HARMAC THERMODILUTION CATHETER

K963336 · Harmac Medical Products, Inc. · DYG · Aug 14, 1997 · Cardiovascular

Device Facts

• Record ID: K963336
• Device Name: HARMAC THERMODILUTION CATHETER
• Applicant: Harmac Medical Products, Inc.
• Product Code: DYG · Cardiovascular
• Decision Date: Aug 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1240
• Device Class: Class 2

Intended Use

The Balloon Thermodilution catheter is indicated for use in measuring cardiac output by the thermodilution method. In addition, this balloon thermodilution catheter can be used to measure right atrial pressure, right ventricular pressure, pulmonary artery pressure, and pulmonary capillary wedge pressure.

Device Story

Harmac Thermodilution Catheter is a balloon-tipped catheter designed for hemodynamic monitoring. Device inserted into vasculature to access right heart and pulmonary artery. Functions by thermodilution principle to measure cardiac output; also enables pressure monitoring (right atrial, right ventricular, pulmonary artery, pulmonary capillary wedge). Used in clinical settings (e.g., ICU, OR) by physicians to assess cardiovascular status. Output provides real-time hemodynamic data to guide clinical management of critically ill patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Balloon-tipped catheter for thermodilution cardiac output measurement and pressure monitoring. Standard catheter materials and design consistent with existing thermodilution devices. No specific ASTM standards or software components described.

Indications for Use

Indicated for patients requiring hemodynamic monitoring, specifically measurement of cardiac output via thermodilution and monitoring of right atrial, right ventricular, pulmonary artery, and pulmonary capillary wedge pressures. Contraindicated for uses other than those specified.

Regulatory Classification

Identification

A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
AUG 14 1997
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20856

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

Re: K963336
Harmac Thermodilution Catheter
Regulatory Class: II (two)
Product Code: 74 DYG
Dated: August 5, 1997
Received: August 8, 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 GMF 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: K963336

Device Name: Harmac Thermodilution Catheter

Indications for Use:

"The Balloon Thermodilution catheter is indicated for use in measuring cardiac output by the thermodilution method. In addition, this balloon thermodilution catheter can be used to measure right atrial pressure, right ventricular pressure, pulmonary artery pressure, and pulmonary capillary wedge pressure."

Contraindications:

"The Balloon thermodilution Catheter 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 K963336

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Harmac Medical Products, Inc.
K963336
Attachment 3