(29 days)
Not Found
No
The device description details a mechanical compression system with a digital manometer and pump, with no mention of AI or ML technologies.
Yes
The device is used for compression of the femoral artery or vein after vessel cannulation and for ultrasound-guided compression repair of a femoral artery pseudoaneurysm, which are medical treatments.
No
Explanation: The device is described as a "Femoral Compression System" used for compression to induce hemostasis after vessel cannulation or for compression repair of a pseudoaneurysm. Its function is to apply mechanical pressure, not to diagnose a condition or disease. While it is used with "ultrasound-guided compression repair," the device itself is not performing the diagnostic imaging; it is a therapeutic/hemostatic device that is guided by a separate diagnostic modality (ultrasound).
No
The device description clearly outlines multiple hardware components including an arch, pneumatic pressure dome, integrated pump, digital manometer, belt, and hemostatic dressing.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- FemoStop® Function: The FemoStop® Femoral Compression System is a mechanical device that applies external pressure to a blood vessel to achieve hemostasis (stop bleeding). It works by physically compressing the vessel, not by analyzing a biological sample.
- Intended Use: The intended use clearly states it's for "compression for the femoral artery or vein after vessel cannulation" and "ultrasounded-guided compression repair of a femoral artery pseudoaneurysm." These are procedures performed directly on the patient's body, not on a sample taken from the body.
- Device Description: The description details the physical components (arch, dome, pump, belt, dressing) and how they apply mechanical pressure. There is no mention of analyzing biological samples.
Therefore, based on the provided information, the FemoStop® Femoral Compression System is a therapeutic/surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
FemoStop® Femoral Compression System is indicated for use in the compression for the femoral artery or vein after vessel cannulation, and in ultrasounded-guided compression repair of a femoral artery pseudoaneurysm .
Product codes
DXC
Device Description
This combination of FemoStop®Femoral Compression System consists of an arch with a sterile pneumatic pressure dome, an integrated pump with a digital manometer, a belt and a hemostatic dressing and is called FemoStop®Gold Femoral Compression System. The pressure dome is placed over the vessel puncture site in the groin. The belt is placed around the patient. The dome applies mechanical pressure over the vessel puncture site to induce hemostasis. The pressure of the dome is controlled by the integrated pump and the manometer. The arch and belt provide counter pressure for the dome. The sterile hemostatic dressing is placed on the skin incision site as a bacterial barrier and for topical control of bleeding,
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral artery or vein, groin
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.)
Not Found
Predicate Device(s)
K024107 FemoStop® HD Femoral Compression System, K062033 BP101 Digital Blood Pressure Monitor
Reference Device(s)
Not Found
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
FEE 26
8
510(k) Summary 5
| Submitter's information: | Radi Medical Systems AB
Palmbladsgatan 10
SE-754 50 Uppsala, Sweden
Phone:(+46) 18161000 |
|--------------------------|---------------------------------------------------------------------------------------------------|
| Contact Person: | Helene Ekstrand |
| Date Prepared: | January 23rd, 2008 |
| Proprietary Name: | FemoStop® Femoral Compression System |
| Regulation Name: | Vascular clamp |
| Product code: | DXC |
| Predicate Devices: | K024107 FemoStop® HD Femoral Compression System
K062033 BP101 Digital Blood Pressure Monitor |
Description of the Device: This combination of FemoStop®Femoral Compression System consists of an arch with a sterile pneumatic pressure dome, an integrated pump with a digital manometer, a belt and a hemostatic dressing and is called FemoStop®Gold Femoral Compression System. The pressure dome is placed over the vessel puncture site in the groin. The belt is placed around the patient. The dome applies mechanical pressure over the vessel puncture site to induce hemostasis. The pressure of the dome is controlled by the integrated pump and the manometer. The arch and belt provide counter pressure for the dome. The sterile hemostatic dressing is placed on the skin incision site as a bacterial barrier and for topical control of bleeding,
Indication for Use of the Device: FemoStop® Femoral Compression System is indicated for use in the compression of the femoral artery or vein after vessel cannulation, and in ultrasound-guided compression repair of a femoral artery pseudoaneurysm.
Technical Characteristics: The technical characteristics of the actual FemoStop® are identical to those of the predicate FemoStop®Femoral Compression System except for the integration of a single-use digital pump.
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Image /page/1/Picture/11 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized eagle or bird. The symbol is composed of three curved lines that converge at the top and then separate into three distinct shapes at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2008
Radi Medical Systems AB c/o Ms. Helene Ekstrand Regulatory Affairs Officer Palmbladsgatan 10 SE-75450 Uppsala Sweden
Re: K080206
Femostop Femoral Compression System Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: DXC Dated: January 23, 2008 Received: January 28, 2008
Dear Ms. Ekstrand:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Helene Ekstrand
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duna R. Vacher
Image /page/2/Picture/5 description: The image shows a black and white abstract drawing. The drawing appears to be a stylized signature or symbol. It consists of curved lines and a sharp angle at the bottom, resembling a simplified letter or character.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use 4
510(k) Number:
Device Name:
FemoStop® Femoral Compression System
Indications for Use:
FemoStop® Femoral Compression System is indicated for use in the compression for the femoral artery or vein after vessel cannulation, and in ultrasounded-guided compression repair of a femoral artery pseudoaneurysm .
Prescription Use______________________________________________________________________________________________________________________________________________________________ X (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ume R. Vi Ames
(Division Sign-Off)
Division of Cardiovascular Devices
510(к) Number_KO8020 6
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