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K Number
K240298
Device Name
Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo
Manufacturer
Bionova Medical, Inc.
Date Cleared
2024-08-21

(202 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K231937
Predicate For
K243181
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Foundation DRS+ Duo 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+ Duo may be cut to size.

Device Description

Foundation DRS+ Duo is a conformable, advanced wound care device comprising 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. The Foundation DRS+ Duo has a semipermeable polyurethane backing layer (offered with or without perforations) providing a flexible covering for the wound surface.

AI/ML Overview

This document is an FDA 510(k) clearance letter for a medical device called "Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo." It does not contain information about an AI/ML-driven medical device, hence it does not provide details on acceptance criteria or studies related to AI/ML performance.

The document discusses the substantial equivalence of the DRS+ Duo device to a predicate device based on:

  1. Biocompatibility Testing: Conducted according to ISO 10093-1:2018, evaluating cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, material-mediated pyrogenicity, bacterial reverse mutation, genotoxicity (Mouse Lymphoma Assay), systemic toxicity study, implantation studies (ISO 10993-6), and bacterial endotoxins.
  2. Performance Testing: Assessed through additional endpoints within the Implantation (ISO 10993-6) model, functionality testing on aged devices (hydration, dimensional stability, handling characteristics) with saline and autologous body fluids.
  3. Animal Testing: 14, 28, 42, and 91-day implantation studies in a porcine wound healing model on full thickness dermal wounds. These evaluated wound healing characteristics, dynamics, biological response, and residence time.
  4. Sterilization and Packaging Validation: Leveraged from previous clearances (K210949 and K231937), performed per ISO 14937, ISO 10993-7, ANSI/AAMI/ISO 11607-1, ASTM D4169, ASTM F2096, and ASTM F88. Viral inactivation was also leveraged.

Conclusion stated: "Clinical testing was not necessary to demonstrate substantial equivalence." This means that the device's clearance was based on non-clinical data as described above, not on a study proving human reader improvement with AI assistance (MRMC) or standalone algorithm performance.

Therefore, I cannot provide the requested information about acceptance criteria and study details related to an AI/ML device per the prompt's outlined points (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, ground truth type, training set size, and training set ground truth establishment), as this document does not pertain to an AI/ML medical device.

N/A