(94 days)
Not Found
No
The description focuses on the electromechanical function of the device for sequential pneumatic compression and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes
The device is described as an "intermittent pneumatic compression system intended to provide sequential compression therapy" for various medical conditions, including preventing DVT, enhancing blood circulation, reducing pain and swelling, and assisting in the healing of ulcers and chronic venous insufficiency. This direct application of compression to treat and alleviate health issues classifies it as a therapeutic device.
No
This device is described as a "compression system" that "provides sequential compression therapy" and is indicated for "preventing deep vein thrombosis (DVT), enhancing blood circulation," and "diminishing post-operative pain and swelling," among other therapeutic uses. There is no mention of it diagnosing any conditions or collecting data for diagnostic purposes.
No
The device description explicitly states that the Vasculaire Compression System includes three components: the Controller, the Sleeve, and the Charger. These are physical hardware components, not solely software.
Based on the provided information, the Vasculaire Compression System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Vasculaire Compression System Function: The Vasculaire Compression System is a physical therapy device that applies external pressure to the lower limbs to improve circulation and prevent blood clots. It does not analyze any biological samples.
- Intended Use: The intended use clearly describes a physical therapy application, not diagnostic testing.
- Device Description: The description details a mechanical system of a controller and sleeves, not equipment for analyzing biological specimens.
Therefore, the Vasculaire Compression System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes
JOW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limb(s)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical setting or home environment.
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)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
1
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 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
PRODUCT 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.
2
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 and |
| controller 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.
3
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.
4
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
5
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 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
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