Not Found
No
The summary describes a collagen-based wound dressing and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the management of wounds, which is a therapeutic purpose.
No
The document describes the device as intended for wound management and composed of porcine collagen in sheet form, indicating it is a therapeutic or wound dressing device, not a diagnostic one.
No
The device description explicitly states the device is primarily composed of porcine collagen supplied in sheet form, indicating it is a physical medical 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 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 "porcine collagen" matrix supplied in sheet form. This is a material applied directly to a wound, not a reagent or instrument used to analyze a biological sample.
- Lack of Diagnostic Information: The description does not mention any analysis of biological samples, detection of biomarkers, or providing information for diagnosis.
Therefore, the SS Matrix™ is a wound care device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SS Matrix™ is intended for the management of wounds including: partial and fullthickness 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 (comma separated list FDA assigned to the subject device)
79KMF, KGN
Device Description
The SS MatrixTM 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 SS Matrix™ was subjected to a panel of tests to assess biocompatibility. The SS Matrix™ passed the requirements of all tests.
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
9. 510(K) SUMMARY
Submitted By: Mark Blever President Cook Biotech Incorporated 3055 Kent Avenue West Lafayette, IN 47906 (765) 497-3355
February 26, 2002
Device:
Trade Name: Common/Usual Name: Proposed Classification Name:
SS MatrixTM Topical Wound Dressing Liquid bandage; 21 CFR 880.5090; Class I Product Code: 79KMF
Intended Use:
The SS Matrix™ is intended for the management of wounds including: partial and fullthickness 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 SS Matrix™ is similar to predicate collagen-based wound dressings that are currently marketed for the management of wounds including the SIS Wound Dressing II (D.C. #K993948) manufactured by Cook Biotech Incorporated, the FIBRACOL* Plus Collagen Wound Dressing (D.C. #K982597) manufactured by Johnson & Johnson Medical, and the EZ Derm™ Biosynthetic Wound Dressing (D.C. #K935189) manufactured by Brennen Medical Incorporated.
Device Description:
The SS MatrixTM 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 SS Matrix™ is similar with respect to indications for use, materials and physical construction to predicate devices in terms of section 510(k) substantial equivalence.
Discussion of Tests and Test Results:
The SS Matrix™ was subjected to a panel of tests to assess biocompatibility. The SS Matrix™ 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.
MAY 3 0 2002
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 0 2002
Mr. Mark Bleyer President Cook Biotech, Inc. 3055 Kent Avenue West Lafayette, IN 47906
Re: K020732
Trade/Device Name: SS Matrix Regulatory Class: unclassified Product Code: KGN Dated: March 5, 2002 Received: March 6, 2002
Dear Mr. Blever:
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 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.
2
Page 2 -- Mr. Mark Bleyer
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Muriam C. Provost
HUCelia 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
3
510(k) Number (if known): K02 0 7 3 2
Device Name: ____SS Matrix™
Indications For Use:
The SS Matrix 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)
Miriàm C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use_