(321 days)
DressSkin is intended for the management of wounds that include:
- Partial and full thickness wounds
- Pressure, diabetic, and venous ulcers
- Second-degree burns
- Surgical wounds-donor sites/grafts, post-moh's surgery, post-laser surgery, podiatric, wound dehiscence
- Trauma wounds-abrasions, lacerations, and skin tears
- Tunneled/undermined wounds
- Draining wounds
DressSkin is a collagen wound dressing. The device is supplied sterile and is provided in sheet form in a variety sizes to be trimmed by the surgeon to meet the individual patient's needs.
This document is a 510(k) Premarket Notification for a wound dressing device named DressSkin™. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving effectiveness through clinical studies with acceptance criteria in the same way a new drug or novel high-risk device might.
Based on the provided text, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria in the typical format of a clinical trial (e.g., target sensitivity, specificity, or outcome measures for wound healing). Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices. The "performance" reported is related to biocompatibility and manufacturing safety.
| Acceptance Criteria (Implied by 510(k) Process) | Reported Device Performance (from text) |
|---|---|
| Substantial Equivalence (Design & Intended Use) | "DressSkin™ is substantially equivalent to other wound dressings with respect to its design as a flexible, collagen sheet which can be used to cover wounds." Intended use for various wound types is identical to predicate devices. |
| Biocompatibility | "A rigorous biocompatibility assessment performed by an independent certified laboratory demonstrated the biocompatibility of DressSkin™." Tests included: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, hemolysis, and pyrogenicity. |
| Viral Inactivation (Manufacturing Safety) | "The manufacturing methods for DressSkin™ were also tested by an independent laboratory to assure safe levels of viral inactivation." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical study with a "test set" in the context of device performance metrics like sensitivity or specificity.
- For Biocompatibility and Viral Inactivation Tests: The sample sizes for these laboratory tests are not specified in the provided text. These are typically in-vitro or animal studies, not human clinical trials.
- Data Provenance: Not applicable in the context of a clinical test set. The laboratory tests were conducted by "an independent certified laboratory" and "an independent laboratory," but the country of origin is not specified. They would generally be prospective for the specific purpose of the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This submission does not involve expert-established ground truth for a clinical test set. The evaluation is based on laboratory testing for biocompatibility and manufacturing safety, and a comparison of design and intended use to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication process is described.
5. 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. Therefore, an MRMC study is not relevant.
6. 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 any algorithm or AI for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the 510(k) submission, the "ground truth" for demonstrating substantial equivalence is primarily:
- Predicate Device Characteristics: The established design, materials, and intended use of the predicate devices (SIS Wound Dressing II and Fibracol Plus Collagen Wound Dressing) serve as a de-facto "ground truth" for comparison.
- Standard Biocompatibility & Safety Testing: Ground truth is established by recognized international standards (e.g., ISO standards for biocompatibility) that define acceptable levels for cytotoxicity, sensitization, etc., as determined by the independent certified laboratories.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
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TEI BIOSCIENCES INC. November 8, 2002
Abbreviated 510(k) Premarket Notification
DressSkin™
SEP 2 9 2003
510(k) Summary
This 510(k) summary for DressSkin is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitted by
TEI Biosciences Inc. 7 Elkins Street Boston, MA 02127 (617) 268-1616 (617) 268-3282 (fax)
Contact Person
Kenneth James, Ph.D. Director of Product Development and Applied Research
Date Prepared
November 8, 2002
Device Information
Proprietary name: DressSkin Classification name: Wound dressing Device classification: Class II
Device Description
DressSkin is a collagen wound dressing. The device is supplied sterile and is provided in sheet form in a variety sizes to be trimmed by the surgeon to meet the individual patient's needs.
Intended Use
DressSkin is intended for the management of wounds that include:
- Partial and full thickness wounds .
- Pressure, diabetic, and venous ulcers .
- Second-degree burns .
- Surgical wounds-donor sites/grafts, post-moh's surgery, post-laser surgery, ● podiatric, wound dehiscence
- . Trauma wounds-abrasions, lacerations, and skin tears
- Tunneled/undermined wounds ●
- Draining wounds ●
Legally Marketed Devices to which Equivalence is Being Claimed
DressSkin™ is substantially equivalent in function and intended use to:
| Predicate Devices | Manufacturer | 510(k) Number |
|---|---|---|
| SIS Wound Dressing II | Cook Biotech | K993948 |
| Fibracol Plus CollagenWound Dressing | Johnson & Johnson Medical | K982597 |
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TEI BIOSCIENCES INC. November 8, 2002
KOZ 3778
Abbreviated 510(k) Premarket Notification
Page 2 of 2
DressSkin™
Summary of Technological Characteristics and Biocompatibility
DressSkin™ is substantially equivalent to other wound dressings with respect to its design as a flexible, collagen sheet which can be used to cover wounds.
A rigorous biocompatibility assessment performed by an independent certified laboratory demonstrated the biocompatibility of DressSkin™. The tests performed included: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, hemolysis, and pyrogenicity. The manufacturing methods for DressSkin™ were also tested by an independent laboratory to assure safe levels of viral inactivation.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol of three human profiles facing right, stacked on top of each other. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 9 2003
Kenneth James, Ph.D. Director of Product Development and Applied Research TEI Biosciences, Inc. 7 Elkins Street Boston, Massachusetts 02127
Re: K023778
Trade/Device Name: DressSkin™ Regulatory Class: Unclassified Product Code: KGN Dated: July 2, 2003 Received: July 3, 2003
Dear Dr. James:
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 reguirements, 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.
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Page 2 - Kenneth James, Ph.D.
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 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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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TEI BIOSCIENCES INC. November 8, 2002
Abbreviated 510(k) Premarket Notification
DressSkin™
2. Indications for Use of the Device
510(k) Number (if known):
Device Name: DressSkin™
Indications for Use:
DressSkin is intended for the management of wounds that include:
- Partial and full thickness wounds ●
- Pressure, diabetic, and venous ulcers ●
- Second-degree burns .
- Surgical wounds--- donor sites/grafts, post-moh's surgery, post-laser surgery, . podiatric, wound dehiscence
- . Trauma wounds-abrasions, lacerations, and skin tears
- Tunneled/undermined wounds .
- Draining wounds ●
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) Or Over-the-Counter Use
(Optional Format 1-2-96)
Miriam C. Provost
(Division Sign-Off) (Division of General, Restorative and Neurological Devices
510(k) Number K023778
N/A