The Parleten® Palypropylene Meslu is a polypropylene mosh intended for the reinforcement of tissue during surgical repair. It is indicated for inguinal hermia», parietal reinforcement of tissues and abdominal wall hernia repair.

Device Description

The Parietene® Polypropylene Mesh is used during open (laparounny) procedures The or during laparoscopic (transperitoneal or preperttoneal) procedures. Parietene® Polypropylene Mesh is offered in several sizes and designs to accommodate the type and approach of the operation as described below:

Parietene® Polypropylene Mesh Models PP 0611, 1510, 1515, 2020, and Parietene® PP 3030 can be used during oven or laparoscopic procedures. Parietence PP 1410, and 1510 are used only during laparoscopic procedures.

All of the models are made from polyethylenc and are available in various sizes.

The Parietene® Polypropylene Mesh are nude from polypropylene sealed monofilament stitches and are offered in square and rectangular shapes with rounded edges. The Parietene® Pulypropylene Mesh are fixed to the patient by either staples or sutures.

The Parietene® Polypropylene Mesh Model 1410 contains a thread made from polyvinyl diffuorene. This thread is used to keep the mesh folded during insertion through a trocar during laparoscopic procedures. The thread is removed when the mesh has been unfolded in the trocar.

AI/ML Overview

Here's an analysis of the provided text regarding the Parietene® Polypropylene Mesh, focusing on acceptance criteria and supporting studies.

Based on the provided K991400 510(k) summary for the Parietene® Polypropylene Mesh, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of demonstrating substantial equivalence to predicate devices rather than meeting specific performance metrics against a defined threshold for clinical efficacy.

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

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implicitly defined by the characteristics of the predicate devices. The "reported device performance" are the results of comparative testing demonstrating similarity to these predicates.

Acceptance Criteria (Implicit from Predicate Devices)	Reported Device Performance (Parietene® Polypropylene Mesh)
Intended Use: Reinforcement of tissue during surgical repair for inguinal hernias, parietal reinforcement of tissues, and abdominal wall repair.	Substantially Equivalent Intended Use: "all used for reinforcement of tissue during surgical repair. It is indicated for inguinal hernias, parietal reinforcement of tissues and abdominal wall repair." (Matches predicate intended uses).
Material: Polypropylene scaled monofilament stitches.	Material: "made from polypropylene sealed monofilament stitches" (Similar to Bard-Davol Visilex and Atrium Mesh predicates. Sofradim Parietex is made from polyethylene terephthalate, but the focus for this claim is the polypropylene predicates).
Physical Characteristics: Density, thickness, elongation, breaking strength, tear resistance, burst resistance, tensile strength comparable to predicate meshes.	Similar Performance Characteristics: "The test results showed that the Sofradim and predicate devices were similar in performance characteristics" for density, thickness, elongation, breaking strength, tear resistance, burst resistance, and tensile strength (tested against Atrium and Visilex Mesh predicates).
Configuration: Various sizes and shapes, with options for open or laparoscopic procedures.	Similar Configuration: "various sizes and designs to accommodate the type and approach of the operation," offered in square and rectangular shapes with rounded edges. Some models for open or laparoscopic, others only laparoscopic. Offered with a lateral slit for cord. (Comparable to predicate offerings).
Fixation Method: Staples or sutures.	Similar Fixation Method: "fixed to the patient by either staples or sutures." (Matches predicate methods).
Sterility: Single-use devices only.	Similar Sterility: "single use devices only." (Matches predicate description).

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

Sample Size: The document does not specify the number of samples tested for each performance characteristic (density, thickness, etc.). It only states that "Testing was performed."
Data Provenance:
- Country of Origin: France. "ITF de LYON, a test laboratory in France."
- Retrospective or Prospective: Not explicitly stated, but typically, this type of lab testing for a 510(k) would be conducted specifically for the submission, making it prospective in nature relative to the submission.

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)

This section is not applicable as the study described is a laboratory performance test of physical material properties, not a clinical study involving human assessment or ground truth determination by experts in a medical context. The "ground truth" here is the measured physical properties of the predicate devices according to ISO standards.

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

This is not applicable. Adjudication methods are typically used in clinical studies or image review where multiple human experts interpret data. The described testing is objective laboratory measurement.

