PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU

K040569 · Oscor, Inc. · DTB · Apr 7, 2004 · Cardiovascular

Device Facts

• Record ID: K040569
• Device Name: PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
• Applicant: Oscor, Inc.
• Product Code: DTB · Cardiovascular
• Decision Date: Apr 7, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3680
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

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

Device Story

Permanent Pacing Lead, Model Refino, is an implantable electrode designed for cardiac pacing and sensing. Device functions as a conduit for electrical signals between the heart (ventricle/atrium) and a compatible implantable pulse generator. Used by cardiologists/electrophysiologists in clinical settings during surgical implantation. Provides electrical stimulation to heart tissue to maintain appropriate heart rate; enables sensing of intrinsic cardiac activity. Benefits patient by restoring or maintaining normal cardiac rhythm in patients with conduction disorders.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design characteristics.

Technological Characteristics

Permanent pacing lead; implantable electrode; designed for ventricular and/or atrial pacing and sensing. Compatible with standard implantable pulse generators. No specific materials or software algorithms described.

Indications for Use

Indicated for pacing and sensing of the ventricle and/or atrium of the heart in patients requiring permanent pacemaker therapy. 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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 7 2004

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

Re: K040569

Trade Name: Permanent Pacing Lead, Model Refino Regulation Number: 21 CFR 870.3680 Regulation Name: Permanent Pacemaker Electrode Regulatory Class: III (three) Product Code: DTB Dated: March 03, 2004 Received: March 04, 2004

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.

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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,

Dina R. Lo Jones

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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## Indications for Use

510(k) Number :K040569

Device Name: Permanent Pacing Lead, Model Refino ™

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

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)

ina P. Lechner

(Division Sign-Off)
Division of C
ervices

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K040569