PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV by Oscor Inc.

This document is a 510(k) clearance letter for a medical device, specifically "Pacing Bipolar Lead Adaptors, Models iLINK". It indicates that the device has been found substantially equivalent to a legally marketed predicate device and can therefore be marketed.

However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document is a regulatory approval letter, not a technical report detailing the device's validation study. Therefore, I cannot extract the requested information from this text.

Summary

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Public Health Service

JUN 1 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Oscor Inc. c/o Ms. Mila Doskocil Director of Regulatory Affairs/Compliance 3816 De Soto Blvd. Palm Harbor, FL 34683

Re: K031164

Trade Name: Pacing Bipolar Lead Adaptors, Models iLINK Regulation Number: 21 CFR 870.3620 Regulation Name: Pacemaker lead adaptor. Regulatory Class: Class II (two) Product Code: DTD Dated: April 11, 2003 Received: April 14, 2003

Dear Ms. Doskocil:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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Page 2 -- Ms. Mila Doskocil

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

N. Deeluth

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 2

Indications for Use Statement

510k Number (if known) -

Device Name: Pacing Bipolar Lead Adaptors, Models iLINK

Pacing bipolar lead adaptors are indicated for connecting the existing pacing lead(s) to a compatible pacemaker header cavity.

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF

NEEDED)

Concurrenceof CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)

Over-The-Counter Use_

KlenCattm

510(k) Number K031164

Regulation Number and Section

§ 870.3620 Pacemaker lead adaptor.

(a)
Identification. A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator produced by a different manufacturer.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions.”