VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) F

K122609 · Venous Health Systems, Inc. · JOW · Dec 21, 2012 · Cardiovascular

Device Facts

• Record ID: K122609
• Device Name: VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) F
• Applicant: Venous Health Systems, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Dec 21, 2012
• 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 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

Mobile, intermittent pneumatic compression system; provides sequential compression to lower limbs. Components: battery-powered electromechanical controller, inflatable multi-cell sleeve (foot/calf or calf-only), and charger. Controller mounts to sleeve for mobility; user selects compression cycles (1-3 cycles/min) and zones (foot/calf or calf-only). System monitors inflation cycles to enhance circulation. Used in clinical or home settings; operated by patients or healthcare providers. Output: mechanical compression of tissue surrounding vasculature. Benefits: DVT prevention, pain/edema reduction, and ulcer healing assistance.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included risk management (ISO 14971), performance verification (airflow rate, operating pressure, pressure leakage/obstruction, venous peak flow velocity), packaging/transit testing, software verification/validation, electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993-1).

Technological Characteristics

Mobile, battery-powered electromechanical controller; multi-cell inflatable sleeves (foot/calf or calf-only). Connectivity: standalone. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 10993-1 (biocompatibility), ISO 14971 (risk management).

Indications for Use

Indicated for patients requiring intermittent pneumatic compression to prevent DVT, enhance circulation, reduce post-op pain/swelling, accelerate wound healing, treat stasis dermatitis, venous/arterial/diabetic leg 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

• Vasculaire Compression System (K103113)
• WizAir DVT™ (K012994)
• ActiveCare++ System (K060146)
• PlexiPulse All-in-1 System (K944567/K981311)

Submission Summary (Full Text)

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#### VENOUS HEALTH SYSTEMS, INC.

# VASCULAIRE COMPRESSION SYSTEM Traditional 510(k): Summary

#### 510(k) SUMMARY

#### 510(k) Notification K _ 122609

#### GENERAL INFORMATION

#### Applicant:

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

#### Contact Person:

Rich Laguna Director Quality Assurance & Operations eMail: [e-mail] Phone: [phone] extension 225 Fax: [phone]

#### Date Prepared: August 24, 2012

#### DEVICE INFORMATION

The Vasculaire Compression System ("Vasculaire System") is a mobile, intermittent pneumatic compression system intended to provide sequential compression therapy to the patient's lower limb(s). The Controller is battery powered, provides selectable compression cycles and system monitoring of the compression therapy. The Sleeves are provided in a foot & calf or a calf only configuration for selectable lower limb(s) compression therapy.

#### Classification:

Compressible Limb Sleeve, 21 CFR§870.5800

Product Code: JOW

Trade Name: Vasculaire Compression System

Generic/Common Name: Compressible Limb Sleeve DEC 2 1 2012

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# 510(k) SUMMARY (Cont.)

# PREDICATE DEVICE(S)

Venous Health Systems, Inc., Vasculaire Compression System (K103113)

Medical Compression Systems (MCS), WizAir DVT™ (K012994)

Medical Compression Systems (MCS), ActiveCare++ "System (K060146)

Kinetic Concepts Inc. (KCI), PlexiPulse All-in-1 System (K944567/K981311)

#### 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

#### PRODUCT DESCRIPTION

The Vasculaire Compression System is a mobile, intermittent pneumatic compression system intended to provide compression therapy to the patient's lower limb(s). The Vasculaire Compression System includes three components: the Controller, the Sleeve and the Charger.

The Sleeve is a multiple-cell bladder intended to be attached directly to the lower limb(s). It is intended to provide compression to the tissue surrounding the vasculature. The Sleeve is provided in two configurations. The first configuration is a foot and calf Sleeve that provides sequential compression to the foot and calf. The second configuration is a calf only Sleeve that provides sequential compression to the calf. The Controller is connected to the Sleeve using two flange ports and can be mounted directly onto the Sleeve for a fully mobile system. The flange ports allow the air from the Controller to effect compression on the foot and calf zones independently. The Controller allows the user to select between foot and calf compression or a calf only compression. The Controller also allows the user to select compression cycles of approximately one to three cycles per minute. 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. The Charger consists of a medical grade power supply and the table top docking station.

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# 510(k) SUMMARY (Cont.)

#### SUBSTANTIAL EQUIVALENCE

The indications for use for the Vasculaire Compression System are equivalent to the 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 efficacy. Thus, the Vasculaire System is a substantially equivalent to the predicate device.

# TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

There is no FDA performance standard required for the Vasculaire Compression System . All necessary bench testing was conducted on the modified Vasculaire System to support determination of substantial equivalence to the predicate devices. The testing performed included:

- ISO 14971:2007 Medical Devices-Application of Risk Management to Medical Devices / . Use & Design Risk analysis
- . Specification bench and performance verification testing; airflow rate, operating pressure, pressure leakage/obstruction, venous peak flow velocity
- . Packaging & Transit testing
- Software verification & validation .
- IEC 60601-1; Medical equipment medical electrical equipment Part 1: General . requirements for basic safety and essential performance
- . IEC 60601-1-2; Medical electrical equipment - part 1: general requirements for safety 2 collateral standard: electromagnetic compatibility - requirements and tests
- . BS EN ISO 10993-1:2009, Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing and the FDA Guidance Document entitled, "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices (G95-1)"

#### SUMMARY

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

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

# DEC 2 1 2012

Venous Health Systems Mr. Rich Laguna 3270 Alpine Rd. Portola Valley, CA 94028

Re: K122609

Trade/Device Name: Vasculaire Compression System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: November 8, 2012 Received: November 8, 2012

#### Dear Mr. Laguna:

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.

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.

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

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Page 2 - Mr. Rich Laguna

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,

# Matthew G. Hillebrenner

for

Bram D. Zuckerman, MD Director, Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### VENOUS HEALTH SYSTEMS, INC.

# VASCULAIRE COMPRESSION SYSTEM TRADITIONAL 510(k)

# SECTION 4

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): _ K122609

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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RH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K122604