PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR

K024156 · Oscor, Inc. · DTD · Jan 14, 2003 · Cardiovascular

Device Facts

• Record ID: K024156
• Device Name: PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR
• Applicant: Oscor, Inc.
• Product Code: DTD · Cardiovascular
• Decision Date: Jan 14, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Pacing Lead Adaptors/Extensions, unipolar/bipolar are indicated for connecting the pacing lead(s) to a compatible pacemaker header cavity.

Device Story

Pacing lead adaptors and extensions serve as mechanical interfaces between pacing leads and pacemaker header cavities. These devices facilitate electrical connectivity when lead and pulse generator connectors are incompatible. Used in clinical settings by physicians during pacemaker implantation or revision procedures. The device acts as a passive bridge to ensure secure electrical contact, allowing the pulse generator to deliver therapy to the patient's heart. No active processing or software involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Passive mechanical connector; bipolar/unipolar configurations; designed for compatibility with standard pacemaker header cavities. No energy source, software, or active components.

Indications for Use

Indicated for patients requiring connection of pacing leads to compatible pacemaker header cavities.

Regulatory Classification

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.

Special Controls

*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.”

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings and head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 1 4 2003

Oscor Inc. Ms. Mila Doskocil Director of RA/QA 3816 DeSota Boulevard Palm Harbor, FL 34683

Re: K024156 Trade/Device Name: Pacing Lead Extensions, Bipolar, Pacing Lead Adaptors Regulation Number: 21 CFR 870.3620 Regulation Name: Pacemaker lead adaptor. Regulatory Class: Class II Product Code: DTD Dated: December 16, 2002 Received: December 17, 2002

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 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.

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Page 2 -- Ms. Mila Doskocil

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 [phone]. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Datum D. Zuckerman, M.D.

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 Lead Adaptors/Extensions, Unipolar/Bipolar

Pacing Lead Adaptors/Extensions, unipolar/bipolar are indicated for connecting the pacing lead(s) to a compatible pacemaker header cavity.

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

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Concurrenceof CDRH, Office of Device Evaluation (ODE)

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

Over-The-Counter Use ____________

ર્ગ (

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number 1<024156