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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Pacemaker, Dual-Chamber Class 3 OVJ24 §870.360025 Pulse-Generator, Pacemaker, External Class 3 DTE26 Relevant Guidance: Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: External Pacemaker Pulse Generator (10/17/2011) [Code of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]