K Number

Device Name

KeraStat Cream

Manufacturer

KeraNetics

Date Cleared

2020-07-16

(317 days)

Product Code

KGN DAT

Regulation Number

N/A

Intended Use

KeraStat® Cream is intended to maintain a moist wound environment. KeraStat® Cream is indicated for the management of a number of partial thickness skin wounds such as: partial thickness (first and second degree) burns, superficial injuries, cuts, and incisions/surgical wounds. Under the direction of a healthcare professional, KeraStat® Cream 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, radiation dermatitis, donor sites, and grafts. KeraStat® Cream is not indicated for full thickness or third degree will be available by prescription.

Device Description

KeraStat® Cream is a non-sterile, non-implantable wound dressing intended to provide a moist environment in the management of a variety of partial thickness dermal wounds. KeraStat® Cream is provided in a screw top tube for multiple uses. Each tube contains 1 oz (29.6 mL) of KeraStat® Cream, which contains 5% keratin protein incorporated into a cream base.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K162759

Reference Devices

K173549

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the chemical composition and biological effects of a cream, with no mention of AI/ML technologies or data processing.

Therapeutic

No
The indications for use describe the product as maintaining a moist wound environment and aiding in the management of partial thickness skin wounds, which are supportive functions rather than directly therapeutic in the sense of actively treating or curing a disease.

Diagnostic

KeraStat® Cream is described as a wound dressing intended to provide a moist environment for the management of various partial thickness dermal wounds, not for diagnosing conditions.

SaMD (Software as a Medical Device)

The device description clearly states it is a "non-sterile, non-implantable wound dressing" in the form of a "cream base" containing "keratin protein." This indicates a physical product, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, KeraStat® Cream is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use of KeraStat® Cream is to manage partial thickness skin wounds by maintaining a moist wound environment. This is a therapeutic purpose, not a diagnostic one.
Device Description: The device is described as a non-sterile, non-implantable wound dressing. This aligns with a topical treatment, not a device used to perform tests on samples taken from the body.
Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition based on such analysis.
Focus on Wound Management: The entire description revolves around the application of the cream to wounds for healing purposes.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. KeraStat® Cream does not fit this definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

KeraStat® Cream is not indicated for full thickness or third degree will be available by prescription.

Product codes

KGN

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Skin

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Healthcare professional, Prescription Use

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 testing was performed to demonstrate substantial equivalence:

Biocompatibility testing:
- Cytotoxicity (ISO 10993-5)
- Sensitization (ISO 10993-10)
- Irritation/Intracutaneous reactivity (ISO 10993-10)
- Acute systemic toxicity (ISO 10993-11)
- Toxicology Risk Assessment (ISO 10993-17)
- Chemical Characterization (ISO 10993-18)
- Implantation Test (ISO 10993-6)
- Rabbit Pyrogenicity Test (USP Chapter )
Performance testing:
- Protein content
- Viscosity
- pH
- Microbial contamination
- Preservative effectiveness
- Size-exclusion chromatography (SEC)
- Stability
Human clinical testing:
- Radiation Dermatitis Clinical Study
- Repeat Insult Patch Test
- Skin Prick Test

Key results: Biocompatibility, performance, and clinical testing support the safety and effectiveness of KeraStat® Cream.

Key Metrics

Not Found

Predicate Device(s)

K162759

Reference Device(s)

K173549

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.

July 16, 2020

KeraNetics Luke Burnett CEO and CSO 200 East First Street, Suite 101, Box#4 Winston Salem, North Carolina 27101

Re: K192386

Trade/Device Name: KeraStat Cream Regulatory Class: Unclassified Product Code: KGN, Dated: June 12, 2020 Received: June 15, 2020

Dear Luke Burnett:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Anjana Jain, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K192386

Device Name KeraStat® Cream

Indications for Use (Describe)

KeraStat® Cream is not indicated for full thickness or third degree will be available by prescription.

