FemoStop® Femoral Compression System is indicated for use in the compression for the femoral artery or vein after vessel cannulation, and in ultrasounded-guided compression repair of a femoral artery pseudoaneurysm

Device Description

The FemoStop®Femoral Compression System consists of an arch with a sterile pneumatic pressure dome attached to an arch, a belt, and a reusable pump with manometer. With this application a sterile hemostatic dressing, HD, is added to the system. The dressing has an active agent made of calcium/sodium salt of micro dispersed oxidized cellulose for topical control of bleeding.

AI/ML Overview

This is a 510(k) summary for the FemoStop® Femoral Compression System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the provided text does not contain any information regarding specific acceptance criteria, study details, or performance data beyond stating substantial equivalence. Therefore, a complete answer as requested cannot be generated from the given input.

The document primarily focuses on establishing substantial equivalence based on technical characteristics and intended use, comparing the new device (with an added hemostatic dressing) to existing FemoStop models and other relevant products.

Based on the provided text, the following information is missing or cannot be extracted:

A table of acceptance criteria and the reported device performance: This information is not present. The document claims technical characteristics are "identical" or "substantially equivalent" to predicate devices, but no performance metrics or specific acceptance criteria are listed.
Sample size used for the test set and the data provenance: No test set or data provenance is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set or ground truth establishment is described.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study is mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, this is a medical device, not an AI algorithm.
The type of ground truth used: Not applicable, as no ground truth is established for performance evaluation.
The sample size for the training set: Not applicable, as this is a medical device, not a machine learning algorithm.
How the ground truth for the training set was established: Not applicable.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and study details based on the provided text. The document is strictly a 510(k) summary aiming for substantial equivalence.

Summary

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K024/07

DEC 2 4 2002

Attachment 4

510(k) Summary

This 510(k) summary is submitted in accordance with the requirements in 21 CFR §807.92

Submitted by:	RADI Medical Systems ABPalmbladsgatan 10SE-754 50 Uppsala, SwedenPhone:(+46) 18161000
Contact Person:	Mats Granlund
Date Prepared:	December 10, 2002
Proprietary Name:	FemoStop® Femoral Compression System
Common Name:	Femoral compression device
Classification Name:	Clamp, DXC
Predicate Devices:	K954669 FemoStop® System
	K982182 FemoStop®II System
	K983471 FemoStop®PLUS System
	K010933 Seal-On Hemostatic Powder Spray
	K920796 DeRoyal Transparent Film Dressing (Transeal
	K962425 Bonopty Coaxial Bone Biopsy System

The FemoStop®Femoral Compression System consists of Description of the Device: an arch with a sterile pneumatic pressure dome attached to an arch, a belt, and a reusable pump with manometer. With this application a sterile hemostatic dressing, HD, is added to the system. The dressing has an active agent made of calcium/sodium salt of micro dispersed oxidized cellulose for topical control of bleeding.

FemoStop® Femoral Compression System is Indication for Use of the Device: 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: The technical characteristics of the actual FemoStop, i.e. are identical to those predicate devices cleared the previous FemoStop applications.

The technical characteristics of the hemostatic dressing - permeable to moisture allowing the skin to breathe but impermeable to water and bacteria, functioning as a bacterial barrier - are substantially equivalent to Transeal, DeRoyal Transparent Film Dressing (K920796) and the technical characteristics of the active substance - induce topical control of bleeding - are substantially equivalent to Seal-On Hemostatic Powder Spray (K010933). The technical characteristics of the

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 4 2002

RADI Medical Systems AB c/o Mr. Mats Granlund Palmbladsgatan 10 SE-754 50 Uppsala, Sweden

Re: K024107

FemoStop® Femoral Compression System Regulation Number: 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: DXC Dated: December 10, 2002 Received: December 13, 2002

Dear Mr. Granlund:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Mr. Mats Granlund

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Utepar majnel

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 2

Indication for Use Statement : 上

510(k) Number:	K024107
Device Name:	FemoStop® Femoral Compression System
Indications for Use:	FemoStop® Femoral Compression System is indicated for use in the compression for the femoral artery or vein after vessel cannulation, and in ultrasounded-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)

Alex May

for Division Sign
BDZ Division of Cardiovascular Devices

.0(k) Number K024107

Prescription Use	OR
(Per 21 CFR 801.109)

Over-The-Counter Use

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).