(469 days)
Not Found
No
The description focuses on the material properties and antimicrobial activity of the wound dressing, with no mention of AI or ML.
Yes
The TT-102 Wound Dressing is indicated for the management of various types of ulcers and wounds, which are conditions that require medical therapy. Its function is to facilitate healing and prevent microbial colonization, aligning with the definition of a therapeutic device.
No
Explanation: This device is a wound dressing designed for managing various types of wounds and preventing microbial colonization. Its function is therapeutic, not diagnostic.
No
The device description clearly states it is a "highly absorbent, sterile, single-use primary dressing comprised of phosphorylated cellulose with ionically bound silver," which is a physical medical device, not software.
Based on the provided information, the TT-102 Wound Dressing is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the management of various types of wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a wound dressing with antimicrobial properties. This aligns with a therapeutic device used to treat wounds.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples from the body (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's condition. IVDs are designed for this purpose.
- Performance Studies: The performance studies focus on the antimicrobial activity of the dressing against various microbes, which is relevant to its therapeutic function in preventing microbial colonization in the wound. This is not a diagnostic performance study.
In summary, the TT-102 Wound Dressing is a therapeutic device intended for wound management, not a diagnostic device used to analyze samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The TT-102 Wound Dressing is indicated for the management of:
Diabetic ulcers
Venous ulcers
Pressure ulcers
Ulcers caused by mixed vascular etiologies
Full thickness and partial thickness wounds
Traumatic wound healing by secondary intention
Dehisced surgical wounds
Abrasions
Donor sites and other bleeding wounds
Product codes
FRO
Device Description
TT-102 Wound Care Dressing is a highly absorbent, sterile, single-use primary dressing comprised of phosphorylated cellulose with ionically bound silver. The dressing prevents microbial colonization in the dressing.
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)
Performance Testing: The antimicrobial activity of the immobilized silver dressing was determined according to ASTM E2149-01 against the following organisms; Staphylococcus aureus ATCC 6538, Staphylococcus aureus, methicillin resistant (MRSA) ATCC 33591, Escherichia coli ATCC 8739, Pseudomonas aeruginosa ATCC 9027, Enterococcus faecalis, vancomycin-resistant enterococci (VRE) ATCC 51575, Candida albicans ATCC 10231.
Performance Summary: TT-102 was found to be an effective antimicrobial dressing for various microbes including Staphylococcus aureus, Staphylococcus aureus (MRSA), Enterococcus faecalis VRE, and other pathogens.
Clinical Evaluation: No clinical evaluation has been done on this device.
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
Tissue Technologies Holdings, LLC
800 East Leigh St., Suite 51 Richmond, VA 23219
Section 5. 510(k) Summary TT-102 1:000 Wound Dressing AUG 1 3 2009 April 30, 2008
Submitter's Name and Address:
Tissue Technologies Holdings, LLC 800 East Leigh Street, Suite 51 Richmond, VA 23219
Contact Person:
Dr. Yousef Mohajer VP of Technical Development Telephone & Fax: (804) 225-7447
Name of Medical Device:
Substantial Equivalence:
Device Classification:
Device Description:
Indications for Use:
Trade name: TT-102 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Wound Dressing Common name: Silver Wound Dressing Classification name: Dressing, Wound, Drug
TT-102 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - equivalent to:
TT-101 Wound Care Dressing (K 061060) Manufactured by an FDA registered contract manufacturer
AQUACEL® Ag with Hydrofiber (K063271) Manufactured by ConvaTec, A division of E. R. Squibb and Sons, LLC
Unclassified, Product Code- FRO
...... Wound Care Dressing is a highly TT-102 absorbent, sterile, single-use primary dressing comprised of phosphorylated cellulose with ionically bound silver. The dressing prevents microbial colonization in the dressing.
The TT-102 - Wound Dressing is indicated for the management of:
- Diabetic ulcers 트
- Venous ulcers 제
- Pressure ulcers 트
- 내 Ulcers caused by mixed vascular etiologies
- Full thickness and partial thickness wounds
- Traumatic wound healing by secondary intention
1
K081246
page 2/2
- Dehisced surgical wounds 트
- 제 Abrasions
- 트 Donor sites and other bleeding wounds
Contraindication:
Technical Characteristics:
Safety:
Performance Testing:
Performance Summary:
Clinical Evaluation:
This dressing is not indicated for burns. The dressing should not be used by persons allergic to silver.
The TT-102 dressing is a cellulose derivative and, like its predicate device AQUACEL® Ag, has a high capacity to absorb and retain wound exudate. Whereas AQUACEL® Ag is composed of carboxymethyl cellulose with ionic silver, TT-102 is made by adding ionic silver into phosphorylated cellulose. In both products, silver is highly bound to the matrix of the dressing allowing it to prevent colonization by microbes.
Biocompatibility studies have demonstrated TT-102 Antimicrobial Wound Dressing to be non-toxic, nonirritating, non-sensitizing and non-cytotoxic.
The antimicrobial activity of the immobilized silver dressing was determined according to ASTM E2149-01 against the following organisms;
Staphylococcus aureus ATCC 6538
Staphylococcus aureus, methicillin resistant (MRSA) ATCC 33591
Escherichia coli ATCC 8739
Pseudomonas aeruginosa ATCC 9027
Enterococcus faecalis, vancomycin-resistant enterococci (VRE) ATCC 51575
Candida albicans ATCC 10231
TT-102 was found to be an effective antimicrobial dressing for various microbes including Staphylococcus aureus, Staphylococcus aureus (MRSA), Enterococcus faecalis VRE, and other pathogens.
No clinical evaluation has been done on this device.
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is written in a bold, sans-serif font. The words are arranged on a single line and are centered horizontally.
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. Above the caduceus, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Tissue Technologies Holdings, LLC % I. Kelman Cohen, MD President and CEO 1400 Aqua Vista Lane Richmond, Virginia 23231
AUG 1 3 2009
Re: K081246
Trade/Device Name: TT-102 Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: August 11, 2009 Received: August 11, 2009
Dear Dr. Cohen:
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 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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
3
Page 2 - I. Kelman Cohen, MD
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 M. Mellema
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| CENTER FOR DEVICES AND RADIOLOGICAL HEALTH | |
|---|---|
| Indications for Use | |
| 510(k) Number (if known): | K081246 |
| Device Name: | TT-102 Wound Dressing |
| Indications for Use: | The TT-102 Wound Dressing is indicated for the management of: |
| Diabetic ulcers | |
| Venous ulcers | |
| Pressure ulcers | |
| Ulcers caused by mixed vascular etiologies | |
| Full thickness and partial thickness wounds | |
| Traumatic wound healing by secondary intention | |
| Dehisced surgical wounds | |
| Abrasions | |
| Donor sites and other bleeding wounds | |
| Contraindications: | This dressing is not indicated for burns. The dressing should not be used by persons allergic to silver. |
| Prescription Use | |
| (Part 21 CFR 801 Subpart D) | X AND/OR Over-The-Counter Use |
| (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)
Daniel Krane for MKM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
..
510(k) Number_K081246
l
Page _ of _