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 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.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the Vasculaire Compression System, focusing on the absence of acceptance criteria and a study proving their fulfillment:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
None specified	None specified

Explanation: The provided 510(k) summary does not contain any explicit acceptance criteria for the Vasculaire Compression System, nor does it present specific performance metrics from a study against such criteria. The submission focuses on demonstrating substantial equivalence to a predicate device based on indications for use and technological characteristics, rather than meeting quantitative performance targets.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the given 510(k) summary. The document mentions "clinical testing" but does not detail the nature of these tests, including sample sizes or data provenance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the given 510(k) summary. Given the absence of detailed clinical study results, there's no mention of ground truth establishment by experts.

4. Adjudication Method for the Test Set

This information is not provided in the given 510(k) summary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in the provided 510(k) summary. The device is a physical compression system, not an AI or imaging diagnostic tool that would typically involve human reader performance comparison with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable to the Vasculaire Compression System. This device is a physical, electromechanical system and does not involve an "algorithm only" component in the way a diagnostic AI would. Its performance is inherent in its mechanical operation and physiological effects, not in a standalone algorithmic assessment.

7. Type of Ground Truth Used

This information is not provided in the given 510(k) summary. As no specific clinical study data is presented, the type of ground truth used is not mentioned.

8. Sample Size for the Training Set

This information is not provided in the given 510(k) summary. The term "training set" is typically associated with AI algorithm development, which is not the primary focus or nature of this device's submission.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the given 510(k) summary. As mentioned above, the concept of a "training set" and its associated ground truth establishment is not relevant to the described device and its substantial equivalence submission.

Summary of the Document's Focus:

The provided 510(k) summary for the Vasculaire Compression System focuses on demonstrating substantial equivalence to an existing predicate device (Medical Compression Systems, ActiveCare + System - K060146). This type of submission relies on showing that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Rather than providing detailed clinical study results with specific acceptance criteria and performance metrics, the document lists preclinical testing categories such as:

Reliability testing of component interactions
Physical bench testing (specification verification and transit testing)
Software verification and validation
Electrical safety and electromagnetic compatibility testing
Cytotoxicity testing

These tests are typically conducted to ensure the device functions as intended and safely, but they are not presented as meeting specific, predefined acceptance criteria with reported performance values in the context of a clinical outcome study. The FDA's clearance is based on the determination of substantial equivalence, not necessarily on a comparative effectiveness study with quantitative acceptance criteria for clinical outcomes.

Summary

{0}------------------------------------------------

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: 650-646-3327 Fax: 650-854-4772

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: 408-400-0856 Fax: 408-400-0865

Date Prepared: October 18, 2010

DEVICE INFORMATION

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)

{1}------------------------------------------------

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

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.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

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.

{3}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 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

{4}------------------------------------------------

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)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
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.(b)
Classification. Class II (performance standards).