Download 3-102 Card Medical electrical equipment, Part 2

Medical electrical equipment, Part 231: Particular requirements for the
basic safety and essential
3-102 Card
performance of external cardiac
pacemakers with internal power
source
60601-231
Edition 08/20/2012 IEC
2.1 201109
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
SWITZERLAND
CDRH Office and Division Associated with Recognized Standards:
OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF CARDIOVASCULAR DEVICES (DCD)
Devices Affected:
External Cardiac Pacemakers with Internal Power Source & consisting of a Nonimplantable 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
Processes Affected:
510(k), PMA, IDE, PDP, HDE
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.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name
Device Product
Class
Code
§870.290021 Cable, Transducer And Electrode, Patient, (Including Connector) Class 2 DSA22
Regulation
Number
Device Name
Device Product
Class
Code
§870.360023 Pulse Generator, External Pacemaker, Dual-Chamber
Class 3 OVJ24
§870.360025 Pulse-Generator, Pacemaker, External
Class 3 DTE26
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Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special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)
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR870.2900]
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. 870.2900 Patient transducer and electrode cable (including
connector).
(a)Identification. A patient transducer and electrode cable
(including connector) is an electrical conductor used to transmit
signals from, or power or excitation signals to, patient-connected
electrodes or transducers.
(b)Classification. Class II (performance standards).
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR870.3600]
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 D--Cardiovascular Prosthetic Devices
Sec. 870.3600 External pacemaker pulse generator.
(a)Identification. An external pacemaker pulse generator is a
device that has a power supply and electronic circuits that
produce a periodic electrical pulse to stimulate the heart. This
device, which is used outside the body, is used as a temporary
substitute for the heart's intrinsic pacing system until a
permanent pacemaker can be implanted, or to control irregular
heartbeats in patients following cardiac surgery or a myocardial
infarction. The device may have adjustments for impulse strength,
duration, R-wave sensitivity, and other pacing variables.
(b)Classification. Class III (premarket approval).
(c)Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for
premarket approval. See 870.3.
[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11,
1987; 78 FR 18234, Mar. 26, 2013]