FIBRACOL* PLUS Collagen Wound Dressing with Alginate is an advanced wound care device composed of collagen and calcium alginate fibers. FIBRACOL PLUS is twice as absorbent as our traditional FIBRACOL* Dressing. Its unique combination of natural biopolymers created by a patented process combines the structural support of collagen and the gel forming properties of alginates into a sterile, soft, absorbent, conformable topical wound dressing. The dressing is manufactured from bovine collagen and medical grade alginate.

The source of collagen is from bovine hide splits from Australia. The hides are from healthy cattle slaughtered under the supervision of a Government appointed Veterinary Officer and subsequently processed further in a controlled clean room in order to avoid the possibility of boyine spongiform encephalpathy (BSE) contamination. The collagen is linked with the calcium alginate using a patented process.

AI/ML Overview

The provided text is a 510(k) summary for the FIBRACOL* PLUS Collagen Wound Dressing with Alginate, a medical device. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study proving performance against defined acceptance criteria.

Therefore, many of the requested sections regarding the study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness are not applicable or cannot be determined from this submission.

Here's an analysis based on the information available:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Comments
Biocompatibility: Device demonstrates acceptable biological response.	Pass. Tests conducted in accordance with ISO 10993 Part 1 Biological Evaluation of Medical Devices (e.g., Agar Overlay Assay, Hemolysis, MEM Elution Test, Muscle Implantation, Systemic Injection, Rabbit Pyrogen Assay, Primary Skin Irritation, Guinea Pig Maximization).	The document states, "FIBRACOL PLUS has been demonstrated to be an acceptable topical wound dressing" and "FIBRACOL PLUS has been demonstrated to be a safe topical wound dressing in accordance with ISO 10993-1." The specific quantitative acceptance criteria for each test (e.g., cytotoxicity levels, irritation scores) are not provided, but the overall conclusion is positive.
Substantial Equivalence: Device is substantially equivalent and identical in function to predicate devices.	Pass. The device is determined to be substantially equivalent to FIBRACOL* Collagen-Alginate Dressing (K925548) and SORBSAN Topical Wound Dressing (K881854, K914575).	This is the primary "acceptance criterion" for a 510(k) submission. The FDA's letter explicitly states, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have found the device is substantially equivalent...".
Absorbency: Twice as absorbent as traditional FIBRACOL* Dressing.	Stated as a physical characteristic: "FIBRACOL PLUS is twice as absorbent as our traditional FIBRACOL* Dressing."	This is a claim of improved performance over a predecessor, but not explicitly stated as an "acceptance criterion" with a defined quantitative threshold for this specific 510(k). The methodology for determining this absorbency difference is not detailed.
Indications for Use: Safe and effective for specified wound types.	Listed indications for use (e.g., Full thickness & partial thickness wounds, Pressure Ulcers, Venous ulcers, Diabetic ulcers, Second-degree burns, Donor sites).	The FDA concurs with the stated indications, with specific labeling limitations (e.g., not for third-degree burns, no claims of accelerating healing). The clinical evidence to support these indications is implicitly covered by substantial equivalence to predicate devices that have these indications.

Study Details (As applicable to a 510(k) for a basic wound dressing)

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Biocompatibility Tests: The 510(k) does not specify the sample sizes for the in vitro and in vivo biocompatibility tests (e.g., number of cells in agar overlay, number of rabbits/mice for animal studies). Data provenance is internal (Johnson & Johnson Medical).
- Substantial Equivalence: No "test set" in the sense of a clinical performance study. Substantial equivalence relies on comparison to predicate devices already on the market.
- Clinical Data: The 510(k) summary does not include explicit clinical study data with a test set of human patients. Typically, for wound dressings of this type, extensive clinical studies are often not required for 510(k) clearance if substantial equivalence can be demonstrated through material characterization, performance testing, and comparison of indications to a predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. For biocompatibility, "ground truth" is established by standard biological testing protocols and expert interpretation of those results by certified labs and regulatory bodies. For substantial equivalence, the "ground truth" is the performance and safety profile of the predicate devices. There's no mention of a ground truth panel of experts for a specific performance test set for this device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication is described in this submission. Biocompatibility test results are typically objective and follow pre-defined criteria, not requiring adjudication in the sense of a clinical expert panel.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a wound dressing, not an AI-powered diagnostic or assistive technology.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical wound dressing, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Biocompatibility: Standardized biological test results (e.g., absence of cytotoxicity, irritation, pyrogenicity) as defined by ISO 10993.
- Substantial Equivalence: The safety and efficacy profile of the predicate devices based on their prior clearances and marketing history.
The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set in that context. The "development" of the device involves material selection, manufacturing process optimization, and testing, not algorithmic training.
How the ground truth for the training set was established:
- Not applicable. As above, no training set in the AI sense. The "ground truth" for the device's design and manufacturing is established through material science, engineering principles, and quality control.

Summary of 510(k) Approach:

This 510(k) submission primarily relies on demonstrating substantial equivalence to legally marketed predicate devices. The "study" that proves the device meets the (implied) acceptance criteria is the comprehensive documentation of its composition, physical properties, indications for use, and a battery of biocompatibility tests (in accordance with ISO 10993). The FDA's clearance letter confirms that, based on this information, the device is substantially equivalent to predicates and can be marketed for the stated indications, subject to specific labeling limitations. The document does not describe a clinical trial with a defined "test set" of patients in the way an AI diagnostic device submission would.

Summary

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510 (k) FIBRACOL* PLUS Collagen Wound Dressing with Alginate

AUG 20 1998

APPENDIX J

510(k) SUMMARY

DATE PREPARED 1.

