FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE

• K Number: K982597
• Device Name: FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE
• Manufacturer: JOHNSON & JOHNSON MEDICAL, INC.
• Date Cleared: 1998-08-20 ( 27 days)
• Product Code: KGN
• Regulation Number: N/A

Intended 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

Device Description

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.

Predicate Devices

K925548, K881854, K914575

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the material composition and physical properties of a wound dressing, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".

Therapeutic

Yes
The device is a wound dressing indicated for the management of various types of wounds, which are medical conditions, and its purpose is to aid in the healing process of these wounds. This falls under the definition of a therapeutic device as it treats or manages a disease or condition.

Diagnostic

No

The device is a wound dressing designed to manage exuding wounds, not to diagnose medical conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a wound dressing composed of collagen and calcium alginate fibers, which are physical materials, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly describes the device as a wound dressing for managing exuding wounds. This is a topical application for wound care, not a test performed on a sample taken from the body to diagnose a condition.
• Device Description: The description details the composition and function of the dressing as a topical wound care product. It doesn't mention any components or processes related to analyzing biological samples.
• Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), diagnostic purposes, or any of the typical characteristics of an IVD device.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic wound dressing applied externally.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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:

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.

Product codes

KGN

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

FIBRACOL PLUS Dressing may be used under compression therapy with healthcare profession supervision.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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.

Key Metrics

Not Found

Predicate Device(s)

K925548, K881854, K914575

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

0

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: [phone] 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

1

• 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.

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.

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.

2

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:

1. This device may not be labeled for use on third degree burns.

2. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.

3. 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

4. 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.

4

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 [phone]. 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 [phone] or [phone] 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:

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, 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