VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017

K023800 · Aircast, Inc. · JOW · Feb 10, 2003 · Cardiovascular

Device Facts

• Record ID: K023800
• Device Name: VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017
• Applicant: Aircast, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Feb 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Prophylaxis for DVT (Deep Vein Thrombosis)

Device Story

VenaFlow Reusable Calf Aircell is a compression limb sleeve component of the Aircast VenaFlow System. Device functions as a pneumatic compression garment applied to the calf to promote venous blood flow and prevent DVT. Operated by healthcare professionals in clinical settings. Output is mechanical compression of the limb. Benefits include reduced risk of DVT formation in patients at risk.

Clinical Evidence

Bench testing only.

Technological Characteristics

Compression limb sleeve; pneumatic inflation mechanism; reusable calf aircell design; Class II device (21 CFR 870.5800).

Indications for Use

Indicated for prophylaxis of Deep Vein Thrombosis (DVT) in patients requiring compression therapy.

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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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 2003

AIRCASTS, INC. Mr. Stephen L. Kenney Director of Quality 691 Central Avenue Murray Hill, NJ 07974

Re: K023800

Trade Name: Aircast VenaFlow System Regulation Number: 21 CFR 870.5800 Regulation Name: Compression Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: October 23, 2002 Received: November 11, 2002

Dear Mr. Kenney:

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.

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. Stephen L. Kenney

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 (OS) 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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Nelle Tellh
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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: VenaFlow Reusable Calf Aircell

Indications for Use: _Prophylaxis for DVT (Deep Vein Thrombosis)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

K. Ogletree

(Division Sign-Off) Division of Cardiovascular Devices

**510(k) Number** K023800

(Optional Format 3-10-98)

Prescription Use Only