TheraBond Antimicrobial Barrier Systems are indicated for use in light to moderately exuding partial and full thickness wounds including traumatic wounds, surgical wounds, donor sites, 1st and 2nd degree burns, as well as decubitus ulcers, diabetic ulcers and vascular ulcers. TheraBond may be used over debrided and partial thickness wounds.

Device Description

The TheraBond Antimicrobial Barrier Systems consist of a knitted, flexible, silver-plated nylon-based fabric. The device is available in several sizes and configurations including wound contact dressings, island dressings and wraps.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the TheraBond Antimicrobial Barrier System, a wound dressing. This is a medical device submission, not an AI/ML device, therefore, much of the requested information (like sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance) is not applicable or not detailed in this type of submission.

However, I can extract the acceptance criteria and the general nature of the studies performed.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Antimicrobial Effectiveness	Met pre-determined criteria
Silver Ion Release	Met pre-determined criteria
Silver Plating Integrity	Met pre-determined criteria
Biocompatibility	Met pre-determined criteria (in accordance with ISO 10993: Biological Evaluation of Medical Devices)

2. Sample size used for the test set and the data provenance

Not Applicable. This is a physical medical device (wound dressing), not a software/AI device that uses test sets for algorithmic evaluation. The "tests" here refer to laboratory and bench testing of the physical properties and biological interactions of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. Ground truth, in the context of AI/ML, refers to annotated data. For this device, "ground truth" would be established by standardized laboratory methods and measurements against pre-defined specifications. The "experts" would be the scientists and technicians conducting the tests according to established protocols.

4. Adjudication method for the test set

Not Applicable. Adjudication methods are typically for evaluating subjective interpretations, such as image analysis. For objective laboratory tests, results are typically compared directly against pre-defined specifications. Any discrepancies would involve re-testing or investigation into methodology, not expert adjudication in the AI/ML sense.

5. 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

No. This is not an AI/ML diagnostic or assistive device. MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical medical device. There is no "algorithm only" performance to evaluate.

7. The type of ground truth used

For antimicrobial effectiveness, silver ion release, and silver plating integrity: Standardized laboratory measurements and assays against pre-defined specifications.
For biocompatibility: Results from standard biocompatibility tests (e.g., cytotoxicity, sensitization, irritation) in accordance with ISO 10993, compared against acceptable limits.

8. The sample size for the training set

Not Applicable. This is a physical medical device. There is no "training set" in the AI/ML sense.

9. How the ground truth for the training set was established

Not Applicable.

Summary

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Traditional 510(k) Premarket Notification November 12, 2007

K073213
page 1 of 1

Section 5-510(k) Summary

Owner's Name: Address:

Telephone Number: Fax Number: Contact Person:

Subject Device Name: Trade Name: Common/Usual Name: Product Code: FDA Regulation: Device Classification:

Predicate Devices:

Trade Name: Common/Usual Name: Product Code: FDA Regulation: Device Classification:

Choice Therapeutics MAY 2 8 2008 One Apple Hill Road, Suite 316 Natick, MA 01760 (508) 720-9803 (508) 650-0260 Peter Hamilton, Vice President of Operations

TheraBond Antimicrobial Barrier Systems TheraBond Wound Dressing (Antimicrobial) FRO - Dressing, Wound, Drug N/A Unclassified

K981299: Silverlon Contact Wound Dressing (Argentum International, LLC) K023612: Antimicrobial Barrier Wound Contact Dressing, Burn Wrap, Burn Contact Dressing & Silverlon Acute Burn Glove (Argentum International, LLC) Silverlon Wound Dressing (Antimicrobial) FRO - Dressing, Wound, Drug N/A Unclassified

Device Description

Intended Use

Performance Testing

Performance data provided in support of this submission include the results of antimicrobial effectiveness testing, silver ion release testing, silver plating integrity testing and biocompatibility testing in accordance with ISO 10993: Biological Evaluation of Medical Devices.

Conclusion

TheraBond Antimicrobial Barrier Systems meet all pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness for its intended use; the TheraBond Antimicrobial Barrier Systems are substantially equivalent to the predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its back, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, emphasizing the department's role within the United States government. The logo is simple, yet recognizable, and is often used on official documents and websites related to health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 28 2008

Choice Therapeutics % Hogan & Hartson LLP Mr. Howard M. Holstein Columbia Square 555 Thirteenth Street, Northwest Washington, District of Columbia 20004

Re: K073213

Trade/Device Name: TheraBond Antimicrobial Barrier Systems Regulatory Class: Unclassified Product Code: FRO Dated: May 6, 2008 Received: May 6, 2008

Dear Mr. Hostein:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Howard M. I-Iolstein

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Milham

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 - Indications for Use Statement

510(k) Number (if known): K073213

Device Name:

TheraBond Antimicrobial Barrier Systems

Indications for Use:

Prescription Use X (Per 21 CFR 801 Subpart D) OR

Over-the -Counter Use (Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

NIL/RP Ogden for rkn
(Division Sign-Off)

Division of General, Restorative. and Neurological Devices

510(k) Number_K073213

Regulation Number and Section

N/A