PROMOGRAN Matrix Wound Dressing is a sterile primary dressing comprised of a freeze-dried composite of 55% collagen and 45% oxidised regenerated cellulose. (Ratios are presented as weight-to-weight).

AI/ML Overview

This document is a 510(k) summary for the PROMOGRAN Matrix Wound Dressing. It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor any of the specific details requested in the prompt (e.g., sample sizes, expert qualifications, ground truth methods, or MRMC studies).

The document is a regulatory submission for premarket notification, focusing on establishing equivalence for marketing purposes. It highlights biocompatibility studies showing the device to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic, but these are general safety assessments, not performance criteria with associated studies as requested.

Summary

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SECTION 2 – 510(k) SUMMARY

FEB 1 4 2002

PROMOGRAN Matrix Wound Dressing

Submitter's Name andAddress:	Johnson & Johnson Medical Ltd.GargraveSKIPTONNorth YorkshireBD23 3RXUnited Kingdom
Contact Person	Sergio Gadaleta, PhDSenior Project ManagerJohnson & Johnson Wound Management Worldwidea Division of Ethicon, Inc.Telephone: 908-218-2893Facsimile: 908-218-2595e-mail: sgadalet@ethus.jnj.com
Name of Medical Device	Classification Name: Dressing, WoundCommon/Usual Name: DressingProprietary Name: PROMOGRAN Matrix Wound Dressing
Substantial Equivalence	PROMOGRAN Matrix Wound Dressing is substantially equivalent to:FIBRACOL Plus Collagen Dressing with Alginate (K982597)manufactured by Johnson & Johnson Medical Ltd., Gargrave,SKIPTON, BD23 3RX, United Kingdom
Device Classification	Currently, wound dressings containing animal derived materials areunclassified by United States Food and Drug Administration's Centerfor Devices and Radiological Health
Device Description	PROMOGRAN Matrix Wound Dressing is a sterile primary dressingcomprised of a freeze-dried composite of 55% collagen and 45%oxidised regenerated cellulose. (Ratios are presented as weight-to-weight).

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Indications for Use

The PROMOGRAN Matrix Wound Dressing is indicated for the management of exuding wounds including:

Diabetic ulcers .
Venous ulcers .
Ulcers caused by mixed vascular etiologies ●
Full thickness and partial thickness wounds .
Donor sites and other bleeding surface wounds .
Abrasions .
Traumatic wounds healing by secondary intention .
Dehisced surgical wounds .

Biocompatibility studies have demonstrated PROMOGRAN Matrix Wound Dressing to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic.

Safety

PROMOGRAM Matrix Wound Dressing Johnson & Johnson Wound Management Worldwide, a Division of Ethicon Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2002

Johnson & Johnson Medical Ltd. c/o Sergio Gadaleta, Ph.D. Senior Project Manager Johnson & Johnson Wound Management Worldwide Route 22 West P.O. Box 151 Somerville, New Jersey 08876

Re: K014129

Trade/Device Name: PROMOGRAN Regulatory Class: Unclassified Product Code: FRO Dated: December 13, 2001 Received: December 17, 2001

Dear Dr. Gadaleta:

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 for ass barner 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.

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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Sergio Gadaleta, Ph.D.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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). 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,

iriam C. Provost

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

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): _ K0|4|29

Device Name: PROMOGRAN Matrix Wound Dressing

Indications for Use:

PROMOGRAN Matrix Wound Dressing is intended for the management of exuding wounds including:

Diabetic ulcers .
. Venous ulcers
Pressure ulcers .
Ulcers caused by mixed vascular etiologies ●
Full thickness and partial thickness wounds .
Donor sites and other bleeding surface wounds ●
Abrasions ●
Traumatic wounds healing by secondary intention ●
Dehisced surgical wounds ●

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ________________

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

K014129 510(k) Number --

PROMOGRAM Matrix Wound Dressing Johnson & Johnson Wound Management Worldwide, a Division of Ethicon Inc.

Regulation Number and Section

N/A