VENAFLOW SYSTEM, MODEL 30A

K992454 · Aircast, Inc. · JOW · Jan 13, 2000 · Cardiovascular

Device Facts

• Record ID: K992454
• Device Name: VENAFLOW SYSTEM, MODEL 30A
• Applicant: Aircast, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Jan 13, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Prophylaxis for Deep Vein Thrombosis (DVT)

Device Story

VenaFlow System Model 30A is a mechanical compression device used for DVT prophylaxis. It operates by applying pneumatic pressure to the patient's limbs to promote venous blood flow and prevent stasis. Used in clinical settings or hospitals, the device is operated by healthcare professionals. It functions as a pneumatic compression system, delivering intermittent or sequential pressure cycles to the extremities. The output consists of controlled compression, which aids in reducing the risk of thrombus formation. Healthcare providers use the device to manage post-operative or immobile patients at risk for DVT, thereby providing a non-pharmacological benefit for venous thromboembolism prevention.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Pneumatic compression system; consists of a control unit and limb cuffs. Operates via intermittent or sequential air pressure delivery. Designed for clinical use. No specific materials or software algorithms detailed in the provided documentation.

Indications for Use

Indicated for prophylaxis of Deep Vein Thrombosis (DVT) in patients requiring mechanical 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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2000

Mr. Stephen L. Kennev Director of Quality Aircast, Inc. 92 River Road Summit, NJ 07902

K992454 Re: VenaFlow System Model 30A Regulatory Class: II (two) Product Code: JOW November 12, 1999 Dated: Received: November 15, 1999

Dear Mr. Kenney:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Stephen L. Kenney

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 and additionally 809.10 for in vitro diagnostic devices), 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Sot. Lyee L. Lamperle

Celia M. Witten, Ph? Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATION FOR USE STATEMENT

Page 1 of 1

510(k) NUMBER (IF KNOWN): K 992454

VenaFlow System DEVICE NAME: _

INDICATION FOR USE: Prophylaxis for Deep Vein Thrombosis (DVT)

Zite & L
Division of Oil & Gas

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K992454

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Concurrence of CDHR, Office of Device Evaluation (ODE)

Prescription Use | (Per 21 CFR 801.109)

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OR

Over-The -Counter Use (Optional Format 1-2-96)