PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE

K090286 · Advanced Vascular Dynamics · DXC · Mar 23, 2009 · Cardiovascular

Device Facts

• Record ID: K090286
• Device Name: PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE
• Applicant: Advanced Vascular Dynamics
• Product Code: DXC · Cardiovascular
• Decision Date: Mar 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

PressureMate™ is a manual femoral access compression device used by medical practitioners to achieve hemostasis post-catheterization. It consists of an aluminum handle with a stainless steel stem that mates with SuperComfort™ Discs. The device is used as an alternative to mechanical clamps or direct hand-holding pressure. By providing an ergonomic handle, it reduces the practitioner's direct contact with bodily fluids and alleviates biomechanical stress associated with traditional digital compression. The device is purely mechanical; it does not contain electronics or software.

Clinical Evidence

Bench testing only. The device was tested to withstand a holding force of 35 pounds.

Technological Characteristics

Materials: Aluminum handle, stainless steel stem. Form factor: Manual handle with two designs (symmetrical or asymmetrical) featuring a female connector for mating with SuperComfort™ Discs. Energy source: None (manual). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients undergoing femoral vascular catheterization or cannulation procedures requiring hemostasis at the access site.

Regulatory Classification

Identification

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

Predicate Devices

• Compass Compression Assist Handle (K053398)
• SuperComfort™ Discs (K040615)

Submission Summary (Full Text)

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KØ9Ø286

MAR 2 3 2009

31 December 2008

## 510(k) Summary

## Company Contact Information

Advanced Vascular Dynamics 1910 NW 23td Place, Portland, Oregon 97210 Herbert J. Semler, President, Advanced Vascular Dynamics Phone: [phone] Fax: [phone]

Name of Device

Trade name - PressureMate™ Compression Assist Handle Common name -- Femoral Access Compression Device Procode/Classification name - DXC/Clamp, Vascular Regulation Number - 870.4450

#### Predicate Device(s)

Compass Compression Assist Handle (K053398) SuperComfort™ Discs (K040615)

Indication for Use

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

### Device Description

The PressureMate™ Compression Assist Handle mates with the SuperComfort™ Discs (K040615) to provide an alternative to the use of mechanical clamping systems or direct hand holding pressure to obtain hemostasis following fernoral vascular catheterization procedures.

The PressureMate™ handle itself is an aluminum handle with stainless steel stem. The stem ends in a female connection which mates to the male connector located on the SuperComfort Discs. The handle can not be used without a Disc.

The PressureMate™ comes in two designs: i) symmetrical, with both ends symmetrically tapering down at each end and centrally located stem or ii) asymmetrical, with one end tapered smaller than the other end and the stem slightly off center. The handle designs, round with tapered ends, enable better fit to an operator's hand.

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.

#### Performance Data

The device is designed and has been tested to withstand a holding force of 35 pounds.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

1.

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The text is in all capital letters.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2009

Advanced Vascular Dynamics c/o Mr. Matthew Semler 1910 NW 23rd Place Portland, OR 97210

Re: K090286

PressureMate™ Manual Femoral Access Compression Device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Compression Device Regulatory Class: Class II Product Code: DXC Dated: January 30, 2009 Received: February 5, 2009

Dear Mr. 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 - Mr. Matthew Semler

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Qimia D: Vulumen

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Bram D. Zuckerman, M.D. Division 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): K090286

Device Name: PressureMate™ Manual Femoral Access Compression Device_

Indications for Use:

This device is indicated for use to provide hemostasis of the femoral vascular access site during and 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)

una R. Valner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_ko90286_