Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-102: IEC 60601-2-31 Edition 2.1 2011-09, Medical electrical equipment, Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source. (Cardiovascular) |
| Address of Standards Organization: |
| International Electrotechnical Commission (IEC) |
| 3, Rue de Varembe' |
| PO Box 131 |
| CH-1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF CARDIOVASCULAR DEVICES (DCD) |
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| Devices Affected: |
External Cardiac Pacemakers with Internal Power Source & consisting of a Non-implantable Pulse Generator & patient cables.
This Does NOT include pacing leads or other equipment for cardiac stimulation which either:
1) forms an integral part of equipment with other functions (e.g., pacing system analysis);
2) applies the stimulus across the thorax externally or in the esophagus; or
3) provides antitachycardia therapy beyond high rate burst pacing; or
4) provides bi-ventricular pacing |
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| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
Complete Standard for Safety
NOTE: FDA may request data demonstrating the device's ability to perform in accordance with its design specification since the IEC particular standard only deals with safety. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §870.2900 |
Cable, Transducer And Electrode, Patient, (Including Connector) |
Class 2 |
DSA |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §870.3600 |
Pulse Generator, External Pacemaker, Dual-Chamber |
Class 3 |
OVJ |
| §870.3600 |
Pulse-Generator, Pacemaker, External |
Class 3 |
DTE |
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| Relevant Guidance: |
| Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: External Pacemaker Pulse Generator (10/17/2011) |
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| FDA Technical Contact: |
| Mitchell J. Shein |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1316 |
| Silver Spring MD 20993 |
| 301/796-6363 |
| Email: mitchell.shein@fda.hhs.gov |
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