HARMAC TEMPORARY PACING CATHETER WITH BALLOON

K962833 · Harmac Medical Products, Inc. · LDF · Oct 15, 1997 · Cardiovascular

Device Facts

• Record ID: K962833
• Device Name: HARMAC TEMPORARY PACING CATHETER WITH BALLOON
• Applicant: Harmac Medical Products, Inc.
• Product Code: LDF · Cardiovascular
• Decision Date: Oct 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Balloon Temporary Pacing catheter is indicated for use in temporary transvenous ventricular cardiac pacing when impulse formation or conduction is impaired.

Device Story

Temporary transvenous ventricular cardiac pacing catheter with integrated balloon; used for patients with impaired cardiac impulse formation or conduction. Device inserted into venous system by physician; balloon facilitates flow-directed placement into ventricle. Provides electrical pacing therapy to heart. Used in clinical settings (e.g., hospital, cardiac catheterization lab). Benefits patient by restoring cardiac rhythm during temporary conduction disturbances.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Temporary transvenous pacing catheter featuring an integrated balloon for flow-directed placement. Mechanical device; no electronic or software components. Materials and sterilization methods consistent with standard temporary pacing catheters.

Indications for Use

Indicated for patients requiring temporary transvenous ventricular cardiac pacing due to impaired impulse formation or conduction. No specific age or gender restrictions provided.

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

OCT 15 1997

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

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

Re: K962833
Harmac Temporary Pacing Catheter with Balloon
Regulatory Class: II (two)
Product Code: 74 LDF
Dated: July 19, 1997
Received: July 25, 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 requirement, 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: K962833

Device Name: Harmac Temporary Pacing Catheter with Balloon

Indications for Use:

"The Balloon Temporary Pacing catheter is indicated for use in temporary transvenous ventricular cardiac pacing when impulse formation or conduction is impaired."

Contraindications:

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation

(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K962833

Prescription Use ☐
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

Harmac Medical Products, Inc.
K962833
Attachment 3