The Vasculaire Compression System is a mobile, intermittent pneumatic compression system intended to provide sequential compression therapy to the lower limb(s) in the clinical setting or home environment.

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 Description

The Vasculaire Compression System is a mobile, intermittent pneumatic compression system intended to provide compression therapy to the lower limb(s) in the clinical setting or home environment. 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 lb.), 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vasculaire Compression System:

Summary of Acceptance Criteria and Device Performance:

The document provided does not contain specific quantitative "acceptance criteria" for device performance in terms of clinical efficacy (e.g., a specific percentage reduction in DVT or improved blood flow measurement). Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This means that the device is considered acceptable if it performs similarly to already legally marketed devices and does not raise new safety or efficacy concerns.

The "device performance" reported is primarily in relation to meeting various regulatory and safety standards, and mitigating hazards, rather than quantifiable clinical outcomes directly.

Here's a table summarizing the "acceptance criteria" inferred from the document and the "reported device performance":

Acceptance Criteria (Inferred)	Reported Device Performance
Substantial Equivalence:	The Vasculaire Compression System's indications for use are equivalent to the predicate devices. Differences in technological characteristics do not raise new safety or efficacy issues. The device is deemed substantially equivalent to the predicate.
Risk Management:	Complies with ISO 14971:2007 (Medical Devices-Application of Risk Management). Includes Home Use & Design Risk analysis.
Biocompatibility:	Complies with BS EN ISO 10993-1:2009 (Biological Evaluation of Medical Devices) and FDA Guidance Document "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices (G95-1)."
Usability/Human Factors:	Complies with ANSI/AAMI/IEC 62366:2007 (Medical devices - Application of usability engineering to medical devices). A Human Factors and Usability validation study was performed for home environment use.
Home Use Safety:	Identified and mitigated home use hazards through design (e.g., elimination of external air tubing and controller attached power cords to prevent tethered trips & falls, and tubing induced skin injury). Conducted MAUDE review and market surveillance search for use hazards. Performed a Home Use/User Failure Modes Effects Analysis (HUFMEA). Conducted a Home Usability Validation Study.

Study Details:

The document describes several essential tests and analyses conducted to support the substantial equivalence claim, rather than a single large-scale clinical efficacy study with specific test sets, ground truths, or expert adjudications in the typical sense of AI/diagnostic device evaluation.

Sample sizes used for the test set and the data provenance:
- The document does not specify sample sizes for a "test set" in the context of clinical performance data. The studies mentioned (Biocompatibility, Usability, Risk Analysis) involve different types of samples relevant to their specific methodologies (e.g., materials for biocompatibility, users for usability testing, potential failure modes for risk analysis).
- Data provenance: Not explicitly stated as "country of origin" for clinical data. The tests are general regulatory compliance tests. The Human Factors and Usability validation was for the "home environment" which implies a realistic use context. It is a retrospective analysis of MAUDE data. The usability validation study would be prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The studies listed are regulatory and engineering compliance tests, not studies requiring expert consensus on a diagnostic outcome. For instance, biocompatibility involves laboratory testing, and usability involves observing users, not clinical experts establishing a ground truth for a medical condition.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable/provided for the types of tests described. These tests do not involve diagnostic or interpretive outcomes that would require adjudications.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The Vasculaire Compression System is a physical medical device (intermittent pneumatic compression system), not an AI-powered diagnostic tool that assists human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a treatment device, not a diagnostic algorithm. Its performance is inherent in its physical operation and effect on the limb, not in an independent algorithm's output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Again, this concept of "ground truth" (in the context of diagnostic accuracy) is not applicable here. The "truth" for the various tests would be:
  - Risk Management: Identification of potential hazards and successful mitigation through design changes.
  - Biocompatibility: Material properties meeting established safety standards (e.g., non-cytotoxic, non-irritating).
  - Usability: Observation of users successfully and safely operating the device in the intended environment, without critical errors.
  - Substantial Equivalence: A determination made by the FDA based on comparison to predicate devices, not an empirically established clinical ground truth.
The sample size for the training set:
- This information is not provided and not applicable as there is no "training set" in the context of an AI or machine learning model for this physical medical device.
How the ground truth for the training set was established:
- This information is not applicable for the same reasons as #7.

Summary

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SECTION 5 510(k) SUMMARY (Cont.)

JUL 1 8 2013

510(k) Notification K 131046

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:

Rich Laguna Director Quality Assurance & Operations eMail: Rlaguna@venoushealth.com Phone: 650-646-3327 extension 225 Fax: 650-854-4722

Date Prepared: February 24, 2013

DEVICE INFORMATION

The Vasculaire Compression System ("Vasculaire System") is a mobile, intermittent pneumatic compression system intended to provide sequential compression therapy to the lower limb(s) in the clinical setting or home environment. 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 ("Vasculaire System") VASCULAIRE SLEEVE (FOOT & CALF) VASCULAIRE SLEEVE (CALF)

Generic/Common Name: Compressible Limb Sleeve

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SECTION 5

510(k) SUMMARY (Cont.)

PREDICATE DEVICE(S)

Venous Health Systems, Inc., / Vasculaire Compression System (K122609) Covidien / Kendall SCD™ 700 Sequential Compression (K120944)

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

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SECTION 5 510(k) SUMMARY (Cont.)

SUBSTANTIAL EQUIVALENCE

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

TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

There is no FDA performance standard required for the Vasculaire Compression System. All necessary 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 / Home Use & Design Risk analysis
. 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)"
. ANSI/AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices / Human Factors and Usability validation for the usability of the Vasculaire Compression System in the home environment

Vasculaire Compression System substantiation for Home Use

Use Hazard(s) Identification Manufacturers and User Facility Device Experience o (MAUDE) review and market surveillance search
o Home use hazard(s) mitigation through design

MDR Identified Hazards	Design Mitigation
Tethered trips & falls	Elimination of external air tubing andcontroller attached power cords.
Tethered limited range of movement
Tubing induced skin injury

Home Use/User Failure Modes Effects Analysis (HUFMEA) 0
Home Usability Validation Study o

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 & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G604 Silver Spring, MD 20993-0002

July 18, 2013

Venous Health Systems. Inc. Rich Laguna 3270 Alpine Road Portola Valley, CA 94028

Re: K131046

Trade/Device Name: Vasculaire Compression System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: II Product Code: JOW Dated: June 19, 2013 Received: June 19, 2013

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 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 clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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,

M.A. Hillerman

for Bram 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.

SECTION 4 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K131046

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)

M.A.Lillehammer

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).