(32 days)
Surgisis is intended for implantation to reinforce soft tissue. The device is intended for one-time use.
Surgical mesh
This document is a Special 510(k) Premarket Notification for a medical device called Surgisis®, a surgical mesh. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria based on performance during testing.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided document does not contain a table of acceptance criteria nor reported device performance data in the typical sense of a clinical or performance study. Instead, it focuses on demonstrating substantial equivalence to a predicate device through a comparison of characteristics. The document states:
- "Both pass the same set of internal tests and release criteria."
However, the specific "internal tests and release criteria" are not detailed, nor are the quantitative results of these tests provided.
Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text.
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 provided in the document. The submission hinges on substantial equivalence based on material and process similarities, not on a test set of data from a study.
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 applicable and therefore not provided. Since there is no described test set involving human assessment, there are no experts establishing ground truth in this context. The determination of substantial equivalence is made by the FDA based on the provided technical information.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. There is no described test set requiring human adjudication.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not applicable here. This document is for a surgical mesh, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as Surgisis® is a physical surgical mesh, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This is not applicable in the context of the provided document. The regulatory submission relies on demonstrating that the device is "substantially equivalent" to an already approved predicate device, meaning it has the same intended use, operating principles, basic design, materials, shelf-life, and passes the same internal tests and release criteria. The "ground truth" here is the established safety and effectiveness of the predicate device, which is inferred by the similarities.
8. The sample size for the training set
This is not applicable as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as this is not an AI/ML device requiring a training set.
Summary of Acceptance Criteria and Study:
The provided document is a Special 510(k) submission for a surgical mesh (Surgisis®). The regulatory pathway for this device, a 510(k), primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than conducting new, elaborate clinical or performance studies with specific statistical acceptance criteria for device performance as one might see for novel high-risk devices or AI/ML technologies.
The "acceptance criteria" and "study" in this context are interpreted as the comparison points and the process of demonstrating substantial equivalence:
| Acceptance Criteria (Demonstrated Similarity to Predicate) | Reported Device Performance (as stated in the submission) |
|---|---|
| Same intended use | "Both have the same intended use." |
| Same operating principles | "Both use the same operating principles." |
| Same basic design | "Both incorporate the same basic design." |
| Same materials | "Both incorporate the same materials." |
| Same shelf-life | "Both have the same shelf-life." |
| Pass same set of internal tests and release criteria | "Both pass the same set of internal tests and release criteria." (Specific tests and results not detailed in submission for public review, but affirmed to be the same) |
| Packaged and sterilized using same materials and processes | "Both are packaged and sterilized using the same materials and processes." |
The "study" that proves the device meets these "acceptance criteria" is the Special 510(k) submission itself, which presents a direct comparison between the new Surgisis® device and its identified predicate. The "proof" lies in the detailed technical information provided to the FDA (which is not fully available in this excerpt) asserting these similarities and justifying that a process change did not affect specifications or performance. This is a regulatory assessment, not a scientific study with a traditional experimental design, test sets, or ground truth adjudication by experts in the sense of AI/ML or diagnostic device validation.
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Special 510(k) Premarket Notification: Surgisis®
2696 7
Attachment 4
Special 510(k) Summary
Submitted by:
Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 Perry Guinn VP Quality Assurance & Regulatory Affairs Tel: (888) 299-4224 x 4942 FAX: (765) 497-2361
OCT 13 2006
| September 15, 2006 | |
|---|---|
| Names of Device:Trade Name: | Surgisis®, Surgisis® ES |
| Common/Usual Name: | Surgical mesh |
| Proposed classification: | Surgical mesh (79FTM)21 CFR 878.3300Class II |
| Performance standards: | No performance standards have been established underSection 514 of the Food, Drug and Cosmetic Act applicableto this device. |
intended use:
Surgisis is intended for implantation to reinforce soft tissue. The device is intended for one-time use.
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Special 510(k) Premarket Notification: Surgisis®
1062696
Attachment 5
Summary of Substantial Equivalence:
Surgisis®, as described in this submission, is substantially equivalent to its predicate with respect to the following characteristics:
Similarities:
- Both have the same intended use. 1.
- Both use the same operating principles. 2.
- Both incorporate the same basic design. 3.
- Both incorporate the same materials. 4.
- Both have the same shelf-life. 5.
- Both pass the same set of internal tests and release criteria. 6.
- Both are packaged and sterilized using the same materials and processes. 7.
Differences:
-
- A process was changed that did not affect specifications or performance of the final device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 13 2006
Cook Biotech Incorporated % Mr. Perry W. Guinn Vice President, Quality Assurance & Regulatory Affairs 1425 Innovation Place West Lafayette, Indiana 47906
Re: K062696
Trade/Device Name: Surgisis® Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: September 14, 2006 Received: September 15, 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 not 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
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Page 2 - Mr. Perry W. Guinn
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 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 vours.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
62696
510(k) Number (if known):
Surgisis® Device Name:
Indications For Use:
Surgisis® is intended for implantation to reinforce soft tissue. The device is intended for one-time use.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
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(Division (Division Sign-On) Restorative, Division of Generative, Division of Neurological Devices
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510(k) Number
510071-1
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.