(104 days)
Not Found
No
The document describes a standard intermittent pneumatic compression system with electromechanical control and does not mention any AI or ML components or functionalities.
Yes
The device is intended to prevent DVT, enhance blood circulation, diminish pain and swelling, reduce wound healing time, treat various ulcers, treat chronic venous insufficiency, and reduce edema, all of which fall under therapeutic applications.
No
This device is a therapeutic device that applies compression to the lower limbs to prevent DVT, enhance circulation, and treat conditions like ulcers and edema. It does not perform any diagnostic functions.
No
The device description clearly outlines hardware components including a Patient Sleeve (multiple-cell bladder), a Controller (electromechanical control unit), and a Charger. The performance studies also include physical bench testing and electrical safety testing, indicating hardware is a significant part of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Vasculaire Compression System is a physical device that applies external compression to the lower limbs. It works by mechanically enhancing blood circulation and reducing swelling.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. Its function is entirely external and mechanical.
- Intended Use: The intended uses listed (preventing DVT, enhancing circulation, reducing pain/swelling, treating ulcers, etc.) are all related to physical therapy and circulatory support, not diagnostic testing of biological samples.
Therefore, the Vasculaire Compression System falls under the category of a therapeutic or physical medicine device, not an in vitro diagnostic device.
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 .
- 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 codes (comma separated list FDA assigned to the subject device)
JOW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limbs, lower limb, foot and 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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.
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
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
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.
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
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.
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