(77 days)
The Parietene™M Macroporous Mesh is intended for the repair of hemias or other fascial deficiencies that require the addition of a reinforcing material.
The Parietene™ Macroporous Mesh is a non-absorbable synthetic surgical mesh made out of bi-dimensional monofilament polypropylene textile. The Parietene™ Macroporous mesh is offered in a flat sheet and pre-cut mesh. The pre-cut mesh facilitates the repair of inguinal hernias via the anterior approach using a tension free technique.
This submission is for a medical device cleared via a 510(k) pathway, specifically a surgical mesh (Parietene™ Macroporous Mesh). This type of clearance relies on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria as you might see for a diagnostic AI device or a drug.
Therefore, the input document does not contain the kind of information requested in your prompt regarding acceptance criteria, device performance, study designs, sample sizes, expert ground truth, or MRMC studies. These elements are typically found in submissions for AI/ML-based diagnostic devices or complex medical devices requiring de novo or PMA pathways.
Instead, this 510(k) summary focuses on demonstrating that the new device, Parietene™ Macroporous Mesh, is substantially equivalent to legally marketed predicate devices (PROLENE™ Soft (Polypropylene) Mesh (K001122) and Parietene™ Flat Sheet Mesh (K140941)).
Here's a breakdown of what can be extracted and why other parts of your request are not applicable based on this document:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The document does not specify quantitative "acceptance criteria" in the way a diagnostic study would (e.g., target sensitivity, specificity). Instead, the acceptance criterion for a 510(k) is demonstrating "substantial equivalence" to a predicate device. This is achieved by showing similar technological characteristics and performance.
- Reported Device Performance: The document lists the types of bench tests performed, but does not provide numerical results for either the subject device or the predicate device that would allow for a direct comparison table. It only states that "The bench results demonstrate that the device is substantially equivalent to the predicate PROLENE™ Soft (polypropylene) Mesh (K001122)."
| Characteristic Assessed (Bench Testing) | Acceptance Criteria (Implicit: Substantial Equivalence to Predicate) | Reported Device Performance (Qualitative) |
|---|---|---|
| Mesh thickness | Similar to Predicate PROLENE™ Soft Mesh (K001122) | Demonstrated substantial equivalence |
| Pore size | Similar to Predicate PROLENE™ Soft Mesh (K001122) | Demonstrated substantial equivalence |
| Surface density | Similar to Predicate PROLENE™ Soft Mesh (K001122) | Demonstrated substantial equivalence |
| Bursting strength | Similar to Predicate PROLENE™ Soft Mesh (K001122) | Demonstrated substantial equivalence |
| Bursting distension | Similar to Predicate PROLENE™ Soft Mesh (K001122) | Demonstrated substantial equivalence |
| Breaking strength | Similar to Predicate PROLENE™ Soft Mesh (K001122) | Demonstrated substantial equivalence |
| Elongation at break | Similar to Predicate PROLENE™ Soft Mesh (K001122) | Demonstrated substantial equivalence |
| Tear strength | Similar to Predicate PROLENE™ Soft Mesh (K001122) | Demonstrated substantial equivalence |
| Suture strength | Similar to Predicate PROLENE™ Soft Mesh (K001122) | Demonstrated substantial equivalence |
| Biocompatibility | Compliance with ISO 10993-1 for a permanent implant | Evaluated in accordance with ISO 10993-1 |
| Shelf-life | Packaging maintains sterility; material stability | Demonstrated by stability results |
2. Sample size used for the test set and the data provenance:
- This information is not provided in the document. Bench testing for medical devices typically involves specific numbers of samples for each test (e.g., n=5 or n=10 per test), but these details are not disclosed in this high-level 510(k) summary. Data provenance (country of origin, retrospective/prospective) is also not applicable as these are laboratory bench tests, not clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable. This document describes bench testing of a physical medical device, not a diagnostic algorithm that requires expert interpretation for ground truth.
4. Adjudication method for the test set:
- This is not applicable for the same reasons as point 3.
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:
- This is not applicable. This is a physical surgical mesh, not an AI/ML diagnostic device, so MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This is a physical surgical mesh, not an algorithm.
7. The type of ground truth used:
- For the bench tests, the "ground truth" would be established by standardized laboratory test methods and measurements (e.g., using calibrated equipment to measure thickness, strength, pore size, etc.). It's not based on expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set:
- This is not applicable. This is a physical surgical mesh, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- This is not applicable for the same reasons as point 8.
