VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017 by AIRCAST, INC.

This device is a Class II compression limb sleeve, and the document is a 510(k) premarket notification. The FDA's 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials with detailed performance criteria and statistical analyses common for novel high-risk devices or software as a medical device (SaMD).

Therefore, based solely on the provided text, the specific information requested about acceptance criteria, detailed study design, sample sizes, expert qualifications, and ground truth establishment is not available. The document pertains to the regulatory clearance of a physical medical device, the Aircast VenaFlow System, based on its equivalence to previously marketed devices.

The text does not contain:

A table of acceptance criteria and reported device performance.
Details on sample sizes, provenance, or specific test sets used.
Information about the number or qualifications of experts for ground truth.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance.
Type of ground truth used (e.g., pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

The FDA's review for this type of device typically focuses on aspects like:

Intended Use: The indicated use for prophylaxis of DVT is stated.
Technological Characteristics: How the device functions (e.g., compression) and its materials.
Performance Data (Bench and/or limited clinical): Often involves testing against recognized standards or comparing performance to the predicate device in a more limited scope than a full clinical trial. However, the details of these tests are not provided in this summary letter.

In summary, the provided document is a regulatory clearance letter, not a detailed study report. It confirms the device's substantial equivalence to a predicate, allowing it to be marketed, but does not offer the granular information requested about specific acceptance criteria and detailed study methodologies.

Summary

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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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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Page 1_of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: VenaFlow Reusable Calf Aircell

Indications for Use: _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)

K. Ogletree

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K023800

(Optional Format 3-10-98)

Prescription Use Only

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
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.(b)
Classification. Class II (performance standards).