(412 days)
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.
Harmac Thermodilution Catheter
I am sorry, but the provided text is a 510(k) clearance letter from the FDA to Harmac Medical Products, Inc. for their Thermodilution Catheter. This document is primarily an administrative letter confirming substantial equivalence and outlining regulatory compliance.
It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
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AUG 114 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
K963336 Re: Harmac Thermodilution Catheter Requlatory Class: II (two) Product Code: 74 DYG Dated: August 5, 1997 Received: Auqust 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 requlations 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 requlatory 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/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
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INDICATIONS FOR USE
510(K) Number: K963336
Harmac Thermodilution Catheter Device Name:
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
Pat. Ph
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
Prescription Use __ (Per 21 CFR 801.109) ેરિ
Over-The-Counter Use __________
Harmac Medical Products, Inc. K963336 Attachment 3
§ 870.1240 Flow-directed catheter.
(a)
Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.(b)
Classification. Class II (performance standards).