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. The submission describes a medical device (surgical mesh), not an AI diagnostic or assistance system. No MRMC study was performed.

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

This is not applicable. The submission describes a medical device (surgical mesh), not an AI algorithm.

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

The "ground truth" for the performance testing was the measured physical properties and characteristics of legally marketed predicate devices (Bard-Davol Visilex® Mesh and Atrium Medical Corporation Atrium® Mesh), adhering to ISO standards. The goal was to show that the new device's properties were "similar" to these established devices, not to obtain a definitive "ground truth" of clinical efficacy.

8. The sample size for the training set

This is not applicable. This is a 510(k) submission for a physical medical device, not an AI or machine learning model that requires a training set.

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

This is not applicable, as there is no training set for a physical medical device.

Summary

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JUL 12 999

K991400

510(k) Summary for Parietene® Polypropylene Mesh

SPONSOR 1.

Sofradim Production 197 Avenue Theodore Kraun 69400 Villefranche sur Saone France

Patrice Becker Contact: 33 04 74 60 03 27 Telephone: Facsimile: 33 04 74 60 03 66

1. DEVICE NAME

Proprietary Name:	Parietene® Polypropylene Mesh
Common/Usual Name:	Surgical Mesh
Classification Name:	Surgical Mesh

1. PREDICATE DEVICES
  Bard-Davol Visilex® Mesh Atrium Medical Corporation Atrium® Mesh Sofradim Parictex® Meshes

DEVICE DESCRIPTION 4.

All of the models are made from polyethylenc and are available in various sizes.

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INTENDED USB 5.

The Parietene® Polypropylene Mesh is a polypropylene mesh intended for the reinforcement of tissue during surgical repair. It is indicated for inguinal hernias, parietal reinforcement of tissues and abdominal wall repair.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE ર્ભ.

The Parietene® Polypropyiene Mesh is substantially equivalent to the Sofradim Parietex® Mesbes, the Bard-Davol Visilex® Mesh, and the Atrium Medical Corporation Atrium® Mesh. The Parietene® Polypropylene Mesh and the predicate devices have the same intended use in that they are all used for reinforcement of tissue during surgical repair. The Parietene®, Parietex® Polypropylene Mesth and the Atrium Mesh are inserted either through open or laparoscopic methous whereas the Bard-Davol Visilex is inserted laparoscopically only.

The Parietene® Polypropylene Mesh. the Bard-Davol Visilex and Atrium Mesh predicate devices are all made from polypropylene scaled monofilament stitches. The Softadim Parietex® mesh is made from polyethylene terephtalate. The proposed and predicate devices all offer various sizes and shapes to accommodate different surgical procedures. The proposed Parietene® Mesh is also offered with a lateral slit for cord for easier insertion during laparoscopic procedures. All of the devices are fixed to the patient by either staples or sutures and are single use devices only.

7. PERFORMANCE TESTING

Testing was performed to determine the performance characteristics of the Mesh. The density, thickness, clongation, breaking strength, tear resistance, burst resistance, tensile strength were sil evaluated by ITF de LYON, a test laboratory in France. All of the testing was performed using Atrium and Visilex Mesh

7/1/99

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predicate devices for comparative purposes and followed ISO standards. The test proults showed that the Sofradim and predicate devices were similar in performance charactcristics.

Sofradim 21000 Sofradim Parietene® Polypropylene Mesh

7/1/99 ·

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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 consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1:2 1999

Sofradim Production c/o Ms. Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K991400

Trade Name: Perietene Polypropylene Mesh Regulatory Class: II Product Code: FTL Dated: April 21, 1999 Received: April 22, 1999

Dear Ms. McNamara:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Mary McNamara-Cullinane, RAC

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K991400 510(k) Number (if known): _

Sofredim Parietung® Polypropylene Mesh Device Name:_

Indications For Use:

(PLEASH IN NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IP NECESSARY

Concurrentes of CDRH, Office of Device Evaluation (ODF.) Forman Sigh-Off in of General Restorative Devices (COO, 1400 ﻟﻠﺘﻨﺎ 510(k) Number -OR Over-The-Counter I.Jan Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96) Sofradim 7/1/99 510(k) Sofradim Parietene® Polypropylene Mesh Page v

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.