(412 days)
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Not Found
No
The summary describes a physical catheter for measuring physiological pressures and cardiac output using a standard thermodilution method. There is no mention of AI, ML, image processing, or data analysis techniques that would suggest the use of such technologies.
No
The device is used for measuring various physiological parameters, which are diagnostic rather than therapeutic.
Yes
The device is used to measure various physiological pressures and cardiac output, which are diagnostic indicators of a patient's cardiovascular status.
No
The device description explicitly states "Harmac Thermodilution Catheter," which is a physical medical device, not software. The intended use also describes a physical catheter and its functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "Balloon Thermodilution catheter" used for measuring pressures and cardiac output directly within the body (right atrial, right ventricular, pulmonary artery, pulmonary capillary). This is an in vivo measurement, not an in vitro test on a sample.
Therefore, the device's function and intended use fall outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / 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."
Product codes
74 DYG
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features an abstract image of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the top of the circle.
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.
1
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
2
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