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

	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® CREAM

Submitter Name:	KeraNetics, Inc.
Submitter Address:	200 East First Street, Box #4, Suite 102
Winston Salem, NC 27101
Phone Number:	1.336.202.1307
Fax Number:	1.336.725.0619
Contact Person:	Luke Burnett, PhD
CEO and CSO, KeraNetics, Inc.
Phone Number:	1.336.202.1307
Fax Number:	1.336.725.0619
Email:	lburnett@keranetics.com
Date Prepared:	July16, 2020
Device Trade Name:	KeraStat® Cream
Device Common Name:	Wound Dressing
Classification Number:	Unclassified
Product Code:	KGN
Product Type Name:	Dressing, Wound, Collagen
Predicate Device:	KeraStat® Gel
KeraNetics Inc.
K162759
Cleared on June 2, 2017
Reference Device:	Biafine®
Valeant Pharmaceuticals
K173549
Cleared on August 13, 2018
Device Description:	KeraStat® Cream is a non-sterile, non-implantable wound
dressing intended to provide a moist environment in the
management of a variety of partial thickness dermal
wounds. KeraStat® Cream is provided in a screw top tube
for multiple uses. Each tube contains 1 oz (29.6 mL) of
KeraStat® Cream, which contains 5% keratin protein
incorporated into a cream base.

Statement of Intended Use :

KeraStat® Cream is intended to maintain a moist wound environment. KeraStat® Cream 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, abrasions, and incisions/surgical wounds. Under the direction of a healthcare professional, KeraStat® Cream 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, radiation dermatitis, donor sites, and grafts.

KeraStat® Cream is not indicated for full thickness or third degree burns. This device will be available by prescription.

Comparison to the Predicate and Reference Devices:

KeraStat® Cream and the predicate wound dressing, KeraStat® Gel, are both designed for dry, light, and moderately exuding partial thickness wounds. The wound dressings are applied to the wound and function to provide a moist environment for wound management. The operational principles of the subject and predicate device are identical, and they contain identical concentrations and composition of human derived keratin protein. The only differences between KeraStat® Cream and the KeraStat® Gel predicate device are that KeraStat® Cream is provided in an emulsion base, is nonsterile, and is intended for multiple uses.

KeraStat® Cream and the reference wound dressing, Biafine®, have the same intended use to provide a moist environment for wound management including wounds caused by radiation dermatitis. Biafine® has similar technological characteristics as KeraStat® Cream, as both are non-sterile, multi-use cream emulsions composed of a protein/amine, emollients, emulsifiers, thickeners, and preservatives.

Performance Data Summary of Non-Clinical Tests:

The following testing was performed to demonstrate substantial equivalence:

Biocompatibility testing: .
- Cytotoxicity (ISO 10993-5) o
- Sensitization (ISO 10993-10) o
- o Irritation/Intracutaneous reactivity (ISO 10993-10)
- Acute systemic toxicity (ISO 10993-11) O
- Toxicology Risk Assessment (ISO 10993-17) O
- Chemical Characterization (ISO 10993-18) o
- Implantation Test (ISO 10993-6) o
- o Rabbit Pyrogenicity Test (USP Chapter )

Performance testing:
- o Protein content
- o Viscosity
- o pH
- Microbial contamination o
- Preservative effectiveness o
- o Size-exclusion chromatography (SEC)
- o Stability

Summary of Clinical Tests:

The following human clinical testing was performed:

Radiation Dermatitis Clinical Study ●
Repeat Insult Patch Test ●
Skin Prick Test

Testing Summary:

Biocompatibility, performance, and clinical testing support the safety and effectiveness of KeraStat® Cream.

Subs tantial Equivalence :

KeraStat® Cream has the same intended use, same principles of operation, and similar technological characteristics as the predicate device KeraStat® Gel (K162759). While the subject device differs from the predicate device with respect to its additional components and multi-use design, both devices share the same mode of action in that they provide a moist environment to support wound healing. Any differences in technological characteristics outlined in Table 1 do not raise new questions about the safety and effectiveness of KeraStat® Cream.

KeraStat® Cream has similar intended use, same principles of operation, and similar technological characteristics as the reference device Biafine® (K173549). Both devices share the same mode of action in that they provide a moist environment to support wound healing, including wounds due to radiation dermatitis. Biafine® has similar technological characteristics as KeraStat® Cream, as both are non-sterile, multiuse cream emulsions composed of a protein/amine, emollients, emulsifiers, thickeners, and preservatives. Any differences in technological characteristics outlined in Table 1 do not raise new questions about the safety and effectiveness of KeraStat® Cream.

