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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Devices (FemoStop® System K954669 and FemoStop® II PLUS System K982182)	Device found to have the same technology and be manufactured with parts of the predicate devices.
Suitability for use in ultrasound-guided compression repair of pseudoaneurysm	Clinical studies conclude the subject device is suitable to replace the ultrasound-probe or other compression technique for ultrasound-guided compression repair of pseudoaneurysm.

Important Note: The provided document does not explicitly state numerical acceptance criteria (e.g., specific accuracy thresholds, sensitivity/specificity targets). Instead, the acceptance criteria are implicitly linked to demonstrating substantial equivalence to existing predicate devices and showing suitability for its intended use based on a review of published literature.

Study Details

The information provided by RADI Medical Systems AB does not describe a detailed study with specific data points or a typical "clinical trial" structure as one might expect for a new AI medical device. Instead, it relies heavily on the equivalence to predicate devices and a review of published journal articles.

Here's an analysis based on the available information:

Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of a prospective, controlled study of the subject device. The "test set" here refers to the data used in the published journal articles that were reviewed. No specific number of patients or cases from these articles is provided for direct testing of the subject device.
- Data Provenance: The data comes from "Published journal articles on the subject 'ultrasound-guided compression repair of pseudoaneurysm' with usage of compression devices such as FemoStop." The specific countries of origin or whether these were retrospective or prospective studies are not detailed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The "ground truth" implicitly comes from the findings and conclusions of the reviewed published journal articles, which would have been peer-reviewed by numerous experts in the field, but no specific number directly involved in this submission's evaluation is mentioned.
- Qualifications of Experts: Not explicitly stated for those establishing ground truth. The implied experts are the authors and reviewers of the published journal articles.
Adjudication method for the test set:
- Adjudication Method: Not applicable. There was no direct "test set" that required adjudication by a panel for this submission. The conclusions are drawn from a review of existing literature.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. This device is a mechanical compression system, not an AI device. Therefore, an MRMC study comparing human readers with AI assistance is not relevant or reported here.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not applicable. This is a mechanical device, not an algorithm.
The type of ground truth used:
- Type of Ground Truth: The "ground truth" is derived from the clinical outcomes and efficacy reported in the reviewed published journal articles regarding the use of similar compression devices (including FemoStop) for ultrasound-guided compression repair of pseudoaneurysm. This implies a reliance on clinical data and expert consensus within the scientific literature.
The sample size for the training set:
- Sample Size for Training Set: Not applicable. The device is a mechanical system, not a machine learning model that requires a training set.
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no training set for a mechanical device.

In summary, this 510(k) submission primarily leverages the concept of substantial equivalence to predicate devices and a review of existing clinical literature to support its claims, rather than presenting novel clinical trial data for the specific subject device.

Summary

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2/23/99

K983471

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:

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".

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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

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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

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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)

Regulation Number and Section

§ 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).