The Triosyn T40™ Antimicrobial Dressing is designed for use in partial and full thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, first- and second-degree burns, donor sites and surgical wounds. The Triosyn T40™ Antimicrobial Dressing may be used over debrided and grafted partial thickness wounds.

Device Description

The Triosyn T40'''' Antimicrobial Wound Dressing is a sterile, primary wound dressing. It is a multi-layer composite dressing consisting of an absorbent polycster non-woven pad, a permeable adhesive, a single layer of Triosyn iodinated resin beads, and a non-adherent high-density polyethylene mesh (HDPE). This non-adhesive composite dressing is designed to be used as a barrier against microbial penetrations and as a method to reduce the microbial load in partial and full thickness wounds'.

AI/ML Overview

The provided text describes the Triosyn T40™ Antimicrobial Wound Dressing and its substantial equivalence to predicate devices, but it does not include a detailed study with specific acceptance criteria and performance metrics in the format requested. The document focuses on the device description, intended use, technological characteristics, and biocompatibility, stating that the device "functioned as intended" based on "laboratory tests."

Therefore, I cannot populate most of the requested fields directly from the provided text. I will indicate where information is missing or inferred.

Acceptance Criteria and Device Performance

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria (if stated)	Reported Device Performance
Antimicrobial Effectiveness (In Vitro)	Effective against a broad spectrum of clinically relevant microorganisms, including gram-positive bacteria, gram-negative bacteria, and fungal organisms. This includes multi-drug resistant organisms Staphylococcus aureus MRSA (ATCC 33591) and Enterococcus faecalis VRE (ATCC 51575).	"The Triosyn T40™ Antimicrobial Wound Dressing was found in laboratory tests to be effective against a broad spectrum of clinically relevant microorganisms including gram-positive bacteria, gram-negative bacteria, and fungal organisms. This list includes multi-drug resistant organisms Staphylococcus aureus MRSA (ATCC 33591) and Enterococcus faecalis VRE (ATCC 51575). In all instances, the Triosyn T40™ Antimicrobial Wound Dressing functioned as intended."
Iodine Release	Consistently release less iodine in simulated wound exudates than a similarly sized Iodoflex dressing.	"The Triosyn T40™ Antimicrobial Wound Dressing was found in laboratory tests to consistently release less iodine in simulated wound exudates than a similarly sized Iodoflex dressing."
Biocompatibility	In accordance with ISO 10993 requirements for ISO 10993 tests: Cytotoxicity, Primary Skin Irritation, Closed Patch Sensitization.	"This product was tested in accordance with ISO 10993 requirements for biocompatibility using the following tests: Cytotoxicity, Primary Skin Irritation, Closed Patch Sensitization." (The document states it was tested in accordance with, implying successful completion, but does not provide specific results like pass/fail.)
Overall Intended Function (Substantial Equivalence)	Functions in a substantially equivalent manner to the predicate devices (Acticoat 7 Composite Wound Dressing and Iodoflex Paste).	"The test results demonstrated that the Triosyn T40™ Antimicrobial Wound Dressing is both effective for its intended use and functions in a substantially equivalent manner to the predicate devices." (This is a conclusion statement; specific comparative data points are not provided in the summary.) The FDA's 510(k) clearance letter also confirms substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified for any of the "laboratory tests."
Data Provenance: The document states "Data on file" for in vitro testing. No country of origin is specified, but the applicant is based in Vermont, USA. The nature of the tests (laboratory/in vitro) suggests they were conducted in a controlled environment as opposed to clinical trials. The data would be considered prospective in the sense that the tests were carried out specifically to evaluate the device for this submission, rather than retrospective analysis of existing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable/not specified. The "effectiveness" claims are based on in vitro laboratory test results against defined microbial strains and simulated exudates, and biocompatibility testing according to ISO standards, not on expert interpretations of clinical cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable/not specified. The assessments are based on laboratory measurements and standards, which typically do not involve human adjudication in the way clinical studies or image interpretation tasks do.

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

MRMC Study: No. This device is a wound dressing, not an AI-assisted diagnostic tool or imaging device that would typically undergo an MRMC study with human readers.

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

Standalone Performance: Not applicable. This is a medical device (wound dressing), not an algorithm or AI system. The performance evaluated is the direct physical/chemical action of the dressing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth:
- Antimicrobial Effectiveness: Defined microbial strains (e.g., ATCC 33591 for MRSA, ATCC 51575 for VRE) and standardized laboratory methods for evaluating microbial reduction.
- Iodine Release: Simulated wound exudates and analytical methods for measuring iodine concentration.
- Biocompatibility: ISO 10993 standards and specified toxicity, irritation, and sensitization tests.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is a medical device, not a machine learning model that requires a training set. The "laboratory tests" described are for performance evaluation, not model training.

