(116 days)
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
The Vasculaire Compression 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.
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.
The provided text describes a 510(k) submission for the Vasculaire Compression System, which is a mobile, intermittent pneumatic compression system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than robust, clinical performance studies with detailed acceptance criteria as one might see for novel technologies. Therefore, many of the requested details about acceptance criteria, specific study designs, and ground truth are not present in this summary.
Based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results in the manner typically associated with clinical efficacy or diagnostic accuracy studies. Instead, it lists the types of testing conducted to support substantial equivalence.
| Acceptance Criteria Category (Implied) | Performance/Testing Conducted |
|---|---|
| Risk Management | ISO 14971:2007 (Use & Design Risk analysis) |
| Performance Verification | Specification bench testing (airflow rate, operating pressure, pressure leakage/obstruction, venous peak flow velocity) |
| Packaging and Transit | Packaging & Transit testing |
| Software Verification | Software verification & validation |
| Electrical Safety | IEC 60601-1 (Basic safety and essential performance) |
| Electromagnetic Compatibility | IEC 60601-1-2 (EMC requirements and tests) |
| Biocompatibility | BS EN ISO 10993-1:2009 and FDA Guidance Document "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices (G95-1)" |
Note: The document explicitly states, "There is no FDA performance standard required for the Vasculaire Compression System." This implies that the 'acceptance criteria' were primarily internal benchmarks derived from the predicate devices and relevant industry standards for safety and basic functionality.
2. Sample Size for the Test Set and Data Provenance
The document does not describe a clinical "test set" in the context of human subjects or patient data. The testing mentioned (bench testing, software verification, etc.) would be performed on the device itself or its components. Therefore, information on sample size and data provenance (country, retrospective/prospective) is not applicable or provided for such testing.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not applicable and not provided. The testing described does not involve expert adjudication or ground truth establishment by clinical experts in the sense of reviewing patient data. The 'ground truth' for bench testing would be the engineering specifications and established standards.
4. Adjudication Method
Not applicable and not provided. There was no clinical data requiring adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The submission is for a physical medical device (compression system), not an AI or imaging diagnostic tool that would typically involve a multi-reader study. The stated purpose of the 510(k) is to demonstrate substantial equivalence to predicate devices based on safety and performance characteristics, not to quantify improvements in human reader performance with AI assistance.
6. Standalone Performance Study (Algorithm Only)
Not applicable and not provided. The device is a physical medical system, not a software algorithm or AI model that would have a standalone performance.
7. Type of Ground Truth Used
For the various bench and engineering tests, the "ground truth" would be established by:
- Engineering Specifications: Designed parameters for airflow, pressure, leakage, etc.
- Industry Standards: Requirements specified in ISO, IEC, and BS EN standards for medical devices (e.g., electrical safety, electromagnetic compatibility, biocompatibility).
- Predicate Device Characteristics: Performance parameters of the legally marketed predicate devices to which the Vasculaire System is claiming substantial equivalence.
There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this device's testing.
8. Sample Size for the Training Set
Not applicable and not provided. This device is not an AI/ML system that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable and not provided, as there is no training set for this device.
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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: 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: 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 (800) 638-2041 or (301) 796-7100 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
§ 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).