VASOGRAD DVT COMPRESSION GARMENT

K102732 · Compression Therapy Concepts · JOW · Oct 19, 2010 · Cardiovascular

Device Facts

• Record ID: K102732
• Device Name: VASOGRAD DVT COMPRESSION GARMENT
• Applicant: Compression Therapy Concepts
• Product Code: JOW · Cardiovascular
• Decision Date: Oct 19, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VasoGrad DVT Compression Garment is an external pneumatic compression device for use with VasoPress DVT Pumps, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.

Device Story

VasoGrad DVT Garment (Model-VG530) is an external pneumatic compression sleeve; designed for use with VasoPress DVT Pumps. Device functions as a limb sleeve to provide intermittent pneumatic compression; aids in venous blood flow to reduce DVT risk. Used in clinical or home settings under physician prescription. Output is mechanical compression of the limb; affects patient hemodynamics to prevent thrombus formation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

External pneumatic compression sleeve; designed for use with VasoPress DVT Pumps. Class II device; Product Code JOW. Mechanical operation via pneumatic inflation/deflation cycles.

Indications for Use

Indicated for patients at risk of deep vein thrombosis (DVT) to lower the risk of DVT development.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

OCT 1 9 2010

Compression Therapy Concepts, Inc. c/o Mr. Leonard Nass 35 James Way Eatontown, NJ 07724

Re: K102732

Trade/Device Name: VasoGrad DVT Garment, Model-VG530 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: September 21, 2010 Received: September 22, 2010

Dear Mr. Nass:

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.

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Page 2 - Mr. Leonard Nass

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/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/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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

Enclosure

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Indications for Use Statement

OCT 1 9 2010

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K102732 510(k) Number:

VasoGrad DVT Compression Garment Device Name:

Indications for Use:

The VasoGrad DVT Compression Garment is an external pneumatic compression device for use with VasoPress DVT Pumps, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.

Prescription Use × (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off)
Division of Cardiovascular Devices
510(k) Number K102732