Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound gel is indicated for topical use in the management of chronic and acute wounds and dermal ulcers including the local management of:

Pressure Ulcers (Stage I-IV)
Venous Stasis Ulcers
Diabetic Ulcers
First and Second Degrec Burns
Surgical wounds
Traumatic wounds
Superficial wounds
Ulcers resulting from arterial insufficiency
Grafted wounds and donor sites

For over the counter use, Hydrolyzed Collagen with 10% Chondroiiin Sulfate Wound Gel may be used for:

minor abrasions
laccrations
minor cuts
minor scalds and burns

Device Description

Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan) Wound Gel is a line extension of the previously approved HyCure® Hydrolyzed Collagen (K955506). Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan) contains Chondroitin Sulfate as Chondroprotec® previously approved for market via 510(k) (K961930). Hydrolyzed Collagcn with 10% Chondroitin Sulfate Wound Gel contains a high concentration of water bound to the hydrolyzed collagen which maintains a moist wound environment as it manages wound healing. Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan) Wound gel is provided in a patient ready, one (1) ounce, collapsible tube.

AI/ML Overview

This document is a 510(k) summary for a medical device called "Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel".

Based on a review of the provided text, the device did not undergo a study to prove it meets acceptance criteria in the way this request describes. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through:

Formulation comparison: The device is described as a "line extension" of a previously approved hydrolyzed collagen product and incorporates an already approved chondroitin sulfate component.
Non-clinical performance data: This data pertains to safety tests (cytotoxicity, irritation, sensitization) rather than efficacy or performance in a clinical setting for wound healing.
Claim of identical intended use: The indications for use are aligned with those of the predicate components.

Therefore, many of the requested fields regarding acceptance criteria and studies are not applicable or cannot be extracted from this specific 510(k) summary. I will fill in what can be gathered and explicitly state when information is not available.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document primarily focuses on demonstrating that the device is safe and performs comparably to its predicate devices, rather than meeting specific performance metrics for wound healing in this submission. The "acceptance criteria" here are implicitly related to the safety standards defined by ISO and the characteristics of the predicate devices.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance
Cytotoxicity	Agar Overlay (direct contact) Cytotoxicity testing (ISO standards)	Grade 0 cytotoxic (non-cytotoxic)
Irritation	ISO Intracutaneous reactivity (Irritation) testing	Non-irritant
Sensitization	Repeat Patch Dermal Sensitization Test (Buehler Method)	Non-sensitizer
Formulation	Identical to HyCure® Hydrolyzed Collagen Wound Gel (K955506) plus Chondroprotec® (K961930)	Contains 10.0% Polysulfated glycosaminoglycan. Formulation does not affect intended use or alter fundamental scientific technology.
Intended Use	Management of full and partial thickness wounds, minor abrasions, cuts, burns, etc., aligned with predicate devices.	Stated intended uses are provided. Equivalence to predicate devices implies meeting these uses.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated as a clinical "test set" for efficacy. The non-clinical tests (cytotoxicity, irritation, sensitization) are typically performed on in vitro models or animal models without a specified "sample size" in this context. The document does not provide details on the number of samples or subjects used for these specific non-clinical tests.
Data Provenance: Not specified. Standardized in vitro or animal tests are typically conducted in a laboratory setting. No country of origin for the data is mentioned.
Retrospective or Prospective: Not applicable, as this refers to clinical studies, and the document explicitly states: "Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel has not been studied in a clinical setting."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There was no clinical test set for which ground truth would be established by experts. The non-clinical safety tests have objective endpoints measured by laboratory protocols.

4. Adjudication method for the test set

Not applicable. There was no clinical test set requiring expert adjudication.

5. 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 gel, not an AI-powered diagnostic or assistive tool, and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a wound gel, not an algorithm.

7. The type of ground truth used

For the non-clinical tests (cytotoxicity, irritation, sensitization), the "ground truth" is determined by objective laboratory measurements and standardized grading against predefined criteria (e.g., cytotoxicity grade 0, non-irritant, non-sensitizer). There is no "expert consensus," "pathology," or "outcomes data" in a clinical sense for these specific tests as presented.

8. The sample size for the training set

Not applicable. As a medical device (wound gel), there is no 'training set' in the context of machine learning or algorithm development.

9. How the ground truth for the training set was established

Not applicable. There is no 'training set' for this device.

