TRIOSYN T40 ANTIMICROBIAL WOUND DRESSING

K051542 · Triosyn Corp. · FRO · Mar 17, 2006 · SU

Device Facts

• Record ID: K051542
• Device Name: TRIOSYN T40 ANTIMICROBIAL WOUND DRESSING
• Applicant: Triosyn Corp.
• Product Code: FRO · SU
• Decision Date: Mar 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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.

Device Story

Sterile, multi-layer composite primary wound dressing; consists of absorbent polyester non-woven pad, permeable adhesive, Triosyn iodinated resin beads, and non-adherent high-density polyethylene (HDPE) mesh. Functions as physical barrier against microbial penetration; reduces microbial load in wounds via iodine release. Used in clinical settings for management of partial/full thickness wounds. Healthcare providers apply dressing to wound site; iodine release provides antimicrobial action. Benefits patient by reducing infection risk in chronic and acute wounds. Device contains iodine; contraindicated for patients with iodine sensitivity or thyroid conditions.

Clinical Evidence

Bench testing only. In vitro studies demonstrated effectiveness against broad spectrum of microorganisms, including MRSA (ATCC 33591) and VRE (ATCC 51575). Biocompatibility testing performed per ISO 10993 standards including cytotoxicity, primary skin irritation, and closed patch sensitization. Iodine release measured in simulated wound exudates compared to Iodoflex.

Technological Characteristics

Multi-layer composite dressing: polyester non-woven pad, permeable adhesive, Triosyn iodinated resin beads, HDPE mesh. Antimicrobial mechanism: iodine release. Biocompatibility: ISO 10993 compliant. Sterile.

Indications for Use

Indicated for patients with partial and full thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, first- and second-degree burns, donor sites, and surgical wounds. May be used over debrided and grafted partial thickness wounds. Contraindicated in patients with known or suspected iodine sensitivity or history of thyroid condition.

Predicate Devices

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

Submission Summary (Full Text)

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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: [phone] Facsimile: [phone] Email: [e-mail]

## 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

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'.

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 [phone]. 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 [phone] or [phone] 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

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510(k) Number__ko51542_