PARIETEX

K982532 · Cogent · FTL · Jan 20, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K982532
• Device Name: PARIETEX
• Applicant: Cogent
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Jan 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K982532 · Jan 20, 1999	PARIETEX	Cogent	Retrospective clinical case series; Medical records/clinical experience data	The submission uses retrospective clinical data from two published studies to demonstrate the clinical tolerance, recurrence rates, and safety profile of the Parietex mesh in hernia repair procedures.	Retrospective study; Hernia repair; Clinical case series; Routine clinical practice

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Laparoscopic and open abdominal wall reconstruction using PARIETEX meshes; Retrospective clinical study; Follow-up/Duration: 1993-1997; Study Period: 1993-1997	2,700 hernia patients (2,445 inguinal, 272 incisional); Sample Size: 2,700	Not applicable for this study	Pain scores, time to return to normal activity, complication rates, recurrence rates
Experience in 1,200 Hernia Repair; Retrospective clinical case series; Follow-up/Duration: 3 to 36 months; Study Period: November 1993 - September 1997	1,200 consecutive hernia repair patients; Sample Size: 1,200; Number of Sites: 1 (Clinique Jeanne d'Arc, LYON)	Not applicable for this study	Complications, recurrence rate, return to normal activity, surgical cost

Indications for Use

The Parietex® meshes has the same intended use as the predicate devices: - reinforcement of tissue during surgical repair

Device Story

Parietex is a sterile, single-use surgical mesh composed of knitted multifibre polyester (PET). It is used by surgeons in clinical settings (OR) for tissue reinforcement during hernia repair (inguinal/incisional) and prolapse repair (genito-urinary/rectal). The mesh is implanted via open or laparoscopic surgical approaches to provide structural support to weakened or damaged tissue. By reinforcing the abdominal wall or pelvic floor, the device aims to reduce recurrence rates and facilitate patient recovery. The mesh is provided as pre-cut implants or slings.

Clinical Evidence

Clinical evidence includes a retrospective study of 2,700 hernias (2,445 inguinal, 272 incisional) treated via laparoscopic or open approach. Results showed lower pain scores and faster return to activity in the laparoscopic group (p<0.001). Complication rates were ~10% across groups. Chronic pain was rare (0.6-0.8%). A second study of 1,200 consecutive hernia repairs using a total extraperitoneal approach reported no visceral complications, no early recurrence, and no sepsis, with a 0.8% recurrence rate at 3-36 months follow-up.

Technological Characteristics

Material: Knitted multifibre polyester (PET). Form factor: Pre-cut implants or slings. Sterilization: Sterile, single-use. Biocompatibility: Tested per ISO 10993-1 (cytotoxicity, systemic/intracutaneous toxicity, sensitization, mutagenicity, implantation).

Indications for Use

Indicated for the repair of Inguinal and Incisional hernias, genito-urinary and rectal prolapses by promontofixation via open abdominal or laparoscopic approach.

Regulatory Classification

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.

Predicate Devices

• Mersilene® (Ethicon, Johnson & Johnson)
• Ercylene® (Davis & Geck)
• Prolene® (Ethicon, J & J)
• Surgipro® (U.S.S.C.)
• Marlex® (Bard - Davol)
• Visilex® (Bard - Davol)
• Atrium® (Atrium)

Submission Summary (Full Text)

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# 510(k) Summary

:

### Submitter Information

| Name: | Sofradim Production |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 116, avenue du formans<br>01600 Trevoux,<br>France |
| Phone number | [phone] |
| Fax number: | [phone] |
| Establishment Registration: | 9615742 |
| Name of contact person:<br>(US Agent) | James McMahon<br>Senior Manager, Regulatory Affairs<br>Covidien<br>15 Crosby drive<br>Bedford, MA 01730 USA<br>Phone: [phone] |
| 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 to<br>which equivalence is claimed | Mersilene®, (Ethicon, Johnson & Johnson)<br>Ercylene®, (Davis & Geck)<br>Prolene®, (Ethicon, J & J)<br>Surgipro®, (U.S.S.C.)<br>Marlex®, Visilex@ (Bard - Davol)<br>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<br>(PET). Each mesh is supplied sterile and nonpyrogenic in a<br>single-use package. |
| Intended use of the device: | The Parietex® meshes has the same intended<br>use as the predicate devices:<br>- reinforcement of tissue during surgical repair |

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Indications for use:

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.

#### 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 [phone] or [phone] 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

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