IODOFLEX

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K190756 Device Name IODOFLEX #### Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------|--| | <div><span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | | | <div><span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) SUMMARY | 510(k) Owner: | Smith + Nephew Medical Ltd<br>101 Hessle Road<br>Hull East Riding Of Yorkshire,<br>UNITED KINGDOM HU3 2BN | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------| | Date Prepared: | December 17, 2019 | | Submitted by (Contact<br>Person): | Ana Castillo, Regulatory Affairs Specialist II, AWM<br>Smith + Nephew, Inc.<br>T (817) 916-1441<br>F (817) 302-3983 | | Name of Device: | IODOFLEX° | | Common Name: | Liquid bandage | | Device Classification Name<br>and Reference: | Dressing, Wound, Drug | | Device Class: | Unclassified | | Panel Code: | General & Plastic Surgery | | Product Code: | FRO | | Predicate Device: | IODOFLEX Paste – K940414<br><br>The predicate device has not been subject to a design related<br>recall. | {4}------------------------------------------------ ### 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. ### 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. 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. ### 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.