(136 days)
Foundation DRS Solo is indicated for the management of wounds including:
- · Full thickness and partial thickness wounds
- Pressure ulcers
- Venous ulcers
- · Ulcers caused by mixed vascular etiologies
- · Diabetic ulcers
- · Partial thickness burns (superficial second-degree burns)
- Donor sites and other bleeding surface wounds
- · Abrasions
- · Trauma wounds (abrasions, lacerations, skin tears)
- Dehisced wounds
- · Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
Foundation DRS Solo may be cut to size.
Foundation DRS Solo is a highly conformable, advanced wound care device comprising a porous matrix of chitosan derived from shellfish and sodium chondroitin sulfate, a glycosaminoglycan. The chitosan- glycosaminoglycan biodegradable, porous matrix provides a scaffold for cellular invasion and capillary growth. The device is applied on the surface of the wound, and provides a moist wound environment. The dressing may be replaced or may remain in place, acting as a scaffold to promote cellular infiltration and capillary growth as the dressing degrades.
The provided text is a 510(k) summary for the Foundation Dermal Regeneration Scaffold (DRS) Solo. This document describes the device, its intended use, and its substantial equivalence to a predicate device.
However, the document states, "Clinical testing was not required for the labeling update to include moistening of the device by autologous bodily fluids, in addition to saline." This immediately indicates that no clinical study was conducted to prove the device meets acceptance criteria related to its clinical performance for the specific change being submitted (the labeling update).
Therefore, I cannot provide information for all the requested points, as no clinical study was performed for this 510(k) submission. The provided information focuses on non-clinical testing performed to support the substantial equivalence claim.
Here's what can be extracted from the document regarding acceptance criteria and non-clinical testing, as well as the points that cannot be answered due to the absence of a clinical study:
Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:
The submission is for a labeling update to an existing device (Foundation DRS Solo, cleared under K210949). The primary focus of the provided document is to demonstrate that this labeling change (allowing moistening with autologous body fluids in addition to saline) does not raise new questions of safety or effectiveness. As such, no new clinical study was required or performed for this specific submission to prove clinical acceptance criteria are met. The document leverages existing data from the predicate device and conducts focused non-clinical tests to address the change.
1. A table of acceptance criteria and the reported device performance
Since no clinical study was performed for this submission, there are no clinical acceptance criteria or performance metrics reported in the typical sense for a clinical trial. The acceptance criteria and performance reported are for non-clinical tests and are aimed at demonstrating that the label change does not negatively impact the device's fundamental characteristics or safety.
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Hydration | • Test performed (results indicate no new safety/effectiveness concerns due to label change) |
| Dimensional stability | • Test performed (results indicate no new safety/effectiveness concerns due to label change) |
| Handling characteristics | • Test performed (results indicate no new safety/effectiveness concerns due to label change) |
| Biocompatibility | • Leveraged from K210949, conducted per ISO 10993-1:2018 (Cytotoxicity, Intracutaneous Study, Guinea Pig Max Sensitization, Acute Systemic Toxicity, Material-Mediated Rabbit Pyrogen Study, Bacterial Reverse Mutation, Genotoxicity Mouse Lymphoma Assay, Systemic Toxicity Study with Full Thickness Skin Breach, Chemical Characterization) |
| Sterilization | • Leveraged from K210949, conducted per ISO 14937, AAMI ST72, ISO 10993-7 |
| Packaging | • Leveraged from K210949, conducted per ANSI/AAMI/ISO 11607-1, ASTM D4169, ASTM F2096, ASTM F88 |
| Performance Testing | • Leveraged from K210949 (Wound Healing Study in a Porcine Model, Functionality Testing on Aged Devices, Viral Inactivation) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Non-Clinical Tests (Hydration, Dimensional Stability, Handling Characteristics): The document states these tests were performed but does not explicitly mention the sample size or exact provenance. These would be laboratory tests, typically conducted prospectively.
