(269 days)
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
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.
Here's an analysis of the provided FDA document regarding the ReyaGel (RG03 - MTP gel 3mL) device, addressing your specific questions.
Based on the provided document, the device in question (ReyaGel) is a wound dressing that is seeking substantial equivalence to a predicate device (XCelliStem Wound Powder). The document primarily focuses on demonstrating this substantial equivalence, rather than detailing the acceptance criteria and a study to prove meeting those criteria in the traditional sense of a performance study for a novel device.
The premise for substantial equivalence is that the subject device is composed of "identical animal source material" and processed using "identical methods" to the predicate, with the key difference being that ReyaGel is solubilized into a gel form with saline.
Therefore, the information presented is largely about why the device is considered substantially equivalent to a predicate device, which implies that the predicate device already met certain performance standards.
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or corresponding reported device performance metrics in a typical table format that would be found for a de novo or new diagnostic device. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device, K172593, which itself would have met certain performance requirements for wound dressings.
The "performance" described is about meeting the requirements to establish substantial equivalence:
| Acceptance Criterion (Implicitly Met for Substantial Equivalence) | Reported Device Performance (as described in the document) |
|---|---|
| Premarket Notification (510(k)) Requirements: | - Device Description: ReyaGel is an extracellular matrix wound product composed of porcine spleen and lung extracellular matrix in a saline gel, off-white, supplied sterile for single use in a syringe for topical application. |
| Indications for Use (Substantial Equivalence to Predicate): | - ReyaGel Indications: Management of partial and full thickness wounds, pressure/venous/diabetic/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, skin tears), tunneled/undermined wounds, and draining wounds. - Comparison: "The subject device and predicate device (K172593) have the same indications for use." |
| Technological Characteristics (Similar to Predicate): | - Material Composition: Identical animal source material (porcine spleen and lung extracellular matrix). - Processing: Sourced and processed using identical methods as the predicate. - Difference & Mitigation: The predicate material is "then made into a gel form to facilitate application" for ReyaGel. - Supportive Testing: To address the technology difference (gel form), additional testing was conducted: "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." |
| Conclusion of Substantial Equivalence: | - Based on the results of the bench, animal, and clinical testing completed on the subject device, it "demonstrates substantial equivalence to the predicate." |
Study Details:
-
Sample sizes used for the test set and the data provenance:
- The document states that "bench, animal, and clinical testing" were conducted on the subject device.
- Specific sample sizes for these tests are not provided in the excerpt.
- The provenance of data for the additional testing (protein characterization, biocompatibility, swine wound healing, HRIPT) is not explicitly stated as retrospective or prospective, nor does it mention country of origin, but it is implied to be new testing conducted for this submission.
- For the leveraged predicate device data (K172593), no details are given.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts to establish "ground truth" for a specific test set. The studies mentioned (e.g., biocompatibility, swine wound healing, HRIPT) would typically have standard outcome measures assessed by qualified personnel, but this isn't detailed in terms of "expert consensus."
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No adjudication method is described.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable. The device (ReyaGel) is a wound dressing, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related effect size data would not be relevant or present.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable as the device is a wound dressing, not a software algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the additional testing mentioned (biocompatibility, swine wound healing, HRIPT), the "ground truth" would be the direct results of these specific scientific tests (e.g., cytotoxicity levels, wound closure rates in swine, skin irritation scores in HRIPT). This is based on objective measurements and established scientific protocols rather than expert consensus on images or pathology.
-
The sample size for the training set:
- This is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
-
How the ground truth for the training set was established:
- This is not applicable as there is no training set for this type of device.
In summary, the document details the substantial equivalence of ReyaGel to an existing predicate device by highlighting shared materials and processing, and by presenting additional non-clinical and clinical testing to address the specific technological differences (gel form). It does not provide the kind of performance data (acceptance criteria vs. reported performance) or study details that would be typical for a new diagnostic device performance study using AI or image analysis.
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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
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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.
N/A