RADAR VASCULAR COMPRESSION DEVICES

K092503 · Advanced Vascular Dynamics · DXC · Nov 19, 2009 · Cardiovascular

Device Facts

• Record ID: K092503
• Device Name: RADAR VASCULAR COMPRESSION DEVICES
• Applicant: Advanced Vascular Dynamics
• Product Code: DXC · Cardiovascular
• Decision Date: Nov 19, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RadAR " Vascular Compression Devices are indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm, including radial artery catheterization, arterial or venous line removal, hemodialysis, and in patients on anticoagulation therapy.

Device Story

RadAR Vascular Compression Device; sterile, single-use mechanical compression device for arm puncture sites. Consists of strap, housing, screw, and movable compression pad. Operated by medical professionals to apply localized pressure to blood vessels. Screw mechanism allows delicate, adjustable compression control without unfastening; enables gradual release of pressure as hemostasis occurs; permits blood flow in compressed vessel at user discretion. Benefits patient by facilitating controlled hemostasis following procedures like radial artery catheterization or hemodialysis.

Clinical Evidence

No clinical data submitted. Evidence based on bench testing, including sterilization, biocompatibility, functional, and performance testing conducted by third parties.

Technological Characteristics

Mechanical vascular compression device. Features adjustable strap, housing, screw, and movable compression pad. Sterile, single-use. No electronic components or software.

Indications for Use

Indicated for medical professionals to promote hemostasis in patients undergoing catheterization or vascular puncture in the arm, including radial artery catheterization, arterial/venous line removal, hemodialysis, and patients on anticoagulation therapy.

Regulatory Classification

Identification

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

Predicate Devices

• TR Band (K070423)
• Comfort-Band (K040208)

Submission Summary (Full Text)

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K092503 pg 1 of 2

RADAR" Vascular Compression Devices 510(k) Notification

## 510(k) SUMMARY

NOV 1 9 2009

| Submitter's name: | Advanced Vascular Dynamics Division |
|-------------------|------------------------------------------|
| | dba Advanced Vascular Dynamics/ClampEase |
| | 1910 NW 23rd Place, Portland, OR 97210 |

Contact name and address: Matthew Semler, President 503-223-2333

August 11, 2009 Date summary prepared:

Device name:

| Proprietary name: | RADAR TM Vascular Compression Devices |
|-----------------------|-----------------------------------------------------|
| Common or usual name: | Vascular compression device |
| Classification name: | Vascular clamp (870.4450). Vascular clamp (74 DXC). |

Legally marketed device for substantial equivalence comparison:

The predicate devices for this submission are the TR Band submitted by Terumo Medical Corp. and cleared for marketing under 510(k) *K070423 and the Comfort-Band submitted by TZ Medical and cleared under 510(k) *K040208.

## Description of the device:

The RadAR " Vascular Compression Devices are compression devices used on the arm. Each device consists of a strap with a housing, a screw permanently inserted into the housing, and a movable compression pad. The product is designed to reduce blood flow in the blood vessel compressed by the pad while allowing blood flow in other vessels in the arm. The user can delicately control the compression applied by the device without unfastening it. This allows gradual release of compression as hemostasis occurs and, at the user's discretion, permits blood flow in the compressed vessel during puncture site hemostasis. The product is provided individually packaged. It is a sterile, single-use device.

Intended use of device:

The RadAR " Vascular Compression Devices are indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm, including radial artery catheterization, arterial or venous line removal, hemodialysis, and in patients on anticoagulation therapy.

Technological characteristics:

The device features of the RadAR" Vascular Compression Devices and the predicate devices are very similar. All three products have an adjustable strap and apply pressure to the puncture site in the patient's arm. There are some design variations, but these do not affect the substantial equivalence of the RadAR.

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K092503 pg 2 of 2

RADAR™ Vascular Compression Devices 510(k) Notification

Testing conducted:

Sterilization, biocompatibility, functional, and performance testing were conducted on , sterilized RadAR devices by third parties in June, July and August of 2009. The RadAR devices successfully passed all tests.

Performance testing:

Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized human figure with outstretched arms, symbolizing care and protection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

NOV 1 9 2009

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

Re: K092503

Trade/Device Name: RadARTM Vascular Compression Device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: DXC Dated: November 9, 2009 Received: November 13, 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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RADAR™ Vascular Compression Devices 510(k) Notification

## Indications for Use

510(k) Number (if known): _ K092503

Device Name: RADAR™ Vascular Compression Devices

Indications for Use:

The RADAR™ Vascular Compression Devices are indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm, including radial artery catheterization, arterial or venous line removal, hemodialysis, and in patients on anticoagulation therapy.

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)

Signature

(Division Sign-Off)
Division of Cardlovas ular Device
510(k) Number K09 2003