(37 days)
The Parietex™ Monofilament Polyester Mesh is indicated for inguinal and ventral hernia repair.
PARIETEX™ - Monofilament Polyester Mesh is made out of a non-absorbable bi-dimensional monofilament polyester knitting and is available in rectangular shape.
This document is a 510(k) summary for a medical device called PARIETEX™ - Monofilament Polyester Mesh. It describes the device and its intended use, but it does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria in terms of diagnostic accuracy or AI performance.
The "Performance Data" section states: "Bench testing has been conducted to evaluate the performance characteristics of PARIETEX™ - Monofilament Polyester Mesh. Testing has shown that the PARIETEX™ - Monofilament Polyester Mesh is similar in performance characteristics to the predicate MERSILENE™."
This indicates a comparison was made to a predicate device, but it's focused on the material's performance characteristics through bench testing, not a study evaluating diagnostic accuracy or a specific set of acceptance criteria for an AI/algorithm-driven device.
Therefore, the requested information for an AI/algorithm-focused study cannot be extracted from this document.
Based on the provided document, the following cannot be answered:
- A table of acceptance criteria and the reported device performance: The document only mentions bench testing showing similarity in performance characteristics to a predicate device, but no specific quantitative acceptance criteria or reported values are given.
- Sample size used for the test set and the data provenance: Not applicable as there is no study described that involves a "test set" in the context of an algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this document pertains to a surgical mesh, not a diagnostic imaging or AI device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable as there is no mention of a training set for an algorithm.
- How the ground truth for the training set was established: Not applicable.
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| K090858 | 510(k) Summary of Safety and Effectiveness | ||
|---|---|---|---|
| SUBMITTER: | Sofradim Production116, avenue du formans01600 Trevoux, FrancePhone: 33 0 4 74 08 90 00 | ||
| CONTACT PERSON: | Angela L. Bunn, RACAssociate Manager, Regulatory AffairsCovidien60 Middletown AvenueNorth Haven, CT 06473 USAPhone: (203) 492-5325 | MAY - 6 2009 | |
| DATE PREPARED: | March 27, 2009 | ||
| TRADE/PROPRIETARY NAME: | PARIETEX™ - Monofilament Polyester Mesh | ||
| COMMON/USUAL NAME: | Surgical Mesh | ||
| CLASSIFICATION NAME: | Mesh, Surgical, Polymeric | ||
| PREDICATE DEVICE(S): | MERSILENE™ (Ethicon) (Preamendment device, marketedprior to May 28, 1976) | ||
| PARIETEX™ COMPOSITE Mono PM Mesh (K081126) | |||
| DEVICE DESCRIPTION: | PARIETEX™ - Monofilament Polyester Mesh is made out of anon-absorbable bi-dimensional monofilament polyester knittingand is available in rectangular shape. | ||
| INTENDED USE: | PARIETEX™ - Monofilament Polyester Mesh is indicated foringuinal and ventral hernia repair. | ||
| TECHNOLOGICALCHARACTERISTICS: | The technological characteristics of PARIETEX™ -Monofilament Polyester Meshes are similar to those of thepredicate devices. The proposed device is similar to thepredicate device (PARIETEX™ Composite Mono PM Mesh) inthat the base materials of polyester are the same. In regardsto other technological aspects the predicate device(MERSILENE™) are similar in form and function. | ||
| MATERIALS: | PARIETEX™ - Monofilament Polyester Mesh is comprised ofbiocompatible materials that are in compliance with ISO10993-1 and/or USP standards. | ||
| PERFORMANCE DATA: | Bench testing has been conducted to evaluate theperformance characteristics of PARIETEX™ - MonofilamentPolyester Mesh. Testing has shown that the PARIETEX™ -Monofilament Polyester Mesh is similar in performancecharacteristics to the predicate MERSILENE™. |
PARIETEX™ - Monofilament Polyester Mesh
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
MAY - 6 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sofradim Production % Covidien Ms. Angela L. Bunn, RAC 60 Middletown Avenue North Haven, Connecticut 06473
Re: K090858
Trade/Device Name: ParietexTM Monofilament Polyester Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: March 27, 2009 Received: March 30, 2009
Dear Ms. Bunn:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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); 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at
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Page 2 - Ms. Angela L. Bunn, RAC
(240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Mil. B.P. Ogle
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative 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: Parietex™ Monofilament Polyester Mesh
Indications For Use:
The Parietex™ Monofilament Polyester Mesh is indicated for inguinal and ventral hernia repair.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krane
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of
510(k) Number KD90858
§ 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.