(30 days)
ETHICON Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
The proposed ETHICON Mesh is a sterile partially absorbable mesh implant, designed for repair of fascial structure of the pelvic floor in vaginal wall prolapse. The mesh implant is constructed of knitted filaments of equal parts of absorbable poliglecaprone-25 monofilament fiber and nonabsorbable polypropylene monofilament fiber.
The provided text, K082216, is a 510(k) premarket notification for a medical device (ETHICON Mesh) and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically seen for AI/ML-driven devices or diagnostics.
Instead, this submission focuses on establishing substantial equivalence to previously marketed predicate devices for a surgical mesh. The "Performance Data" section is brief and refers to material biocompatibility and functional requirements, not clinical or diagnostic performance criteria as one would find for an AI algorithm.
Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes, ground truth information, expert details, or MRMC study results because this document does not contain that type of information.
The relevant information from the document related to "performance" is:
- Performance Data Mentioned: "Biological reactivity of the materials has been assessed using methods specified in ISO 10993-1, and the material was found to be acceptable for its intended use. Results of functional performance testing indicate that the proposed device meets or exceeds all functional requirements."
- Conclusion Basis: Substantial equivalence to predicate devices (GYNECARE GYNEMESH® PS PROLENE® Soft Mesh and GYNECARE PROLIFT+M™ Pelvic Floor Repair Systems) based on similar technological characteristics.
This type of 510(k) submission generally relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through material characterization, mechanical testing, and comparison of technological characteristics, rather than extensive clinical performance studies with specific statistical endpoints that would be required for a novel device or a device making diagnostic claims.
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SEP - 5 2008
SUMMARY OF SAFETY AND EFFECTIVENESS
Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, in respect to safety and effectiveness is summarized below.
Submitted by:
Bryan A. Lisa Manager, Regulatory Affairs ETHICON, Inc., A Johnson & Johnson Company Route 22 West, PO Box 151 Somerville, NJ 08876 Phone: (908) 218-3392 / Fax: (908) 218-2595
Name/Classification of Device:
Class II in 21 CFR § 878.3300, Surgical Mesh (FTL)
Trade Name:
ETHICON Mesh (TBD)
Predicate Devices:
- GYNECARE GYNEMESH® PS PROLENE® Soft Mesh (ETHICON, Inc.)-K013718 .
- GYNECARE PROLIFT+M™ Pelvic Floor Repair Systems (ETHICON, Inc.) K071512 .
Statement of Intended Use:
ETHICON Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
Device Description:
The proposed ETHICON Mesh is a sterile partially absorbable mesh implant, designed for repair of fascial structure of the pelvic floor in vaginal wall prolapse. The mesh implant is constructed of knitted filaments of equal parts of absorbable poliglecaprone-25 monofilament fiber and nonabsorbable polypropylene monofilament fiber.
Summary of Technological Characteristics of New Device to Predicate Devices:
The modified device has similar technological characteristics as the predicate devices. Like currently marketed devices, the implantable component is a sterile, mesh implant intended for the repair of vaginal wall prolapse. The mesh implant component of the proposed device is made of nonabsorbable and absorbable polymers.
Performance Data:
Biological reactivity of the materials has been assessed using methods specified in ISO 10993-1, and the material was found to be acceptable for its intended use. Results of functional performance testing indicate that the proposed device meets or exceeds all functional requirements.
Conclusions:
Based on the similarities to the predicate devices identified in this submission, we conclude that the modified device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The image is in black and white.
SEP - 5 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ETHICON, Inc. % Mr. Bryan A. Lisa Manager, Regulatory Affairs Route 22 West, P.O. Box 151 Somerville. New Jersey 08876
Re: K082216
Trade/Device Name: ETHICON Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: August 4, 2008 Received: August 6, 2008
Dear Mr. Lisa:
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.
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Page 2 - Mr. Bryan A. Lisa
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, permitte 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Prestmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse eventual (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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. Milliman
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
510(k) Number (if known):
Device Name: ETHICON Mesh
Indications for Use: ETHICON MESH is indicated for tissue reinforcement and long lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
Mark A. Mellersen
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_
Prescription Use X AND/OR Over-The-Counter Use __
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.