(245 days)
Not Found
No
The device description and performance studies focus on the material properties and biological effects of a hydrogel wound dressing, with no mention of AI or ML technologies.
Yes
The device is a wound dressing designed to manage various partial thickness skin wounds, which falls under the definition of a therapeutic device as it provides benefit to a patient by treating or managing a medical condition.
No
Explanation: The device is a wound dressing designed to create a moist environment and absorb exudate from wounds. Its intended use is therapeutic (management of wounds), not diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly states it is a "water-based gelatinous (hydrogel) wound dressing" provided in a "sterile, screw top tube," indicating it is a physical product, not software.
Based on the provided information, KeraStat® Gel is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use of KeraStat® Gel is to provide a moist environment and absorb wound exudate for the management of various partial thickness skin wounds. This is a therapeutic function applied directly to the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a sterile, non-implantable, water-based gelatinous wound dressing. This aligns with a topical wound care product, not a device used for in vitro testing.
- Lack of In Vitro Testing: The description of the device and its intended use does not involve any testing of samples (like blood, urine, tissue, etc.) outside of the body. IVD devices are specifically designed for such testing.
- Performance Studies: The performance studies mentioned focus on biocompatibility, clinical testing (like patch tests), and non-clinical studies related to wound healing and safety when applied to the skin. These are typical for a wound dressing, not an IVD.
In summary, KeraStat® Gel is a wound dressing intended for direct application to the skin for therapeutic purposes, which is not the function of an In Vitro Diagnostic device.
N/A
Intended Use / 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
KGN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin wounds
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare practitioner
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following testing was performed to demonstrate substantial equivalence:
- Biocompatibility testing:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Subacute Systemic Toxicity
- Pyrogenicity
- Toxicology Risk Assessment
- Clinical testing:
- Repeat Insult Patch Test
- Skin Prick Test
- Other testing:
- Nucleic acid testing
- Viral inactivation testing
- Porcine thermal burn
- Keratin characterization
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure, with three overlapping profiles facing to the right. The profiles are stylized and appear to be made of flowing lines.
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)
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 |
| Winston Salem, NC 27101 | |
| Phone Number: | 1.336.725.0621 |
| Fax Number: | 1.336.725.0619 |
| Contact Person: | Kenneth G. Butz |
| Associate 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 Dressings |
| Keratec Limited | |
| K080949 | |
| Cleared on February 11, 2009 | |
| 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. |
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,
4
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 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, donor sites and grafts | Dry, light, and moderately exuding partial
and full 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-IV)
and venous stasis ulcers, ulcers caused by
mixed vascular etiologies, diabetic ulcers,
donor sites and grafts |
| Mode of Action | Absorbs exudate and provides a moist
environment that is supportive of
wound healing. | Absorbs exudate and provides a moist
environment that is supportive of wound
healing. |
| Technological
Characteristics | Mixture of human hair derived keratin
proteins intended to absorb exudate and
create a moist environment packaged as
sterile dressing | Mixture of sheep wool derived keratin
proteins intended to absorb exudate and
create a moist environment packaged as
sterile dressing |
| Primary
Component | Human derived keratin protein | Animal derived keratin protein |
| Additional
Components | Purified water, phenoxyethanol, and
ethylhexylglycerin | Purified water, lactic acid,
hydroxyethylcellulose, glycerin, paraben,
phenoxyethanol, sorbitol, and propylene
glycol |
| Form of Wound
Dressing | Hydrogel | Hydrogel |
| Application
Method | Topical | Topical |
| Sterility | Sterile | Sterile |
| Number of Uses | Single use | Single use |
| Prescription Use | Yes | Yes |
| Performance
Testing | Bench, biocompatibility, nonclinical,
and clinical testing | Bench, biocompatibility, nonclinical, and
clinical testing |