VASCULAIRE COMPRESSION SYSTEM

K103113 · Venous Health Systems, Inc. · JOW · Feb 2, 2011 · Cardiovascular

Device Facts

• Record ID: K103113
• Device Name: VASCULAIRE COMPRESSION SYSTEM
• Applicant: Venous Health Systems, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Feb 2, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vasculaire Compression System is indicated for use in: - Preventing deep vein thrombosis (DVT) . - . Enhancing blood circulation - Diminishing post-operative pain and swelling . - t Reducing wound healing time - Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial . and diabetic leg ulcers - Treatment of chronic venous insufficiency . - . Reducing edema

Device Story

Ambulatory, intermittent pneumatic compression system; provides sequential compression to lower limbs. Components: patient sleeve (multiple-cell bladder), controller, charger. Controller mounts to sleeve; battery-powered; electromechanical. Uses two independent flange ports to control inflation cycles in calf and foot zones. Used by patients for ambulatory therapy; intended to enhance circulation and treat venous/ulcer conditions. Healthcare providers use output (therapy delivery) to manage edema, DVT risk, and wound healing. Benefits patient via improved venous return and reduced post-operative symptoms.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including reliability testing, physical specification verification, transit testing, software verification/validation, electrical safety, electromagnetic compatibility, and cytotoxicity testing.

Technological Characteristics

Ambulatory intermittent pneumatic compression system. Components: multi-cell bladder sleeve, electromechanical controller, charger. Controller is battery-powered, <1 lb. Features independent flange ports for calf and foot zone inflation control. Software-controlled inflation cycles. Biocompatible materials (cytotoxicity tested).

Indications for Use

Indicated for patients requiring sequential compression therapy to lower limbs for DVT prevention, circulation enhancement, pain/swelling reduction, wound healing, and treatment of stasis dermatitis, venous/arterial/diabetic ulcers, chronic venous insufficiency, and edema.

Regulatory Classification

Identification

A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.

Predicate Devices

• Medical Compression Systems, ActiveCare + System (K060146)

Submission Summary (Full Text)

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### 510(k) Summary

510(k) Notification:

FEB - 2 2011

GENERAL INFORMATION --Applicant: Venous Health Systems, Inc. 3270 Alpine Road Portola Valley, CA 94028 U.S.A. Phone: [phone] Fax: [phone]

### Contact Person:

Albert Boniske Regulatory Affairs Project Manager Experien Group, LLC 155-A Moffett Park Drive, Suite 210 Sunnyvale, CA 94089 U.S.A. Phone: [phone] Fax: [phone]

Date Prepared: October 18, 2010

### DEVICE INFORMATION

The Vasculaire Compression System is an ambulatory, intermittent pneumatic compression system intended to provide sequential compression therapy to a patient's lower limbs. The Vasculaire Compression System includes three components: the Patient Sleeve, the Controller, and the Charger.

### Classification:

Compressible Limb Sleeve, 21 CFR§870.5800

Product Code:

JOW .

Trade Name: Vasculaire Compression System

Generic/Common Name: Compressible Limb Sleeve

#### PREDICATE DEVICE

Medical Compression Systems, ActiveCare + System (K060146)

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### 510(k) SUMMARY

## INDICATIONS FOR USE

The Vasculaire Compression System is indicated for use in:

- Preventing deep vein thrombosis (DVT) .
- . Enhancing blood circulation
- Diminishing post-operative pain and swelling .
- t Reducing wound healing time
- Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial . and diabetic leg ulcers
- Treatment of chronic venous insufficiency .
- . Reducing edema

## PRODUCT DESCRIPTION

The Vasculaire Compression System is an ambulatory, intermittent pneumatic compression system intended to provide sequential compression therapy to a patient's lower limbs. The Vasculaire Compression System includes three components: the Patient Sleeve, the Controller, and the Charger.

The Patient Sleeve is a multiple-cell bladder intended to be attached directly to the patient's lower limb. It is intended to provide compression action to the tissue surrounding the venous vasculature in the foot and calf of a patient. The Controller is connected to the Patient Sleeve using two independent Flange Ports and can be mounted directly onto the Patient Sleeve for a completely ambulatory system. The Flange Ports allow the air from the Controller to control the compression action on the Calf go Foot Zones independently. The Controller is a lightweight (less than 1 Ib), battery-powered, electromechanical control unit intended to provide and monitor the inflation cycle for enhanced circulation therapy.

## SUBSTANTIAL EQUIVALENCE

The indications for use for the Vasculaire Compression System are substantially equivalent to the proposed indications for use for the predicate device. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the Vasculaire System is substantially equivalent to the predicate device.

# TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

There are no FDA performance standards established and required for the proposed device. All necessary bench and clinical testing was conducted on the Vasculaire System to support a determination of substantial equivalence to the predicate device. The preclinical testing performed included:

- Reliability testing of component interactions .
- . Physical bench testing including specification verification and transit testing
- . Software verification and validation
- Electrical safety and electromagnetic compatibility testing .
- Cytotoxicicity testing ●

### SUMMARY

The Vasculaire Compression System is substantially equivalent to the predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MI) 20993-0002

FEB -- 2 201

Venous Health Systems, Inc. c/o Mr. Albert Boniske Regulatory Affairs Project Manager Experien Group, LLC 155-A Moffett Park Drive, Suite 210 Sunnyvale, CA 94089

Re: K103113

Vasculaire Compression System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II-Product Code: JOW Dated: January 7, 2011 Received: January 10, 2011

Dear Mr. Boniske:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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## Page 2 - Mr. Albert Boniske

Enclosure

ff 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.

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/ucm11.5809.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/ResourcesforYou/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

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## SECTION 4 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Vasculaire Compression System

## Indications For Use:

The Vasculaire Compression System is indicated for use in:

- Preventing deep vein thrombosis (DVT) .
- . Enhancing blood circulation
- . Diminishing post-operative pain and swelling
- Reducing wound healing time .
- Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial . and diabetic leg ulcers
- . Treatment of chronic venous insufficiency
- . Reducing edema

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Vision 3 -017-017 Division of Cardiovas 1 12:20 24 510(k) Number