Recognition List Number: 023 Publication Date: 05/05/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-73: AAMI / ANSI EC57:1998/(R) 2008, Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms. (Cardiovascular)
Date of Standard: 2008. |
| Addresses of Standards Organizations: |
| Association for the Advancement of Medical Instrumentation (AAMI) |
| 4301 North Fairfax Drive |
| Suite 301 |
| Arlington, VA 22203 |
| |
| American National Standards Institute (ANSI) |
| 25 West 43rd Street |
| 4th Floor |
| 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; Guidance for Industry and FDA (10/28/2003) |
|
| FDA Technical Contacts: |
| Charles Ho, Ph.D. |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1318 |
| Silver Spring MD 20993 |
| 301/796-6320 |
| Email: charles.ho@fda.hhs.gov |
|
| James Cheng |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1326 |
| Silver Spring MD 20993 |
| 301/796-6306 |
| Email: james.cheng@fda.hhs.gov |
|
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