- Leveraged Tests (Biocompatibility, Sterilization, Packaging, Performance): These were leveraged from the primary predicate device (K210949). Specific sample sizes and provenance for these original tests are not detailed in this 510(k) summary. These would also be laboratory or animal studies, conducted prospectively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical study with human readers/experts establishing ground truth was performed for this submission. The ground truth for non-clinical tests is based on established scientific methods and standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study requiring human interpretation and adjudication was performed for this submission.
5. 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
Not applicable. This device is not an AI-assisted diagnostic tool, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical product (dermal scaffold), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests (hydration, dimensional stability, handling), the ground truth is based on physical and chemical measurements against defined specifications and industry standards.
- For the leveraged biocompatibility, sterilization, and packaging tests, the ground truth is established through adherence to the specified ISO/ASTM standards and methods.
- For the leveraged performance tests (e.g., wound healing in porcine model), the ground truth would be based on physiological observations and measurements in the animal model.
8. The sample size for the training set
Not applicable. This is a medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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Image /page/0/Picture/0 description: The image contains 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 13, 2023
Bionova Medical, Inc. % Lucie Dalet Senior Consultant Ram+ 2251 San Diego Ave Suite B-257 San Diego, California 92110
Re: K231937
Trade/Device Name: Foundation Dermal Regeneration Scaffold (DRS) Solo Regulatory Class: Unclassified Product Code: FRO Dated: June 29, 2023 Received: June 30, 2023
Dear Lucie Dalet:
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.
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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 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 (QS) 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 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).
Sincerelv.
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
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OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231937
Device Name
Foundation Dermal Regeneration Scaffold (DRS) Solo
Indications for Use (Describe)
Foundation DRS Solo is indicated for the management of wounds including:
- · Full thickness and partial thickness wounds
- Pressure ulcers
- Venous ulcers
- · Ulcers caused by mixed vascular etiologies
- · Diabetic ulcers
- · Partial thickness burns (superficial second-degree burns)
- Donor sites and other bleeding surface wounds
- · Abrasions
- · Trauma wounds (abrasions, lacerations, skin tears)
- Dehisced wounds
- · Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
Foundation DRS Solo may be cut to size.
| 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
DATE PREPARED
November 9, 2023
MANUFACTURER AND 510(k) OWNER
Bionova Medical Inc. 3012 Centre Oak Way, Suite 103 Germantown, TN 38138 USA Telephone: (901) 748-2581 Official Contact: Alex Greene, Director, Clinical and Regulatory
REPRESENTATIVE/CONSULTANT
Lucie Dalet, PhD. Allison C. Komiyama, Ph.D., RAC RQM+ 2251 San Diego Ave. Ste B-257 San Diego, CA 92110 USA Telephone: (412) 816-8253 Email: ldalet@rqmplus.com akomiyama@rqmplus.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | Foundation Dermal Regeneration Scaffold (DRS) Solo |
|---|---|
| Common Name: | Dressing, Wound, Drug |
| Regulation Number: | Unclassified |
| Class: | Unclassified |
| Product Code: | FRO, KGN |
| Review Panel: | General & Plastic Surgery |
| Premarket Review: | Premarket Review by Infection Control and Plastic Surgery Devices (DH4TB) |
PREDICATE DEVICE IDENTIFICATION
The Foundation DRS Solo is substantially equivalent to the following predicate and reference devices:
| 510(k) Number | Predicate Device Name / Manufacturer | Predicate |
|---|---|---|
| K210949 | Foundation Dermal Regeneration Scaffold (DRS) Solo / BioNovaMedical, Inc. | Primary |
| K172140 | NovoSorb BTM Wound Dressing / PolyNovo Biomaterials Pty Ltd | Secondary |
| K112888 | Meso Wound Matrix / Kensey Nash Corporation | Secondary |
| 510(k) Number | Reference Device Name / Manufacturer |
|---|---|
| K103787 | Medeor™ Matrix / Kensey Nash Corporation |
| BK210661 | RegenKit®-Wound Gel-2 / Regen Lab SA |
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DEVICE DESCRIPTION
Foundation DRS Solo is a highly conformable, advanced wound care device comprising a porous matrix of chitosan derived from shellfish and sodium chondroitin sulfate, a glycosaminoglycan. The chitosan- glycosaminoglycan biodegradable, porous matrix provides a scaffold for cellular invasion and capillary growth. The device is applied on the surface of the wound, and provides a moist wound environment. The dressing may be replaced or may remain in place, acting as a scaffold to promote cellular infiltration and capillary growth as the dressing degrades.
