(11 days)
No
The device description focuses on mechanical compression and a hemostatic dressing. There is no mention of AI, ML, or any computational analysis of the ultrasound guidance.
Yes
The device is indicated for use in the compression for the femoral artery or vein after vessel cannulation and in ultrasound-guided compression repair of a femoral artery pseudoaneurysm, which are therapeutic interventions.
No
The device is indicated for compression and hemostasis, not for diagnosing a condition. Its use of "ultrasound-guided" is for application, not for diagnostic imaging itself.
No
The device description explicitly lists hardware components such as an arch, pneumatic pressure dome, belt, reusable pump with manometer, and a sterile hemostatic dressing.
Based on the provided information, the FemoStop® Femoral Compression System 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 the body.
- FemoStop® Function: The FemoStop® system is a mechanical compression device applied externally to the body to control bleeding from a vessel cannulation site or to compress a pseudoaneurysm. It works by applying physical pressure.
- Intended Use: The intended use clearly describes a physical intervention on the body, not a diagnostic test performed on a sample.
- Device Description: The description details mechanical components (arch, dome, pump, belt) and a hemostatic dressing, all of which are used for external application and physical action.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, performing chemical reactions, or generating diagnostic data from bodily fluids or tissues.
Therefore, the FemoStop® Femoral Compression System falls under the category of a therapeutic or interventional medical device, not an In Vitro Diagnostic.
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
The FemoStop®Femoral Compression System consists of: an arch with a sterile pneumatic pressure dome attached to an arch, a belt, and a reusable pump with manometer. With this application a sterile hemostatic dressing, HD, is added to the system. The dressing has an active agent made of calcium/sodium salt of micro dispersed oxidized cellulose 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
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)
K954669 FemoStop® System, K982182 FemoStop®II System, K983471 FemoStop®PLUS System, K010933 Seal-On Hemostatic Powder Spray, K920796 DeRoyal Transparent Film Dressing (Transeal, K962425 Bonopty Coaxial Bone Biopsy System
Reference Device(s)
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
K024/07
DEC 2 4 2002
Attachment 4
510(k) Summary
This 510(k) summary is submitted in accordance with the requirements in 21 CFR §807.92
| Submitted by: | RADI Medical Systems AB
Palmbladsgatan 10
SE-754 50 Uppsala, Sweden
Phone:(+46) 18161000 |
|----------------------|---------------------------------------------------------------------------------------------------|
| Contact Person: | Mats Granlund |
| Date Prepared: | December 10, 2002 |
| Proprietary Name: | FemoStop® Femoral Compression System |
| Common Name: | Femoral compression device |
| Classification Name: | Clamp, DXC |
| Predicate Devices: | K954669 FemoStop® System |
| | K982182 FemoStop®II System |
| | K983471 FemoStop®PLUS System |
| | K010933 Seal-On Hemostatic Powder Spray |
| | K920796 DeRoyal Transparent Film Dressing (Transeal |
| | K962425 Bonopty Coaxial Bone Biopsy System |
The FemoStop®Femoral Compression System consists of Description of the Device: an arch with a sterile pneumatic pressure dome attached to an arch, a belt, and a reusable pump with manometer. With this application a sterile hemostatic dressing, HD, is added to the system. The dressing has an active agent made of calcium/sodium salt of micro dispersed oxidized cellulose for topical control of bleeding.
FemoStop® Femoral Compression System is Indication for Use of the Device: 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, i.e. are identical to those predicate devices cleared the previous FemoStop applications.
The technical characteristics of the hemostatic dressing - permeable to moisture allowing the skin to breathe but impermeable to water and bacteria, functioning as a bacterial barrier - are substantially equivalent to Transeal, DeRoyal Transparent Film Dressing (K920796) and the technical characteristics of the active substance - induce topical control of bleeding - are substantially equivalent to Seal-On Hemostatic Powder Spray (K010933). The technical characteristics of the
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 4 2002
RADI Medical Systems AB c/o Mr. Mats Granlund Palmbladsgatan 10 SE-754 50 Uppsala, Sweden
Re: K024107
FemoStop® Femoral Compression System Regulation Number: 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: DXC Dated: December 10, 2002 Received: December 13, 2002
Dear Mr. Granlund:
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.
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
2
Page 2 - Mr. Mats Granlund
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 Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Utepar majnel
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Attachment 2
Indication for Use Statement : 上
:
| 510(k) Number: | K024107 |
|---|---|
| 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 |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Alex May
for Division Sign
BDZ Division of Cardiovascular Devices
.0(k) Number K024107
| Prescription Use | OR |
|---|---|
| (Per 21 CFR 801.109) |
Over-The-Counter Use