(321 days)
Not Found
No
The device description and intended use clearly describe a collagen wound dressing, with no mention of AI or ML capabilities. The "Not Found" entries for AI/ML mentions and performance studies further support this conclusion.
Yes
The device is a wound dressing intended for the management of wounds, which is a therapeutic purpose.
No
Explanation: The device is described as a "collagen wound dressing" intended for the management of various types of wounds, not for diagnosis. Its purpose is to treat wounds, not to identify or characterize medical conditions.
No
The device description explicitly states that DressSkin is a collagen wound dressing supplied in sheet form, indicating it is a physical product, not software.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the management of various types of wounds. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as a collagen wound dressing, which is a material applied directly to a wound for healing purposes. This is consistent with a medical device used for treatment, not for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests in a laboratory setting, or providing diagnostic information.
The information provided strongly indicates that DressSkin is a medical device intended for wound management, which falls under a different regulatory category than IVDs.
N/A
Intended Use / 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 ●
Product codes
KGN
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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 Collagen | ||
| Wound Dressing | Johnson & Johnson Medical | K982597 |
1
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.
2
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.
3
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
4
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 ●
(Please do not write below this line-continue on another page if needed)
-
-
- ★ ★ * * * *
-
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