(77 days)
The TT101 Wound Care Dressing is indicated for the management of exuding wounds including: Diabetic ulcers Venous ulcers Ulcers caused by mixed vascular etiologies Full thickness and partial thickness wounds Donor sites and other bleeding surface wounds Abrasions Traumatic wounds healing by secondary intention Dehisced surgical wounds
TT101 Wound Care Dressing is a sterile primary dressing comprised of phosphorylated cellulose, formed into a sheet approximately 3 mm thick cut into various size pieces. When placed on a wound, the dressing provides a moist wound environment that is supportive to wound healing.
The provided text does not include information about acceptance criteria, device performance metrics, or any study details that would typically be associated with proving a device meets acceptance criteria. The text is a 510(k) summary and regulatory letter for a wound dressing, focusing on its substantial equivalence to a predicate device and its intended use.
Therefore, I cannot populate the requested table or answer the specific questions about study design, sample sizes, ground truth, or expert involvement. The document primarily addresses regulatory clearance for a physical medical device (wound dressing) based on substantial equivalence, not performance metrics derived from a study to establish acceptance criteria.
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| Exhibit D: | 510(k) Summary of Safety and Effectiveness | K061060page 1 of 10 | |
|---|---|---|---|
| Submitter's Name and Address: | Tissue Technologies Holdings LLC800 East Leigh St, Unit 51Richmond, VA 23219804-225-7447 | JUL - 3 2006 | |
| Contact Person: | Yousef Mohajer | ||
| Name of Medical Device: | Classification Name:Common/Usual Name:Proprietary Name: | Dressing, WoundDressingTT101 Wound Care Dressing | |
| Substantial Equivalence: | TT101 Wound Care Dressing is substantially equivalent to:PROMOGRAN Matrix Wound Dressing (K014129) manufactured by Johnson &Johnson Medical Ltd., Gargrave, North Yorkshire, BD23 3RX, United Kingdom | ||
| Device Classification: | Currently, wound dressings containing animal derived materials are unclassified byUnited States Food and Drug Administration's Center for Devices and RadiologicalHealth | ||
| Device Description: | TT101 Wound Care Dressing is a sterile primary dressing comprised ofphosphorylated cellulose, formed into a sheet approximately 3 mm thick cut intovarious size pieces. When placed on a wound, the dressing provides a moist woundenvironment that is supportive to wound healing. | ||
| Indications for Use: | Wound Dressing is indicated for the management of exuding wounds including:Diabetic ulcersVenous ulcersUlcers caused by mixed vascular etiologiesFull thickness and partial thickness woundsDonor sites and other bleeding surface woundsAbrasionsTraumatic wounds healing by secondary intentionDehisced surgical wounds | ||
| Safety: | Biocompatibility studies have demonstrated TT101 Wound Care Dressing |
to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic.
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Image /page/1/Picture/1 description: The image shows a stylized black and white drawing of what appears to be a bird in flight. The bird is represented with thick, curved lines that suggest movement and form. The design is simple yet dynamic, capturing the essence of flight with a minimalist approach.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 3 2006
Tissue Technologies Holdings c o Bio-Track LLC Mark Licata President 800 East Leigh Street Richmond, Virginia 23219
Re: K061060
Trade/Device Name: TT101 Wound Care Dressing Regulatory Class: Unclassified Product Code: FRO Dated: June 21, 2006 Received: June 21, 2006
Dear Mr. Licata:
We have reviewed your Scction 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. Iisting 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 legally
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Page 2 - Mark Licata
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Barbara Bruem
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Exhibit C
page 19)
Indications for Use
510(k) Number (if known):
Ko61660
TT101 Wound Care Dressing Device Name:
Indications For Use: The TT101 Wound Care Dressing is indicated for the management of exuding wounds including:
Diabetic ulcers Venous ulcers Ulcers caused by mixed vascular etiologies Full thickness and partial thickness wounds Donor sites and other bleeding surface wounds Abrasions Traumatic wounds healing by secondary intention Dehisced surgical wounds
Hukl
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
1061060 510(k) Number_
Prescription Use (Part 21 CFR 801 Subpart D)
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)
N/A