(167 days)
IHM Bandage is intended for the management and external temporary control of bleeding from minor scrapes, minor abrasions and minor lacerations.
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.
The IHM Technology Bandage, a topical hemostatic wound dressing, was evaluated for substantial equivalence to predicate devices, specifically the QuikClot eX (K072474). The device is intended for the management and external temporary control of bleeding from minor cuts, scrapes, abrasions, and lacerations.
The acceptance criteria and reported device performance are summarized below:
| Acceptance Criteria / Test Description | Reported Device Performance (Conclusion) |
|---|---|
| Efficacy of Hemostatic Activity (QMS_PB_TECH013 Rev A: Comparison of Hemostatic Activity of Gauzes using Bioluminescent Assay) | IHM bandage was substantially equivalent to other hemostatic gauze products; it produced clots and behaved in an essentially similar manner in tests and physical inspection of clot quality. |
| Heat Generation Comparison (Comparison of Temperature Changes by Two Gauzes Carrying Mineral-based Hemostatic Agents) | Neither product (IHM™ Technology Bandage vs. QuikClot ACG) produces enough heat to cause a patient safety issue. The two products are substantially equivalent with regard to heat generation. |
| Hemostatic Efficacy in vivo (HLR016-IS17: An Acute GLP Study to Evaluate the IHM Bandage vs. QuikClot Advanced Clotting Gauze - Rat tail transaction test) | IHM Bandage was found substantially equivalent to QuikClot in its efficacy to control bleeding in minor cuts, minor scrapes, minor abrasions, and minor lacerations. |
| Safety in vivo (HLR018-IS39: A CHRONIC GLP STUDY TO EVALUATE THE SAFETY OF IHM GAUZE IN A PORCINE MODEL - Minor skin incision) | Findings support an acceptable safety profile of the IHM Gauze, with minimal to no risks to the porcine subjected to minor skin incisions (based on overall animal health, gross observation of incision sites, and tissue response). |
| Biocompatibility - Cytotoxicity (L929 MEM Elution test according to ISO 10993- 5:2009) | Non-cytotoxic |
| Biocompatibility - Irritation Reactivity (ISO 10993-10:2010, 'Biological Evaluation of Medical Devices, Part 10; Tests for Skin Irritation and Sensitization') | Slight Irritant |
| Biocompatibility - Sensitization (ISO 10993-10:2010, 'Biological Evaluation of Medical Devices, Part 10; Tests for Skin Irritation and Sensitization') | Non-sensitizing |
| Biocompatibility - Pyrogenicity (ISO 10993-11:2006, 'Biological Evaluation of Medical Devices, Part 11: Tests for Systemic Toxicity') | Non-pyrogenic |
| Biocompatibility - Acute Systemic Toxicity (ISO 10993-11:2017, 'Biological Evaluation of Medical Devices, Part 11: Tests for Systemic Toxicity') | Pass |
Here's the breakdown of the study details:
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Sample size used for the test set and the data provenance:
- Bench Testing (In vitro studies): No specific sample sizes for each test are provided, but the description indicates "acceptable methods" were used. The provenance is from internal testing ("QMS_PB_TECH013 Rev A" and "Comparison of Temperature Changes by Two Gauzes").
- Animal Testing (In vivo studies):
- Rat tail transaction test (HLR016-IS17): Specific sample size not explicitly stated, but it was an "Acute GLP Study" comparing IHM Bandage to QuikClot.
- Porcine model (HLR018-IS39): Specific sample size not explicitly stated, but it was a "CHRONIC GLP STUDY" to evaluate safety.
- Data Provenance: The studies appear to be conducted by or for the manufacturer ("Protege Biomedical") based on the numbering scheme (e.g., QMS_PB_TECH013, HLR). The animal studies are referred to as GLP (Good Laboratory Practice) studies, implying adherence to regulated standards for animal research. The biocompatibility tests cite ISO standards, indicating third-party or internal testing conforming to international standards. The country of origin of the data is not specified beyond the manufacturer's location in Eden Prairie, Minnesota, USA. No information is provided on whether the data is retrospective or prospective, though animal studies are typically prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For these types of medical devices (topical hemostatic bandages), the "ground truth" is established through measurable physiological responses (e.g., clot formation, bleeding control, temperature changes, biocompatibility reactions) rather than expert interpretation of images or symptoms in test sets. The animal studies would have involved veterinarians and laboratory personnel responsible for observation and assessment.
