HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET

K963073 · Harmac Medical Products, Inc. · LDF · Aug 14, 1997 · Cardiovascular

Device Facts

• Record ID: K963073
• Device Name: HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET
• Applicant: Harmac Medical Products, Inc.
• Product Code: LDF · Cardiovascular
• Decision Date: Aug 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bipolar Temporary Pacing Catheter with Stylet is indicated for use in temporary transvenous cardiac pacing when impulse formation or conduction is impaired.

Device Story

The Harmac Bipolar Temporary Pacing Catheter with Stylet is a medical device used for temporary transvenous cardiac pacing. It is inserted into the venous system to provide electrical stimulation to the heart when natural impulse formation or conduction is impaired. The device includes a stylet to assist in placement. It is intended for use by healthcare professionals in a clinical setting. The catheter delivers electrical impulses to the heart muscle to maintain cardiac rhythm. It is a temporary solution for patients with conduction disorders.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bipolar temporary pacing catheter with stylet. Design and materials are consistent with standard transvenous pacing catheters used for temporary cardiac stimulation.

Indications for Use

Indicated for patients requiring temporary transvenous cardiac pacing due to impaired impulse formation or conduction. No specific age or gender restrictions provided. Contraindicated for any use other than indicated.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20856

AUG 14 1997

Mr. Michael Guzzo
Quality Assurance Engineer
Harmac Medical Products, Inc.
2201 Bailey Avenue
Buffalo, New York 14211-1797

Re: K963073
Harmac Temporary Pacing Catheter with Stylet
Regulatory Class: II (two)
Product Code: 74 LDF
Dated: July 31, 1997
Received: August 7, 1997

Dear Mr. Guzzo:

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 (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 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, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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 sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Michael Guzzo

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 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and 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] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


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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# INDICATIONS FOR USE

510(K) Number: K963073

Device Name: Harmac Bipolar Temporary Pacing Catheter with Stylet

Indications for Use:

"The Bipolar Temporary Pacing Catheter with Stylet is indicated for use in temporary transvenous cardiac pacing when impulse formation or conduction is impaired."

Contraindications:

"This device is not designed, sold, or intended for use except as indicated."

David A. Ru
(Division Manager)
and Sec. Manager
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PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation

Prescription Use ☐
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

Harmac Medical Products, Inc.
K963073
Attachment 3