(30 days)
The Oasis® Wound Matrix device's intended use is 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 supplied sterile and is intended for one-time use.
Animal-derived, extracellular matrix wound care product
This document describes a 510(k) submission for the Oasis® Wound Matrix, a medical device for wound management. The information provided is primarily administrative and regulatory. It does not contain a study that demonstrates the device meets specific acceptance criteria in terms of performance metrics.
Therefore, many of the requested details related to a performance study cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of performance criteria (e.g., healing rate, complication rate). The document mentions "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act applicable to this device." The approval is based on "substantial equivalence" to a predicate device, which implies that its intended use and safety/efficacy profile are similar, rather than meeting specific quantifiable performance targets.
- Reported Device Performance: Not provided in this document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not present in the provided text. The document is an FDA 510(k) summary and approval letter, not a clinical study report.
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)
- This information is not present in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not present in the provided text.
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
- This device is not an AI-assisted diagnostic tool, but rather a wound matrix. Therefore, an MRMC study or AI-related performance metrics are not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable as this is a wound matrix product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- This information is not present in the provided text. For a wound matrix, ground truth in a clinical study would typically involve wound closure rates, reduction in wound size, absence of infection, etc., but no such study details are included here.
8. The sample size for the training set
- This information is not present in the provided text. This document does not describe a machine learning algorithm that would have a "training set."
9. How the ground truth for the training set was established
- Not applicable for this type of device and submission.
{0}------------------------------------------------
Attachment 4 (Modified 18 July 2006)
SPECIAL 510(K) SUMMARY
JUL 1 9 2006
Submitted By: Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 Perry Guinn, VP Quality Assurance & Regulatory Affairs Tel: (765) 497-3355 Fax: (765) 497-2361
Names of Device:
Trade Name: Common/Usual Name: Classification:
OASIS® Wound Matrix Animal-derived, extracellular matrix wound care product
Unclassified
July 18, 2006
Performance Standards: No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act applicable to this device.
Intended Use:
The Oasis® Wound Matrix device's intended use is 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 supplied sterile and is intended for one-time use.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "HUMAN SERVICES - USA" and "DEPARTMENT OF HEALTH" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 9 2006
Cook Biotech, Inc. % Mr. Perry W. Guinn Vice President, Quality Assurance and Regulatory Affairs 1425 Innovation Place West Lafayette, Indiana 47906
Re: K061711
Trade/Device Name: Oasis Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: June 16, 2006 Received: June 19, 2006
Dear Mr. Guinn:
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. Perry W. Guinn
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 (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/industry/support/index.html.
Sincerely yours,
Obarbara Buchemo
tcr
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
K061711 510(k) Number (if known):
Device Name:
Oasis Wound Matrix
Indications For Use:
The Oasis Wound 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.
Prescription Use X Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Ruelius for MKM
sion of General, Restorative and Neurological Devi
510(k) Number K061711
Page 1 of 1
N/A