KeraStat® Gel is intended to provide a moist environment and absorb excess wound exudate. KeraStat® Gel is indicated for management of a number of partial thickness skin wounds such as: partial thickness (first and second degree) burns, severe sunburns, superficial injuries, cuts, and incisions/surgical wounds. Under the direction of a healthcare practitioner. KeraStat® Gel also may be used in the management of dry, light, and moderately exuding partial thickness wounds including: pressure (stage I-II) ulcers, venous stasis ulcers caused by mixed vascular etiologies, diabetic ulcers, donor sites, and grafts.

KeraStat® Gel is not indicated for full thickness (third degree) burns. This device will be available by prescription.

Device Description

KeraStat® Gel is a sterile, non-implantable, water-based gelatinous (hydrogel) wound dressing intended to act as a protective covering in the management of a variety of partial thickness dermal wounds. KeraStat Gel is provided in a sterile, screw top tube for one-time use. Each tube contains 5 mL of KeraStat Gel, which contains 5% keratin protein rehydrated and polymerized in a water base, and is available by prescription from a healthcare professional.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the KeraStat® Gel device:

This document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving the device meets specific performance acceptance criteria in the same way a PMA (Premarket Approval) would. Therefore, the information provided is geared towards showing similarity to an already approved device rather than standalone performance against pre-defined metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Because this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" for clinical performance metrics (like sensitivity, specificity, or improvement rates) are not typically defined or reported for the new device in the same way they would be for a novel device. Instead, the "acceptance criteria" are effectively that the new device (KeraStat® Gel) is demonstrated to be as safe and effective and performs as well as the legally marketed predicate device (Keratec Wound Dressings) through various non-clinical and clinical tests.

The document states:

"Biocompatibility and device performance study results support the safety and effectiveness of KeraStat Gel. Biocompatibility, non-clinical, and clinical testing have confirmed that KeraStat Gel functions as intended without adverse effects."
"KeraStat Gel is as safe and effective and performs as well as the legally marketed predicate device based on an evaluation of biocompatibility, bench, nonclinical, and clinical performance; any differences in technological characteristics outlined in Table 1 do not raise new questions about the safety and effectiveness of KeraStat Gel."

So, the "reported device performance" is essentially that it meets the safety and effectiveness profile of the predicate device, although no specific quantitative metrics are provided in this summary.

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

The document lists "Clinical testing: ● Repeat Insult Patch Test O - Skin Prick Test O" and "nonclinical, and clinical testing" under Performance Testing. However, it does not specify the sample size used for these clinical tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for any clinical or non-clinical studies.

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

This type of information is not applicable or not provided in this 510(k) summary. The clinical tests mentioned (Repeat Insult Patch Test, Skin Prick Test) are designed to assess direct physiological responses (e.g., allergic reactions) rather than requiring expert interpretation of diagnostic images or outcomes for establishing a "ground truth" in the way it might be needed for an AI/CAD decision support system. These tests are typically evaluated by qualified medical professionals (e.g., dermatologists or allergists), but the specific number and qualifications are not detailed here.

4. Adjudication Method for the Test Set

This information is not applicable or not provided. Since the primary clinical tests mentioned are patch and prick tests for biocompatibility (allergies/irritation), they don't typically involve adjudication methods like those used for expert consensus on image interpretation. The outcome of such tests is usually a direct observation of a physical reaction.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The KeraStat® Gel device is a wound dressing, not an AI or CAD (Computer-Aided Detection) system that assists human readers in interpreting data. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.

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

This information is not applicable. As stated above, KeraStat® Gel is a wound dressing, not an algorithm or AI device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the biocompatibility aspects, the "ground truth" would be established by the direct physiological response observed during the Repeat Insult Patch Test and Skin Prick Test (e.g., presence or absence of a reaction) and possibly standard toxicological endpoints in animal studies. For device performance in wound healing, while not explicitly detailed how results are measured in this summary, the "ground truth" would typically relate to clinical assessment of wound healing, reduction in exudate, and absence of adverse events, observed during clinical use or in animal models (like the "Porcine thermal burn" mentioned). However, the specific methodology for establishing this in the context of clinical observations is not described.

8. The Sample Size for the Training Set

This information is not applicable or not provided. This is not an AI/ML device that requires a training set. If there were multiple studies performed, the sample sizes for participant enrollment in those studies are not detailed.

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

This information is not applicable. Since this is not an AI/ML device, there is no "training set" in that context.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 2, 2017

Keranetics, LLC. % Kenneth G. Butz, M.Sc. Associate Director PPD. LLC. 3900 Paramount Parkway Morrisville, North Carolina 27560-7200

Re: K162759 Trade/Device Name: Kerastat® Gel Regulatory Class: Unclassified Product Code: KGN Dated: April 27, 2017 Received: April 28, 2017

Dear Kenneth Butz:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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 - Kenneth G. Butz, M.Sc.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Jennifer R. Stevenson -S3

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K162759

Device Name KeraStat® Gel

Indications for Use (Describe)

KeraStat® Gel is not indicated for full thickness (third degree) burns. This device will be available by prescription.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY— KERASTAT® GEL

