K Number
K180893
Device Name
IHM Technology Bandage
Manufacturer
Date Cleared
2018-09-19

(167 days)

Product Code
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IHM Bandage is intended for the management and external temporary control of bleeding from minor scrapes, minor abrasions and minor lacerations.
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.
More Information

Not Found

No
The device description and performance studies focus on the material composition and physical properties of the bandage for hemostasis, with no mention of AI/ML or related concepts.

Yes.
The device is intended for the management and external temporary control of bleeding, which is a therapeutic function.

No

The device description and intended use indicate it is for external temporary control of bleeding from minor wounds, which is a therapeutic function, not a diagnostic one.

No

The device description explicitly states it is comprised of physical components (IHM compound and gauze) and the performance studies involve bench and animal testing of these physical materials. There is no mention of software as a component or function of the device.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for the "management and external temporary control of bleeding from minor scrapes, minor abrasions and minor lacerations." This is a direct application to the body for a therapeutic purpose (controlling bleeding).
  • Device Description: The description details a bandage with a mineral-based compound applied to gauze. This is a physical device applied externally.
  • Lack of In Vitro Activity: An IVD is a device intended for use in vitro for the examination of specimens, including blood, tissues, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not involve the examination of specimens outside the body.
  • Performance Studies: The performance studies focus on hemostatic activity (controlling bleeding), heat generation, safety in animal models, and biocompatibility. These are all related to the device's direct interaction with the body and its ability to stop bleeding, not its ability to analyze biological samples.

The device is a topical hemostatic dressing, which is a type of medical device, but not an IVD.

N/A

Intended Use / Indications for Use

IHM Bandage is intended for the management and external temporary control of bleeding from minor scrapes, minor abrasions and minor lacerations.

Product codes (comma separated list FDA assigned to the subject device)

QSY, FRO

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Bench testing consisted of the following:

  • QMS_PB_TECH013 Rev A: Comparison of Hemostatic Activity of Gauzes using Bioluminescent Assay. Description: To evaluate the efficacy of the gauze pad of an IHM technology Bandages vs. FDA-cleared and commercially available hemostatic gauze products. Conclusion: IHM bandage was substantially equivalent to other hemostatic gauze products since it produced clots and behaved in an essentially similar manner in tests and physical inspection of clot quality.
  • Comparison of Temperature Changes by Two Gauzes Carrying Mineral-based Hemostatic Agents. Description: To compare the heat generated by the IHM™ Technology Bandage to that of QuikClot ACG upon exposure to blood. Conclusion: Neither product produces enough heat to cause a patient safety issue. The two products are substantially equivalent with regard to heat generation.

In Vivo Animal testing consisted of the following:

  • HLR016-IS17: An Acute GLP Study to Evaluate the IHM Bandage vs. QuikClot Advanced Clotting Gauze. Description: Rat tail transaction test to demonstrate hemostatic efficacy of IHM Bandage compared to QuikClot Advanced Clotting Gauze. Conclusion: IHM Bandage was found substantially equivalent to QuikClot in its efficacy to control bleeding in minor cuts, minor scrapes, minor abrasions, and minor lacerations.
  • HLR018-IS39: A CHRONIC GLP STUDY TO EVALUATE THE SAFETY OF IHM GAUZE IN A PORCINE MODEL. Description: The purpose of this study was to demonstrate the safety of the IHM Gauze in a porcine model of minor skin incision. Conclusion: With respect to the assessments of overall animal health, gross observation of the incision sites, and tissue response to the study articles, the findings of this study support an acceptable safety profile of the IHM Gauze, with minimal to no risks to the porcine subjected to minor skin incisions.

