Parietex™ surgical mesh; slings or pre-cut implants are intended for the repair of Inguinal and Incisional hernias, genito-urinary and rectal prolapses by promontofixation via open abdominal or laparoscopic approach. No applications other than the ones indicated are recommended.

Device Description

Mesh made of Biocompatible, knitted multifibre polyester (PET). Each mesh is supplied sterile and nonpyrogenic in a single-use package.

AI/ML Overview

The provided text describes a 510(k) summary for the Parietex Surgical Mesh, which is a medical device for surgical repair. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined metrics.

Here's a breakdown of the requested information based on the provided text, along with an explanation of why some points cannot be fully addressed:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define acceptance criteria in terms of specific performance metrics with target values for this device. Instead, it relies on demonstrating substantial equivalence to predicate devices through comparisons of mechanical properties and reported clinical outcomes literature.

Category	Acceptance Criteria (Not explicitly stated as such)	Reported Device Performance
Mechanical Properties	Similar to predicate devices (Mersilene, Prolene, Marlex) for thread resistance, tear resistance, and breaking resistance.	Thread Resistance (N): Chain: 68.5, Weft: 55.4 (Compared to Mersilene: Chain 115.2, Weft 15.5; Prolene: Chain 57, Weft 74.6; Marlex: Chain 57.2, Weft 55.8)Tear Resistance (daN): Chain: 3.36, Weft: 2.78 (Compared to Mersilene: Chain 0.64, Weft 0.68; Prolene: Chain <0.1, Weft 4.41; Marlex: Chain 0.66, Weft 4.03)Breaking Resistance (daN): Chain: 39.11, Weft: 63.6 (Compared to Mersilene: Chain 20.53, Weft 10.04; Prolene: Chain 59.74, Weft 76.74; Marlex: Chain 43.2, Weft 56.7)
Biocompatibility	Pass ISO 10993-1 Standards and FDA requirements for various tests.	Passed all specified tests: Cytotoxicity, Systemic toxicity, Intracutaneous toxicity, Sensitization, Mutagenicity (Ames's test, Chromosomal aberration, Sister chromatid exchange), and Implantation tests (Short term, Long term).
Clinical Outcomes	Favorable complication, pain, and recurrence rates compared to previously published reports and predicate device performance.	Study 1 (2,700 hernias): Average incidence of total reported events (complications) ~10%, similar to previously published reports. Chronic pain (inguinal hernias): 0.6% (laparoscopic), 0.8% (open). Sepsis: 1/1526 (laparoscopic), 2/380 (open). Recurrence rates: below 1%.Study 2 (1,200 hernias): No visceral complication, no early recurrence, no sepsis. Follow-up 3-36 months in 90% of patients with a low recurrence rate (0.8%). One patient reoperated for chronic pain.

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

Clinical Studies:
- Study 1: "Laparoscopic and open abdominal wall reconstruction using PARIETEX® meshes"
  - Sample Size: 2,445 inguinal hernias and 272 incisional hernias (total 2,717 cases, however, the summary states "2.700 hernias" and "a series of 2.445 inguinal hernias and 272 incisional hernias").
  - Data Provenance: Not explicitly stated, but the submission is from a French company (Sofradim Production), and the lead author of the second study is from Lyon, France, suggesting European (likely French) data.
  - Retrospective or Prospective: Retrospective study.
- Study 2: "Laparoscopic Hernia Repair. Total Extra-Peritoneal Approach • Experience in 1,200 Hernia Repair"
  - Sample Size: 1,200 hernias.
  - Data Provenance: Clinique Jeanne d'Arc, LYON (FRANCE).
  - Retrospective or Prospective: Retrospective for the initial presentation as "We report our experience with 1.200 consecutive hernia repair." The conclusion mentions "The early results of this technique experienced during this short study have been encouraging."
Biocompatibility Studies:
- Sample Size: Not specified for individual tests.
- Data Provenance: "All tests were performed according to GLP in an American Laboratory."
- Retrospective or Prospective: Not applicable, these are lab tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The clinical studies cited are retrospective observational summaries of surgical outcomes from medical practitioners (surgeons) and their patients, not a test set for an AI device. The "ground truth" here is the actual clinical outcome reported by the treating physicians and follow-up data.

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

Not applicable. This is not a study involving human readers or a model output that requires adjudication. The clinical results are reported from existing patient records.

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 submission is for a surgical mesh, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This submission is for a surgical mesh, not an algorithm or AI device.

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

For the clinical studies, the "ground truth" is based on outcomes data (e.g., pain scores, time to return to normal activity, complication rates, sepsis rates, recurrence rates) as reported by the treating physicians in clinical practice. For biocompatibility, the ground truth is the pass/fail criteria established by ISO and FDA standards for the specific tests.

8. The sample size for the training set

Not applicable. This submission is for a physical medical device (surgical mesh), not an AI algorithm. Therefore, there is no "training set."

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

Not applicable (as explained in point 8).

