(475 days)
Not Found
Not Found
No
The summary describes a physical catheter for pressure measurement and blood sampling, with no mention of AI/ML terms, image processing, or data analysis that would typically involve such technologies.
No
The device is used for diagnostic purposes (sampling blood for oxygen levels and measuring pressure) rather than directly treating a disease or condition.
Yes
The intended use explicitly states that the device is indicated for "sampling blood for oxygen levels and measuring pressure" in various parts of the heart and circulatory system. These are diagnostic procedures used to assess physiological parameters and help in diagnosing conditions.
No
The device description explicitly states "Harmac Balloon Wedge Pressure Catheter," indicating a physical catheter, which is a hardware component. The intended use also describes a physical catheter's function (sampling blood, measuring pressure). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device function: The description clearly states the device is a catheter used for:
- Sampling blood for oxygen levels: While blood is sampled, the primary function is the sampling within the body, not the analysis of the blood sample itself. The analysis of the oxygen levels would likely be done using a separate IVD device (like a blood gas analyzer) on the collected sample.
- Measuring pressure in the right heart: This is a direct measurement of physiological parameters within the body.
The device is an invasive medical device used for diagnostic purposes within the patient's body, not for testing specimens outside the body.
N/A
Intended Use / 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."
Product codes
74 DQO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
right heart, any chamber which can be entered from the right heart
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 870.1200 Diagnostic intravascular catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
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
K963335 Re: 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 affectinq 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 requlation 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. 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 (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.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan, Ph.D.
gallahan, 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: K963335
Harmac Balloon Wedge Pressure Catheter Device Name:
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 | |
| 510(k) Number | K963335 |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) |
Harmac Medical Products, Inc. Kae3333 Attachment 4