COMPASS COMPRESSION ASSIST HANDLE

K053398 · Semler Technologies, Inc. Dba · DXC · Mar 10, 2006 · Cardiovascular

Device Facts

• Record ID: K053398
• Device Name: COMPASS COMPRESSION ASSIST HANDLE
• Applicant: Semler Technologies, Inc. Dba
• Product Code: DXC · Cardiovascular
• Decision Date: Mar 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Compass Compression Assist Handle with the SuperComfort™ Disc is intended for use following femoral vascular catheterization procedures to assist in obtaining and maintaining hemostasis.

Device Story

Compass Compression Assist Handle is a manual femoral access compression device used by medical practitioners to obtain hemostasis post-catheterization. The device consists of a polycarbonate handle that mates with a sterile SuperComfort disc. The practitioner manually positions the disc at the femoral access site and applies sufficient holding force to maintain hemostasis. This system replaces direct digital compression, reducing bio-mechanical stress on the clinician and avoiding direct contact with bodily fluids. It is used in clinical settings where femoral access is performed. The device provides a mechanical interface for applying pressure, benefiting the clinician through improved ergonomics and comfort during the compression process.

Clinical Evidence

Bench testing only. Testing verified mechanical fit between the Compass handle and the SuperComfort Disc, including multiple assembly/extraction cycles to ensure proper insertion/removal forces.

Technological Characteristics

Polycarbonate handle; mates with SuperComfort disc. Manual operation; no energy source. Dimensions/form factor not specified. Non-sterile handle; sterile disc. No software or electronic components.

Indications for Use

Indicated for use to provide hemostasis of the femoral vascular access site following catheterization or cannulation procedures in patients undergoing such procedures.

Regulatory Classification

Identification

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

Predicate Devices

• EZ Hold Femoral Compression Device (K973731)

Reference Devices

• CompressAR® SuperComfort™ Disc

Submission Summary (Full Text)

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MAR 1 0 2006

K053398

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ADVANCED VASCULAR DYNAMICS

A Semler Technologies Company

## 510(k) Summary

Herbert J. Semler Official Correspondent 6 March 2006

Trade name - Compass™ Compression Assist Handle Common name - femoral access compression device Classification name - Clamp, Vascular (21 CFR 870.4450 DXC) Predicate device - EZ Hold Femoral Compression Device (K973731)

This device is similar to the EZ Hold handle. The Compass device provides an alternative to the use of mechanical clamping systems or direct hand holding pressure to obtain hemostasis following femoral vascular catheterization procedures.

A sterile SuperComfort disc is affixed to the handle. Then the disc is manually positioned at the femoral vascular access site. The medical practitioner then applies holding force sufficient to obtain hemostasis.

Use of the handle and disc by a medical practitioner avoids prolonged direct contact with bodily fluids, and alleviates bio-mechanical stress which may occur during traditional direct digital compression of the femoral artery post-cardiac catheterization.

The Compass Compression Assist Handle with the SuperComfort™ Disc is intended for use following femoral vascular catheterization procedures to assist in obtaining and maintaining hemostasis.

The handle and disc provide a mechanical means for a medical practitioner to hold external pressure at or near the site of femoral vascular access. Direct pressure is used to obtain and maintain hemostasis on the access site or at a pressure point.

Unlike the predicate device, the Compass handle mates with the SuperComfort™ Disc. The predicate device is made of stainless steel; the Compass handle is made of polycarbonate.

Market testing determined that use of a handle and disc for holding manual pressure, rather than use of fingers directly on the access site, was more comfortable and less stressful to the care giver.

Testing was conducted to determine that the Compass device provides mechanical fit to the CompressAR® SuperComfort™ Disc and may be used to apply pressure. Multiple assembly/extraction cycles verified proper fit and acceptable insertion/removal forces. It was concluded that the Compass Compression Assist Handle, used with the SuperComfort™ Disc, is equivalent to the predicate device.

> 2326 NW EVERETT ST., PORTLAND, OR 97210 P 503-223-2333, P 800-525-2555, F 503-223-8448, WWW.COMPRESSAR.COM

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2006

Advanced Vascular Dynamics c/o Herbert J. Semler, M.D. Official Correspondent 2326 NW Everett Street Portland, OR 97210

Re: K053398

Compass™ Manual Femoral Access Compression Device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (Two) Product Code: DXC Dated: February 24, 2006 Received: February 27, 2006

## Dear Dr. Semler:

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.

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Page 2 - Herbert J. Semler, M.D.

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 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/industry/support/index.html.

Sincerely yours,

R. Vachner

A 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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## Indications for Use

510(k) Number (if known): _K053398

Device Name:

Indications for Use:

This device is indicated for use to provide hemostasis of the femoral vascular access site following catheterization or cannulation procedures.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R. kchner

(Division Sign-Off) Division of Cardiovascular Devices

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510(k) Number K6533 9 8

(Posted November 13, 2003)