IHM Technology Bandage

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. April 21, 2023 Protege Biomedical Mike Corcoran Regulatory Consultant 10909 Valley View Rd. Eden Prairie, Minnesota 55344 Re: K180893 Trade/Device Name: IHM Technology Bandage Regulatory Class: Unclassified Product Code: QSY Dear Mike Corcoran: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 19, 2018. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov. Sincerely, # Julie A. Morabito -S Julie Morabito, Ph.D. Assistant Director 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 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that. September 19, 2018 Protege Biomedical Mike Corcoran Regulatory Consultant 10909 Valley View Rd. Eden Prairie, Minnesota 55344 Re: K180893 Trade/Device Name: IHM Technology Bandage Regulatory Class: Unclassified Product Code: FRO Dated: August 17, 2018 Received: August 20, 2018 Dear Mike Corcoran: 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 avare 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good {2}------------------------------------------------ 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # David Krause -S for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) k180893 Device Name IHM Technology Bandage Indications for Use (Describe) IHM Bandage is intended for the management and external temporary control of bleeding from minor scrapes, minor abrasions and minor lacerations. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### 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." {4}------------------------------------------------ # 510(k) Summary of Ionic Hemostatic Mineral (IHM) Technology Bandage This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part §807.92. | 510(k) Submitter: | Protégé Biomedical<br>10909 Valley View Rd.<br>Eden Prairie, MN 55344<br>USA<br>Establishment Registration Number: NA | |----------------------|-----------------------------------------------------------------------------------------------------------------------| | Contact Person: | Mike Corcoran<br>Regulatory Consultant<br>E-mail: mpcorcoran@gmail.com<br>Phone: 612-226-2915 | | Date Prepared: | August 15, 2018 | | Device Name | | | Trade Name: | IHM Technology Bandage | | Product Code: | FRO | | Common Name: | Topical Hemostatic Wound Dressing | | Classification Name: | Not Applicable | | Classification: | Unclassified | #### Predicate Devices: An IHM Technology Bandage is substantially equivalent to the following devices: | 510(k) | Decision<br>Date | Device Name | Manufacturer | |---------|------------------|-------------|----------------------| | K072474 | Apr. 12, 2013 | QuikClot eX | Z-MEDICA CORPORATION | {5}------------------------------------------------ ## Device Description: IHM Technology Bandages are comprised of two primary components; IHM compound and gauze. IHM is a mineral based compound comprised of aluminum silicate and aluminum sulfate. The IHM compound is then coated on gauze or the gauze pad of an adhesive bandage. The combination creates a new type of bandage. #### Intended Use: IHM Technology Bandage is intended for the management and external temporary control of bleeding from minor cuts, minor scrapes, minor abrasions, and minor lacerations. ## Comparison with Predicate Devices: The technological characteristics of IHM Technology Bandages differ from the predicates in that two commonly used hemostatic agents are combined in a single device and applied to gauze or gauze pad of an adhesive bandage. Equivalent performance between IHM Technology Bandages and commercially available bandages is demonstrated using standard test methods for time to clot formation. By applying acceptable methods to evaluate effects on safety and effectiveness, substantial equivalence to the predicates is established. ## Performance Testing Summary: Bench and animal testing was performed to assure substantial equivalence to the predicate device and to demonstrate the device performs as intended. All testing was performed on product representative of the finished device. | Test | Description | Conclusion | |----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | QMS_PB_TECH013 Rev<br>A: Comparison of<br>Hemostatic Activity of<br>Gauzes using<br>Bioluminescent Assay | To evaluate the<br>efficacy of the gauze<br>pad of an IHM<br>technology Bandages<br>vs. FDA-cleared and<br>commercially available<br>hemostatic gauze<br>products. | IHM bandage was substantially<br>equivalent to other hemostatic gauze<br>products since it produced clots and<br>behaved in an essentially similar manner<br>in tests and physical inspection of clot<br>quality. | | Comparison of<br>Temperature Changes<br>by Two Gauzes<br>Carrying Mineral-based<br>Hemostatic Agents | To compare the heat<br>generated by the<br>IHM™ Technology<br>Bandage to that of<br>QuikClot ACG upon<br>exposure to blood | Neither product produces enough heat to<br>cause a patient safety issue. The two<br>products are substantially equivalent<br>with regard to heat generation. | #### Bench testing consisted of the following: {6}------------------------------------------------ #### In Vivo Animal testing consisted of the following: | Test | Description | Conclusion | |------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | HLR016-IS17: An<br>Acute GLP Study to<br>Evaluate the IHM<br>Bandage vs. QuikClot<br>Advanced Clotting<br>Gauze. | Rat tail transaction test to<br>demonstrate hemostatic<br>efficacy of IHM Bandage<br>compared to QuikClot<br>Advanced Clotting Gauze | IHM Bandage was found<br>substantially equivalent to<br>QuikClot in its efficacy to control<br>bleeding in minor cuts, minor<br>scrapes, minor abrasions, and<br>minor lacerations. | | HLR018-IS39: A<br>CHRONIC GLP STUDY<br>TO EVALUATE THE<br>SAFETY OF IHM<br>GAUZE IN A<br>PORCINE MODEL. | The purpose of this study<br>was to demonstrate the<br>safety of the IHM Gauze in a<br>porcine model of minor skin<br>incision. | With respect to the assessments of<br>overall animal health, gross<br>observation of the incision sites,<br>and tissue response to the study<br>articles, the findings of this study<br>support an acceptable safety<br>profile of the IHM Gauze, with<br>minimal to no risks to the<br>porcine subjected to minor skin<br>incisions. | #### Biocompatibility testing was performed on the subject device in conformance with ISO 10993-1 guidelines: | Test | Description | Conclusion | |-------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------| | Cytotoxicity | L929 MEM Elution test according to ISO<br>10993- 5:2009, 'Biological Evaluation of<br>Medical Devices | Non-cytotoxic | | Irritation<br>Reactivity | ISO 10993-10:2010, 'Biological<br>Evaluation of Medical Devices, Part 10;<br>Tests for Skin Irritation and Sensitization | Slight Irritant | | Sensitization | ISO 10993-10:2010, 'Biological<br>Evaluation of Medical Devices, Part 10;<br>Tests for Skin Irritation and Sensitization | Non-sensitizing | | Pyrogenicity | ISO 10993-11:2006, 'Biological<br>Evaluation of Medical Devices, Part 11:<br>Tests for Systemic Toxicity' | Non-pyrogenic | | Acute<br>Systemic<br>Toxicity | ISO 10993-11:2017, 'Biological<br>Evaluation of Medical Devices, Part 11:<br>Tests for Systemic Toxicity' | Pass | ## Conclusion: The IHM Technology Bandage has been shown to be substantially equivalent to the predicates based on technological comparison, indications for use, laboratory and other safety testing.