Submitter Name:	KeraNetics, LLC.
Submitter Address:	200 East First Street, Box #4, Suite 102Winston Salem, NC 27101
Phone Number:	1.336.725.0621
Fax Number:	1.336.725.0619
Contact Person:	Kenneth G. ButzAssociate Director, PPD, LLC.Consultant to KeraNetics, LLC.
Phone Number:	1.919.456.5493
Fax Number:	1.919.882.9754
Email:	kenneth.butz@ppdi.com
Date Prepared:	April 25, 2017
Device Trade Name:	KeraStat® Gel
Device Common Name:	Wound Dressing
Device Class:	Unclassified, Pre-amendment
Product Code:	KGN
Product Type Name:	Dressing, Wound, Collagen
Predicate Device(s):	Keratec Wound DressingsKeratec LimitedK080949Cleared on February 11, 2009
Device Description:	KeraStat® Gel is a sterile, non-implantable, water-basedgelatinous (hydrogel) wound dressing intended to act as aprotective covering in the management of a variety ofpartial thickness dermal wounds. KeraStat Gel is providedin a sterile, screw top tube for one-time use. Each tubecontains 5 mL of KeraStat Gel, which contains 5% keratinprotein rehydrated and polymerized in a water base, and isavailable by prescription from a healthcare professional.

Statement of Intended Use:

KeraStat® Gel is intended to provide a moist environment and absorb excess wound exudate. KeraStat Gel is indicated for management of a number of partial thickness skin wounds such as: partial thickness (first and second degree) burns, severe sunburns,

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superficial injuries, cuts, abrasions, and incisions/surgical wounds. Under the direction of a healthcare practitioner, KeraStat® Gel also may be used in the management of dry, light, and moderately exuding partial thickness wounds including: pressure (stage I-II) ulcers, venous stasis ulcers, ulcers caused by mixed vascular etiologies, diabetic ulcers, donor sites, and grafts.

KeraStat Gel is not indicated for full thickness (third degree) burns. This device will be available by prescription.

Comparison to the Predicate Device:

KeraStat Gel and the predicate wound dressing are both designed for dry, light, and moderately exuding partial thickness wounds. The wound dressings are applied to the wound and function to absorb exudate and provide a moist environment to support wound healing. The operational principles of the subject and predicate devices are identical. The major difference between KeraStat Gel and the predicate device is the source of keratin proteins included in the final device. Table 1 provides a comparison of the subject and predicate devices.

Summary of Non-Clinical Tests:

The following testing was performed to demonstrate substantial equivalence:

. Biocompatibility testing:
- Cytotoxicity о
- о Sensitization
- Irritation O
- Acute Systemic Toxicity O
- Subacute Systemic Toxicity O
- O Pyrogenicity
- Toxicology Risk Assessment O
Clinical testing: ●
- Repeat Insult Patch Test O
- Skin Prick Test O
Other testing: ●
- Nucleic acid testing o
- Viral inactivation testing O
- Porcine thermal burn o
- Keratin characterization O

Performance Summary:

Biocompatibility and device performance study results support the safety and effectiveness of KeraStat Gel. Biocompatibility, non-clinical, and clinical testing have confirmed that KeraStat Gel functions as intended without adverse effects.

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Substantial Equivalence:

KeraStat Gel has the same intended use and principles of operation and similar technological characteristics as Keratec Wound Dressings (K080949). While the subject device differs from the predicate device in the source of keratin protein (human vs. sheep), both devices share the same mode of action in that they absorb exudate and provide a moist environment to support wound healing. KeraStat Gel is as safe and effective and performs as well as the legally marketed predicate device based on an evaluation of biocompatibility, bench, nonclinical, and clinical performance; any differences in technological characteristics outlined in Table 1 do not raise new questions about the safety and effectiveness of KeraStat Gel.

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Table 1. Substantial equivalence information.

Trade Name	Subject Device:KeraStat® Gel	Predicate Device:Keratec Wound Dressings
510(k) No.	K162759	K080949
Intended Use	Wound dressing for management ofpartial thickness wounds	Wound dressing for management of partialand full thickness wounds
Indications	Dry, light, and moderately exudingpartial thickness wounds such as: firstand second degree burns, severesunburns, superficial injuries, cuts,abrasion, and surgical wounds; mayalso be used under the guidance of ahealth care professional in themanagement of pressure (stage I-II)and venous stasis ulcers, ulcers causedby mixed vascular etiologies, diabeticulcers, donor sites and grafts	Dry, light, and moderately exuding partialand full thickness wounds such as: first andsecond degree burns, severe sunburns,superficial injuries, cuts, abrasion andsurgical wounds; may also be used underthe guidance of a health care professionalin the management of pressure (stage I-IV)and venous stasis ulcers, ulcers caused bymixed vascular etiologies, diabetic ulcers,donor sites and grafts
Mode of Action	Absorbs exudate and provides a moistenvironment that is supportive ofwound healing.	Absorbs exudate and provides a moistenvironment that is supportive of woundhealing.
TechnologicalCharacteristics	Mixture of human hair derived keratinproteins intended to absorb exudate andcreate a moist environment packaged assterile dressing	Mixture of sheep wool derived keratinproteins intended to absorb exudate andcreate a moist environment packaged assterile dressing
PrimaryComponent	Human derived keratin protein	Animal derived keratin protein
AdditionalComponents	Purified water, phenoxyethanol, andethylhexylglycerin	Purified water, lactic acid,hydroxyethylcellulose, glycerin, paraben,phenoxyethanol, sorbitol, and propyleneglycol
Form of WoundDressing	Hydrogel	Hydrogel
ApplicationMethod	Topical	Topical
Sterility	Sterile	Sterile
Number of Uses	Single use	Single use
Prescription Use	Yes	Yes
PerformanceTesting	Bench, biocompatibility, nonclinical,and clinical testing	Bench, biocompatibility, nonclinical, andclinical testing

Regulation Number and Section

N/A