Summary

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510(k) Summary

Summary Information:

OCT 3 0 2008

Submitters Name and Address: .
Applied Nutritionals 1890 Bucknell Drive Bethlehem, PA 18015
Contact Person: Anita Petito . Director of Marketing Phone: 610-865-9876 E-Mail: apetito@hymed.com
Establishment Number: 2530949 .
User Fee ID Number: MD6036808-956733 .
Date of Summary Preparation: June 9, 2008 .
Name of Device: .
- Hydrolyzed Collagen with 10% Chondroitin Sulfate Proprietary: O (PSGAG, polysulfated glycosaminoglycan) Wound Gel
- Common: Moist wound gel ்
- Classification Name: Hydrophilic Wound Dressing ্
Medical Device Classification: Unclassified .
Identification of predicate devices to which substantial equivalence is being . claimed:

o HyCure® Hydrolyzed Collagen	K955506
o HeliDerm™ Collagen Wound Dressing	K990086
o Integra ® Bilayer Matrix Wound Dressing	K021792
o Chondroprotec® (10% Polysulfated GlycosaminoGlycan)	K961930
o Integra® Flowable Wound Matrix	K072113

Description of the Device: Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan) Wound Gel is a line extension of the previously approved HyCure® Hydrolyzed Collagen (K955506). Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan) contains Chondroitin Sulfate as Chondroprotec® previously approved for market via 510(k) (K961930). Hydrolyzed Collagcn with 10% Chondroitin Sulfate Wound Gel contains a high concentration of water bound to the hydrolyzed collagen which maintains a moist wound environment as it manages wound healing. Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan)

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Wound gel is provided in a patient ready, one (1) ounce, collapsible tube.

Intended use of the Device: Hydrolyzed Collagen with 10% Chondroitin Sulfate . Wound Gel is an absorbent wound dressing that provides a moist wound environment. As an Rx, Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel is useful in the management of full and partial thickness wounds including dermal ulcers, leg ulcers, superficial wounds, first and second degree burns and donor sites. As an Over the Counter preparation, Hydrolyzed Collagen with 10% Wound Gel is useful in the management of minor abrasions, lacerations, minor cuts and minor scalds and burns. Contraindicated for individuals with a known sensitivity to bovine or collagen.
Technology Characteristics: Hydrolyzed Collagen with 10% Chondroitin Sulfate ● Wound Gel is an aqueous hydrogel identical in formulation to HyCure® Hydrolyzed Collagen Wound Gel (K955506) combined with Chondroprotec® (K961930). Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel contains 10.0% Polysulfated glycosaminoglycan for the purpose of improving wound fluid retention within the gel and facilitating fibroblast mobility within the wound as in predicate products currently in commercial distribution. Chondroprotec® (10% Chondroitin Sulfate) is currently approved for market (K961930) for use in the identical indications as referenced herein. This particular formulation does not affect the intended use or alter the fundamental scientific technology of the device.
Non-Clinical Performance Data: Hydrolyzed Collagen with 10% Chondroitin . Sulfate Wound Gel has been evaluated in accordance with Part 10-993 of the International Standard Organization (180). Standard tests which include:
- . Agar Overlay (direct contact) Cytotoxicity testing (Exhibit I) indicated a grade 0 cytotoxic grade.
- ISO Intracutaneous reactivity (Irritation) testing indicates a non-. irritant
- Repeat Patch Dermal Sensitization Test (Buehler Method) . indicates the product is a non-sensitizer.

Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel has not been studied in a clinical setting.

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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 caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 0 2008

Applied Nutritionals % Ms. Anita Petito President 1890 Bucknell Drive Bethlehem, Pennsylvania 18015

Re: K081724

Trade/Device Name: Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel Regulatory Class: Unclassified Product Code: KGN Dated: October 10, 2008 Received: October 17, 2008

Dear Ms. Petito:

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. Anita Petito

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,

Mark M. Milliman

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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Rx Indications for Use

8/1724

510(k) Number: K081724

Device Name: Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel

Indications for Use:

Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound gel is indicated for topical use in the management of chronic and acute wounds and dermal ulcers including the local management of:

Pressure Ulcers (Stage I-IV) .
Venous Stasis Ulcers .
Diabetic Ulcers ●
First and Second Degrec Burns .
Surgical wounds .
. Traumatic wounds
Superficial wounds .
Ulcers resulting from arterial insufficiency .
Grafted wounds and donor sites ●

Contraindications:

Contraindicated for individuals with a known sensitivity to bovine or ● collagen

Prescription Use	X
(Part 21 CFR 801 Subpart AND/OR D)
Over-The-Counter Use
(21 CFR 801 Subpart C)

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

Ail RPOhl for mxa
(Division Sign-Off)

Division of General. Restorative, and Neurological Devices

510(k) Number K081724

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Over the Counter (OTC) Indications for Use

510(k) Number: K081724

Device Name: Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel

Indications for Use:

For over the counter use, Hydrolyzed Collagen with 10% Chondroiiin Sulfate . Wound Gel may be used for:
- minor abrasions -
- laccrations -
- minor cuts -
- minor scalds and burns

Contraindications:

Contraindicated for individuals with a known sensitivity to bovine or . collagen
Over-The-Counter Use X Prescription Use AND / OR (21 CFR 801 Subpart (Part 21 CFR 801 Subpart C) D)

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

Nèdre Ople formen

(Division Sign-Off (Division Sign-On)
Division of General, Restorative, Division of Occal Devices

Nursing
510(k) Number K081724

Regulation Number and Section

N/A