In summary, the provided document is a 510(k) summary for a surgical mesh, focusing on demonstrating substantial equivalence through bench testing. It does not contain the detailed clinical study data, expert consensus, or AI/ML-specific information requested in your prompt.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 17, 2014
Sofradim Production % Ms. Jennifer Brennan Covidien LLC Senior Manager, Regulatory Affairs 60 Middleton Avenue North Haven, Connecticut 06473
Re: K142091
Trade/Device Name: Parietene" Macroporous Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: July 1, 2014 Received: August 1, 2014
Dear Ms. Brennan:
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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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 Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 yours,
Jiyoung Dang -S
On behalf of Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K142091
Device Name
Parietene™ Macroporous Mesh
Indications for Use (Describe)
The Parietene™M Macroporous Mesh is intended for the repair of hemias or other fascial deficiencies that require the addition of a reinforcing material.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (1/14)
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K142091
510(k) Summary
| Submitter Information | |
|---|---|
| Name: | Sofradim Production (subsidiary of Covidien LLC) |
| Address: | 116, avenue du formans01600 Trevoux,France |
| Phone number | +33 (0)4 74 08 90 00 |
| Fax number: | +33 (0) 4 74 08 90 02 |
| Establishment Registration: | 9615742 |
| Name of contact person: | Jennifer BrennanSr. Manager, Regulatory Affairs60 Middletown AvenueNorth Haven, CT 06473Phone: (203) 492-5346Fax: (203) 492-5029 |
| Date prepared: | July 21st, 2014 |
| Name of device | |
| Trade or proprietary name: | Parietene™ Macroporous Mesh |
| Common or usual name: | Surgical Mesh |
| Classification name: | Mesh, Surgical, Polymeric |
| Classification panel: | General and Plastic Surgery (79) |
| Regulation: | 21 CFR 878.3300 |
| Product Code: | FTL |
| Legally marketed devices to | which equivalence is claimed: PROLENE™Soft (Polypropylene) Mesh (K001122) Parietene™Flat Sheet Mesh (K140941) |
| Reason for 510(k) submission: | To obtain market clearance of the Parietene™ Macroporous Mesh. |
| Device description: | The Parietene™ Macroporous Meshis a non-absorbable synthetic surgical mesh made out of bi-dimensional monofilament polypropylene textile. The Parietene™Macroporous mesh is offered in a flat sheet and pre-cut mesh. The pre-cut mesh facilitates the repair of inguinal hernias via the anteriorapproach using a tension free technique. |
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Parietene™ Macroporous Mesh
Intended use of the device: intended for the reinforcement of soft tissue where weakness exists during surgical repair. Indications for use: The Parietene™ Macroporous Mesh is indicated for the repair of hernias or other fascial deficiencies that require the addition of a reinforcing material. Summary comparing the technological characteristics of the subject and predicate The subject Parietene™ Macroporous Mesh is substantially equivalent to the devices: predicate device PROLENE™ Soft (Polypropylene) Mesh (K001122) in terms of design for the following technological characteristics: - Indications - Polypropylene textile performance - Design: flat sheet meshes with similar shape and size. The subject Parietene™ Macroporous Mesh is substantially equivalent to the predicate device Parietene™ Flat Sheet Mesh (K140941) in terms of design for the following technological characteristics: - Polypropylene material - Design: flat sheet meshes with similar shape and size. Performance data: Bench testing has been conducted in accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh issued March 2, 1999 to evaluate the performance characteristics of the subject Parietene™ Macroporous Mesh. The following mesh characteristics were assessed: mesh thickness, pore size, surface density, bursting strength, bursting distension, breaking strength, elongation at break, tear strength, suture strength. The bench results demonstrate that the device is substantially equivalent to the predicate PROLENE™ Soft (polypropylene) Mesh (K001122). Parietene™ Macroporous Mesh is made out of material that has been evaluated for biocompatibility in accordance with ISO 10993-1 for a permanent implant, a recognized standard by FDA (#2-179). Parietene™ Macroporous Mesh shelf-life has been demonstrated by the stability results of the material and the ability of packaging to maintain product sterility per sealing. In conclusion, all testing demonstrates that the subject Parietene™ Macroporous Mesh is substantially equivalent to the predicate Prolene™ Soft Mesh.
§ 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.