KeraStat(R) Gel

K162759 · Keranetics, LLC · KGN · Jun 2, 2017 · SU

Device Facts

• Record ID: K162759
• Device Name: KeraStat(R) Gel
• Applicant: Keranetics, LLC
• Product Code: KGN · SU
• Decision Date: Jun 2, 2017
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for 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, 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.

Device Story

KeraStat® Gel is a sterile, non-implantable, water-based hydrogel wound dressing containing 5% human-derived keratin protein. Applied topically by healthcare professionals or patients under direction, it functions as a protective covering to absorb wound exudate and maintain a moist environment to support healing. The device is supplied in 5 mL single-use tubes. It is intended for partial thickness wounds; it is not indicated for full thickness burns. Clinical benefit is derived from the moist wound environment, which facilitates the natural healing process.

Clinical Evidence

Evidence includes biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity), toxicology risk assessment, and clinical testing (repeat insult patch test, skin prick test). Additional non-clinical testing included nucleic acid testing, viral inactivation, porcine thermal burn model, and keratin characterization. Results confirm the device functions as intended without adverse effects.

Technological Characteristics

Hydrogel wound dressing; 5% human-derived keratin protein in water base with phenoxyethanol and ethylhexylglycerin. Topical application; sterile, single-use 5 mL tube. No electronic components or energy sources.

Indications for Use

Indicated for management of partial thickness skin wounds (first/second degree burns, severe sunburns, superficial injuries, cuts, abrasions, surgical wounds) and dry, light, to moderately exuding partial thickness wounds (stage I-II pressure ulcers, venous stasis ulcers, mixed vascular etiology ulcers, diabetic ulcers, donor sites, grafts). Not for full thickness (third degree) burns. Prescription use.

Predicate Devices

• Keratec Wound Dressings (K080949)

Submission Summary (Full Text)

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

| 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 102<br>Winston Salem, NC 27101 |
| Phone Number: | 1.336.725.0621 |
| Fax Number: | 1.336.725.0619 |
| Contact Person: | Kenneth G. Butz<br>Associate Director, PPD, LLC.<br>Consultant to KeraNetics, LLC. |
| Phone Number: | 1.919.456.5493 |
| Fax Number: | 1.919.882.9754 |
| Email: | [e-mail] |
| 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 Dressings<br>Keratec Limited<br>K080949<br>Cleared on February 11, 2009 |
| Device Description: | KeraStat® Gel is a sterile, non-implantable, water-based<br>gelatinous (hydrogel) wound dressing intended to act as a<br>protective covering in the management of a variety of<br>partial thickness dermal wounds. KeraStat Gel is provided<br>in a sterile, screw top tube for one-time use. Each tube<br>contains 5 mL of KeraStat Gel, which contains 5% keratin<br>protein rehydrated and polymerized in a water base, and is<br>available 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:<br>KeraStat® Gel | Predicate Device:<br>Keratec Wound Dressings |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | K162759 | K080949 |
| Intended Use | Wound dressing for management of<br>partial thickness wounds | Wound dressing for management of partial<br>and full thickness wounds |
| Indications | Dry, light, and moderately exuding<br>partial thickness wounds such as: first<br>and second degree burns, severe<br>sunburns, superficial injuries, cuts,<br>abrasion, and surgical wounds; may<br>also be used under the guidance of a<br>health care professional in the<br>management of pressure (stage I-II)<br>and venous stasis ulcers, ulcers caused<br>by mixed vascular etiologies, diabetic<br>ulcers, donor sites and grafts | Dry, light, and moderately exuding partial<br>and full thickness wounds such as: first and<br>second degree burns, severe sunburns,<br>superficial injuries, cuts, abrasion and<br>surgical wounds; may also be used under<br>the guidance of a health care professional<br>in the management of pressure (stage I-IV)<br>and venous stasis ulcers, ulcers caused by<br>mixed vascular etiologies, diabetic ulcers,<br>donor sites and grafts |
| Mode of Action | Absorbs exudate and provides a moist<br>environment that is supportive of<br>wound healing. | Absorbs exudate and provides a moist<br>environment that is supportive of wound<br>healing. |
| Technological<br>Characteristics | Mixture of human hair derived keratin<br>proteins intended to absorb exudate and<br>create a moist environment packaged as<br>sterile dressing | Mixture of sheep wool derived keratin<br>proteins intended to absorb exudate and<br>create a moist environment packaged as<br>sterile dressing |
| Primary<br>Component | Human derived keratin protein | Animal derived keratin protein |
| Additional<br>Components | Purified water, phenoxyethanol, and<br>ethylhexylglycerin | Purified water, lactic acid,<br>hydroxyethylcellulose, glycerin, paraben,<br>phenoxyethanol, sorbitol, and propylene<br>glycol |
| Form of Wound<br>Dressing | Hydrogel | Hydrogel |
| Application<br>Method | Topical | Topical |
| Sterility | Sterile | Sterile |
| Number of Uses | Single use | Single use |
| Prescription Use | Yes | Yes |
| Performance<br>Testing | Bench, biocompatibility, nonclinical,<br>and clinical testing | Bench, biocompatibility, nonclinical, and<br>clinical testing |