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K Number
K161991
Device Name
Curasite
Manufacturer
IZUN PHARMACEUTICALS
Date Cleared
2017-03-03

(227 days)

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

For Prescription Use Indication:
Under the supervision of a healthcare professional, Curasite is intended for the management of the following:

  • Diabetic foot ulcers
  • Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)
  • Pressure ulcers/sores (partial and full thickness)
  • 1st and 2nd degree partial thickness burns

For Over-the-Counter Use Indication:
For Over-the-Counter (OTC) use, Curasite may be used for the management of:

  • Minor abrasions
  • Minor lacerations
  • Minor cuts
  • Minor scalds and minor burns
Device Description

Not Found

AI/ML Overview

The provided document (K161991) is a 510(k) "Substantial Equivalence" determination for the device "Curasite." This type of document primarily confirms that a new device is as safe and effective as existing legally marketed devices.

Critical Information Missing for an AI/ML Device Study Description:

The document DOES NOT describe a study for an AI/ML (Artificial Intelligence/Machine Learning) device. Instead, it seems to be for a medical product (likely a wound care product given the "Indications for Use"). Therefore, most of the requested fields regarding acceptance criteria, study performance, ground truth, and expert involvement for an AI/ML device are not applicable and cannot be extracted from this document.

Based on the provided document, here's what can be extracted:

  • Device Name: Curasite
  • Product Code: FRO (Note: This code, according to FDA, typically refers to "Wound dressing, hydrogel" or similar. It is not an AI/ML product code.)
  • Indications for Use:
    • Prescription Use: Management of diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcers, mixed etiology), pressure ulcers/sores (partial and full thickness), and 1st and 2nd degree partial thickness burns.
    • Over-the-Counter Use: Management of minor abrasions, minor lacerations, minor cuts, minor scalds, and minor burns.

Therefore, I cannot provide the requested information regarding AI/ML device acceptance criteria and study details because the document is not about an AI/ML device.

The questions you've asked (about acceptance criteria, sample size, ground truth, expert adjudication, MRMC studies, standalone performance, training sets, etc.) are highly relevant for the regulatory review of AI/ML-driven medical devices. However, this specific 510(k) clearance letter does not contain the data from such a study.

N/A