The FemoStop IIruss 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.

AI/ML Overview

The provided 510(k) summary for the FemoStop®II PLUS System does not contain detailed information regarding acceptance criteria or a specific study proving the device meets those criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device.

Here's a breakdown of the available information and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not explicit: The document states "Safety and performance testing was performed to demonstrate that the FemoStop®IIPLUS System." However, no specific performance metrics or acceptance criteria (e.g., maximum allowable leakage, pressure stability over time, or clinical success rates) are provided.	The document states: "The minor change in packaging has addressed in an identical as the predicate device which the same satisfying results." This implies that the performance is considered "satisfying" and equivalent to the predicate, but no quantitative results are presented.

2. Sample Size for the Test Set and Data Provenance:

Sample Size: Not specified.
Data Provenance: Not specified. The document only mentions "safety and performance testing was performed." It does not indicate if this involved human subjects, animal studies, or purely bench testing, nor does it mention the country of origin or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not Applicable. Given the nature of a 510(k) summary that emphasizes substantial equivalence mainly through technical characteristics and a "minor change in packaging," expert-established ground truth for a clinical test set is not discussed. There is no mention of a clinical study that would require such expert assessment.

4. Adjudication Method for the Test Set:

Not Applicable. No clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC study is typically associated with AI/imaging devices and involves human readers evaluating cases with and without AI assistance. This device is a mechanical compression system, and an MRMC study is not relevant to its evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is not an algorithmic device. Performance for this device would relate to its mechanical function, material compatibility, and effectiveness in achieving compression.

7. The Type of Ground Truth Used:

Not explicitly stated for performance testing. For mechanical and material checks, the "ground truth" would likely be established through engineering specifications, material safety standards, and physical measurements. For clinical effectiveness, the "ground truth" (if a study were performed beyond equivalence) would be successful hemostasis or closure of the vessel, typically assessed by clinical observation. However, the document does not detail this.

8. The Sample Size for the Training Set:

Not Applicable. This device, being a mechanical compression system, does not involve a training set as would be found in machine learning or AI-based devices.

9. How the Ground Truth for the Training Set was Established:

Not Applicable. As no training set is involved, this question is not relevant.

Summary of the Study (as described in the 510(k) summary):

The 510(k) summary for the FemoStop®II PLUS System indicates that "Safety and performance testing was performed to demonstrate that the FemoStop®IIPLUS System" is safe and effective. However, the main thrust of the submission for demonstrating this is through substantial equivalence to an existing predicate device, the FemoStop®II System.

The document explicitly states: "The FemoStop IIruss System is very similar to FemoStop II System, rearding materials, construction, packaging, sterilization and indication for use." It further mentions: "The minor change in packaging has addressed in an identical as the predicate device which the same satisfying results."

This implies that the "study" demonstrating performance was primarily an equivalence assessment, comparing the new device's technical characteristics to its predicate, particularly noting a "minor change in packaging." No distinct clinical trial or detailed performance study results are described; rather, the safety and effectiveness are inferred from its similarity to a legally marketed and presumably safe and effective predicate device.

Summary

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L980878

SECTION IV APR 21 1998 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 GranlundQuality Manager
Date of Preparation:	March 6, 1998

Device Name:

Trade Names:

Common Name: Classification Name:

Predicate Device Names:

FemoStop®II System with FemoStop®II Disposable Set. FemoStop®II Compression Arch and FemoStop®II Pump

Device Description:

FemoStop®IIPLUS System with

FemoStop®II Pump and

Not known

FemoStop®IIPLUS Disposable Set, FemoStop®II Compression Arch,

FemoStop®II Bilateral Adapter

Femoral Compressor Device

Intended Use:

The FemoStop IIrLUS System is indicated in the compression of the femoral artery or vein after catheterization.

Technical Characteristics Summary:

The FemoStop Irrus System is very similar to FemoStop II System, rearding materials, construction, packaging, sterilization and indication for use.

Performance Data:

Safety and performance testing was performed to demonstrate that the FemoStop®]["LUS System. The minor change in packaging has addressed in an identical as the predicate device which the same satisfying results.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle emblem. The eagle is depicted with three heads, each facing forward, and its wings are represented by curved lines. The text is in all caps and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 | 1998

Mr. Mats Granlund Quality Manager Radi Medical Systems AB Palmbladsqatan 10 S-754 50 Uppsala, Sweden

Re: K980898 FemoStop®IIPLUS System Trade Name: Requlatory Class: II Product Code: DXC Dated: March 6, 1998 Received: March 9, 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, Druq, 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 Requlations, 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 assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this

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Page 2 - Mr. Granlund

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 labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other qeneral 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

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INDICATIONS FOR USE

510(k) Number:

FemoStop®IIPLUS System Device Name:

Indications for Use:

11.00

The FemoStop®IIPLUS System is indicated in the compression of the femoral artery or vein after catheterization.

(PLEASE DO NOT WRITE BELCW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

OR Over-The-Counter Use ________________ Prescription Use (Per 21 CFR 801.109)

(Optional Format 1/2/96)

Th A h

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_ AGORO

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).