· Full thickness and partial thickness wounds
Pressure ulcers
Venous ulcers
· Ulcers caused by mixed vascular etiologies
Diabetic ulcers
· First dearee burns
· 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.

Device Description

Foundation DRS+ Solo is a conformable, advanced wound care device that consists of a porous matrix of chitosan derived from shellfish, sodium chondroitin sulfate, a glycosaminoglycan, and hyaluronic acid. The chitosan- glycosaminoglycan- hyaluronic acid 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.

AI/ML Overview

The provided document is a 510(k) summary for the Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo. It details that this device is substantially equivalent to a previously cleared predicate device, Foundation DRS+ Duo (K240298), with the primary difference being the absence of a backing layer. It also leverages information from a secondary predicate, Foundation Dermal Regeneration Scaffold (DRS) Solo (K231937), which also lacks a backing layer but has a different matrix formulation.

The document states that clinical testing was not necessary to demonstrate substantial equivalence. This means there was no multi-reader multi-case (MRMC) comparative effectiveness study, nor a standalone performance study in the traditional sense of evaluating an algorithm's performance against a clinical ground truth.

Therefore, the acceptance criteria and study that proves the device meets them are focused on non-clinical performance characteristics rather than clinical efficacy or diagnostic accuracy.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a non-clinical submission, the "acceptance criteria" are related to physical and biological properties. The document mentions that the tests performed "indicate that the Foundation DRS+ Solo is substantially equivalent to the predicate devices." This implies that the results of the performed tests met pre-defined internal acceptance criteria for substantial equivalence to the predicates.

Acceptance Criteria	Reported Device Performance
Hydration	Results indicate substantial equivalence to predicate devices.
Dimensional Stability	Results indicate substantial equivalence to predicate devices.
Handling Characteristics	Results indicate substantial equivalence to predicate devices.
Sterilization (per ISO 14937, ISO 10993-7)	Validation performed and leveraged from predicate K240298 and K231937; results indicate substantial equivalence.
Packaging (per ANSI/AAMI/ISO 11607-1, ASTM D4169, ASTM F2096, ASTM F88)	Validation performed and leveraged from predicate K240298 and K231937; results indicate substantial equivalence.
Viral Inactivation	Leveraged from predicate K231937; chitosan is identical and from the same supplier as in K231937.
Biocompatibility (per ISO 10993-1:2018 and sub-parts)	Testing conducted and leveraged from predicate K240298; evaluated for Cytotoxicity, Intracutaneous reactivity, Sensitization, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Bacterial Reverse Mutation, Genotoxicity, Systemic Toxicity Study with Full Thickness Skin Breach, Implantation studies, Bacterial Endotoxins Test, and Biological Evaluation. Results indicate substantial equivalence.
No new questions of safety or effectiveness	Based on all testing, the removal of the backing layer does not raise different questions of safety or effectiveness compared to the primary predicate.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify exact sample sizes for each non-clinical test (e.g., number of units tested for hydration or dimensional stability). Regulatory submissions often state compliance with standards, which implicitly defines aspects of sample sizes.
Data Provenance: The data is generated from laboratory testing of the device itself and leveraged from previous FDA clearances (K240298 and K231937). The country of origin for the data is not explicitly stated, but it's likely linked to the manufacturer's R&D/testing facilities. The testing is prospective in the sense that it was performed specifically for this 510(k) submission, or leveraged from previous submissions.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This question is not applicable in the context of this 510(k) submission. "Ground truth" in this context refers to the defined acceptable ranges and standards for material properties and biological responses, which are established by industry standards (e.g., ISO, ASTM, USP) and regulatory guidance, not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set:

This is not applicable as there is no human interpretation of data requiring adjudication for clinical endpoints. The "adjudication" is essentially confirming that the test results meet the specified acceptance criteria of the relevant standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence." Therefore, no MRMC study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No. This device is a medical product (dermal scaffold), not a software or AI algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. The closest equivalent is the standalone performance of the physical device in meeting its non-clinical specifications.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical tests is established by validated test methods, industry standards (e.g., ISO, ASTM), and predetermined specifications for material properties, sterility, packaging integrity, and biocompatibility. It's not based on expert consensus, pathology, or outcomes data related to human clinical performance.

8. The Sample Size for the Training Set:

This question is not applicable as this is not an AI/ML device requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable as this is not an AI/ML device requiring a training set.

Summary

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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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 31, 2024

Bionova Medical, Inc. % Lucie Dalet Principal ROM+ 2790 Mosside Blvd. Suite 800 Monroeville, Pennsylvania 15146

Re: K243181

Trade/Device Name: Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo Regulatory Class: Unclassified Product Code: FRO Dated: September 30, 2024 Received: September 30, 2024

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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.

