PARIETEX PROGRIP by SOFRADIM PRODUCTION

Parietex Progrip™ TEM2015G and TEM3015G are rectangular meshes made of knitted monofilament polyester with polylactic acid (PLA) resorbable pins on one of the sides. The PLA pins facilitate placement, positioning and fixation of the mesh to the surrounding tissue.

AI/ML Overview

The provided document is a 510(k) summary for the Parietex Progrip™ Mesh, specifically for new sizes TEM2015G and TEM3015G. It states that these new sizes are substantially equivalent to a previously cleared predicate device (K081050).

Based on the provided information, the document does not contain a study that proves the device meets specific acceptance criteria in the traditional sense of a clinical or performance study with defined metrics for the device itself.

Instead, this 510(k) submission relies on the concept of substantial equivalence to a predicate device. This means that the new device sizes are considered safe and effective because they are fundamentally similar to a device already legally marketed.

Here's a breakdown of why a table of acceptance criteria and reported device performance isn't applicable in the way you've requested, and how to address the other points based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided document. The 510(k) summary explicitly states:

"No additional bench testing has been conducted."
"The materials of the new Parietex Progrip™ references are identical to the predicate Parietex Progrip™ and therefore, the performance data submitted in the predicate Parietex Progrip™ Traditional 510k (K081050) applies to the two additional sizes."

This indicates that specific acceptance criteria and performance data for the new device sizes (TEM2015G and TEM3015G) were not generated independently. Their performance is inferred from the predicate device (K081050), which would have had its own performance data and acceptance criteria at the time of its clearance. Without the K081050 document, we cannot construct such a table for these specific acceptance criteria and performance results directly from this text.

Regarding the requested study information:

Since no new study was conducted for TEM2015G and TEM3015G, most of the following points are not applicable or cannot be determined from the provided text for these specific device sizes. The information below pertains to the absence of such studies for this 510(k) submission.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable for this 510(k). No new test set data was generated. The submission relies on data from the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable for this 510(k). As no new test set was generated, there was no need for expert ground truth establishment for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this 510(k). No new test set was generated.

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.

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 algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for this 510(k). No new ground truth for performance was established for the new device sizes.

8. The sample size for the training set

Not applicable. This device is a surgical mesh; the concept of a "training set" is not relevant in this context.

9. How the ground truth for the training set was established

Not applicable. This device is a surgical mesh.

Summary of what can be derived from the document:

Device: Parietex Progrip™ Mesh (TEM2015G and TEM3015G)
Indication: Inguinal and incisional hernia repair.
Mechanism of Clearance: Substantial Equivalence to predicate device Parietex Progrip™ Mesh (K081050).
Reason for Substantial Equivalence: The new sizes are comprised of identical materials and share the same intended use and fundamental technology as the predicate device. No new performance or testing data was required or submitted for these specific models, as the performance data from the predicate device's 510(k) (K081050) was deemed applicable.

Summary

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Special 510(k) – Parietex Progrip™: TEM2015G and TEM3015G references

510(k) Summary of Safety and Effectiveness

SUBMITTER:	Sofradim Production116, avenue du formans01600 Trevoux, FrancePhone: 33 04 74 08 90 00	MAR - 4 201
CONTACT PERSON:	James McMahonManager, Regulatory AffairsCovidien15 Crosby AvenueBedford, MA 01730Phone: 781-839-1787
DATE PREPARED:	December 16th, 2010
TRADE/PROPRIETARY NAME:	Parietex Progrip™ Mesh (TEM2015G and TEM3015G)
COMMON/USUAL NAME:	Surgical Mesh
CLASSIFICATION NAME:	Mesh, Surgical, Polymeric
PREDICATE DEVICE(S):	Parietex Progrip™ Mesh (K081050)
DEVICE DESCRIPTION:	Parietex Progrip™ TEM2015G and TEM3015G are rectangularmeshes made of knitted monofilament polyester with polylacticacid (PLA) resorbable pins on one of the sides. The PLA pinsfacilitate placement, positioning and fixation of the mesh to thesurrounding tissue.
INDICATION:	Parietex Progrip™ mesh is indicated for inguinal and incisionalhernia repair.
TECHNOLOGICALCHARACTERISTICS:	Parietex Progrip™ meshes are made with knitted monofilamentpolyester and monofilament polylactic acid resorbable pins. Theintended use and fundamental technology of the two additionalsizes, of Parietex Progrip™ Mesh are equivalent to that of thepredicate Parietex Progrip™mesh.
MATERIALS:	Parietex Progrip™ mesh is comprised of biocompatible materialsthat are in compliance with ISO 10993-1 standard.
PERFORMANCE DATA:	No additional bench testing has been conducted. The materials ofthe new Parietex Progrip™ references are identical to thepredicate Parietex Progrip™ and therefore, the performance datasubmitted in the predicate Parietex Progrip™ Traditional 510k(K081050) applies to the two additional sizes.

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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 & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The graphic is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Sofradim Production % Covidien Mr. James McMahon 15 Crosby Drive Bedford; Masschusetts 01730

MAR - 4 2011

Re: K103682

Trade/Device Name: Parietex ProGrip™ Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: February 15, 2011 Received: February 16, 2011

Dear Mr. McMahon:

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

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Page 2 - Mr. James McMahon

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 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 yours,

Aling B. R.te
fa

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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Special 510(k) – Parietex Progrip™: TEM2015G and TEM3015G references P

Indications For Use

K103682 510(k) Number (if known):

Parietex Progrip™ Mesh Device Name:

Indications For Use:

Parietex Progrip™ Mesh is indicated for inguinal and incisional hernia repair.

Prescription Use × (Part 21 CFR 801 Subpart D) 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)

Daniel Kromefh MXM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

Regulation Number and Section

§ 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.