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K Number
K111578
Device Name
CORELEADER COLLA-ALGI FIBER MODEL CAW
Manufacturer
CORELEADER BIOTECH CO., LTD.
Date Cleared
2011-09-23

(108 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K925548,K982597,K921009,K910059
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Coreleader Colla-Algi Fiber Dressing is indicated for management of exuding wounds including:

  • Full-thickness and partial-thickness wounds .
  • Pressure ulcers .
  • Venous ulcers
  • Ulcers caused by mixed vascular etiologies .
  • Diabetic ulcers ●
  • Second-degree burns ●
  • Donor sites and other bleeding surface wounds ●
  • Abrasions
  • Traumatic wounds healing by secondary intention .
  • Dehisced surgical incisions .
Device Description

Coreleader Colla-Alig Fiber Dressing with Alginate is wound care dressing with 10% collagen composition. Colla-Alig Fiber Wound Dressing with Alginate combines with exudate to maintain a moist wound environment. The moist environment provided by the Colla-algi fibers may provide an environment favorable to the wound healing process. It is non-adherent, removes easily and leaves wound free of fiber. It maintains initial integrity when wet. Soft, conformable sheet can be cut to fit any size wound. Coreleader Colla-Algi Fiber Dressing with Alginate is an advanced wound care device composed of collagen and calcium alginate fibers. Its unique combination of natural biopolymers created by Wet-Spinning process combines the structure support of collagen and gel forming properties of alginates into a sterile, soft, absorbent. conformable topical wound dressing. The dressing is manufactured from bovine collage and medical grade alginate.

AI/ML Overview

This document concerns a 510(k) submission for a topical wound dressing, the Coreleader Colla-Algi Fiber. The 510(k) process is for demonstrating substantial equivalence to a predicate device, not for proving device performance against specific acceptance criteria through a clinical study in the way a PMA (Premarket Approval) would.

Therefore, the provided text does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving the device meets them.

Specifically:

  1. Table of acceptance criteria and reported device performance: Not present. The document focuses on establishing substantial equivalence to existing predicate devices.
  2. Sample size, test set data provenance: Not present. Clinical studies with test sets are not described.
  3. Number of experts and qualifications for ground truth: Not present. Ground truth establishment for a clinical study is not described.
  4. Adjudication method: Not present.
  5. MRMC comparative effectiveness study: Not present. This type of study is more common for imaging or diagnostic AI devices.
  6. Standalone (algorithm only) performance: Not applicable. This is a physical wound dressing, not an algorithm.
  7. Type of ground truth used: Not present.
  8. Sample size for training set: Not applicable and not present. This is not an AI/ML device.
  9. How ground truth for training set was established: Not applicable and not present.

The document describes the device, its intended use, and indicates that biocompatibility studies have demonstrated the Coreleader Colla-Algi Fiber Dressing to be non-irritating, non-sensitizing, and non-cytotoxic. However, it does not provide details about these studies (e.g., sample sizes, specific criteria, results documentation) beyond this summary statement.

The core of this 510(k) submission is the claim of "substantial equivalence" to predicate devices, meaning it is as safe and effective as existing legally marketed devices. The FDA's letter (pages 2-3) confirms this determination.

N/A