HARMAC QUADPOLAR MAPPING PACING CATHETER

K963074 · Harmac Medical Products, Inc. · DRF · Jun 25, 1997 · Cardiovascular

Device Facts

• Record ID: K963074
• Device Name: HARMAC QUADPOLAR MAPPING PACING CATHETER
• Applicant: Harmac Medical Products, Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: Jun 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Mapping of electrical signals of the His bundle and also used to stimulate the myocardium to depolarize at a rate higher than the intrinsic heart rate or at a rate sufficient to maintain adequate cardiac output until definitive treatment can be instituted.

Device Story

Harmac Quadpolar Mapping Pacing Catheter with Stylet; used for electrophysiological mapping of His bundle signals and temporary cardiac pacing. Device inserted into heart chambers; allows physician to record intracardiac electrical activity and deliver electrical stimuli to myocardium to increase heart rate or maintain cardiac output. Used in clinical settings by trained medical professionals. Provides diagnostic mapping data and therapeutic pacing capability; assists in managing cardiac arrhythmias or hemodynamic instability until definitive treatment. Benefits patient by providing temporary rhythm support and diagnostic information.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Quadpolar electrode configuration; includes stylet for structural support/placement; designed for intracardiac mapping and pacing. Materials and sterilization methods consistent with standard cardiovascular catheter requirements.

Indications for Use

Indicated for patients requiring His bundle electrical signal mapping or temporary cardiac pacing to maintain cardiac output.

Regulatory Classification

Identification

An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.

Submission Summary (Full Text)

{0}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 25 1997

Mr. Joseph M. Konieczny
Regulatory Affairs Engineer
Harmac Medical Products, Inc.
2201 Bailey Avenue
Buffalo, New York 14211-1797

Re: K963074
Trade Name: Harmac Quadpolar Mapping Pacing Catheter
Regulatory Class: II
Product Code: 74DRF
Dated: March 25, 1997
Received: March 28, 1997

Dear Mr. Konieczny:

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.

{1}

Page 2 - Mr. Joseph M. Konieczny

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

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

Enclosure

{2}

# INDICATIONS FOR USE

510(K) Number: K963074

Device Name: Harmac Quadpolar MappingPacing Catheter with Stylet

Indications for Use:

"Mapping of electrical signals of the His bundle and also used to stimulate the myocardium to depolarize at a rate higher than the intrinsic heart rate or at a rate sufficient to maintain adequate cardiac output until definitive treatment can be instituted."

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

Prescription Use ☑ (Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

Thomas J. Callahan

(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K963074

Harmac Medical Products, Inc.

K963074

Attachment 3