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K Number
K241904
Device Name
DermiSphere Dermal Template
Manufacturer
FesariusTherapeutics Inc.
Date Cleared
2025-01-06

(189 days)

Product Code
KGN
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K022127
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

DermiSphere™ hDRT hydrogel Dermal Regeneration Template is a wound dressing indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second degree burns, skin tears) and draining wounds. This device is intended for one-time use.

Device Description

DermiSphere™ hDRT hydrogel Dermal Regeneration Template is an advanced wound dressing comprised of crosslinked bovine collagen microspheres embedded in bovine collagen hydrogel matrix. This composite biodegradable wound dressing provides a scaffold for native tissue cellular invasion and capillary growth.

AI/ML Overview

The provided text does not contain information about acceptance criteria and the study that proves the device meets them. The text primarily focuses on the FDA's clearance of the DermiSphere™ hDRT (K241904) as substantially equivalent to a predicate device (Avagen Matrix Wound Dressing, K022127).

It mentions:

  • Biocompatibility testing
  • Bench testing including dimensions, drapability, and pyrogenicity.

However, it does not provide:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes for test sets or data provenance.
  3. Number of experts or their qualifications for establishing ground truth.
  4. Adjudication methods.
  5. Information about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
  6. Information about standalone (algorithm only) performance studies.
  7. The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

The conclusion states that nonclinical tests demonstrated substantial equivalence, with safety and effectiveness demonstrated through bench testing, biocompatibility, and comparison to the predicate device. However, the specifics of these tests and their results against predefined acceptance criteria, as requested, are not detailed in this document.

N/A