Table 1. Substantial Equivalence Information
Trade Name	Subject Device:
KeraStat® Cream	Predicate Device:
KeraStat® Gel	Reference Device:
Biafine®
510(k) No.		K162759	K173549
Intended Use	Wound dressing for
management of partial
thickness wounds	Wound dressing for
management of partial
thickness wounds	Wound dressing for
management of partial and
full thickness wounds
Indications	Dry, light, and moderately
exuding partial thickness
wounds such as: first and
second degree burns, severe
sunburns, superficial injuries,
cuts, abrasion, and surgical
wounds; may also be used
under the guidance of a health
care professional in the
management of pressure
(stage I-II) and venous stasis
ulcers, ulcers caused by
mixed vascular etiologies,
diabetic ulcers, radiation
dermatitis, donor sites and
grafts	Dry, light, and moderately
exuding partial thickness
wounds such as: first and
second degree burns, severe
sunburns, superficial injuries,
cuts, abrasion, and surgical
wounds; may also be used
under the guidance of a health
care professional in the
management of pressure
(stage I-II) and venous stasis
ulcers, ulcers caused by mixed
vascular etiologies, diabetic
ulcers, donor sites and grafts	OTC indications:
Management of superficial
wounds such as minor cuts,
minor scrapes, minor
irritations, minor
abrasions, minor blisters, 1st
degree burns including
sunburns, minor skin
irritations following post non
ablative laser therapy
procedures,
microdermabrasion therapy or
superficial chemical peels.
May also be used for relief of
itch, pain and burning from
minor skin irritations,
lacerations, abrasions and
minor burns.
Rx Indications: management
of full thickness wounds,
pressure sores, dermal ulcers
including lower leg ulcers,
radiation dermatitis, donor
sites and 2nd degree burns.
May also be used for relief of
itch, pain and burning from
minor skin irritations,
lacerations, abrasions and
minor burns.
Mode of Action	Provides a moist environment
that is supportive of wound
healing	Absorbs exudate and provides
a moist environment that is
supportive of wound healing	Provides a moist environment
that is supportive of wound
healing
Technological
Characteristics	Mixture of human hair
derived keratin proteins in a
cream base intended to a
create a moist environment
and packaged as a non-	Mixture of human hair
derived keratin proteins
intended to absorb exudate
and create a moist
environment and packaged as	Trolamine/sodiumalginate in
a cream base intended to a
create a moist environment
and packaged as a non-sterile,
multi-use dressing
Trade Name	Subject Device:	Predicate Device:	Reference Device:
	KeraStat® Cream	KeraStat® Gel	Biafine®
510(k) No.		K162759	K173549
Components	Purified water, glycerin,
mineral oil, keratin, caprylic
triglyceride, dimethicone,
sodiumpolyacrylate,
hydrogenated polydecene,
trideceth-6, sodiumstearoyl
glutamate, phenoxyethanol,
and ethylhexylglycerin	Purified water, keratin,
phenoxyethanol, carbomer,
sodiumhydroxide, and
ethylhexylglycerin	Purified water, liquid paraffin,
ethylene glycol monostearate,
stearic acid, propylene
glycol, paraffin wax.
squalane, avocado oil,
trolamine/sodiumalginate,
triethanolamine,cetyl
palmitate, methylparaben
(sodiumsalt), sorbic acid (as
potassiums alt ), propyl
paraben (sodium
salt), and fragrance
Form of Wound
Dressing	Cream	Hydrogel	Cream
Application
Method	Topical	Topical	Topical
Sterility	Non-sterile	Sterile	Non-sterile
Numberof
Uses	Multi-use	Single use	Multi-use
Prescription
Use	Yes	Yes	Yes (also OTC)

Table 1. Substantial Equivalence Information

Conclusion:

KeraStat® Cream demonstrates substantial equivalence to the predicate device, KeraStat® Gel (K162759) and there are not different questions of safety and effectiveness.