Dextile™ Anatomical Mesh is intended to be used for the reinforcement of soft tissues where weakness exists during repair of inguinal hernia by laparoscopic approach.

Device Description

Dextile™ Anatomical Mesh is designed to be placed in a pre-peritoneal site by laparoscopic approach. The device has an anatomical shape with sealed edges allowing coverage of inguinal hernia defects and facilitating laparoscopic mesh deployment and handling. The mesh is made of a non-absorbable macroporous monofilament polypropylene textile. A green marking is placed on the medial side of the mesh to help positioning and orienting the mesh: "ML" letters designate Medial Line. The green marking is made of monofilament polyester yarn. The "D&C Green No. 6" dye is used for the marking.

AI/ML Overview

This document describes the Dextile Anatomical Mesh, a surgical mesh intended for reinforcing soft tissues during inguinal hernia repair. The device is compared to a predicate device, the 3DMAX Light Mesh (K091659), to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

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

The document states that in vitro (bench) tests were performed in accordance with the FDA Guidance "Guidance for the Preparation of a Premarket Notification Application of a Surgical Mesh" issued March 2, 1999, to evaluate the performance characteristics of the subject device in comparison with the predicate. While specific numerical acceptance criteria or performance values are not provided in the document, the listed characteristics below were "assessed" and the overall conclusion is that the subject device is "substantially equivalent" to the predicate. This implies that the performance fell within acceptable limits or matched the predicate device for these parameters.

Acceptance Criteria / Performance Characteristic Assessed	Reported Device Performance (Relative to Predicate)
Pore size	Assessed; substantial equivalence determined.
Surface density	Assessed; substantial equivalence determined.
Thickness	Assessed; substantial equivalence determined.
Bursting strength	Assessed; substantial equivalence determined.
Bursting deflection	Assessed; substantial equivalence determined.
Tensile breaking strength	Assessed; substantial equivalence determined.
Elongation at break	Assessed; substantial equivalence determined.
Tear strength	Assessed; substantial equivalence determined.
Suture pull-out strength	Assessed; substantial equivalence determined.
Mesh integrity after trocar passage	Demonstrated; mesh integrity preserved.
Tissue integration (in animal model)	No difference observed compared to predicate.
Shelf life stability	Demonstrated.
Biocompatibility	Compliant with ISO Standard 10993-1.
Usability	Acceptable for intended users, uses, and environments.

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

The document does not explicitly state the sample sizes for the various tests.

In vitro (bench) tests: Implied to be performed by the manufacturer, Sofradim Production, which is based in France. No specific sample sizes mentioned for the mesh characteristics.
Trocar passage testing: No specific sample size mentioned.
In vivo pre-clinical tests: Conducted on a "representative animal model." The specific animal model and number of animals are not provided.
Stability study: No specific sample size mentioned.
Biocompatibility evaluation: No specific sample size mentioned, as this refers to compliance with a standard.
Usability tests: No specific sample size or details of participants are given.

The provenance for tests performed by Sofradim Production would be France. The provenance of the animal model for in vivo testing is not specified.

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 device is a surgical mesh, not an AI or diagnostic device that requires expert interpretation for ground truth establishment in the typical sense (e.g., radiologists interpreting images). The "ground truth" for this device's acceptance criteria primarily relies on objective physical measurements, in vitro testing, animal study observations, and compliance with established biocompatibility and usability standards. Therefore, the concept of "experts establishing ground truth for a test set" as described in the prompt does not directly apply in the context of this traditional medical device submission. The FDA evaluates the submitted data and methodology to determine substantial equivalence.

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

Not applicable. As this is not an AI or diagnostic device submission involving human interpretation of data, there is no adjudication method used for a test set in this context. The evaluation is based on scientific testing and comparison to a predicate device.

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 is a surgical mesh, not an AI-assisted diagnostic or interpretation device. Therefore, no MRMC study was conducted.

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

Not applicable. This is a physical medical device (surgical mesh), not an algorithm or AI system.

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

For the Dextile Anatomical Mesh, the "ground truth" for establishing substantial equivalence and meeting acceptance criteria relies on:

Objective quantitative measurements: For in vitro (bench) tests such as pore size, density, strength, elongation, etc. The "truth" is derived from calibrated measurement instruments.
In vivo observations in animal models: For tissue integration, observed by qualified veterinary professionals or researchers.
Compliance with recognized standards: Such as ISO Standard 10993-1 for biocompatibility.
Functional demonstrations: Like the preservation of mesh integrity during trocar passage.
Comparative analysis: Direct comparison of the subject device's characteristics and performance to those of the legally marketed predicate device (3DMAX Light Mesh K091659).

