE (ANSI) | | |

| | | |

|  11 WEST 42ND STREET | | |

| | | |

|  NEW YORK, NY 10036 | | |

| | | |

|  | | |

| | | |

| | | |

| |

|CDRH Office and |

|Division Associated with Recognized Standards: |

| |

| |

| |

|OFFICE OF DEVICE EVALUATION (ODE) |

| |

| |

|DIVISION OF CARDIOVASCULAR DEVICES (DCD) |

| |

| |

| |

| |

| |

|Devices |

|Affected: |

| |

| |

|ELECTROCARDIOGRAPHIC (ECG) SYSTEMS WITH DIRECT WRITING DEVICES |

| |

| |

| |

|Processes |

|Affected: |

| |

| |

|510(K), IDE, PMA, PDP, HDE |

| |

| |

| |

|Type of |

|Standard: |

| |

| Test Method & Device Specification, National, |

|Vertical |

| |

|Extent of |

|Recognition: |

| |

| |

|Complete Standard, except the following: |

| |

|Method D of clause 3.2.7.2 Frequency and impulse response is not recognized. |

| |

|Method D of clause 4.2.7.2 Frequency and impulse response is not recognized. |

| |

|This standard includes design, testing, and labeling requirements. Recommendations in the "Relevant Guidance" listed below are not |

|superseded by this standard. |

| |

|NOTE: Cables and leadwires must meet the FDA mandatory standard 21 CFR 898.12. |

| |

| |

| |

|Related CFR Citations |

|and Product Codes: |

| |

| |

|Regulation |

|Number |

|Device Name |

|Device |

|Class |

|Product |

|Code |

| |

|§870.2340 |

|Electrocardiograph |

|Class 2 |

|DPS |

| |

|  |

| |

| |

| |

| |

| |

| |

|Relevant |

|Guidance: |

| |

| |

|Guidance for Industry -- Diagnostic ECG Guidance (including Non-Alarming ST Segment Measurement) issued by Pacing Devices Branch (now |

|assigned to the CEMB Branch) of CDRH/ODE/DCD on November 5, 1998 |

| |

| |

| |

| |

| |

|Recognition List Number: |

|020 Effective Date: 09/09/2008  |

| |

|Part B: |

|SUPPLEMENTARY INFORMATION |

| |

|Recognition Number 3-45: |

|AAMI / ANSI EC57 1998/(R) 2003, Testing and reporting |

|performance results of cardiac rhythm and ST-segment measurement |

|algorithms. (Cardiovascular) |

| |

|Date of Standard: |

|2003.  |

| |

|Addresses of Standards |

|Organizations: |

| | | |

| | | |

|  ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION (AAMI) | | |

| | | |

|  1110 N. GLEBE ROAD | | |

| | | |

|  SUITE 220 | | |

| | | |

|  ARLINGTON, VA 22201-5762 | | |

| | | |

|  | | |

| | | |

|  AMERICAN NATIONAL STANDARDS INSTITUTE (ANSI) | | |

| | | |

|  11 WEST 42ND STREET | | |

| | | |

|  NEW YORK, NY 10036 | | |

| | | |

|  | | |

| | | |

| | | |

| |

|CDRH Office and |

|Division Associated with Recognized Standards: |

| |

| |

| |

|OFFICE OF DEVICE EVALUATION (ODE) |

| |

| |

|DIVISION OF CARDIOVASCULAR DEVICES (DCD) |

| |

| |

| |

| |

| |

|Devices |

|Affected: |

| |

| |

|Arrhythmia detectors and alarms, cardiac monitors and electrocardiographs |

| |

| |

| |

|Processes |

|Affected: |

| |

| |

|510(k), PMA, PDP, IDE, HDE, Quality System Regulation |

| |

| |

| |

|Type of |

|Standard: |

| |

| National, Vertical, Test Methods |

| |

|Extent of |

|Recognition: |

| |

| |

|Complete recognition of this set of recommendations (protocol) for testing cardiac rhythm and ST measurement and reporting the results |

|of those tests. It is not a performance standard. |

| |

|The recommended practice applies to testing algorithms implemented in the device which use automated methods to analyze the |

|electrocardiogram (ECG), and not entire systems. |

| |

|NOTE: There is a typographical error on page 13 (Frequency Domain Indices). The upper limit of the frequency band of very low frequency|

|power (VLF) should be 0.040 Hz and not 0.40 Hz. |

| |

| |

| |

|Related CFR Citations |

|and Product Codes: |

| |

| |

|Regulation |

|Number |

|Device Name |

|Device |

|Class |

|Product |

|Code |

| |

|§870.1025 |

|Detector And Alarm, Arrhythmia |

|Class 2 |

|DSI |

| |

|§870.1025 |

|Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |

|Class 2 |

|MHX |

| |

|§870.1025 |

|Monitor, St Segment With Alarm |

|Class 2 |

|MLD |

| |

|  |

| |

| |

| |

| |

|Regulation |

|Number |

|Device Name |

|Device |

|Class |

|Product |

|Code |

| |

|§870.2300 |

|Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) |

|Class 2 |

|DRT |

| |

|  |

| |

| |

| |

| |

|Regulation |

|Number |

|Device Name |

|Device |

|Class |

|Product |

|Code |

| |

|§870.2340 |

|Electrocardiograph |

|Class 2 |

|DPS |

| |

|§870.2340 |

|Monitor, St Segment |

|Class 2 |

|MLC |

| |

|  |

| |

| |

| |

| |

|Regulation |

|Number |

|Device Name |

|Device |

|Class |

|Product |

|Code |

| |

|§870.2800 |

|Electrocardiograph, Ambulatory, With Analysis Algorithm |

|Class 2 |

|MLO |

| |

|  |

| |

| |

| |

| |

| |

| |

|Relevant |

|Guidance: |

| |

| |

|Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm; Draft Guidance for Industry and FDA |

| |

| |

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