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Adjudication method for the test set: Not applicable. As the "ground truth" is based on direct measurements and observed physiological responses, adjudication by human experts in the traditional sense (e.g., 2+1, 3+1 for medical image interpretation) is not relevant. The GLP studies would have had internal quality control and oversight.
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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 physical bandage, not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies and the concept of human readers improving with AI assistance do not apply.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device.
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The type of ground truth used:
- For efficacy: Direct observation of clot formation, cessation of bleeding, and comparison of these with a predicate device.
- For safety: Physiological responses in animal models (e.g., temperature changes, overall animal health, gross observation of incision sites, tissue response), and standard biocompatibility endpoints (cytotoxicity, irritation, sensitization, pyrogenicity, systemic toxicity).
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The sample size for the training set: Not applicable. This device is not an AI/ML algorithm that requires a training set. The descriptions pertain to pre-market testing.
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How the ground truth for the training set was established: Not applicable.
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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
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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
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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
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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)
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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 Biomedical10909 Valley View Rd.Eden Prairie, MN 55344USAEstablishment Registration Number: NA |
|---|---|
| Contact Person: | Mike CorcoranRegulatory ConsultantE-mail: mpcorcoran@gmail.comPhone: 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) | DecisionDate | Device Name | Manufacturer |
|---|---|---|---|
| K072474 | Apr. 12, 2013 | QuikClot eX | Z-MEDICA CORPORATION |
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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 RevA: Comparison ofHemostatic Activity ofGauzes usingBioluminescent Assay | To evaluate theefficacy of the gauzepad of an IHMtechnology Bandagesvs. FDA-cleared andcommercially availablehemostatic gauzeproducts. | IHM bandage was substantiallyequivalent to other hemostatic gauzeproducts since it produced clots andbehaved in an essentially similar mannerin tests and physical inspection of clotquality. |
| Comparison ofTemperature Changesby Two GauzesCarrying Mineral-basedHemostatic Agents | To compare the heatgenerated by theIHM™ TechnologyBandage to that ofQuikClot ACG uponexposure to blood | Neither product produces enough heat tocause a patient safety issue. The twoproducts are substantially equivalentwith regard to heat generation. |
Bench testing consisted of the following:
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In Vivo Animal testing consisted of the following:
| Test | Description | Conclusion |
|---|---|---|
| HLR016-IS17: AnAcute GLP Study toEvaluate the IHMBandage vs. QuikClotAdvanced ClottingGauze. | Rat tail transaction test todemonstrate hemostaticefficacy of IHM Bandagecompared to QuikClotAdvanced Clotting Gauze | IHM Bandage was foundsubstantially equivalent toQuikClot in its efficacy to controlbleeding in minor cuts, minorscrapes, minor abrasions, andminor lacerations. |
| HLR018-IS39: ACHRONIC GLP STUDYTO EVALUATE THESAFETY OF IHMGAUZE IN APORCINE MODEL. | The purpose of this studywas to demonstrate thesafety of the IHM Gauze in aporcine model of minor skinincision. | With respect to the assessments ofoverall animal health, grossobservation of the incision sites,and tissue response to the studyarticles, the findings of this studysupport an acceptable safetyprofile of the IHM Gauze, withminimal to no risks to theporcine subjected to minor skinincisions. |
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 ISO10993- 5:2009, 'Biological Evaluation ofMedical Devices | Non-cytotoxic |
| IrritationReactivity | ISO 10993-10:2010, 'BiologicalEvaluation of Medical Devices, Part 10;Tests for Skin Irritation and Sensitization | Slight Irritant |
| Sensitization | ISO 10993-10:2010, 'BiologicalEvaluation of Medical Devices, Part 10;Tests for Skin Irritation and Sensitization | Non-sensitizing |
| Pyrogenicity | ISO 10993-11:2006, 'BiologicalEvaluation of Medical Devices, Part 11:Tests for Systemic Toxicity' | Non-pyrogenic |
| AcuteSystemicToxicity | ISO 10993-11:2017, 'BiologicalEvaluation of Medical Devices, Part 11: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.
N/A