PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB

K024053 · Oscor, Inc. · DTB · Jan 31, 2003 · Cardiovascular

Device Facts

• Record ID: K024053
• Device Name: PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB
• Applicant: Oscor, Inc.
• Product Code: DTB · Cardiovascular
• Decision Date: Jan 31, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3680
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

Permanent pacing lead, Model Physique™ is indicated for pacing and sensing of the ventricle and/or atrium of the heart. This lead is used in conjunction with a compatible implantable pulse generator (pacemaker).

Device Story

Permanent Pacing Lead, Model Physique™ is an implantable lead designed for cardiac pacing and sensing. It functions as an electrical conduit between an implantable pulse generator and the heart tissue (ventricle and/or atrium). The device is implanted by a physician in a clinical setting. It delivers electrical impulses from the generator to the heart to regulate rhythm and senses intrinsic cardiac electrical activity to inform generator function. The device benefits patients by providing necessary cardiac pacing therapy for rhythm management.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Implantable cardiac pacing lead. Designed for ventricular and/or atrial sensing and pacing. Connects to compatible implantable pulse generators. Class III device (21 CFR 870.3680).

Indications for Use

Indicated for patients requiring pacing and sensing of the heart's ventricle and/or atrium. Used in conjunction with a compatible implantable pulse generator.

Regulatory Classification

Identification

Temporary pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. Permanent pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 31 2003

Oscor, Inc. c/o Ms. Mila Doskocil Director, RA/QA 3816 DeSoto Boulevard Palm Harbor, FL 34683

Re: K024053

Trade Name: Permanent Pacing Lead, Model Physique™ Regulation Number: 21 CFR 870.3680 Regulation Name: Permanent Pacing Lead Regulatory Class: Class III (three) Product Code: DTB Dated: January 6, 2003 Received: January 8, 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. Insting 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.

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Page 2 - Ms. Mila Doskocil

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. 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 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,

N. Zuckerma Till
Bram 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: Permanent Pacing Lead, Model Physique™

Permanent pacing lead, Model Physique™ is indicated for pacing and sensing of the ventricle and/or atrium of the heart. This lead is used in conjunction with a compatible implantable pulse generator (pacemaker).

(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)

OR

Over-The-Counter Use

Deike Tule

**510(k) Number** K024053