(469 days)
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
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.
The TT-102 Wound Dressing is a medical device. The provided text describes the acceptance criteria and a study demonstrating the device's performance, but it primarily focuses on antimicrobial activity and biocompatibility as part of its substantial equivalence claim, rather than a clinical effectiveness study.
Here's an analysis of the provided information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Non-toxic, non-irritating, non-sensitizing, and non-cytotoxic. |
| Antimicrobial Activity | Effective against: Staphylococcus aureus ATCC 6538Staphylococcus aureus, methicillin resistant (MRSA) ATCC 33591Escherichia coli ATCC 8739Pseudomonas aeruginosa ATCC 9027Enterococcus faecalis, vancomycin-resistant enterococci (VRE) ATCC 51575Candida albicans ATCC 10231 |
| Absorbency | High capacity to absorb and retain wound exudate (comparable to AQUACEL® Ag). |
| Silver Binding | Silver is highly bound to the matrix of the dressing, preventing colonization by microbes (comparable to AQUACEL® Ag). |
Study Details
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Sample size used for the test set and the data provenance:
- Biocompatibility: Not specified, but standard tests typically involve in vitro and in vivo models using specific cell lines or animal subjects. The data provenance is not mentioned, but these are typically laboratory-based studies.
- Antimicrobial Activity: Not specified in terms of the number of unique samples of the dressing or replicates. The organisms used (listed above) are standard laboratory strains. Data provenance is laboratory testing.
- Absorbency/Silver Binding: These are described as technical characteristics and compared to a predicate device (AQUACEL® Ag), suggesting internal testing for these properties. Sample size and provenance are not explicitly stated for these comparative evaluations.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The studies described are laboratory-based performance tests (biocompatibility and antimicrobial) or technical characteristic comparisons, not studies requiring expert interpretation of clinical data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This type of adjudication is typically used in studies involving human interpretation of images or clinical outcomes, which is not the case here.
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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: Not applicable. This device is a wound dressing, not an AI-powered diagnostic or assistive tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical wound dressing and does not involve an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Biocompatibility: Ground truth is established through standardized toxicological, irritation, sensitization, and cytotoxicity assays.
- Antimicrobial Activity: Ground truth is established by measuring the reduction in microbial counts according to the specified standard (ASTM E2149-01). The "ground truth" is a quantifiable reduction in colony-forming units (CFUs) or similar microbial load indicators.
- Absorbency/Silver Binding: Ground truth would be the measurement of these physical/chemical properties and their comparison to the predicate device.
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The sample size for the training set: Not applicable. This is not a machine learning or AI-based device, so there is no "training set."
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How the ground truth for the training set was established: Not applicable, as there is no training set.
Overall Study Summary
The submission for the TT-102 Wound Dressing relies on laboratory performance testing to demonstrate its substantial equivalence to a legally marketed predicate device (AQUACEL® Ag with Hydrofiber). The key studies cited are:
- Biocompatibility studies: These tests demonstrated the device to be "non-toxic, non-irritating, non-sensitizing and non-cytotoxic," establishing its safety for contact with tissue.
- Antimicrobial activity testing: Conducted according to ASTM E2149-01, this study showed the dressing was effective against a panel of common wound-related pathogens, including Staphylococcus aureus, MRSA, Escherichia coli, Pseudomonas aeruginosa, VRE, and Candida albicans.
- Technical Characteristics comparison: The device's absorbency and silver binding mechanism are described as similar to its predicate, highlighting its capacity to absorb exudate and prevent microbial colonization.
"No clinical evaluation has been done on this device." This statement indicates that the regulatory submission for TT-102 Wound Dressing did not include human clinical trials to demonstrate effectiveness in a patient population. Instead, its substantial equivalence was based on its material composition, technical characteristics, and in vitro performance relative to a predicate device.
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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
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K081246
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- 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.
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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.
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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
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| 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 ulcersVenous ulcersPressure ulcersUlcers caused by mixed vascular etiologiesFull thickness and partial thickness woundsTraumatic wound healing by secondary intentionDehisced surgical woundsAbrasionsDonor 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
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510(k) Number_K081246
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