1 July, 1998

2. SUBMITTER

Johnson & Johnson Medical A Division of Ethicon Inc. 2500 Arbrook Blvd. P.O. Box 90130 Arlington, TX 76004-3130

3. CONTACT PERSON

Terry James Dagnon Regulatory Affairs Project Manager Phone: 817-784-4953 817-784-4992 or 817-784-5292 Fax:

NAME OF THE MEDICAL DEVICE 4.

Classification Name: Common/Usual Name: Proprietary Name:

Dressing. Wound Topical wound dressing FIBRACOL* PLUS Collagen Wound Dressing with Alginate

DEVICE CLASSIFICATION 5.

Unclassified Product Code/Classification Number: Unclassified Regulatory Class:

STATEMENT OF SUBSTANTIAL EQUIVALENCE 6.

FIBRACOL* PLUS Collagen Wound Dressing with Alginate is substantially equivalent and identical in function to FIBRACOL* Collagen-Alginate Dressing (K925548) manufactured by Johnson & Johnson Medical, and SORBSAN Topical Wound Dressing (K881854 Steriseal) & (K914575 Dow B. Hickam) Distributed by Dow Hickam Pharmaceuticals, Inc.

7. INDICATIONS FOR USE

FIBRACOL* PLUS Dressing is indicated for the management of exuding wounds including:

Full thickness & partial thickness wounds .
. Pressure Ulcers
. Venous ulcers
Ulcers caused by mixed vascular etiologies .
. Diabetic ulcers
. Second-degree burns

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Donor sites and other bleeding surface wounds .
. Abrasions
Traumatic wounds healing by secondary intention .
. Dehisced surgical incisions
- . Precautions:

FIBRACOL PLUS Dressing may be used when visible signs of infection are present in the wound area only when proper medical treatment addresses the underlying cause. FIBRACOL PLUS Dressing may be used under compression therapy with healthcare profession supervision.

. Contraindications: FIBRACOL PLUS is not indicated for wounds with active vasculitis, thirddegree burns, or patients with known sensitivity to collagen or alginates.

PHYSICAL DESCRIPTION 8.

9. BIOCOMPATIBILITY

FIBRACOL PLUS has been demonstrated to be an acceptable topical wound dressing.

The following safety testing was conducted in accordance with ISO 10993 Part 1 Biological Evaluation of Medical Devices to support the biocompatibility of this product.

Agar Overlay Assay (L929 Cells) .
Hemolysis (Rabbit RBCs) .
MEM Elution Test .
. Muscle Implantation (Rabbits)
Systemic Injection (Mice) .
Rabbit Pyrogen Assay .
Primary Skin Irritation (Rabbits) .
Guinea Pig Maximization .

In taking all the test results on FIBRACOL. PLUS as a whole, FIBRACOL PLUS has been demonstrated to be a safe topical wound dressing in accordance with ISO 10993-1.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or banner. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 2007

Mr. Terry J. Dagnon Regulatory Affairs Project Manager Johnson & Johnson Medical, Inc. 2500 Arbrook Blvd. P.O. Box 90130 Arlington, Texas 76004

K982597 Re:

R962397
Trade Name: Fibracol Plus Collagen Wound Dressing with Alginate Regulatory Class: Unclassified Product Code: KGN Dated: July 23, 1998 Received: July 24, 1998

Dear Mr. Dagnon:

This letter corrects our substantially equivalent letter of August 20, 1998.

We have reviewed your Section 510(k) premarket notification of intent to market the We have reviewed your Section 910(x) premised is substantially equivalent (for the device referenced above and have closure) to legally marketed predicate devices marketed
indications for use stated in the enclose and states of the Medical Device indications for use stated in the chelosare) to together date of the Medical Device in in interstate commerce prior to May 20, 1770, the enordance with the provisions of
Amendments or to devices that have been reclassified in accordance approvel of a Amendments of to devices that have been (Act) that do not require approval of a
the Federal Food, Drug, and Cosmetic Act (Act) that do not requires aubicot to the the Federal Food, Drug, and Cosment Act (10) interess, subject to the general
premarket approval (PMA). You may, therefore, market the device, subject to the general premarket approval (1 Mrx). Tou may, arontrols provisions of the Act include controls provisions of the Act. "The gentiral of devices, good manufacturing practice,
requirements for annual registration, listing of devices and the following requirements for annual registration, nealing or and adulteration and the following limitations:

This device may not be labeled for use on third degree burns.
This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.

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Page 2 - Mr. Terry J. Dagnon

This device may not be labeled as a treatment or a cure for any type of wound.

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

This letter will allow you to continue 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.

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Page 3 - Mr. Terry J. Dagnon

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 10 . You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Milliken

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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K982597 510(k) Number :

Johnson & Johnson Medical Applicant: A Division of Ethicon Inc. 2500 Arbrook Blvd. Arlington, TX 76004-3130

Device Name: FIBRACOL* PLUS Collagen Wound Dressing with Alginate (FIBRACOL PLUS)

Indications for Use: FIBRACOL* PLUS Dressing is indicated for the management of exuding wounds including:

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

Precautions:

Contraindications:

FIBRACOL PLUS is not indicated for wounds with active vasculitis, third-degree burns, or patients with known sensitivity to collagen or alginates.

(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 General Restorative Devices
510(k)Number	KG823597

Prescription Use	Or Over-The-Counter Use
(Per 21 CFR 801.109)

Trademark

Regulation Number and Section

N/A