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.

Device Description

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.

AI/ML Overview

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:

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.
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.
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.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable.
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.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithmic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable.
The sample size for the training set:
Not applicable. No new training set was used as no new algorithm or performance study was conducted.
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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 20, 2019

Smith & Nephew Medical Ltd. Ana Castillo Senior Regulatory Affairs Specialist 101 Hessle Road Hull East Riding of Yorkshire, HU3 2BN GB

Re: K190756

Trade/Device Name: IODOFLEX Regulatory Class: Unclassified Product Code: FRO Dated: October 1, 2019 Received: October 3, 2019

Dear Ana Castillo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kimberly M. Ferlin, Ph.D. Assistant Director (Acting) DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190756

Device Name IODOFLEX

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

510(k) Owner:	Smith + Nephew Medical Ltd101 Hessle RoadHull East Riding Of Yorkshire,UNITED KINGDOM HU3 2BN
Date Prepared:	December 17, 2019
Submitted by (ContactPerson):	Ana Castillo, Regulatory Affairs Specialist II, AWMSmith + Nephew, Inc.T (817) 916-1441F (817) 302-3983
Name of Device:	IODOFLEX°
Common Name:	Liquid bandage
Device Classification Nameand Reference:	Dressing, Wound, Drug
Device Class:	Unclassified
Panel Code:	General & Plastic Surgery
Product Code:	FRO
Predicate Device:	IODOFLEX Paste – K940414The predicate device has not been subject to a design relatedrecall.

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Device Description:

Indications for Use

Comparison of Technological Characteristics with the Predicate Device

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.

Regulation Number and Section

N/A