The Foundation DRS Solo is identical to the predicate cleared in K210949.
INDICATIONS FOR USE
Foundation DRS Solo is indicated for the management of wounds including:
- . Full thickness and partial thickness wounds
- Pressure ulcers ●
- Venous ulcers ●
- Ulcers caused by mixed vascular etiologies ●
- Diabetic ulcers ●
- Partial thickness burns (superficial second-degree burns)
- Donor sites and other bleeding surface wounds ●
- Abrasions ●
- Trauma wounds (abrasions, lacerations, skin tears) ●
- . Dehisced wounds
- Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, ● podiatric, wound dehiscence)
Foundation DRS Solo may be cut to size.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Bionova Medical Inc. believes that the Foundation DRS Solo is substantially equivalent to the predicate devices based on the information summarized here:
The subject device has the same design and dimensions and uses identical materials as the devices cleared in K210949. The subject device has the same intended use and technological characteristics as the devices cleared in K210949. The only difference is an update to the labeling to include an option to moisten the device with autologous body fluids. This information is provided in the event the user chooses to hydration fluids other than saline and does not affect the intended use, the technological characteristics, or the principle of operation of the device. The technological characteristics of the Foundation DRS Solo have undergone testing to ensure the device is as safe and effective as the primary predicate.
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SUMMARY OF NON-CLINICAL TESTING
The following tests were performed on the subject device to demonstrate safety based on current industry standards:
- Hydration .
- Dimensional stability ●
- Handing characteristics .
In addition, since the subject and primary predicate devices have identical indications for use and technological characteristics, the following tests were leveraged from K210949:
-
Biocompatibility:
Biocompatibility testing was conducted in accordance with ISO 10993-1:2018. The subject device was evaluated for: -
Cytotoxicity per ISO 10993-5 -
-
Intracutaneous Study in Rabbits per ISO 10993-10 -
-
-Guinea Pig Max Sensitization per ISO 10993-10
-
Acute Systemic Toxicity in Mice per ISO 10993-11 -
-
Material-Mediated Rabbit Pyrogen Study per ISO 10993-11 and USP <151> -
-
Bacterial Reverse Mutation per ISO 10993-3 -
-
Genotoxicity Mouse Lymphoma Assay per ISO 10993-3 -
-
Systemic Toxicity Study with Full Thickness Skin Breach- 28 Days in Rats per ISO -10993-11 and ISO 10993-6
-
Chemical Characterization per ISO 10993-18 -
-
Sterilization: ●
Sterilization validation was performed in accordance with the following standards:
- Sterilization validation per ISO 14937 -
- Bacterial Endotoxins Testing (LAL) per AAMI ST72 -
- Ethylene oxide sterilization residuals per ISO 10993-7 -
- Packaging:
Packaging validation testing was performed according to the following standards:
- ANSI/AAMI/ISO 11607-1 -
- ASTM D4169 -
- ASTM F2096 -
- ASTM F88 -
- Performance Testing: ●
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The results of these tests indicate that the Foundation DRS Solo is substantially equivalent to the primary predicate device.
SUMMARY OF CLINICAL TESTING
Clinical testing was not required for the labeling update to include moistening of the device by autologous bodily fluids, in addition to saline.
CONCLUSION
The Foundation DRS Solo is the same device as the primary predicate device cleared in K210949, with the only change being a labeling change to include the addition of autologous body fluids as possible hydration fluids. Based on the testing performed, including hydration, dimensional stability as well as handling, it can be concluded that the subject device does not raise new questions of safety or effectiveness compared to the predicate devices. The similar intended use, technological characteristics, and performance characteristics of the subject device are considered substantially equivalent to the predicate devices.
N/A