(499 days)
No
The 510(k) summary describes a passive wound dressing made of biological materials. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on biological and functional properties, not algorithmic performance.
Yes
The device is indicated for the management of various wounds, including ulcers and burns, and acts as a scaffold to promote cellular infiltration and capillary growth, which are therapeutic actions aimed at healing or alleviating a condition.
No
This device is described as an "advanced wound care device" that provides a "scaffold for cellular invasion and capillary growth" and creates a "moist wound environment." Its intended use is for the "management of wounds," which indicates a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "highly conformable, advanced wound care device comprising a porous matrix of chitosan derived from shellfish and sodium chondroitin sulfate, a glycosaminoglycan," indicating it is a physical material applied to a wound, not software.
Based on the provided information, the Foundation DRS Solo device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being applied on the surface of the wound for the management of various types of wounds. This is a direct application to the body for therapeutic purposes.
- Device Description: The description details a "highly conformable, advanced wound care device" that provides a "scaffold for cellular invasion and capillary growth" and a "moist wound environment." This aligns with the function of a wound dressing or matrix, not a diagnostic test performed in vitro (outside the body).
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue) to provide diagnostic information about a patient's condition.
- Performance Studies: The performance studies mentioned (Wound Healing Study in a Porcine Model, Functionality Testing) are focused on the device's ability to promote wound healing and function as a wound care product, not on its diagnostic accuracy.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Foundation DRS Solo device is a therapeutic device applied directly to the wound.
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 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.
Product codes
FRO
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.
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 (Part 21 CFR 801 Subpart D)
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)
Summary of Nonclinical Testing
Biocompatibility testing was conducted for Foundation DRS Solo, in accordance with International Standard ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Guidance on selection of tests and Good Laboratory Practices (GLP). The subject device was evaluated for:
- Cytotoxicity
- Intracutaneous Study in Rabbits
- Guinea Pig Max Sensitization ●
- Acute Systemic Toxicity in Mice
- Material-Mediated Rabbit Pyrogen Study ●
- Bacterial Reverse Mutation ●
- Genotoxicity Mouse Lymphoma Assay ●
- Systemic Toxicity Study with Full Thickness Skin Breach- 28 Days in Rats ●
- Implantation Test in Rabbits .
Further, additional characterization testing was performed on the subject device including:
-
Bacterial Endotoxins Testing (LAL) was performed in accordance with:
- AAMI ST72 Bacterial endotoxins Test methods, routine monitoring, and . alternatives to batch testing (2019)
-
Chemical Characterization (Extractables and Leachables) was performed in . accordance with:
- ISO 10993-18 Biological evaluation of medical devices Part 18: ● Chemical characterization of medical device materials within a risk management process (2020)
-
Sterilization Validation was performed in accordance with: ●
- ISO 14937 Sterilization of health care products General requirements . for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (2009)
- ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (2008)
-
Packaging Validation was performed in accordance with: .
- ANSI/AAMI/ISO 11607-1 Packaging for Terminally Sterilized Medical . Devices- Part 1: Requirements for materials, sterile barrier systems and packaging systems ((2006(R2010)/A1:2014)
- . ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and System (2016)
- . ASTM F2096 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) (2011)
- . ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials (2015)
Performance testing was also performed including:
- Wound Healing Study in a Porcine Model ●
- . Functionality Testing on Aged Devices
- . Viral Inactivation was leveraged from the predicate device. The chitosan used in the subject device is identical and from the same supplier as the predicate device.
All tests found the device to meet study endpoints and meet acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K123961, Sentrex BioSponge ● MPD (Bionova Medical, Inc.)
Reference Device(s)
K081635, Integra Meshed Bilayer Wound Matrix ● (Integra LifeSciences Corp.), K021792, Integra Bilayer Wound . Matrix (Integra LifeSciences Corp.)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
August 11, 2022
Bionova Medical Inc. Alex Greene Director, Clinical & Regulatory 3012 Centre Oak Way, Ste 102 Germantown, Tennessee 38138
Re: K210949
Trade/Device Name: Foundation Dermal Regeneration Scaffold (DRS) Solo Regulatory Class: Unclassified Product Code: FRO Dated: May 17, 2021 Received: May 18, 2021
Dear Alex Greene:
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 (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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).
