(90 days)
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Not Found
No
The summary describes a mechanical clamp for applying pressure and does not mention any computational or data-driven components indicative of AI/ML.
No.
The device facilitates hemostasis but does not treat a disease or condition.
No
Explanation: The device is used to apply pressure for hemostasis after a procedure, which is a therapeutic or post-procedural function, not a diagnostic one. It does not identify or detect a disease or condition.
No
The device description explicitly states "Femoral Artery Vascular Clamp-Hand Held," indicating a physical, hardware-based device used to apply pressure. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The FAVC-HH: Femoral Artery Vascular Clamp-Hand Held is a physical device used to apply pressure directly to the body (specifically, the femoral artery puncture site) to stop bleeding. It does not analyze any samples or perform any diagnostic tests.
The device's function is entirely mechanical and therapeutic (stopping bleeding), not diagnostic.
N/A
Intended Use / Indications for Use
The FAVC-HH: Femoral Artery Vascular Clamp-Hand Held is used to provide pressure hemostasis after the removal of arterial catheters following femoral catherterization procedures. The FAVC-HH: Femoral Artery Vascular Clamp-Hand Held is positioned prior to removal of femoral catheters and applies controlled pressure to the puncture site until hemostasis is complete.
Product codes
DXC
Device Description
FAVC-HH: Femoral Artery Vascular Clamp-Hand Held
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
Femoral artery puncture site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol resembles a stylized caduceus, with three intertwined lines representing snakes or streams, and a base that suggests a staff or foundation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 25 1997
Mr. Delbert L. Rice RMDS, Inc. 1208 SE 104th Avenue Vancouver, Washington 98664-4740
Re : K973216 Femoral Artery Vascular Clamp Hand Held FAVC-HH : II (two) Regulatory Class: Product Code: DXC Dated: August 25, 1997 August 27, 1997 Received:
Dear Mr. Rice:
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 reqistration, 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 Failure to Drug Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your premarket the Federal Register. 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
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) 594-4648. 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 requlation 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
Thomas J. Čallahan, 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 Statement: 18
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: FAVC-HH: Femoral Artery Vascular Clamp-Hand Held
Indications For Use:
The FAVC-HH: Femoral Artery Vascular Clamp-Hand Held is used to provide pressure hemostasis after the removal of arterial catheters following femoral catherterization procedures. The FAVC-HH: Femoral Artery Vascular Clamp-Hand Held is positioned prior to removal of femoral catheters and applies controlled pressure to the puncture site until hemostasis is complete.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
| Prescription Use | ✓ |
|---|---|
| ------------------ | ----------------------------- |
| OR | Over-The-Counter Use | |
|---|---|---|
| (Optional Format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K973276 |
RMDS, Inc. * Delbert L. Rice * 1208 SE 104th Avenue * Vancouver * WA * 98664-4740 1-360-256-8623 * 1-360-256-8623 FAX -