(269 days)
Not Found
No
The 510(k) summary describes a wound gel composed of extracellular matrix and saline. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies leverage data from a predicate device and focus on biological and material properties, not algorithmic performance.
Yes
The intended use explicitly states "ReyaGel is intended for the management of wounds," which aligns with the definition of a therapeutic device designed to treat or manage a medical condition.
No
Explanation: The device, ReyaGel, is a wound management product intended for healing various types of wounds, not for diagnosing conditions. Its description focuses on its composition and application for wound treatment.
No
The device description clearly states it is a "Wound Gel" composed of physical materials (porcine spleen and lung extracellular matrix in a saline gel) and is supplied in a syringe for topical application. This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that ReyaGel is for the "management of wounds." This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a "wound product composed of porcine spleen and lung extracellular matrix in a saline gel, for the management of wounds." This describes a material applied directly to a wound for healing purposes, not a test performed on a sample.
- Lack of Diagnostic Elements: There is no mention of analyzing bodily fluids, tissues, or other samples to gain diagnostic information. The device is applied topically to the wound itself.
Therefore, ReyaGel falls under the category of a wound management product, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ReyaGel is intended for the management of wounds that include:
- · Partial and full thickness wounds
- · Pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers
- · Second degree burns
- · Surgical wounds donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence
- · Trauma wounds abrasions, lacerations, and skin tears
- · Tunneled/undermined wounds
- · Draining wounds
Product codes
KGN
Device Description
ReyaGel Wound Gel is an extracellular matrix wound product composed of porcine spleen and lung extracellular matrix in a saline gel, for the management of wounds. It is an off-white gel supplied in a syringe for topical application. The product is provided sterile for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Because the subject device is composed of the identical as the predicate device, the bench, animal, and clinical testing from K172593 was leveraged for the subject device. To support the substantial equivalence to the difference in technology, additional testing was conducted on the including; protein characterization, biocompatibility including cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, materials mediated pyrogenicity, a swine full-thickness wound healing study, and clinical testing including Human Repeat Insult Patch Testing,
Based on the results of the bench, animal, and clinical testing completed on the subject device device demonstrates substantial equivalence to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
April 19, 2024
FetTech Clay Fette, CEO 10871 NW 52nd St, Ste 4 Sunrise, Florida 33351
Re: K232204 Trade/Device Name: ReyaGel (RG03 - MTP gel 3mL) Regulatory Class: Unclassified Product Code: KGN Dated: March 18, 2024 Received: March 19, 2024
Dear Clay Fette:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming
1
product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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.
Mustafa A. Mazher -S
for Yu-Chieh Chiu. Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
Device Name
ReyaGel (RG03 - MTP gel 3mL)
Indications for Use (Describe)
ReyaGel is intended for the management of wounds that include:
- · Partial and full thickness wounds
- · Pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers
- · Second degree burns
- · Surgical wounds donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence
- · Trauma wounds abrasions, lacerations, and skin tears
- · Tunneled/undermined wounds
- · Draining wounds
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) #: K232204
510(k) Summary
Prepared on: 2024-04-19
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | FetTech | 21 CFR 807.92(a)(1) |
|---|---|---|
| Applicant Address | 10871 NW 52nd St Ste 4 Sunrise FL 33351 United States | |
| Applicant Contact Telephone | 561-324-9507 | |
| Applicant Contact | Mr. Clay Fette | |
| Applicant Contact Email | cfette@fettech.com |
| Device Name | 21 CFR 807.92(a)(2) |
|---|---|
| ------------- | --------------------- |
| Device Trade Name | ReyaGel (RG03 - MTP gel 3mL) |
|---|---|
| Common Name | Wound dressing |
| Classification Name | Wound dressing with animal derived material |
| Regulation Number | Unclassified |
| Product Code | KGN |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
|---|---|
| ------------------------------------ | --------------------- |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K172593 | XCelliStem Wound Powder | KGN |
| Device Description Summary | 21 CFR 807.92(a)(4) |
|---|---|
| ---------------------------- | --------------------- |
ReyaGel Wound Gel is an extracellular matrix wound product composed of porcine spleen and lung extracellular matrix in a saline gel, for the management of wounds. It is an off-white gel supplied in a syringe for topical application. The product is provided sterile for single use.
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) |
|---|---|
| ---------------------------------- | --------------------- |
ReyaGel is intended for the management of wounds that include:
• Partial and full thickness wounds
• Pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers
• Second degree burns
• Surgical wounds - donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence
• Trauma wounds - abrasions, lacerations, and skin tears
• Tunneled/undermined wounds
• Draining wounds
Indications for Use Comparison
21 CFR 807.92(a)(5)
The subject device and predicate device (K172593) have the same indications for use.
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Technological Comparison
The subject device (RevaGel) and predicate device (XCelliStem Wound Powder) are composed of identical animal source material composed of extracellular matrix material from porcine spleen and lung. The ReyaGel subject device has been solubilized and also contains saline. The material is sourced, and processed using identical methods. For ReyaGel, the final predicate device material is then made into a gel form to facilitate application.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Because the subject device is composed of the identical as the predicate device, the bench, animal, and clinical testing from K172593 was leveraged for the subject device. To support the substantial equivalence to the difference in technology, additional testing was conducted on the including; protein characterization, biocompatibility including cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, materials mediated pyrogenicity, a swine fullthickness wound healing study, and clinical testing including Human Repeat Insult Patch Testing,
Based on the results of the bench, animal, and clinical testing completed on the subject device device demonstrates substantial equivalence to the predicate.