(248 days)
Not Found
Not Found
No
The 510(k) summary describes a biological wound dressing and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a wound dressing intended for temporary coverage of skin loss injuries and chronic ulcers, which is a therapeutic function.
No
The device is described as a wound dressing for temporary coverage of skin injuries, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "SIS Wound Dressing" supplied in "sheet form" and measured in "cm²", indicating a physical, material-based device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for temporary coverage of partial-thickness skin loss injuries. This is a therapeutic application, directly treating a wound on the patient's body.
- Device Description: The device is a wound dressing applied externally to the skin.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose a condition, or monitor treatment.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This wound dressing does not fit that description.
N/A
Intended Use / Indications for Use
The SIS Wound Dressing is intended for temporary coverage of partial-thickness skin loss injury, such as burns, abrasions, decubitus and chronic vascular ulcers, and autograft donor sites. This device is intended for one-time use.
Product codes
KGN
Device Description
The SIS Wound Dressing is supplied in sheet form in sizes ranging from 16 cm3 to 360 cm². The device is supplied sterile and is intended for one-time use. Reasonable assurance of biocompatibility of the materials comprising the SIS Wound Dressing is provided by the established history of use of porcine-derived tissues in medical product manufacturing as well as meeting the requirements of the appropriate biocompatibility tests.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
APR 3 0 1998
510(k) Premarket Notification SIS Wound Dressing
510(K) SUMMARY L.
Submitted By:
Neal E. Fearnot, Ph.D., E.E. President Cook Biotech, Incorporated P.O. Box 2402 West Lafayette, IN 47906 (765) 497-3355 August 22, 1997
Device:
Trade Name:
SIS Wound Dressing
影 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
: p
Common/Usual Name:
Wound Dressing, Burn Dressing, Porcine Burn Dressing
Proposed Classification Name:
Not Classified, FDA proposed classification: Porcine Burn Dressings 21 CFR Part 878.4026 or 878.4140, (79KG)
Predicate Devices:
The SIS Wound Dressing is similar to predicate tissue-derived wound dressings that are currently marketed, having the same intended use of temporary coverage of partialthickness skin loss injuries.
Device Description:
The SIS Wound Dressing is supplied in sheet form in sizes ranging from 16 cm3 to 360 cm². The device is supplied sterile and is intended for one-time use. Reasonable assurance of biocompatibility of the materials comprising the SIS Wound Dressing is provided by the established history of use of porcine-derived tissues in medical product manufacturing as well as meeting the requirements of the appropriate biocompatibility tests.
Substantial Equivalence:
The SIS Wound Dressing will be manufactured according to specified process controls and a Quality Assurance Program. This device is similar with respect to indications for use, materials and physical construction to predicate devices in terms of section 510(k) substantial equivalency.
10
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Image /page/1/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 image of a bird or abstract human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2007
Neal E. Fearnot, Ph.D. President Cook Biotech Incorporated Box 2603, 3055 Kent Avenue West Lafayette, Indiana 47906
Re: K973170 Trade Name: SIS Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: March 27, 1998 Received: March 30, 1998
Dear Dr. Fearnot:
This letter corrects our substantially equivalent letter of April 30, 1998.
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 (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 and the following limitations:
-
This device may not be labeled for use on third degree burns.
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This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
-
This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
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Page 2 - Neal E. Fearnot, Ph.D.
- This device may not be labeled as a treatment or a cure for any type of wound.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).
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); 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 continue 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.
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Page 3 - Neal E. Fearnot, Ph.D.
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/dsma/dsmamain.html
Sincerely yours,
ely yours,
RoR
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The SIS Wound Dressing is intended for temporary coverage of partial-thickness skin loss injury, such as burns, abrasions, decubitus and chronic vascular ulcers, and autograft donor sites. This device is intended for one-time use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices K973170
510(k) Number
Image /page/4/Picture/7 description: The image shows the words "Prescription Use" and the phrase "(Per 21 CFR 801/109)". There is a line through the words "Prescription Use" and the phrase. The text is in black and the background is white.