Summary

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510(k) Summary

Submitter Information

Name:	Sofradim Production
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:(US Agent)	James McMahonSenior Manager, Regulatory AffairsCovidien15 Crosby driveBedford, MA 01730 USAPhone: (781) 839 1787
Date prepared:	June 25, 2012
Name of device
Trade or proprietary name:	Parietex
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 towhich equivalence is claimed	Mersilene®, (Ethicon, Johnson & Johnson)Ercylene®, (Davis & Geck)Prolene®, (Ethicon, J & J)Surgipro®, (U.S.S.C.)Marlex®, Visilex@ (Bard - Davol)Atrium®, (Atrium)
Reason for 510(k) submission:	To obtain market clearance on the Parietex Surgical Mesh.
Device description:	Mesh made of Biocompatible, knitted multifibre polyester(PET). Each mesh is supplied sterile and nonpyrogenic in asingle-use package.
Intended use of the device:	The Parietex® meshes has the same intendeduse as the predicate devices:- reinforcement of tissue during surgical repair

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Indications for use:

Mechanical Properties:

Comparative Table		Parietex™	Mersilene®	Prolene®	Marlex®
		(Polyester)	(Polyester)	(Polypropylene)	(Polypropylene)
Thread	Chain	68.5	115.2	57	57.2
Resistance (N)	Weft	55.4	15.5	74.6	55.8
Tear Resistance	Chain	3.36	0.64	<0.1	0.66
(daN)	Weft	2.78	0.68	4.41	4.03
Breaking	Chain	39.11	20.53	59.74	43.2
resistance (daN)	Weft	63.6	10.04	76.74	56.7

Source : U. Klinge, J. Conze, B. Klosterhalfen, W. Limberg, B. Obolenski, A.P. Öttinger, V. Schumpelick : "Atteration of abdominal wall mechanics after mesh implantation. Experimental alteration of mests stablifly. Langenbecks - Archiv für Chirurgie, Band 381 Heft 6, 1996

Performance data:

Biocompatibility Tests Standard biocompatibility testing was performed according to the ISO 10993 - 1 Standards and FDA requirements.

The device passed all of the following biocompatibility tests:

- Cytotoxicity

Systemic toxicity
Intracutaneous toxicity
Sensitization

- Mutagenicity tests:	Ames's test
	Chromosomal aberration
	Sister chromatid exchange
- Implantation tests:	Short term implantation
	Long term implantation

All tests were performed according to GLP in an American Laboratory.

Clinical Tests:

"Iaparoscopic and open abdominal wall reconstruction using PARIETEX® meshes" · Clinical results on 2.700 hernias. (Paper accepted by "HERNIA" 1998)

Summary:

The authors report a series of 2.445 inguinal hernias and 272 incisional hernias treated between 1993 and 1997 by the insertion of a Parietex® mesh via either a laparoscopic (1,595 procedures) or an open approach (578 procedures). Pain scores and time to return to normal activity were lower in the laparoscopic group

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than in the open surgery group (p<0.001). In all of the groups, the average incidence of the total reported events (complications) was around 10 % with no statistical difference. This ratio seemed to compare favorably too previously published reports. Considering inguinal hernias in particular, chronic pains was extremely rare (0.6 % in the laparoscopic group and 0.8 % in the open surgery group). Whatever the approach was, sepsis was also very rare (1/1526 laparoscopic procedures, 2/380 open operations). These finding& illustrate the local tolerance of the mesh. Recurrence rates were below 1: % with no statistical difference between groups. This retrospective study demonstrates the clinically apparent local tolerance of this type of mesh. Prospective and long term clinical results will be necessary to demonstrate that the optimized short term tolerance of

"Laparoscopic Hernia Repair. Total Extra-Peritoneal Approach • Experience in 1,200 Hernia Repair". Complete Literature Review. S. Benchetrit, M.D. - Clinique Jeanne d'Arc, LYON (FRANCE). (Paper accepted by "Surgical Endoscopy" 1998)

Parietex® mesh will influence the long term functional results.

Summary:

We report our experience with 1 .200 consecutive hernia repair by total extraperitoneal approach. Between November 1993 and the end of September 1997, 1,200 hernias have been repaired using the extra-peritoneal approach with a balloon trocar in our center. A balloon dissector was used to dissect the extra-peritoneal space in all patients. A 15 x 10 cm mesh was used. There were no visceral complication, no early recurrence and no sepsis. The follow up was from 3 to 36 months in 90 % of the patients with a low recurrence rate (0.8 %). One patient needed to be reoperated for chronic pain. Return to normal activity was 1-3 days. Surgical cost was compensated by social cost savings due to a shorter hospital stay and a quicker return to normal activity compared to open hernia repair. The early results of this technique experienced during this short study have been encouraging.

Conclusions drawn from the preclinical and clinical testing

The Parietex® meshes are substantially equivalent to the predicate devices because they have the same intended use, very similar indications, principles of operation, and technological characteristics, and any difference in the Parietex® mesh technological characteristics do not raise any new questions of safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted in blue and consists of a staff with two snakes coiled around it, topped with wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the caduceus in a circular fashion.

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

AUG 2 0 2012

Sofradim Productions % Mr. Howard M. Holstein Hogan & Hartson 555 Thirteenth Street, Northwest Washington, District of Columbia 20004

Re: K982532

Trade/Device Name: Parietex® Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: December 4, 1998 Received: December 4, 1998

Dear Mr. Holstein:

This letter corrects our substantially equivalent letter of January 20, 1999.

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

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Page 2 - Mr. Howard M. Holstein

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Mark A. Millman

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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Indication for Use Statement

510(k) Number (if known): K982532

Parietex™ ProSup mesh Device Name:

Indications for Use: PARIETEX™M ProSup™ mesh; slings or pre-cut implants are intended for the repair of Inguinal and Incisional hernias, genito-urinary and rectal prolapses by promontofixation via open abdominal or laparoscopic approach. No applications other than the ones indicated are recommended.

Prescription Use X (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 Knaebel MM

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

510(k) Number Ka962532

Confidential

.
. . .

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.