(45 days)
Not Found
No
The summary describes a biological wound dressing and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes.
The device is intended for the management of wounds, which is a therapeutic purpose.
No
The provided text indicates that the SIS Wound Dressing II is intended for the management of wounds, not for diagnosis. Its description as a collagen-based dressing and its intended use for wound treatment and healing further support this.
No
The device description explicitly states it is composed of porcine collagen in sheet form, indicating it is a physical wound dressing, 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 states the device is for the "management 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 a wound dressing made of porcine collagen. This is a physical material applied to a wound, not a reagent or instrument used to analyze biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
The information provided describes a medical device used for wound care, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The SIS Wound Dressing II is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.
Product codes
KGN
Device Description
The SIS Wound Dressing II is primarily composed of porcine collagen that is supplied in sheet form in sizes ranging from 2 x 4 cm to 20 x 40 cm.
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)
The SIS Wound Dressing II was subjected to a panel of tests to assess biocompatibility. The SIS Wound Dressing II passed the requirements of all tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K973170, K982597, K913023, K910944
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510(K) SUMMARY 9.
Submitted By:
Neal E. Fearnot, Ph.D. President Cook Biotech. Incorporated 3055 Kent Avenue West Lafavette, IN 47906 (765) 497-3355
November 18, 1999
Device:
Trade Name: Common/Usual Name: Proposed Classification Name: SIS Wound Dressina II Topical Wound Dressing Unclassified (79KMF)
Intended Use:
The SIS Wound Dressing II is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.
Predicate Devices:
The SIS Wound Dressing II is similar to predicate collagen-based wound dressings that are currently marketed for the management of wounds including the SIS Wound Dressing (D.C. #K973170) manufactured by Cook Biotech, Incorporated, the FIBRACOL * Plus Collagen Wound Dressing with Alginate (D.C. #K982597) manufactured by Johnson and Johnson Medical, and the SkinTemp® Kollagen Wound Management Material (D.C. #K913023) and Medifil® Kollagen Particles (D.C. #K910944) manufactured by Biocore Medical Technologies.
Device Description:
The SIS Wound Dressing II is primarily composed of porcine collagen that is supplied in sheet form in sizes ranging from 2 x 4 cm to 20 x 40 cm.
Substantial Equivalence:
The SIS Wound Dressing II is similar with respect to indications for use, materials and physical construction to predicate devices in terms of section 510(k) substantial equivalency.
Discussion of Tests and Test Results:
The SIS Wound Dressing II was subjected to a panel of tests to assess biocompatibility. The SIS Wound Dressing II passed the requirements of all tests.
Conclusions Drawn from Tests:
This device is, with respect to intended use and technological characteristics, substantially equivalent to the predicate devices.
1
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 the department's name encircling a stylized image of three human profiles facing right. The profiles are connected and appear to be emerging from a single form. The text is arranged in a circular fashion around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAH 1 9 200/
Neal E. Fearnot, Ph.D. President Cook Biotech, Inc. 3055 Kent Avenue West Lafayette, Indiana 47906
K993948 Re: Trade Name: SIS Wound Dressing II Regulatory Class: Unclassified Product Code: KGN Dated: November 18, 1999 Datod: November 22, 1999
Dear Dr. Fearnot:
This letter corrects our substantially equivalent letter of January 6, 2000.
We have reviewed your Section 510(k) premarket notification of intent to market the We have reviewed your Section 5 U(K) premailser in substantially equivalent (for the
device referenced above and have determined the devices marketed device referenced above and have determined the device is substantinate devices marketed
indications for use stated in the enclosure) to legally marketed predical Device indications for use stated in the enclosure) to legally that the Medical Device in
in interstate commerce prox to May 28, 1976, the enactment date of the provisions in interstate commerce prior to May 28, 1976, the enactment cate of the provisions of
Amendments or to devices that have been recuassified in accordance with the provisions o Amendments or to devices that have been technologic and the require approval of a
the Federal Food, Drug, and Cosme of the device, subject to the the Federal Food, Drug, and Cosmetic Act (Act) that do fict togule . pubject to the general
premarket approval (PMA). You may, therefore, market the device, subject to the g premarket approval (PMA). You may, merelore, mancovais as of the Act include
controls provisions of the Act. The general controls provisions of the Act include controls provisions of the Act. Ine general controls provides
requirements for annual registration, listing of devices, good manufacturing practice, requirements for anilual registration, noting
If your device is classified (see above) into either class II (Special Controls) or class III
ng your and the states and liveral controls. Fristing major regulations affect If your device is classified (see above) into either criass in (special ons affecting your
(PMA), it may be subject to additional controls. Existing major regulations affect (PMA), it may be subject to additional controls. Existing fille/ 1. Parts 800 to 898. In
device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 800 device can be found in the Code of Federal Regulations, THS 31, 2017
addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Neal E. Fearnot, Ph.D.
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.
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
Mark N. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
510(k) Number (if known): __ K 993948
Device Name: __ SIS Wound Dressing II
Indications For Use:
The SIS Wound Dressing II is intended for the management of wounds including:
- ·Partial and full-thickness wounds
- ·Pressure ulcers
- ·Venous ulcers
- · Diabetic ulcers
- •Chronic vascular ulcers
- Tunneled/undermined wounds
- · Surgical wounds (donor sites/grafts, post-moh's surgery, post-
- laser surgery, podiatric, wound dehiscence)
- · Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
- •Draining wounds.
The 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)
Prescription Use (Per 21 CFR 801.109)