FERRIS POLYOSTOMY STERILE WOUND DRESSING by FERRIS MFG. CORP.

The provided text is a 510(k) clearance letter from the FDA for a device called "PolyOstomy Sterile Wound Dressing". This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, device performance studies, or details about ground truth, sample sizes, expert qualifications, or adjudication methods.

The letter is a regulatory approval document and focuses on the administrative aspects of device clearance rather than the detailed technical and clinical study data used to establish substantial equivalence. To answer your request, one would typically need access to the actual 510(k) submission, which would include the performance data and supporting studies.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 27 1999

Mr. Theodore R. Thorsen Directory, Ouality Assurance Ferris Manufacturing Corporation 16W300 83rd Street Burr Ridge, Illinois 60521

Re: K991729

Trade Name: PolyOstomy Sterile Wound Dressing Regulatory Class: Unclassified Product Code: KMF Dated: July 14, 1999 Received: July 15, 1999

Dear Mr. Thorsen:

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 requirement, as set forth in the Quality System Regulation (OS) 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. Theodore R. Thorsen

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 (301) 594-4595. 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" (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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Neil R.P. Ogden
Colin M. Winter Ph.D., P.Eng.

Celia M. Witten, Ph.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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COULL PART SURVE

1779

Page I of

510(K) NUMBER (IF KNOWN) : _ K991729

DEVICE NAME: FERRIS POLYOSTOMY STERILE WOUND DRESSING

INDICATIONS FOR USE:

Ostomy Tube Sites

Drainage Tube Sites

Gastrointestinal Tube Sites

Feeding Tube Sites

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter-Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

Regulation Number and Section

§ 880.5090 Liquid bandage.

(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.