(62 days)
Parietene™ Duo and Parietene™ Quadra Polypropylene Meshes are 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.
Parietene™ Duo and Parietene™ Quadra are monofilament polypropylene prolapse repair meshes. The nonabsorbable, polypropylene mesh provides a long-term reinforcement for support structures. Parietene™ Duo Polypropylene Mesh is a pre-shaped mesh for posterior prolapse repair. Parietene™ Quadra Polypropylene Mesh is a pre-shaped mesh for anterior prolapse repair. Parietene™ Duo and Parietene™ Quadra meshes have a soft knit in the central section for compliant organ support and a strong knit in the lateral sides to provide strength for tension-free fixation of the mesh.
The provided text describes a 510(k) summary for the Parietene™ Duo and Parietene™ Quadra Polypropylene Meshes. This document focuses on the substantial equivalence of the device to predicate devices rather than establishing novel performance criteria through a study comparing it to specific acceptance thresholds.
Therefore, the requested information regarding detailed acceptance criteria and the specifics of a study proving the device meets those criteria (especially in the context of AI/algorithms) is not present in the provided text.
The closest information related to "acceptance criteria" is the demonstration of "substantial equivalence" to a predicate device through performance data.
Here's a breakdown of what can be extracted or inferred from the text, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Inferred from Substantial Equivalence): The implicit acceptance criterion is that the device's performance characteristics demonstrate "substantial equivalence" to the predicate device, UGYTEX™ Dual Knit Mesh. This implies that its mechanical, biological, and material properties are comparable.
- Reported Device Performance: The document states: "Testing was conducted to determine the performance characteristics of the subject meshes. The results demonstrate that the Parietene™ Duo and Parietene™ Quadra Polypropylene Meshes are substantially equivalent to the predicate UGYTEX™ Dual Knit Mesh."
- Specific performance metrics (e.g., tensile strength, pore size, biocompatibility results) are NOT provided in this summary. The summary only states that testing was done and yielded substantial equivalence.
2. Sample size used for the test set and the data provenance
- Not provided. The text does not mention specific sample sizes for any testing nor the provenance of any data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. This device is a surgical mesh, not an imaging or diagnostic AI device that would typically involve experts establishing ground truth for a test set in the way AI performance studies do. The evaluation likely involved laboratory testing by engineers and scientists, and potentially animal studies or clinical trials (though details are not in this summary).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are common in diagnostic accuracy studies for AI, where human interpreters' discrepancies are resolved. This is not relevant for the type of device and evaluation described.
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
- Not applicable. This device is a surgical mesh, not an AI-assisted diagnostic tool. An MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a surgical mesh, not an AI algorithm.
7. The type of ground truth used
- Ground Truth (Inferred): For a surgical mesh, "ground truth" would relate to its physical properties, biocompatibility, and intended mechanical function. This would be established through laboratory testing conforming to engineering standards (e.g., tensile strength calculations, material composition analysis), biocompatibility testing (e.g., ISO 10993 standards), and possibly animal studies or clinical observations of healing/integration (though specific results are not here). The "ground truth" for showing substantial equivalence would be the established performance characteristics of the predicate device.
8. The sample size for the training set
- Not applicable/Not provided. Surgical mesh devices do not have "training sets" in the context of AI or machine learning. They undergo manufacturing processes and quality control.
9. How the ground truth for the training set was established
- Not applicable/Not provided. See point 8.
In summary, the provided 510(k) summary is for a physical medical device (surgical mesh) and its focus is on demonstrating substantial equivalence to a predicate device based on performance characteristics. It does not contain the kind of information typically found in FDA submissions for AI/ML-driven diagnostic devices regarding specific acceptance criteria, test set details, or human reader performance.
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510(k) Summary of Safety and Effectiveness
| SUBMITTER: | Sofradim Production116, avenue du Formans01600 Trevoux, FranceTel. No.: (33) 04 74 08 90 00 |
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DEC 1 9 2007
| CONTACT PERSON: | Sharon AlexanderSenior Associate, Regulatory AffairsCovidien150 Glover AvenueNorwalk, CT 06856 USATel. No.: (203) 492-6060 |
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| DATE PREPARED: | October 17, 2007 |
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| TRADE/PROPRIETARY NAME: | Parietene™ Duo Polypropylene MeshParietene™ Quadra Polypropylene Mesh |
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| COMMON/USUAL NAME: | Surgical Mesh |
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| -------------------- | --------------- |
| CLASSIFICATION NAME: | Mesh, Surgical, Polymeric |
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| ---------------------- | --------------------------- |
| PREDICATE DEVICE(S): | UGYTEXT™ Dual Knit Mesh (K051503)Parietene™ Polypropylene Mesh (K991400) |
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| ---------------------- | ------------------------------------------------------------------------------ |
| DEVICE DESCRIPTION: | Parietene™ Duo and Parietene™ Quadra are monofilamentpolypropylene prolapse repair meshes. The nonabsorbable,polypropylene mesh provides a long-term reinforcement forsupport structures. Parietene™ Duo Polypropylene Mesh is apre-shaped mesh for posterior prolapse repair. Parietene™Quadra Polypropylene Mesh is a pre-shaped mesh for anteriorprolapse repair. Parietene™ Duo and Parietene™ Quadrameshes have a soft knit in the central section for compliantorgan support and a strong knit in the lateral sides to providestrength for tension-free fixation of the mesh. |
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| INTENDED USE: | Parietene™ Duo and Parietene™ Quadra PolypropyleneMeshes are indicated for tissue reinforcement and long-lastingstabilization of fascial structures of the pelvic floor in vaginalwall prolapse where surgical treatment is intended either asmechanical support or bridging material for the fascial defect. |
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| --------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| TECHNOLOGICALCHARACTERISTICS: | The technological characteristics, design and materials of themeshes are substantially equivalent to the predicateUGYTEX™ Dual Knit Mesh. |
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| MATERIALS: | Parietene™ Duo and Parietene™ Quadra PolypropyleneMeshes are comprised of materials that have been evaluatedfor biocompatibility for their intended patient contact profileaccording to ISO 10993-1 and/or USP standards. |
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1022951
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PERFORMANCE DATA: Testing was conducted to determine the performance characteristics of the subject meshes. The results demonstrate that the Parietene™ Duo and Parietene™ Quadra Polypropylene Meshes are substantially equivalent to the predicate UGYTEX™ Dual Knit Mesh.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, and it is often used on official documents and websites.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sofradim Production % Ms. Sharon Alexander Senior Associate, Regulatory Affairs Covidien 150 Glover Avenue NORWALK CT 06856
SEP 2 8 2012
Re: K072951
Trade/Device Name: Parietene™ Duo and Parietene™ Quadra Polypropylene Meshes Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP, OTO Dated: November 26, 2007 Received: November 27, 2007
Dear Ms. Alexander:
This letter corrects our substantially equivalent letter of December 19, 2007.
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 (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 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
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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 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" (21 CFR 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Benjamin R. Fuchs
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological 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: Parietene™ Duo and Parietene™ Quadra Polypropylene Meshes
Indications for Use:
Parietene™ Duo and Parietene™ Quadra Polypropylene Meshes are 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.
| Prescription Use(Part 21 CFR 801 Subpart D) | X |
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| 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)
Division of General, Restorative, and Neurological Devices
| 510(k) Num | 16072957 |
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| ------------ | ---------- |
§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.
(a)
Identification. Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.