(31 days)
Not Found
No
The device description focuses on the material composition and biological function of the wound dressing, with no mention of AI or ML capabilities. The performance studies are non-clinical and do not involve data analysis that would typically utilize AI/ML.
Yes.
The device is used for the management of wounds, which is a therapeutic purpose.
No
Explanation: The device is described as an "advanced wound care device" that provides a "scaffold for cellular invasion and capillary growth" and "provides a moist wound environment." Its intended use is for the management of various types of wounds, indicating it is a therapeutic or treatment device rather than one used for diagnosis.
No
The device description clearly states it 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," which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the management of wounds by providing a scaffold and moist environment. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details the composition and function of the device as a wound dressing that promotes healing. It does not mention any components or processes related to analyzing samples from the body to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other bodily fluid or sample. There is no mention of detecting biomarkers, pathogens, or any other indicators of disease.
- Performance Studies: The performance studies focus on characteristics relevant to a wound dressing (hydration, stability, handling, biocompatibility), not on diagnostic accuracy metrics like sensitivity, specificity, or AUC.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to directly interact with and aid in the healing of a wound, which is a therapeutic intervention.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
FRO, KGN
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 chitosa- 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.
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
Prescription Use
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 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, the following tests were leveraged from K240298 and K231937:
Sterilization validation per ISO 14937 and Ethylene oxide sterilization residuals per ISO 10993-7.
Packaging validation testing according to ANSI/AAMI/ISO 11607-1, ASTM D4169, ASTM F2096, and ASTM F88.
Viral inactivation was leveraged from K231937.
Biocompatibility testing on the final finished Foundation DRS+ Duo in accordance with ISO 10993-1:2018, evaluating: 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 Pyrogenicity per ISO 10993-11 and USP , 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.
Key results: The results of these tests indicate that the Foundation DRS+ Solo is substantially equivalent to the predicate devices. Clinical testing was not necessary to demonstrate substantial equivalence.
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/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.
1
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.
2
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
3
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 Surgery |
| Devices (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 / Bionova | |
| Medical, Inc. | Secondary |
5
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.
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.
6
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 -
- 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.