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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).

Sincerely,

Mustafa A. Mazher -S

For Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices 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

Submission Number (if known)

K243181

Device Name

Foundation Dermal Regeneration Scaffold Plus (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
· First dearee burns
· 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 K243181

DATE PREPARED

October 31, 2024

MANUFACTURER AND 510(k) OWNER

Bionova Medical Inc. 3012 Centre Oak Way, Suite 103 Germantown, TN 38138 USA Telephone: Official Contact: Alex Greene, Director, Clinical and Regulatory

REPRESENTATIVE/CONSULTANT

Lucie Dalet, PhD. Joy Gutermuth Allison C. Komiyama, Ph.D., RAC RQM+ Telephone: (412) 816-8253 Email: ldalet@rqmplus.com, jgutermuth(@rqmplus.com akomiyama@rqmplus.com

DEVICE INFORMATION

Proprietary Name/Trade Name:	Foundation Dermal Regeneration Scaffold Plus (DRS+) Sold
Common Name:	Dressing, Wound, Drug
Regulation Number:	Unclassified
Class:	Unclassified
Product Code:	FRO, KGN
Review Panel:	General & Plastic Surgery
Premarket Review:	Premarket Review by Plastic and Reconstructive SurgeryDevices (DH4TB)

PREDICATE DEVICE IDENTIFICATION

The Foundation DRS+ Solo is substantially equivalent to the following predicate device:

510(k) Number	Predicate Device Name / Manufacturer	Predicate
K240298	Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo /Bionova Medical, Inc.	Primary
K231937	Foundation Dermal Regeneration Scaffold (DRS) Solo / BionovaMedical, Inc.	Secondary

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DEVICE DESCRIPTION

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 ●
. First degree burns
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 AND SUBSTANTIAL EQUIVALENCE

Bionova Medical Inc. believes that the Foundation DRS+ Solo is substantially equivalent to the predicate device based on the information summarized here:

The subject device has the exact same intended use, indications for use, and matrix formulation, as the Foundations DRS+ Duo device (cleared in K240298). The only difference with the primary predicate device is that the subject device does not have a backing layer. This is similar to the secondary predicate Foundation DRS Solo (K231937), that also has no backing layer (yet a different matrix formulation). Since the removal of the backing layer does not change the mechanism of action, intended use, and conditions of use of the device, this modification does not raise different questions of safety or effectiveness compared to the primary predicate. The different configuration of the subject device has undergone testing to ensure that the device is as safe and effective as the predicates.

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SUMMARY OF NON-CLINICAL TESTING

The following tests were performed on the subject device to demonstrate substantial equivalence with the predicate devices based on current industry standards:

Hydration -
-Dimensional stability
Handling characteristics -

In addition, since the subject and primary predicate devices have identical indications for use and similar technological characteristics, the following tests were leveraged from K240298 and K231937:

Sterilization:

Sterilization validation was performed in accordance with the following standards:

Sterilization validation per ISO 14937 -
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 -

Viral Inactivation:

Viral inactivation was leveraged from the device previously cleared in K231937. The chitosan used in the subject device is identical and from the same supplier as the device cleared in K231937.

Biocompatibility:

Biocompatibility testing was conducted on the final finished Foundation DRS+ Duo in accordance with ISO 10993-1:2018. The device was evaluated for:

Cytotoxicity per ISO 10993-5 -
Intracutaneous reactivity per ISO 10993-23 -
Sensitization per ISO 10993-10 -
-Acute Systemic Toxicity per ISO 10993-11
Material-Mediated Pvrogenicity 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
Implantation studies per ISO 10993-6 -
Bacterial Endotoxins Test (BET) per ANSI/AAMI ST72:2019 -
Biological Evaluation per ISO 10993-1 -

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The results of these tests indicate that the Foundation DRS+ Solo is substantially equivalent to the predicate devices.

SUMMARY OF CLINICAL TESTING

Clinical testing was not necessary to demonstrate substantial equivalence.

CONCLUSION

The Foundation DRS+ Solo is identical to the primary predicate device cleared in K240298, with the only change being that the subject device does not have a backing layer. Based on the testing performed, including hydration capability, dimensional stability, and handling characteristics, and biocompatibility and chemical characterization testing leveraged from K240298 and K231937, it can be concluded that the subject device does not raise different questions of safety or effectiveness compared to the predicate. The identical intended use, formulation, labeling instructions, and performance characteristics of the subject device are considered substantially equivalent to the predicate devices.

Regulation Number and Section

N/A