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

Summary

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December 6, 2019

Sofradim Production % Angela Arsdale Regulatory Affairs Manager Covidien 60 Middletown Avenue North Haven, Connecticut 06473

Re: K192443

Trade/Device Name: Dextile Anatomical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: September 4, 2019 Received: September 6, 2019

Dear Angela Arsdale:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192443

Device Name Dextile Anatomical Mesh

Indications for Use (Describe)

Dextile Anatomical Mesh is intended to be used for the reinforcement of soft tissues where weakness exists during repar of inguinal hernia by laparoscopic approach.

Type of Use (Select one or both, as applicable)

Transactional Use (Per 31 CFR 30.2, Subpart B)
Customer Service Use (Per 31 CFR 30.2, Subpart C)

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date Prepared:	November 26, 2019
Submitter:	Sofradim Production (subsidiary of Covidien Llc)
	116, avenue du Formans01600 Trevoux, FranceTelephone: +33 (0)4 74 08 90 00Fax: +33 (0) 4 74 08 90 02
Contact:	Angela Van ArsdaleRegulatory Affairs Manager60 Middletown AvenueNorth Haven, CT 06473Phone: (203) 492-5787Fax: (203) 492-5029Email: angela.vanarsdale@medtronic.com
Name of device:	Dextile™ Anatomical Mesh
Trade/Proprietary name:	Surgical Mesh
Common name:	Mesh, Surgical, Polymeric
Classification name:	Panel number and product code: 79 FTLRegulation number: 21 CFR 878.3300
Predicate Device:	3DMAX™ Light Mesh
Trade/Proprietary name:	Surgical Mesh
Common name:	Mesh, Surgical, Polymeric
Classification name:	Panel number and product code: 79 FTLRegulation number: 21 CFR 878.3300
510(k) Number:	K091659
Manufacturer:	Davol Inc., Subsidiary of C.R. Bard, Inc Route 22 West
Device Description:	Dextile™ Anatomical Mesh is designed to be placed in a pre-peritoneal site by laparoscopic approach.The device has an anatomical shape with sealed edges allowingcoverage of inguinal hernia defects and facilitating laparoscopicmesh deployment and handling.The mesh is made of a non-absorbable macroporousmonofilament polypropylene textile.A green marking is placed on the medial side of the mesh to helppositioning and orienting the mesh: "ML" letters designate MedialLine. The green marking is made of monofilament polyester yarn.The "D&C Green No. 6" dye is used for the marking.
Intended Use:	Dextile™ Anatomical Mesh is intended for the reinforcement ofsoft tissue where weakness exists.
Indications for use:	Dextile™ Anatomical Mesh is intended to be used for thereinforcement of soft tissues where weakness exists during repairof inguinal hernias by laparoscopic approach.
Summary comparingthe technologicalcharacteristics of thesubject and predicatedevice:	The subject Dextile™ Anatomical Mesh is substantially equivalentto the predicate device 3DMAX™ Light Mesh (K091659) in termsof indications and design for the following technologicalcharacteristics:Design: anatomical shape of the mesh with sealed edges,presence of a medial marker, three mesh sizes Polypropylene textile performance
Materials:	Dextile™ Anatomical Mesh has been evaluated and foundcompliant with ISO Standard 10993-1.
Performance data:	The following performance data is provided in support of thesubstantial equivalence determination:In vitro (bench) tests have been performed in accordance withthe FDA Guidance "Guidance for the Preparation of aPremarket Notification Application of a Surgical Mesh" issuedMarch 2, 1999 to evaluate the performance characteristics ofthe subject Dextile™ Anatomical Mesh in comparison with thepredicate 3DMAX™ Light Mesh (K091659). The followingmesh characteristics were assessed: Pore size Surface density Thickness Bursting strength Bursting deflection Tensile breaking strength Elongation at break Tear strength Suture pull-out strength Trocar passage testing was conducted to demonstrate that themesh integrity is preserved when used by laparoscopy. In vivo pre-clinical tests on representative animal model wereconducted in comparison with the predicate 3DMAX™ LightMesh (K091659) to evaluate the tissue integration. Resultsdemonstrate that no difference was observed between thesubject Dextile™ Anatomical Mesh and the predicate3DMAX™ Light Mesh (K091659) in terms of tissue integration. Stability study was conducted, and the proposed device shelflife was demonstrated. Biocompatibility evaluation was performed and confirmed thatDextile™ Anatomical Mesh and its constitutive components

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are compliant with ISO Standard 10993-1 for their intended patient contact profile.

. Usability tests were conducted and demonstrate that the subject Dextile™ Anatomical Mesh is acceptable for the intended users, uses and use environments.
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.

Conclusion:

All testing demonstrates that the subject Dextile™ Anatomical Mesh is substantially equivalent to the predicate device, 3DMAX™ Light Mesh (K091659).

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.