(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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