FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER

K983471 · Radi Medical Systems AB · DXC · Feb 23, 1999 · Cardiovascular

Device Facts

• Record ID: K983471
• Device Name: FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER
• Applicant: Radi Medical Systems AB
• Product Code: DXC · Cardiovascular
• Decision Date: Feb 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

FemoStop System is a mechanical femoral compression device; consists of an arch, sterile pneumatic pressure dome, connection tubing, belt, and reusable pump with manometer. Optional adapter allows bilateral compression. Device applied with dome over groin and belt around patient; user manually controls inflation via pump to apply mechanical pressure to bleeding site. Arch and belt distribute counter-force. Used in clinical settings to achieve hemostasis post-cannulation or to repair pseudoaneurysms under ultrasound guidance. Replaces manual compression or ultrasound-probe compression techniques, reducing clinician burden and providing consistent pressure.

Clinical Evidence

No clinical trials performed. Evidence based on review of published journal articles regarding ultrasound-guided compression repair of pseudoaneurysms using compression devices.

Technological Characteristics

Mechanical compression system; pneumatic pressure dome; manual pump with manometer; arch and belt assembly. No electronic or software components. Materials identical to predicate devices.

Indications for Use

Indicated for compression of femoral artery or vein post-cannulation and ultrasound-guided compression repair of femoral artery pseudoaneurysm in patients requiring hemostasis or pseudoaneurysm management.

Regulatory Classification

Identification

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

Predicate Devices

• FemoStop® System (K954669)
• FemoStop® II PLUS System (K982182)

Submission Summary (Full Text)

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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:

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.

## 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 [phone] or [phone] 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.

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# 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)