The Keratec Wound Dressings may also be used under guidance of a health care professional in the management of the following types of dry, light and moderately exudating partial and full thickness wounds:

Pressure (stage I-IV) and venous stasis ulcers
Ulcers caused by mixed vascular etiologies
Diabetic ulcers
Donor sites and grafts

Keragel is intended for dry to moderately exuding wounds, Keraderm for low to highly exuding wounds and Kerafoam for moderately exuding wounds to highly exuding wounds.

The Keratec Wound Dressings are not intended to be used on third degree burns.

Device Description

The Keratec Keragel, Kerafoam and Keraderm Wound Dressings (Keratec Wound Dressings) are designed as chronic wound treatment devices for dry to heavily exuding wounds. The Keratec Wound Dressings are sterile, single-use wound care dressings that include keratin proteins derived from sheep wool for use in moist wound management.

The primary mode of action of keratin containing dressings Keragel, Keraderm and Kerafoam is to absorb and interact with wound fluids to form a soft, hydrophilic keratin gel that facilitates a moist wound healing environment. The secondary mode of action is to provide the cells in the wound with a friendly structural framework that allows cellular migration where no framework exists.

Keragel is a gel dressing that provides moisture to dry wound beds by using water. emollients, and biocompatible thickeners in a similar manner to other hydrogels.

Kerafoam is a keratin film coated on a polyurethane foam substrate for use in multilayered advanced wound dressings. The keratin film is in matrix form with soluble keratin proteins. The Kerafoam product forms a gel when in contact with wound exudates. The Kerafoam provides the exudate management features of other advanced moist wound dressings.

Keraderm is open-celled foam derived from freeze-dried keratin protein. Keraderm is re-absorbed into the developing tissue without traumatic dressing changes. Keraderm provides a bio-absorbable "scaffold" for the rapid growth of new tissue in three dimensions. Keraderm is provided in an acellular form of keratin protein.

AI/ML Overview

The Keratec Wound Dressings (Keratec Keragel, Kerafoam, and Keraderm) are wound care dressings containing keratin proteins from sheep wool, intended for moist wound management.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not include specific quantifiable acceptance criteria in a tabular format with corresponding reported device performance metrics. Instead, it relies on a comparison to predicate devices and a general statement of positive performance testing.

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Device does not cause adverse effects.	"safety testing has been performed to support the use of keratin in the Keratec Wound Dressing, demonstrating that the dressings do not cause adverse effects." "All of the testing showed that the dressings function as intended without adverse effects."
Efficacy/Functionality: Device functions as intended.	"Performance testing has been conducted that confirms that the Keratec Wound Dressings are able to function as intended without causing damage to the tissues." "All of the testing showed that the dressings function as intended without adverse effects." "The primary mode of action of keratin containing dressings...is to absorb and interact with wound fluids to form a soft, hydrophilic keratin gel that facilitates a moist wound healing environment." "The secondary mode of action is to provide the cells in the wound with a friendly structural framework that allows cellular migration where no framework exists."
Biocompatibility: Device is compatible with biological systems.	"biocompatibility...testing ha[s] been performed"
Substantial Equivalence to Predicate Devices:	"The similarities in intended use, technical specifications, and functional performance between the Keratec Wound Dressings and the Biocore Medical Technologies Inc. MediFil Collatek Hydrogel (K022995), the Johnson & Johnson Collagen ORC Antimicrobial Matrix (K033523), the Medical Technologies Collatek Foam (K012997) and the Cook Biotech (Healthpoint) (K061711) Oasis Wound Matrix leads to a conclusion of substantial equivalence between the proposed and predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

The summary states that "Extensive bench, biocompatibility, animal and clinical testing have been performed." However, it does not specify the sample size for any of these test sets. The provenance of the data (country of origin, retrospective or prospective) is not explicitly mentioned for these tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the 510(k) summary. The document does not detail how specific ground truths for "safety" or "efficacy" were established by experts for the performance testing.

4. Adjudication Method for the Test Set

The adjudication method (e.g., 2+1, 3+1) for establishing ground truth in performance testing is not specified in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This device is a wound dressing, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The Keratec Wound Dressings are physical medical devices (dressings) and do not involve an algorithm or AI. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The document broadly refers to "safety and efficacy" demonstrated through "bench, biocompatibility, animal and clinical testing." This implies that the ground truth for these tests would have been established through:

Bench Testing: Engineering specifications, material properties, absorption rates (measurable parameters).
Biocompatibility Testing: Standards-based biological response (e.g., cytotoxicity, sensitization, irritation).
Animal Testing: Physiological responses, wound healing rates, tissue integration in animal models.
Clinical Testing: Clinical outcomes related to wound healing, adverse event rates, patient comfort (likely adjudicated by healthcare professionals, though not explicitly stated).

8. The Sample Size for the Training Set

This question is not applicable as the Keratec Wound Dressings are not AI/ML devices that require a "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as the Keratec Wound Dressings are not AI/ML devices.

