(108 days)
ETHICON PHYSIOMESH™ may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
ETHICON PHYSIOMESH™, Flexible Composite Mesh, is a sterile, low profile, flexible composite mesh designed for the repair of hernias and other fascial deficiencies. The mesh product is composed of a nonabsorbable, macroporous polypropylene mesh laminated between two undyed polyglecaprone-25 films. An undyed polydioxanone film provides the bond between the polyglecaprone-25 film and polypropylene mesh. The polypropylene component is constructed of knitted filaments of extruded polypropylene. An additional dyed polydioxanone film marker has been added for orientation purposes.
The provided document describes a 510(k) summary for the ETHICON PHYSIOMESH™, Flexible Composite Mesh. This document focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study evaluating the performance of an AI/ML device. Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth establishment) are not applicable to this submission.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Text) | Reported Device Performance (from Text) |
|---|---|
| Intended Criteria (not explicitly defined) | "ETHICON PHYSIOMESH™, Flexible Composite Mesh underwent a comprehensive bench, and animal testing program and passed all intended criteria in accordance with appropriate test protocols and standards.""During bench testing the device was subject to testing such as device thickness, pore size, burst strength, device weight, tensile strength, device stiffness, suture pullout strength, burst strength and tear resistance.""Additionally, in-vitro and in-vivo testing was provided showing that the device performed as intended.""ETHICON PHYSIOMESH™, Flexible Composite Mesh met all testing criteria, demonstrated substantial equivalence to its predicate devices and did not raise any new questions of safety or effectiveness." |
| Substantial equivalence to predicate devices: | Demonstrated substantial equivalence to: |
| - PROCEED Mesh (K031925 & K060713) for Indications for Use | - For Indications for Use and technological characteristics |
| - ULTRAPRO Hernia System (K071249) for technological characteristics related to the polyglecaprone 25 Film | - For technological characteristics related to the polyglecaprone 25 Film |
| - ULTRAPRO Mesh (K033337) for technological characteristics related to the mesh materials polyglecaprone 25 & polypropylene | - For technological characteristics related to the mesh materials polyglecaprone 25 & polypropylene |
| Safety and Effectiveness (implicitly, by not raising new questions) | "did not raise any new questions of safety or effectiveness." |
2. Sample size used for the test set and the data provenance
This information is not provided. The document refers to "bench, and animal testing program" and "in-vitro and in-vivo testing," but no specific sample sizes for these tests are mentioned. As this is not an AI/ML device, concepts like "test set" and "data provenance" in the context of clinical data are not explicitly applicable in the way they are for AI/ML device studies. This submission relies on engineering and biological testing rather than clinical study data a machine learning model would use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device. The "ground truth" for the performance characteristics of the mesh would be established through standardized physical, chemical, and biological testing methods.
4. Adjudication method for the test set
Not applicable. This is not an AI/ML device.
5. If a multi-reader multicase (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
Not applicable. This is not an AI/ML device, and no human readers are involved in its primary function or evaluation in the way an MRMC study would apply.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for this medical device would be based on:
- Physical and Mechanical Properties: Measured values from bench testing (e.g., thickness, pore size, burst strength, weight, tensile strength, stiffness, suture pullout strength, tear resistance) against predefined specifications and industry standards.
- Biological Compatibility: Results from in-vitro and in-vivo (animal) biocompatibility and performance studies, assessing tissue response, degradation profiles (for absorbable components), and overall biological integration as per recognized standards (e.g., ISO 10993 series).
- Substantial Equivalence: Comparison of these characteristics, and the indications for use, to those of already legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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K093932
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510(K) SUMMARY
APR - 9 2010
Submitter Name: 1.
ETHICON, INC. P.O. Box 151 Route 22 West Somerville, J.J. 08876 Phone: + 1.908.218.3323 FAX: + 1.908.218.2595
2. Date:
March 18, 2010
Contact Information: 3.
Neelu Medhekar Director, Regulatory Affairs ETHICON, INC. Phone: + 1.908.218.3323 FAX: +1.908.218.2595
4. Substantially Equivalent To:
The ETHICON PHYSIOMESH™ is substantially equivalent to:
| PROCEED Mesh (K031925 &K060713) | For Indications for Use and technological characteristics |
|---|---|
| ULTRAPRO Hernia System(K071249) | For technological characteristics related to thepoligelcaprone 25 Film |
| ULTRAPRO Mesh (K033337) | For technological characteristics related to the meshmaterials poliglecaprone 25 & polypropylene |
Description of the Device Subject: ડ.
ETHICON PHYSIOMESH™, Flexible Composite Mesh, is a sterile, low profile, flexible composite mesh designed for the repair of hernias and other fascial deficiencies. The mesh product is composed of a nonabsorbable, macroporous polypropylene mesh laminated between two undyed polyglecaprone-25 films. An undyed polydioxanone film provides the bond between the polyglecaprone-25 film and polypropylene mesh. The polypropylene component is constructed of knitted filaments of extruded polypropylene. An additional dyed polydioxanone film marker has been added for orientation purposes.
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K093932
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Indications for Use: 6.
11
ETHICON PHYSIOMESH™ may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
7. Performance Data:
ETHICON PHYSIOMESH™, Flexible Composite Mesh underwent a comprehensive bench, and animal testing program and passed all intended criteria in accordance with appropriate test protocols and standards. During bench testing the device was subject to testing such as device thickness, pore size, burst strength, device weight, tensile strength, device stiffness, suture pullout strength, burst strength and tear resistance. Additionally, invitro and in-vivo testing was provided showing that the device performed as intended.
Overall Performance Conclusion: 8.
ETHICON PHYSIOMESHTM, Flexible Composite Mesh met all testing criteria, demonstrated substantial equivalence to its predicate devices and did not raise any new questions of safety or effectiveness.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, suggesting themes of protection and service.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR - 9 2010
Ethicon, Inc. % Neelu Medhekar Director, Regulatory Affairs P.O. Box 151, Route 22 West Somerville, New Jersey 08876
Re: K093932
Trade/Device Name: Ethicon Physiomesh™, Flexible Composite Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: March 19, 2010 Received: March 22, 2010
Dear Neelu Medhekar:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
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Page 2 - Neelu Medhekar
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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IV.INDICATIONS FOR USE
510(k) No (if known):
Device Name: ETHICON PHYSIOMESH™, Flexible Composite Mesh
Indications for Use:
ETHICON PHYSIOMESH™ may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Prescription Use ﯾﮯ (Part 21 CFR 801 Subpart D)
រ
- 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)
Page 1 of 1
Daniel Krone for MXM
(Division Sign Off)
(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093932
§ 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.