(144 days)
Not Found
No
The device description and performance studies focus on mechanical compression and manual control, with no mention of AI/ML terms or functionalities.
Yes
The device is used to compress the femoral artery or vein to stop bleeding, which is a therapeutic action. It is also used in the repair of a femoral artery pseudoaneurysm, which is a direct treatment of a medical condition.
No
The FemoStop system is indicated for mechanical compression of blood vessels (femoral artery or vein) for hemostasis, not for diagnosis. While ultrasound is mentioned in conjunction with its use for pseudoaneurysm repair, the device itself provides compression, not diagnostic imaging or analysis.
No
The device description clearly outlines physical components like an arch, pneumatic pressure dome, tubing, belt, and pump with a manometer. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the compression of the femoral artery or vein after vessel cannulation and for ultrasound-guided compression repair of a femoral artery pseudoaneurysm. This is a mechanical intervention performed directly on the patient's body.
- Device Description: The device is described as a system that applies mechanical pressure externally to the patient's groin area. It involves a pneumatic dome, belt, and pump. This is a physical device used for external compression.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide diagnostic information. IVDs are specifically designed for testing samples in vitro.
The device's function is to physically compress a blood vessel to stop bleeding or repair a pseudoaneurysm, which is a therapeutic and procedural application, not an in vitro diagnostic one.
N/A
Intended Use / Indications for Use
The FemoStop® 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.
Product codes
DXC
Device Description
The FemoStop System consists of an arch with a sterile pneumatic pressure dome, a connection tubing and belt, a reusable pump with manometer and an optional adapter for bilateral compression. The device is applied on the patient with the dome over the groin and the belt around the patient. The user controls the inflation of the dome by increasing or decreasing the pressure with the connected pump. Then the dome applies a mechanical pressure over the spot where there is a bleeding to stem, while the arch and belt absorb and evenly distribute the opposite force from the dome.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound-guided
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
Due to the extreme similarity in design and materials between subject and predicate devices further performance testing has not been considered necessary. Published journal articles on the subject "ultrasound-guided compression repair of pseudoaneurysm" with usage of compression devices such as FemoStop have been reviewed as input to the product labeling.
Key Metrics
Not Found
Predicate Device(s)
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
2/23/99
510(K) SUMMARY 9
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and CFR 21 8807.92.
Submitter's Information:
| Name: | RADI Medical Systems AB |
|---|---|
| Address: | Palmbladsgatan 10, S-754 50 Uppsala, Sweden |
| Phone: | 46-18-161000 |
| Fax: | 46-18-161099 |
| Contact Person: | Mats Granlund |
| Date of Preparation: | September 30, 1998 |
| Device Name: | e |
Trade Names: Common Name: Classification Name: FemoStop" System. Femoral Compressor Device. Clamp
FemoStop® System (K954669) FemoStop® II PLUS System (K982182)
Device Description:
Predicate Device Names:
The FemoStop System consists of an arch with a sterile pneumatic pressure dome, a connection tubing and belt, a reusable pump with manometer and an optional adapter for bilateral compression. The device is applied on the patient with the dome over the groin and the belt around the patient. The user controls the inflation of the dome by increasing or decreasing the pressure with the connected pump. Then the dome applies a mechanical pressure over the spot where there is a bleeding to stem, while the arch and belt absorb and evenly distribute the opposite force from the dome.
Intended Use:
The FemoStop® 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 Summary:
Subject device has the same technology, and is manufactured with parts of the predicate devices.
Performance Data:
Due to the extreme similarity in design and materials between subject and predicate devices further performance testing has not been considered necessary. Published journal articles on the subject "ultrasound-guided compression repair of pseudoaneurysm " with usage of compression devices such as FemoStop have been reviewed as input to the product labeling.
Conclusions
The conclusions drawn from the clinical studies is that the subject device is suitable to replace the ultrasound-probe or other compression technique at ultrasound-guided compression repair of pseudoaneurysm".
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 3 1999
Mr. Mats Granlund RADI Medical Systems AB Palmbladsgatan 10 SE-754 50 UPPSALA SWEDEN
K983471 Re : FemoStop® System Trade Name: Regulatory Class: II Product Code: DXC December 15, 1998 Dated: Received: December 23, 1998
Dear Mr. Granlund:
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 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). 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 affecting your device can be found in the Code of Federal Regulations, 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 requlation (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 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 miqht have under sections 531 through 542 of the Act for devices
2
Page 2 – Mr. Mats Granlund
under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 diaqnostic devices), please contact the Office of Compliance at (301) Additionally, for questions on the promotion and advertising 594-4586. of your device, please contact the Office of Compliance at (301) 594-Also, please note the regulation entitled, "Misbranding by 4639. reference to premarket notification" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callak Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Statement of Indications for Use 2
K983471 510(k) Number: FemoStop® System Device Name: The FemoStop® system is indicated for use in Indications for Use: the compression of the femoral artery or vein after vessel cannulation, and in ultrasound-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)
ﺎ Prescription Use_ (Per 21 CFR 801.109)
OR Over-The-Counter Use _
Thomas J. Callahan
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
(Optional Format 1/2/96)