(50 days)
Bard Electrophysiology's fixed diagnostic electrode catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.
The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification summary and an FDA clearance letter for the "Clipper Diagnostic Electrode Catheter."
This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a randomized clinical trial with specific performance acceptance criteria. The FDA clearance is based on the device having the same intended use and similar technological characteristics as previously cleared devices, and it does not detail specific performance metrics or studies as requested in the prompt.
Therefore, I cannot provide the requested information based on the provided text.
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Kalanos APPENDIX E
Summary of Safety and Effectiveness
| GeneralProvisions: | Trade Name: Clipper Diagnostic Electrode CatheterCommon/Classification Name: Electrode recording catheter. |
|---|---|
| Name ofPredicateDevices: | Bard Viking Diagnostic Electrode CatheterBard Woven Diagnostic Electrode Catheter |
| Classification: | Class II |
| PerformanceStandards: | Performance standards have not been established by the FDAunder section 514 of the Food, Drug and Cosmetic Act. |
| Intended Useand DeviceDescription: | Bard Electrophysiology's fixed diagnostic electrode catheters areintended for temporary intracardiac sensing, recording, stimulation andtemporary pacing during the evaluation of cardiac arrhythmias.The device description of the Clipper Diagnostic Electrode catheteris as follows:6Fwoven fixed curve construction113 – 128cm usable lengthCurve Configurations: Josephson, Cournand, & DamatoElectrode Spacing: 2mm / 5mm / 2mm, 5mm / 1cmNumber of Electrodes: 4Electrode Width: 1.5mm Proximal / 2mm DistalCable: EasyMate |
| Biocompatibility: | All tissue and body fluid contacting materials used in the Clippercatheter are biocompatible. |
| Summary ofSubstantialEquivalence: | The Clipper Diagnostic Electrode Catheters are substantiallyequivalent to the previously cleared Viking Diagnostic Electrodecatheters and to the Pre-Amendment Woven Diagnostic Electrodecatheters. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized wings.
SEP 2 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bard Electrophysiology c/o Ms. Deborah L. Herrington Manager, Regulatory Affairs 55 Technology Drive Lowell, MA 01851
Re: K042105
Trade Name: Clipper Diagnostic Electrode Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: 21 CFR 876.1220
Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: II (two) Product Code: DRF Dated: September 03, 2004 Received: September 07, 2004
Dear Ms. Herrington:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we have reviewed your Security promatics is substantially equivalent (for the indications for use stated in the enclosure) the arresed predicate devices marketed in interstate for use stated in the encrosule) to regally mancted position in the Medical Device Amendments, or to commerce prior to May 28, 1970, the encordance with the provisions of the Federal Food, Drug, devices that have been reciassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval as a provisions of the Act. The and Cosment Act (Act) that do not require approval controls provisions of the Act. The Act. The You may, therefore, market the device, basics to the most registration, listing of
general controls provisions of the Act include requirements for annual registration, listin general controls provisions of the Fiel networks and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (seculove) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Lines. Title 21, Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. be found in the Cour of Poucha Singerning your device in the Federal Register.
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Page 2 – Ms. Deborah L. Herrington
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a succession with other requirements of the Act
that FDA has made a determination that your device complies with other mast that FDA has made a decermination that your as ress by other Federal agencies. You must or any Federal statures and regulations administration of thinked to: registration and listing (21
comply with all the Act's requirements, including, but not limited to: res comply with all the Act s requirements, more and manufacturing practice requirements as set CFR Part 807), rabeing (21 CFR Part 800); good and art 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decleons of the as described in your Section 510(k)
This letter will allow you to begin marketing your device as described in your devic I ms letter will anow you to begin maxically your antial equivalence of your deversits your deventify premarket nothication. The PDA include of backandal of a courte and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (1 CFR Part 801), please If you desire specific advice for your device of your device note the regulation entitled, the counces attitled, a comact the Office of Compunation at (3% r rification" (21CFR Part 807.97). You may obtain Misolallung by responsibilities w premail.org/w/index.php?title=1990_11_11_11_11_11_11_11_1 other general information on your responsive is toll-free number (800) 638-2041 or Manufacturers, International and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Blumner for
Dr. Zukerman, M.D.
Bram D. Zuckerman, M.E. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K042105
Device Name: Clipper Diagnostic Electrode Catheter
Indications For Use: Bard Electrophysiology's fixed diagnostic electrode catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.
Contraindications: The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle patch. The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhummer
Divis., : Cardiovascular Devices
510(k) Number K042105
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).