Pre-cut, elliptic mesh with slit and self-gripping, overlapping flap. Right or left anatomical side.
Rectangular mesh.
The mesh and the overlapping flaps of the pre-cut versions are made of knitted monofilament polypropylene with polylactic acid monofilament resorbable hooks on one of the sides. These hooks facilitate placing, positioning and temporary fixation of the overlapping flap and the mesh to the surrounding tissue. A colored yarn marker is placed on the medial edge of the pre-cut mesh to help with orientation.
The subject modified ProGrip™ self-gripping polypropylene mesh is different from the predicate ProGrip™ self-gripping polypropylene mesh (K140941) in labeling and new sterilizer facilities with the same ethylene oxide method. There is no change to the technology, engineering, or material specifications.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called "ProGrip Self-Gripping Polypropylene Mesh." The purpose of this submission is to demonstrate that the revised device is substantially equivalent to a legally marketed predicate device (K140941). The primary changes described are related to labeling updates and the addition of new sterilization facilities using the same ethylene oxide (EO) method.

Given this context, the request to describe "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI/algorithm performance (e.g., impact on human readers, standalone performance, ground truth establishment, training set details) is not applicable to this specific submission.

Here's why, and what information can be extracted relevant to the submission:

Key Takeaway: This is a 510(k) for a physical medical device (surgical mesh), not an AI/Software as a Medical Device (SaMD). The "studies" conducted are non-clinical validations related to manufacturing processes, not diagnostic algorithm performance.

Therefore, I cannot provide the requested information for AI/algorithm performance. However, I can explain the acceptance criteria and supporting "studies" (validations) for this physical device:

Acceptance Criteria and Supporting Studies for ProGrip Self-Gripping Polypropylene Mesh (K220540)

This 510(k) submission primarily focuses on demonstrating that the changes made to the ProGrip Self-Gripping Polypropylene Mesh (labeling and new sterilization facilities) do not alter its substantial equivalence to the predicate device (K140941) regarding safety and effectiveness. The "acceptance criteria" here relate to maintaining established standards for sterilization, aeration, biocompatibility, and product performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criterion	Reported Device Performance / Validation Outcome
Sterilization	Reliable and consistent sterilization to achieve the same Sterility Assurance Level (SAL) as the predicate device.	Validation studies demonstrated that the sterilization processes at new sites are capable of reliably and consistently sterilizing the product, achieving the same SAL as K140941.
Aeration (EtO Residuals)	Ethylene Oxide (EtO) residual levels must comply with allowable limits: ≤ 4mg/device, per ISO 10993-7.	EtO residual evaluation was conducted (ISO 10993-7 compliant). ProGrip™ Self-Gripping Polypropylene Mesh complies with the allowable limits of EtO residual: ≤ 4mg/device. The new sterilizers use a dynamic aeration process.
Biocompatibility	Biological safety must be compliant with ISO 10993-1, with no negative impact from new sterilization facilities.	Existing biocompatibility assessments remain applicable as there is no material or manufacturing change. Compliance with ISO 10993-1 for biological safety was found. The new sterilization facilities have no biocompatibility impact.
Stability	No adverse impact on device stability due to minor differences in sterilization parameters or changes to packaging integrity.	Minor differences in sterilization parameters have been shown to have no impact on the stability of the device. Packaging sealing and overall packaging integrity remain unchanged.
Product Performance	Device performance remains unchanged despite new sterilization facilities.	Product performance remains unchanged as there are no changes to the design or materials. New sterilizers maintain the same sterilization method and SAL.
Indications for Use (IFU)	Updated IFU aligns with global IFU and does not significantly affect safety and effectiveness compared to the predicate device.	The IFU was updated to "Inguinal hernia repair via anterior tension-free approach." This is considered an insignificant change to limit use that does not significantly affect safety and effectiveness.
Materials/Design	No changes to raw materials or design that would impact safety or effectiveness.	Stated that the device description is "identical to the predicate," "no design change," "no change to the technology, engineering, or material specifications."