Summary

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Ko 80949
page 1 of 3

510(k) Summary for Keratec Limited Keratec Wound Dressings

FEB 1 1 2009

1. SUBMITTER/510(K) HOLDER

Keratec Limited. Canterbury Agriculture and Science Centre Gerald Street, Lincoln 7608 Canterbury NEW ZEALAND

Contact Person:	Clive Marsh
Telephone:	64 3 325 9106
Date Prepared:	April 2, 2008

2. DEVICE NAME

Proprietary Name:	Keratec Wound Dressings
Common/Usual Name:	Wound Dressings
Classification Name:	Wound and Burn Dressings

3. PREDICATE DEVICES

Oasis Wound Matrix by Healthpoint (K061711)
Biocore Medical Technologies Inc. MediFil Collatek Hydrogel (K022995) ●
Biocore Medical Technologies Collatek Foam (K012997) .
Johnson & Johnson Collagen ORC Antimicrobial Matrix (K033523)

DEVICE DESCRIPTION 4.

The primary mode of action of keratin containing dressings Keragel, Keraderm and Kerafoam is to absorb and interact with wound fluids to form a soft, hydrophilic keratin

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Image /page/1/Picture/0 description: The image contains handwritten text on a white background. The first line reads 'K080949', and the second line reads 'page 2 of 3'. The text appears to be written with a dark marker or pen, and the handwriting is somewhat stylized. The text likely represents a page number or identification code within a larger document.

gel that facilitates a moist wound healing environment. The secondary mode of action is to provide the cells in the wound with a friendly structural framework that allows cellular migration where no framework exists.

Keragel is a gel dressing that provides moisture to dry wound beds by using water. emollients, and biocompatible thickeners in a similar manner to other hydrogels.

INTENDED USE 5.

The Keratec Keragel, Kerafoam and Keraderm Wound Dressings are indicated for dry, light and moderately exudating partial and full thickness wounds such as:

. first and second degree burns
. severe sunburns
. superficial injuries, cuts, abrasions and surgical wounds

The Keratec Wound Dressings may also be used under the guidance of a health care professional in the management of the following types of dry, light and moderately exudating partial and full thickness wounds:

Pressure (stage I-IV) and venous stasis ulcers ●
Ulcers caused by mixed vascular etiologies .
Diabetic ulcers .
. Donor sites and grafts

The Keratec Wound Dressings are not intended to be used on third degree burns.

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K080949
page 39-3

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

Both the proposed Keratec Wound Dressings and the predicate wound dressings are designed for dry, light and moderately exudating partial and full thickness wounds. These devices differ in formulation but all include a protein component that is intended to provide enhanced wound healing.

The operational principles of the proposed and predicate devices are identical. The wound dressing is applied to the wound and functions to absorb exudates and create a scaffold for tissue ingrowth. The major difference between the proposed Keratec Wound Dressings and the predicate dressings is the type of protein incorporated in the dressing. Performance testing has been conducted that confirms that the Keratec Wound Dressings are able to function as intended without causing damage to the tissues. Animal derived proteins such as collagen have been used for many years in wound dressing products without adverse effects. Additionally, safety testing has been performed to support the use of keratin in the Keratec Wound Dressing, demonstrating that the dressings do not cause adverse effects and function as intended.

The similarities in intended use, technical specifications, and functional performance between the Keratec Wound Dressings and the Biocore Medical Technologies Inc. MediFil Collatek Hydrogel (K022995), the Johnson & Johnson Collagen ORC Antimicrobial Matrix (K033523), the Medical Technologies Collatek Foam (K012997) and the Cook Biotech (Healthpoint) (K061711) Oasis Wound Matrix leads to a conclusion of substantial equivalence between the proposed and predicate devices.

PERFORMANCE TESTING 7.

Extensive bench, biocompatibility, animal and clinical testing have been performed to support the safety and efficacy of the Keratec Wound Dressings. All of the testing showed that the dressings function as intended without adverse effects.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2009

Keratec Limited % Medical Device Consultants, Inc. Ms. Mary McNamara-Cullinane, RAC Senior Regulatory Consultant 49 Plain Street North Attleboro, Massachusetts 02760

Re: K080949

Trade/Device Name: Keratec Wound Dressings Regulatory Class: Unclassified Product Code: FRO Dated: January 26, 2009 Received: January 28, 2009

Dear Ms. McNmara-Cullinane:

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 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) 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. Iisting 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 -- Ms. Mary McNamara-Cullinane, RAC

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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/industry/support/index.html.

Sincerely yours.

Marti N. Milkman

Mark N. Melkerson 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): K080949

Keratec Wound Dressings Device Name:

Indications for Use:

The Keratec Keragel, Kerafoam and Keraderm Wound Dressings are intended for the management of partial and full thickness wounds such as:

first and second degree burns
severe sunburns
superficial injuries, cuts, abrasions and surgical wounds

Pressure (stage I-IV) and venous stasis ulcers
Ulcers caused by mixed vascular etiologies
Diabetic ulcers
Donor sites and grafts ●

Keragel is intended for dry to moderately exuding wounds, Keraderm for low to highly exuding wounds and Kerafoam for moderately exuding wounds to highly exuding wounds.

The Keratec Wound Dressings are not intended to be used on third degree burns.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number

Keratec Limited Additional Information - K080949 October 9, 2008

08/949

Regulation Number and Section

N/A