(116 days)
Not Found
No
The description focuses on electromechanical components and selectable compression cycles, with no mention of AI/ML terms or data-driven decision making.
Yes
The device is indicated for medical conditions such as preventing DVT, enhancing blood circulation, diminishing post-operative pain and swelling, treating chronic venous insufficiency, and healing ulcers, which are all therapeutic uses.
No
The device is a therapeutic compression system designed to prevent DVT, enhance circulation, and aid in healing, rather than diagnose conditions.
No
The device description clearly outlines hardware components: a Controller (electromechanical control unit), Sleeves (multiple-cell bladders), and a Charger (power supply and docking station). The software is part of the Controller's functionality but is not the sole component of the medical device.
Based on the provided information, the Vasculaire Compression System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended uses listed are all related to applying physical compression to the lower limbs for therapeutic purposes (preventing DVT, enhancing circulation, reducing pain/swelling, treating ulcers, etc.). These are all in vivo applications, meaning they are applied directly to the patient's body.
- Device Description: The description details a system that provides intermittent pneumatic compression through sleeves attached to the patient's limbs. This is a mechanical therapy, not a diagnostic test performed on biological samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Vasculaire Compression System does not fit this definition.
N/A
Intended Use / 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 codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limb(s), foot, calf
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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)"
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K103113, K012994, K060146, K944567/K981311
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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.
2
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.
3
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
4
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
5
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