(88 days)
Not Found
Not Found
No
The device description and summary of performance studies indicate a purely mechanical compression system with manual pressure control. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is indicated for "compression of the femoral artery or vein after catheterization," which is a therapeutic intervention aimed at stopping bleeding or reducing swelling.
No
The device is described as a system for compression of the femoral artery or vein after catheterization, which is a therapeutic or post-procedure management function, not a diagnostic one. It does not mention identifying, analyzing, or monitoring any medical conditions or parameters.
No
The device description clearly outlines physical components like a compression dome, arch, belt, and pump, indicating it is a hardware-based medical device.
Based on the provided information, the FemoStop®IIPLUS System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "compression of the femoral artery or vein after catheterization." This describes a physical intervention on the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device description details a mechanical system for applying pressure externally. This is consistent with a therapeutic or post-procedure device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The FemoStop®IIPLUS System's function is purely mechanical compression.
N/A
Intended Use / Indications for Use
The FemoStop®IIPLUS System is indicated in the compression of the femoral artery or vein after catheterization.
Product codes
DXC
Device Description
The FemoStop II "65 System consists of a single use compression dome attached to an arch which is located on the patient together with a belt. The pump is connected to the dome to manually control the pressure over the femoral artery/vein puncture site. The bilateral adapter facilitates simultaneous compression of both the left and right side.
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)
Safety and performance testing was performed to demonstrate that the FemoStop®IPUS System. The change in materials has been tested according to suggestions in: ISO 10993-1, Biological evaluation of medical devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
FemoStop®IIPLUS System with FemoStop®IIPLUS Disposable Set, FemoStop®II Compression Arch, FemoStop®II Bilateral Adapter and FemoStop®II Pump
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
SEP | 8 |998
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS FEMOSTOP® II PLUS SYSTEM
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 §807.92.
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 |
| Quality Manager | |
| Date of Preparation: | June 22, 1998 |
| Device Name: | |
| Trade Names: | FemoStop®II System with |
| FemoStop®IIPLUS Disposable Set, | |
| FemoStop®IIPLUS Compression Arch, | |
| FemoStop®IIPLUS Bilateral Adapter and | |
| FemoStop®IIPLUS Pump | |
| Common Name: | Femoral Compressor Device |
| Classification Name: | Clamp, Vascular |
| Predicate Device Names: | FemoStop®IIPLUS System with |
| FemoStop®IIPLUS Disposable Set, | |
| FemoStop®II Compression Arch, | |
| FemoStop®II Bilateral Adapter and | |
| FemoStop®II Pump | |
| Jarian Dogomistian: |
Device Description:
The FemoStop II "65 System consists of a single use compression dome attached to an arch which is located on the patient together with a belt. The pump is connected to the dome to manually control the pressure over the femoral artery/vein puncture site. The bilateral adapter facilitates simultaneous compression of both the left and right side.
Intended Use:
The FemoStop IIPLUS System is indicated in the compression of the femoral artery or vein after catheterization.
Technical Characteristics Summary:
The FemoStop IreUS System is very similar to FemoStop II System, regarding materials, construction, packaging, sterilization and indication for use.
Performance Data:
Safety and performance testing was performed to demonstrate that the FemoStop®IPUS System. The change in materials has been tested according to suggestions in: ISO 10993-1, Biological evaluation of medical devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features the department's name encircling a stylized symbol. The symbol consists of three parallel lines that curve and converge, resembling a stylized human form. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 8 1998
Mr. Mats Granlund Quality Manager Radi Medical Systems AB Palmbladsqatan 10, S-754 50 UPPSALA, Sweden
Re : K982182 Trade Name: FemoStop®II System with FemoStop®II Plus Disposable Set, FemoStop@II Plus Compression Arch, FemoStop®II Plus Bilateral Adapter and FemoStop®II Plus Pump Requlatory Class: II Product Code: DXC Dated: June 18, 1998 Received: June 22, 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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with 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 Drug Administration (FDA) will verify such
2
Page 2 - Mr. Mats Granlund
assumptions. Failure to comply with the GMP regulation 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 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.
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) 594-4586. 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 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
| 510(k) Number: | K982182 |
|---|---|
| Device Name: | FemoStop®II PLUS System |
The FemoStop®IIPLUS System is indicated in the Indications for Use: compression of the femoral artery or vein after catheterization.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
V Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109)
(Optional Format 1/2/96)
M. Rybín
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, | |
| and Neurological Devices | |
| 510(k) Number | K982182 |