HARMAC BALLOON WEDGE PRESSURE CATHETER

K963335 · Harmac Medical Products, Inc. · DQO · Oct 16, 1997 · Cardiovascular

Device Facts

• Record ID: K963335
• Device Name: HARMAC BALLOON WEDGE PRESSURE CATHETER
• Applicant: Harmac Medical Products, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Oct 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Balloon Wedge Pressure catheter is indicated for use in sampling blood for oxygen levels and measuring pressure in the right heart (including central venous pressure, right ventricular pressure, pulmonary artery pressure and pulmonary artery wedge pressure). In the case of anatomical cardiac defect or situations requiring left transseptal access, this catheter may be used in any chamber which can be entered from the right heart.

Device Story

Harmac Balloon Wedge Pressure Catheter is a diagnostic catheter used for hemodynamic monitoring. It is inserted into the right heart to measure central venous, right ventricular, pulmonary artery, and pulmonary artery wedge pressures; also used for blood oxygen sampling. In cases of anatomical defects or transseptal access, it may be used in other accessible cardiac chambers. Operated by physicians in clinical settings (e.g., catheterization labs). The device provides direct pressure measurements and blood samples to assist clinicians in assessing cardiac function and diagnosing cardiovascular conditions. It functions as a mechanical conduit for pressure transmission and fluid aspiration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Catheter-based device for pressure monitoring and blood sampling. Mechanical design for insertion into cardiac chambers. No electronic, software, or energy-based components described.

Indications for Use

Indicated for patients requiring right heart pressure monitoring and blood oxygen sampling. Applicable for use in cardiac chambers accessible from the right heart, including cases of anatomical cardiac defects or left transseptal access. Contraindicated for uses other than those specified.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

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 20850

OCT 16 1997

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

Re: K963335
Harmac Balloon Wedge Pressure Catheter
Regulatory Class: II (two)
Product Code: 74 DQO
Dated: July 30, 1997
Received: August 6, 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: K963335

Device Name: Harmac Balloon Wedge Pressure Catheter

Indications for Use:

"The Balloon Wedge Pressure catheter is indicated for use in sampling blood for oxygen levels and measuring pressure in the right heart (including central venous pressure, right ventricular pressure, pulmonary artery pressure and pulmonary artery wedge pressure). In the case of anatomical cardiac defect or situations requiring left transseptal access, this catheter may be used in any chamber which can be entered from the right heart."

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

10(k) Number K963335

Prescription Use ☑ (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Harmac Medical Products, Inc.
K963335
Attachment 4