Sincerely,
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210949
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
- · 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.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Bionova Medical, Inc. Applicant: 3012 Centre Oak Way, Suite 102 Germantown. TN 38138 Ph: (901) 748-2581 Fax: (901) 748-2583
Official Correspondent: Anike Freeman Principal Consultant RQM+ Phone: (412) 899-7422 Email: afreeman@rqmplus.com
Date of Submission: 26 March 2021
Proprietary Name: Foundation Dermal Regeneration Scaffold (DRS) Solo Common Name: Dressing, Wound, Drug Regulatory Class: Unclassified
Product Codes: FRO
Predicate Devices:
- Primary predicate: K123961, Sentrex BioSponge ● MPD (Bionova Medical, Inc.)
- Reference Device: K081635, Integra Meshed Bilayer Wound Matrix ● (Integra LifeSciences Corp.)
- Reference Device: K021792, Integra Bilayer Wound . Matrix (Integra LifeSciences Corp.)
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.
Intended 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) ●
4
- 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.
Summary of Technological Characteristics and Substantial
Equivalence Foundation DRS Solo is substantially equivalent in function and intended use to the predicate devices. It is a sterile, porous matrix made from chitosan, derived from shellfish, which is a non-toxic, biodegradable, biocompatible, natural-based biopolymer and sodium chondroitin sulfate, a glycosaminoglycan. The chitosanglycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth.
Summary of Nonclinical Testing
Biocompatibility testing was conducted for Foundation DRS Solo, in accordance with International Standard ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Guidance on selection of tests and Good Laboratory Practices (GLP). The subject device was evaluated for:
- Cytotoxicity
- Intracutaneous Study in Rabbits
- Guinea Pig Max Sensitization ●
- Acute Systemic Toxicity in Mice
- Material-Mediated Rabbit Pyrogen Study ●
- Bacterial Reverse Mutation ●
- Genotoxicity Mouse Lymphoma Assay ●
- Systemic Toxicity Study with Full Thickness Skin Breach- 28 Days in Rats ●
- Implantation Test in Rabbits .
Further, additional characterization testing was performed on the subject device including:
- Bacterial Endotoxins Testing (LAL) was performed in accordance with:
- AAMI ST72 Bacterial endotoxins Test methods, routine monitoring, and . alternatives to batch testing (2019)
- Chemical Characterization (Extractables and Leachables) was performed in . accordance with:
- ISO 10993-18 Biological evaluation of medical devices Part 18: ● Chemical characterization of medical device materials within a risk management process (2020)
- Sterilization Validation was performed in accordance with: ●
- ISO 14937 Sterilization of health care products General requirements . for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (2009)
- ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (2008)
5
- Packaging Validation was performed in accordance with: .
- ANSI/AAMI/ISO 11607-1 Packaging for Terminally Sterilized Medical . Devices- Part 1: Requirements for materials, sterile barrier systems and packaging systems ((2006(R2010)/A1:2014)
- . ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and System (2016)
- . ASTM F2096 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) (2011)
- . ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials (2015)
Performance testing was also performed including:
- Wound Healing Study in a Porcine Model ●
- . Functionality Testing on Aged Devices
- . Viral Inactivation was leveraged from the predicate device. The chitosan used in the subject device is identical and from the same supplier as the predicate device.
All tests found the device to meet study endpoints and meet acceptance criteria.
Determination of Substantial Equivalence
The claim of substantial equivalence of Foundation DRS to the predicate devices is based on the comparison of the intended use, device description, product technical/material characteristics, and performance characteristics. Foundation DRS Solo is substantially equivalent to the predicate device with regard to safety and effectiveness.