HT, MODEL HT PB

K990142 · Sulzer Oscor, Inc. · DTB · Jul 30, 1999 · Cardiovascular

Device Facts

• Record ID: K990142
• Device Name: HT, MODEL HT PB
• Applicant: Sulzer Oscor, Inc.
• Product Code: DTB · Cardiovascular
• Decision Date: Jul 30, 1999
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 870.3680
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The tined passive tip permanent lead is indicated for ventricular placement. The lead is used in conjunction with an implantable pulse generator. A variety of pulse generators can be used in combination with the lead. The lead will connect directly to many commercially available pulse generators. Some pulse generators require the use of a commercially available adapter to make the connection to the lead.

Device Story

The Sulzer Oscor Model HT-PB is a permanent, passive tined pacing lead designed for ventricular placement. It functions as an electrical conduit between an implantable pulse generator and the heart muscle to facilitate cardiac pacing. The device is implanted by a physician in a clinical setting. It connects directly to various commercially available pulse generators, occasionally requiring an adapter. The lead's passive tined design aids in fixation within the ventricle. By delivering electrical impulses from the generator to the myocardium, the lead supports cardiac rhythm management, benefiting patients with bradycardia or other conduction disorders.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Passive tined pacing lead; ventricular placement; compatible with various implantable pulse generators; includes Model SS Positioning Stylet accessory.

Indications for Use

Indicated for ventricular placement in patients requiring an implantable pulse generator for cardiac pacing.

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

JUL 30 1999

Ms. Mila Doskocil Manager, Quality Assurance and Regulatory Affairs Sulzer Oscor, Inc. 3816 DeSoto Boulevard Palm Harbor, FL 34683

K990142 Re: Model HT PB Pacing Leads & Model SS Positioning Stylet Accessory Requlatory Class: III (three) Product Code: DTB April 28, 1999 Dated: May 3, 1999 Received:

Dear Ms. Doskocil:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such Existing major requlations affecting your device can be additional controls. found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the regulation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of vour device to a leqally 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- __. Additionally, for questions on the promotion or advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] at [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,
Christopher.A.Horton

Thomas J.Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)- K990142

Device Name:

Sulzer Oscor Permanent, Passive Tined Pacing Lead, Model HT-PB

## Indications for Use:

The tined passive tip permanent lead is indicated for ventricular placement. The lead is used in conjunction with an implantable pulse generator. A variety of pulse generators can be used in combination with the lead. The lead will connect directly to many commercially available pulse generators. Some pulse generators require the use of a commercially available adapter to make the connection to the lead.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

OR

Over-The-Counter Use

Myrtle for Callahan

Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number