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.

AI/ML Overview

Here's an analysis of the provided text regarding the FemoStop®II PLUS System.

Important Note: The provided document is a 510(k) summary for a medical device (Femoral Compressor Device). These types of summaries primarily aim to demonstrate substantial equivalence to a predicate device rather than providing detailed, comprehensive performance studies with specific statistical acceptance criteria and extensive ground truth establishment as would be seen for complex diagnostic AI/ML algorithms. Therefore, much of the requested information (especially regarding statistical methods, expert consensus, multi-reader studies, and AI-specific ground truth) is not present in this type of document.

Acceptance Criteria and Reported Device Performance

The 510(k) summary for the FemoStop®II PLUS System focuses on demonstrating substantial equivalence to its predicate device, the FemoStop®II System. The "acceptance criteria" here are implicitly tied to showing that the new device is as safe and effective as the predicate, especially given a change in materials.

Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility: The new materials used in the FemoStop®II PLUS System are safe for human contact and do not elicit adverse biological responses.	"The change in materials has been tested according to suggestions in: ISO 10993-1, Biological evaluation of medical devices." This implies that the tests performed met the recommendations of this standard, indicating acceptable biocompatibility.
Functional Equivalence: The FemoStop®II PLUS System performs its intended function (compression of femoral artery/vein after catheterization) as effectively as the predicate device.	"The FemoStop®IIPLUS System is very similar to FemoStop®II System, regarding materials, construction, packaging, sterilization and indication for use." This statement is the primary assertion of functional equivalence. The 510(k) process accepts this similarity as sufficient evidence of comparable performance for this type of device, especially when the core mechanism of action remains the same. The FDA letter confirms the device is "substantially equivalent" for the stated indications for use.
Manufacturing Quality: The device is manufactured under appropriate quality systems.	The FDA letter mentions: "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." This is an implicit acceptance criterion assumed to be met.

Study Details (Based on available information)

1. A table of acceptance criteria and the reported device performance:
* See the table above.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* Sample Size (Test Set): Not specified. The document describes material safety testing (ISO 10993-1), but does not detail human clinical trials or a specific "test set" in the context of diagnostic accuracy.
* Data Provenance: Not specified for the performance data. The manufacturer is based in Uppsala, Sweden. The biocompatibility testing reference (ISO 10993-1) is an international standard.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
* Not applicable / Not specified. This type of medical device (a mechanical compression system) does not typically require expert labeling of "ground truth" images or data in the same way an AI diagnostic algorithm would. The "ground truth" for this device would be its physical properties, biocompatibility, and functional performance in reducing bleeding after catheterization. The document focuses on demonstrating substantial equivalence based on materials, construction, and design, not on diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable / Not specified. No adjudication method is described as this device does not involve subjective interpretation or diagnostic labeling.

5. 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:
* Not applicable. No MRMC study was performed or is relevant for this non-diagnostic, non-AI medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* The "ground truth" for this device would primarily be:
* Biocompatibility test results: Conformance to ISO 10993-1 standards (e.g., cytotoxicity assays, irritation tests).
* Material properties: Chemical composition, physical strength, durability, etc.
* Functional performance: The ability of the device to apply and maintain pressure, as designed, to achieve hemorrhage control. This is implicitly linked to the "very similar" construction and materials to the predicate.
* No expert consensus, pathology, or specific outcomes data is detailed in this summary.

8. The sample size for the training set:
* Not applicable / Not specified. This device does not use an AI model that requires a "training set."

9. How the ground truth for the training set was established:
* Not applicable / Not specified. No AI training set is involved.

Summary

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SEP | 8 |998

K982182

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:

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.

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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

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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

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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

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).