VASOPRESS DVT SYSTEM, MODEL VP500D

K061814 · Compression Therapy Concepts, Inc. · JOW · Nov 30, 2006 · Cardiovascular

Device Facts

• Record ID: K061814
• Device Name: VASOPRESS DVT SYSTEM, MODEL VP500D
• Applicant: Compression Therapy Concepts, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Nov 30, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VasoPress pump (VP500D) is an external pneumatic compression device for use with VasoPress DVT garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.

Device Story

VasoPress DVT System (Pump Model VP500D) is an external pneumatic compression device; used with VasoPress DVT garments. Device applies intermittent pneumatic compression to limbs to promote venous blood flow; intended to reduce DVT risk. Operated in clinical or home settings; prescribed by physicians. System consists of electronic pump unit connected to inflatable garments. Output is mechanical compression; assists in preventing venous stasis. Benefits patient by reducing DVT incidence.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and technological comparison.

Technological Characteristics

External pneumatic compression pump; electronic control system; pneumatic output to inflatable limb garments. Class II device (21 CFR 870.5800).

Indications for Use

Indicated for patients at risk of deep vein thrombosis (DVT) to lower risk via external pneumatic compression.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 U 2006

Compression Therapy Concepts, Inc. c/o Mr. Leonard Nass 1750 Brielle Avenue, Suite B6 Wanamassa, NJ 07712

Re: K061814

VasoPress DVT System, Pump Model VP500D Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: October 23, 2006 Received: October 24, 2006

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Duma R. Vochner

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

. . . . . . . . .

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

. . . . . . .

Device Name: VasoPress DVT System, Pump Model VP500D

、

Indications For Use:

The VasoPress pump (VP500D) is an external pneumatic compression device for use with VasoPress DVT garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.

× Prescription Use (Part 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)

Duna R. Vochner

(Division Sigil-Off) (Division Sign-Sign-Sign-Sign-Sign-Sign-Sign-Sign-Sign-Sign-Sign-Sign-Sign-Sign-Seatle-Seat

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510(k) Number Korel8) 4