(280 days)
No
The description focuses on the physical composition and antimicrobial properties of the dressing, with no mention of AI or ML.
Yes
The device is described as an "Antimicrobial Dressing" designed for use in various wounds to "reduce the microbial load," which indicates active treatment or management of a disease or condition.
No
This device is a wound dressing designed to reduce microbial load and act as a barrier against microbial penetration in wounds. It does not perform any diagnostic function.
No
The device description clearly states it is a "sterile, primary wound dressing" composed of physical materials like a non-woven pad, adhesive, resin beads, and mesh. This indicates it is a physical medical device, not software.
Based on the provided information, the Triosyn T40™ Antimicrobial Dressing is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating wounds on the human body (in vivo), not for testing samples taken from the body (in vitro).
- Device Description: The description details a wound dressing applied directly to the wound, not a device used to analyze biological samples.
- Performance Studies: The performance studies describe laboratory tests of the dressing's effectiveness against microorganisms, which is relevant to its function as a wound dressing, not as a diagnostic test.
IVD devices are used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. The Triosyn T40™ is a therapeutic device applied to the body.
N/A
Intended Use / Indications for Use
The Triosyn T40TM 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.
Product codes
FRO
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'.
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)
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.
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 Iodoflex dressing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Triosyn Corp., Traditional 510(k)
Triosyn T40 Antimicrobial Wound Dressing
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
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.
1
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
2
Triosyn T40 Antimicrobial Wound Dressing
2:fe 3out3
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.
3
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
4
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
5
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_