VENAFLOW SYSTEM, MODEL 30A by AIRCAST, INC.

The provided document is a 510(k) clearance letter from the FDA for a device called the "VenaFlow System Model 30A." This type of letter indicates that the device has been found substantially equivalent to a legally marketed predicate device, thereby permitting its market entry.

However, the document does not contain any information about specific acceptance criteria or a study that proves the device meets such criteria.

The 510(k) pathway primarily relies on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics as a predicate device, or if it has different technological characteristics, that the new device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness. This often involves comparing device specifications, materials, and intended use to a previously cleared device, rather than requiring extensive clinical trials with predefined performance metrics like those for a Premarket Approval (PMA) application or a de novo classification.

Therefore, I cannot provide the requested information, including:

A table of acceptance criteria and the reported device performance: This information is not present in the 510(k) clearance letter.
Sample size used for the test set and the data provenance: No test set information is provided.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no such study is described.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The document only states the device's name ("VenaFlow System Model 30A"), its indication for use ("Prophylaxis for Deep Vein Thrombosis (DVT)"), and its regulatory class (Class II). It confirms that the FDA reviewed the 510(k) notification and determined substantial equivalence.

Summary

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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 (301) 594-4648. 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 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 (800) 638-2041 or (301) 443-6597 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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTIUNE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDHR, Office of Device Evaluation (ODE)

Prescription Use | (Per 21 CFR 801.109)

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

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).