Search Results

IODOFLEX is indicated for use in managing wet ulcers and wounds such as venous stasis ulcers, pressure sores, and infected traumatic and surgical wounds. IODOFLEX assists in wound area protection and in reducing the microbial load in the wound dressing, retards eschar formation and keeps the lesion soft and pliable.

IODOFLEX consists of approximately 0.1mm diameter biodegradable spherical hydrophilic beads of cadexomer which incorporate 0.9% weight per weight iodine mixed with polyethylene glycols. The beads are composed of a three dimensional network of macromolecular chains of cross linked dextrin which is large enough to allow substances with a molecular weight of less than 1,000 to enter freely. As with all products having these characteristics, substances with a molecular weight of 1000 - 5000 enter the beads less freely, while those with a molecular weight greater than 5000 remain in the interspaces between the beads.

This document K190756 is a 510(k) summary for a medical device called IODOFLEX. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with acceptance criteria and device performance data in the typical sense of a diagnostic or AI device.

Therefore, many of the requested sections about acceptance criteria, study performance, sample sizes, and expert adjudication are not applicable to this type of submission. This document confirms that the "IODOFLEX" device (a cadexomer iodine wound dressing) is substantially equivalent to a previously cleared predicate device ("IODOFLEX Paste – K940414"), based on the fact that no changes have been made to the product other than labeling changes.

Here's a breakdown of the applicable information:

1. A table of acceptance criteria and the reported device performance:
   This is not applicable as this 510(k) submission establishes substantial equivalence based on the lack of change to the device itself compared to a predicate, rather than new performance data against specific acceptance criteria. The "performance" being demonstrated is that the device is still the same as the legally marketed predicate.

2. Sample size used for the test set and the data provenance:
   Not applicable. No new test set data was generated for device performance as the physical device itself has not changed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. No new test set requiring expert ground truth was created.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   Not applicable. This device is a wound dressing, not an AI or imaging device that would involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not applicable.

8. The sample size for the training set:
   Not applicable. No new training set was used as no new algorithm or performance study was conducted.

9. How the ground truth for the training set was established:
   Not applicable.

Summary of Relevant Information from the Document:

• Device Name: IODOFLEX
• Predicate Device: IODOFLEX Paste – K940414
• Basis for Substantial Equivalence: "No changes have been made to the product other than labeling changes (e.g. contraindications, precautions/warnings). As the changes to the labeling do not affect the product performance, the product remains substantially equivalent to the predicate device."
• Indications for Use: IODOFLEX is indicated for use in managing wet ulcers and wounds such as venous stasis ulcers, pressure sores, and infected traumatic and surgical wounds. It assists in wound area protection and in reducing the microbial load in the wound dressing, retards eschar formation and keeps the lesion soft and pliable.

Ask a specific question about this device