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated as "sample size" in the context of a test set for diagnostic performance. Instead, validation studies were performed on product batches from the new sterilization sites. The specific number of units tested for sterilization, EtO residuals, and stability would be detailed in the underlying validation reports, but this summary document does not provide those specific numbers.
Data Provenance: The data comes from internal validation studies conducted by Covidien/Medtronic, related to their manufacturing processes and new sterilization facilities. The location of these new facilities is not specified (e.g., country), but the general context is a US FDA submission. The studies are by nature prospective validations of the manufacturing and sterilization processes.

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

Not Applicable. This is not an AI/diagnostic device. "Ground truth" in this context would relate to established standards (e.g., ISO for sterilization, biocompatibility, EtO residuals) and the qualifications of the engineers/scientists conducting the validation tests, not expert readers.

4. Adjudication method for the test set

Not Applicable. This is not an AI/diagnostic device where adjudication of diagnostic outputs by multiple experts is relevant. Compliance with standards is demonstrated through test results.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

Not Applicable. This is not an AI/diagnostic device, so MRMC studies comparing human reader performance are irrelevant.

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

Not Applicable. This is a physical surgical mesh, not an algorithm.

7. The type of ground truth used

Regulatory/Engineering Standards: The "ground truth" for this submission is adherence to established regulatory and engineering standards (e.g., ISO 10993-1 for biocompatibility, ISO 10993-7 for EtO residuals), and internal quality system validation protocols for sterilization and product performance. The predicate device (K140941) also serves as a benchmark for equivalence.

8. The sample size for the training set

Not Applicable. This is a physical surgical mesh, not an AI/machine learning model, so there is no "training set."

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

Not Applicable. See #8.

In summary, the provided document is a regulatory submission for a physical medical device. The "acceptance criteria" and "studies" it references are related to demonstrating the continued safety and effectiveness of the device despite manufacturing and labeling changes, primarily through non-clinical validation testing against established industry and regulatory standards.

Summary

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9/22/2022

Covidien Jonas Gulmez Senior Regulatory Affairs Specialist 15 Hampshire Street Mansfield, Massachusetts 02048

Re: K220540

Trade/Device Name: ProGrip Self-Gripping Polypropylene Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: August 9, 2022 Received: August 11, 2022

Dear Jonas Gulmez:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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,

Deborah Fellhauer RN. BSN 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) K220540

Device Name Progrip™ Self-Gripping Polypropylene Mesh

Indications for Use (Describe) Inguinal hernia repair via anterior tension-free approach.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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September 13, 2022

Submitter Information:

Covidien 15 Hampshire Street, Mansfield, MA 02048 (Cube:1-1-71) Establishment Registration Number: 1282497

Contact Person:

Jonas Gulmez, MSRA Senior Regulatory Affairs Phone: +1 (857) 222-6125 Email: Jonas.Gulmez@medtronic.com,

ldentification of Device:

Proprietary/Trade Name: ProGrip™ Self-Gripping Polypropylene Mesh Regulatory Class: Class II Classification Name: Mesh, Surgical, Polymeric Regulations Number: 878.3300 Product Code: FTL Review Panel: General and Plastic Surgery

Predicate Device:

Proprietary/Trade Name: ProGrip™ Self-Gripping Polypropylene Mesh 510(k) Number: K140941 (May 7, 2014) Regulatory Class: Class II Classification Name: Mesh, Surgical, Polymeric Regulation Number: 878.3300 Product Code: FTL Review Panel: General and Plastic Surgery

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Device Description

Following device description of the proposed ProGrip™ self-gripping polypropylene mesh is identical to the predicate ProGrip™ Self-gripping Polypropylene Mesh (K140941). There is no design change included in this submission.

The proposed ProGrip™ self-gripping polypropylene mesh is available in 2 forms;

Pre-cut, elliptic mesh with slit and self-gripping, overlapping flap. Right or left anatomical side.
Rectangular mesh.

The mesh and the overlapping flaps of the pre-cut versions are made of knitted monofilament polypropylene with polylactic acid monofilament resorbable hooks on one of the sides. These hooks facilitate placing, positioning and temporary fixation of the overlapping flap and the mesh to the surrounding tissue. A colored yarn marker is placed on the medial edge of the pre-cut mesh to help with orientation.