Biocompatibility testing was performed on the subject device in conformance with ISO 10993-1 guidelines:

  • Cytotoxicity. Description: L929 MEM Elution test according to ISO 10993- 5:2009, 'Biological Evaluation of Medical Devices. Conclusion: Non-cytotoxic.
  • Irritation Reactivity. Description: ISO 10993-10:2010, 'Biological Evaluation of Medical Devices, Part 10; Tests for Skin Irritation and Sensitization. Conclusion: Slight Irritant.
  • Sensitization. Description: ISO 10993-10:2010, 'Biological Evaluation of Medical Devices, Part 10; Tests for Skin Irritation and Sensitization. Conclusion: Non-sensitizing.
  • Pyrogenicity. Description: ISO 10993-11:2006, 'Biological Evaluation of Medical Devices, Part 11: Tests for Systemic Toxicity'. Conclusion: Non-pyrogenic.
  • Acute Systemic Toxicity. Description: ISO 10993-11:2017, 'Biological Evaluation of Medical Devices, Part 11: Tests for Systemic Toxicity'. Conclusion: Pass.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K072474

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

N/A

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

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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 Biomedical
10909 Valley View Rd.
Eden Prairie, MN 55344
USA
Establishment Registration Number: NA |
|----------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mike Corcoran
Regulatory Consultant
E-mail: mpcorcoran@gmail.com
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
Date | 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.

TestDescriptionConclusion
QMS_PB_TECH013 Rev
A: Comparison of
Hemostatic Activity of
Gauzes using
Bioluminescent AssayTo evaluate the
efficacy of the gauze
pad of an IHM
technology Bandages
vs. FDA-cleared and
commercially available
hemostatic gauze
products.IHM bandage was substantially
equivalent to other hemostatic gauze
products since it produced clots and
behaved in an essentially similar manner
in tests and physical inspection of clot
quality.
Comparison of
Temperature Changes
by Two Gauzes
Carrying Mineral-based
Hemostatic AgentsTo compare the heat
generated by the
IHM™ Technology
Bandage to that of
QuikClot ACG upon
exposure to bloodNeither product produces enough heat to
cause a patient safety issue. The two
products are substantially equivalent
with regard to heat generation.

Bench testing consisted of the following:

6

In Vivo Animal testing consisted of the following:

TestDescriptionConclusion
HLR016-IS17: An
Acute GLP Study to
Evaluate the IHM
Bandage vs. QuikClot
Advanced Clotting
Gauze.Rat tail transaction test to
demonstrate hemostatic
efficacy of IHM Bandage
compared to QuikClot
Advanced Clotting GauzeIHM Bandage was found
substantially equivalent to
QuikClot in its efficacy to control
bleeding in minor cuts, minor
scrapes, minor abrasions, and
minor lacerations.
HLR018-IS39: A
CHRONIC GLP STUDY
TO EVALUATE THE
SAFETY OF IHM
GAUZE IN A
PORCINE MODEL.The purpose of this study
was to demonstrate the
safety of the IHM Gauze in a
porcine model of minor skin
incision.With respect to the assessments of
overall animal health, gross
observation of the incision sites,
and tissue response to the study
articles, the findings of this study
support an acceptable safety
profile of the IHM Gauze, with
minimal to no risks to the
porcine subjected to minor skin
incisions.

Biocompatibility testing was performed on the subject device in conformance with ISO 10993-1 guidelines:

TestDescriptionConclusion
CytotoxicityL929 MEM Elution test according to ISO
10993- 5:2009, 'Biological Evaluation of
Medical DevicesNon-cytotoxic
Irritation
ReactivityISO 10993-10:2010, 'Biological
Evaluation of Medical Devices, Part 10;
Tests for Skin Irritation and SensitizationSlight Irritant
SensitizationISO 10993-10:2010, 'Biological
Evaluation of Medical Devices, Part 10;
Tests for Skin Irritation and SensitizationNon-sensitizing
PyrogenicityISO 10993-11:2006, 'Biological
Evaluation of Medical Devices, Part 11:
Tests for Systemic Toxicity'Non-pyrogenic
Acute
Systemic
ToxicityISO 10993-11:2017, 'Biological
Evaluation 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.