AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS

K964238 · Aircast, Inc. · JOW · Sep 8, 1997 · Cardiovascular

Device Facts

• Record ID: K964238
• Device Name: AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS
• Applicant: Aircast, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Sep 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The cuff is a part of the VenaFlow System Indication for use is as a prophylaxis for DVT (Deep Vein Thrombosis)

Device Story

Aircast VenaFlow Sterile Disposable Cuff functions as a component of the VenaFlow System; provides mechanical compression to limbs to prevent Deep Vein Thrombosis (DVT). Device is a sterile, single-use sleeve applied to patient limbs; operates via pneumatic inflation/deflation cycles controlled by the VenaFlow System pump. Used in clinical settings; applied by healthcare professionals. Output is physical compression of the limb; aids in venous blood flow return to reduce DVT risk.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use comparison to existing predicate technology.

Technological Characteristics

Sterile, disposable pneumatic cuff; designed for use with VenaFlow System pump. Mechanical compression principle; non-powered component (requires external pump).

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
SEP - 8 1997
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20856

Mr. Stephen L. Kenney
Director of Quality
Aircast, Incorporated
P.O. Box 709
92 River Road
Summit, New Jersey 07902-0709

Re: K964238
AIRCAST Sterile VenaFlow™ Disposable Cuff
Regulatory Class: II (Two)
Product Code: 74 JOW
Dated: July 24, 1997
Received: July 29, 1997

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 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). 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 regulations 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 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 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" (21 CFR 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/dsmamain.html."

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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870·5800 - JOW II - Compressible Limb Slee

510(k) Number (if known): K 964238

Device Name: Aircast Venaflow Sterile Disposable Cuff

Indications For Use:
- Same as the predicate device
- The cuff is a part of the VenaFlow System
- Indication for use is as a prophylaxis for DVT (Deep Vein Thrombosis)

(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, Respiratory, and Neurological Devices
510(k) Number K964238

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)