The subject modified ProGrip™ self-gripping polypropylene mesh is different from the predicate ProGrip™ self-gripping polypropylene mesh (K140941) in labeling and new sterilizer facilities with the same ethylene oxide method. There is no change to the technology, engineering, or material specifications.

Indications for Use

Indications for use statement in the subject ProGrip™ self-gripping polypropylene mesh IFU was updated to align with the global IFU as shown below. Section 17 - Labeling in this submission contains further details and assessment for the indications for use and the other labeling changes.

Previous Indications for Use:

"Inguinal and Incisional hernia repair."

Proposed Indications for Use:

"Inguinal hernia repair via anterior tension-free approach."

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Summary of Technological Characteristics

The subject device ProGrip™ Self-Gripping Polypropylene Mesh is substantially equivalent to the predicate device ProGrip™ Self-Gripping Polypropylene Mesh(K140941) in terms of:

. Indications: There are some insignificant changes made in the indications for use section to limit use that do not significantly affect safety and effectiveness of the device. Refer to Section 17 Labeling in this submission for further analysis.
Raw Materials .
Design .
Performance characteristics ●
Biocompatibility .
Stability .
. Sterility: Two new sterilization facility were added with the same sterilization method (EO) with no change to the sterility assurance level (SAL) Section 15 - Sterilization and Stability section contains further assessment of this change.

Substantial Equivalence - Non-Clinical Evidence:

The following testing has been performed for the new sterilizer sites to demonstrate substantial equivalence to the predicate device.

Sterilization Validation

Validation studies demonstrated that the sterilization processes at new sterilization sites are capable of reliably and consistently sterilizing the ProGrip™ self-gripping polypropylene mesh product. The new sterilizers use the same sterilization method and achieve the same sterility assurance level as compared to the predicate device K140941. Therefore, sterilization process of the proposed ProGrip™ Self-Gripping Polypropylene Mesh is equivalent to the predicate ProGrip™ Self-Gripping Polypropylene Mesh (K140941). Section 15 Sterilization and Stability section contains further assessment for this change.

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Aeration Validation

In order to improve Ethylene Oxide emissions, the new sterilizers use a dynamic aeration process rather than a static aeration process implemented at the current sterilizer. EtO residual evaluation is conducted in accordance with ISO 10993-7 – Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals. ProGrip™ Self-Gripping Polypropylene Mesh complies with the allowable limits of EtO residual: ≤ 4mg/device. As predicate ProGrip™ Self-Gripping Polypropylene Mesh, K140941. Section 15 Sterilization and Stability section contains further assessment for this change.

Biocompatibility

Consequently, the current biocompatibility assessments of the devices remain applicable as there is no material or manufacturing change for the Progrip™ Self-Gripping Polypropylene Mesh. EtO residual evaluation is conducted in accordance with ISO 10993-7 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals. ProGrip™ Self-Gripping Polypropylene Mesh complies with the allowable limits of EtO residual: ≤ 4mg/device The biological safety evaluation of the impacted devices has been found compliant with the biological safety requirements of ISO 10993-1. Therefore, introducing the new sterilization facilities has no biocompatibility impact for the Progrip™ Self-Gripping Polypropylene Mesh.

Stability

There are no changes to the design or materials of the device as a result of this 510(k) premarket notification. The minor differences in sterilization parameters have been shown to have no impact on the stability of the device. Progrip™ Self-Gripping Polypropylene Mesh packaging sealing, and over all packaging integrity remain as is. Please see Section 15 for further assessment for stability.

Product Performance

There are no changes to the design or materials of the device as described in this submission. Product performance remains unchanged. The new sterilizers will maintain the same sterilization, method, and sterility assurance level. The minor differences in sterilization parameters will not impact device performance. Please see Section 15 for further assessment for product performance.

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Substantial Equivalence -Clinical Evidence:

Clinical evidence was not necessary to show substantial equivalence.

Conclusion:

The information provided in this 510(k) demonstrates that the proposed ProGrip™ Self-Gripping Polypropylene Mesh is substantially equivalent to its predicate ProGrip™ Self-Gripping Polypropylene Mesh, K140941 for new sterilizers and labeling change.

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.