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

Ground Truth for Training Set: Not applicable, as there is no training set for this device type.

Summary

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Triosyn Corp., Traditional 510(k)

Triosyn T40 Antimicrobial Wound Dressing

K051542

By 1 cut 3

Section 8: 510(k) Summary 8.

8.1. Submitter and Contact Information

MAR 17 2005

Submitter: Triosyn Corp. 1191 South Brownell Road Williston, VT 05495
Contact: Kyle Anderson, Director of Life Science Telephone: (802) 865-5084 Facsimile: (802) 658-2681 Email: kanderson@triosyn.com

8.2. Date of Preparation

June 8, 2005

8.3. Device Name

Trade Name:	Triosyn T40TM Antimicrobial Wound Dressing
Common Name:	Wound and Burn Dressing
Classification:	Unclassified

8.4. Legally Marketed Predicate Devices

Acticoat 7 Composite Wound Dressing (K001519) Iodoflex Paste (K940414)

8.5. Device Description

7 Based on in vitro testing. Data on file.

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8.6. Intended Use

K051542 ps 2. ut 3

The Triosyn T40TM Antimicrobial Dressing provides an effective barrier to microbial penctration. The barrier function of the dressing may help reduce infection in partial and full thickness wounds, including:

. pressure ulcers
. venous ulcers
. diabetic ulcers
. first and second-degree burns
donor sites .
. surgical wounds

Triosyn Antimicrobial Dressings may be used over debrided and grafted partial thickness wounds.

8.7. Technological Characteristics

The differences between the subject device and predicate devices raise no new questions of safety and effectiveness.

8.8. Performance Information

The Triosyn T40'M Antimicrobial Wound Dressing was found in laboratory tests to be effective against a broad spectrum of clinically relevant microorganisms including gram-positive bacteria, gram-negative bacteria, and fungal organisms. This list includes multi-drug resistant organisms Staphylococcus aureus MRSA (ATCC 33591) and Enterococcus faccalis VRE (ATCC 51575).

In all instances, the Triosyn T40131 Antimicrobial Wound Dressing functioned as intended. The test results demonstrated that the Triosyn T40 " Antimicrobial Wound Dressing is both effective for its intended use and functions in a substantially equivalent manner to the predicate devices.

8.9. Biocompatibility

This product was tested in accordance with ISO 10993 requirements for biocompatibility using the following tests:

Cytotoxicity Primary Skin Irritation Closed Patch Sensitization

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Triosyn T40 Antimicrobial Wound Dressing

K051542

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8.10 Safety

The Triosyn T40 M Antimicrobial Wound Dressing was found in laboratory tests to consistently release less iodine in simulated wound exudates than a similarly sized lodoflex dressing. The labeling for the Triosyn T40'14 Antimicrobial Wound Dressing clearly identifies the product as containing iodine and warns that the dressing should not be used in patients with known or suspected iodine sensitivity or in patients with a history of a thyroid condition.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight, arranged in a row.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAE 1 7 2003

Triosyn Corp. c/o Ms. Annc-Marie Gendron Senior Director, Science & Project Management 1191 South Brownell Road Willistown, Vermont 05495

K051542 Re: Trade/Device Name: Triosyn T40™ Antimicrobial Dressing Regulatory Class: Unclassified Product Code: FRO

Dated: February 20, 2006 Received: February 22, 2006

Dear Ms. Gendron:

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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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

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Page 2 - Ms. Anne-Marie Gendron

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Q.mde

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

Enclosure

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Indications for Use

510(k) Number (if known):

-105448 K051542

Device Name:

Triosyn T40TM Antimicrobial Dressing

Indications For Use:

The Triosyn T40™ Antimicrobial Dressing is designed for use in partial and full thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, first- and The Triosyn T40TM second-degree burns, donor sites and surgical wounds. Antimicrobial Dressing may be used over debrided and grafted partial thickness wounds.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Office of Device Evaluation (ODE) Concurrence of CDRH, Office of the Vitro-Diagnostic Devices (ONA)

elamre

(Division Sign-Off) Division of General, Restorative. and Neurological Devices

Page 1 of

510(k) Number__ko51542_

Regulation Number and Section

N/A