FEMOSTOP FEMORAL COMPRESSION SYSTEM

K024107 · Radi Medical Systems AB · DXC · Dec 24, 2002 · Cardiovascular

Device Facts

• Record ID: K024107
• Device Name: FEMOSTOP FEMORAL COMPRESSION SYSTEM
• Applicant: Radi Medical Systems AB
• Product Code: DXC · Cardiovascular
• Decision Date: Dec 24, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

FemoStop Femoral Compression System provides mechanical compression to femoral vessels; consists of arch, belt, reusable pump with manometer, and sterile pneumatic pressure dome. New addition includes sterile hemostatic dressing (HD) containing calcium/sodium salt of micro-dispersed oxidized cellulose for topical bleeding control. Used in clinical settings (e.g., post-cannulation) by healthcare professionals. Device applies controlled pneumatic pressure to site; hemostatic dressing acts as barrier and active agent to induce clotting. Benefits include effective hemostasis and pseudoaneurysm repair.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and performance comparisons to predicate devices.

Technological Characteristics

Mechanical compression system comprising arch, belt, pneumatic pressure dome, and pump with manometer. Hemostatic dressing consists of calcium/sodium salt of micro-dispersed oxidized cellulose. Dressing is moisture-permeable, water/bacteria-impermeable. No software or electronic components.

Indications for Use

Indicated for patients requiring compression of the femoral artery or vein following vessel cannulation, or for ultrasound-guided compression repair of femoral artery pseudoaneurysms.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• FemoStop® System (K954669)
• FemoStop®II System (K982182)
• FemoStop®PLUS System (K983471)
• Seal-On Hemostatic Powder Spray (K010933)
• DeRoyal Transparent Film Dressing (Transeal) (K920796)
• Bonopty Coaxial Bone Biopsy System (K962425)

Submission Summary (Full Text)

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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 AB<br>Palmbladsgatan 10<br>SE-754 50 Uppsala, Sweden<br>Phone:[phone] |
|----------------------|---------------------------------------------------------------------------------------------------|
| 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 |

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### 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