Proxy Biomedical VITAMESH™ surgical mesh is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing

Device Description

The synthetic mesh is constructed of knitted filaments of an alternative polypropylene resin. This material change does not affect the device description (or the device description on the package and instructions for use.) The proposed VitaMESH™ with the material supplier change is knitted by the same process as the predicate VitaMESH™, which interlinks each fiber junction and which provides for elasticity in both directions are.

AI/ML Overview

The document describes a 510(k) summary for the VitaMESH™ Macroporous PP Surgical Mesh. The submission is based on a material supplier change for the polypropylene resin used in the mesh. The primary goal is to demonstrate that the device, with the new material, is substantially equivalent to the predicate device (VitaMESH™ Macroporous PP Surgical Mesh, K060520).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document doesn't provide a direct "acceptance criteria" table in the form of specific numerical thresholds for each test. Instead, it states that the tests were performed to show that the device with the alternative polypropylene continues to meet specifications or that the properties are the same as the predicate device. The performance is reported as meeting these specifications or showing substantial equivalence.

Acceptance Criteria Category	Specific Tests Performed	Reported Device Performance
Mechanical Performance	Aerial density	Met specifications; same as predicate.
	Device stiffness	Met specifications; same as predicate.
	Tensile strength	Met specifications; same as predicate.
	Suture pullout strength	Met specifications; same as predicate.
	Tear resistance	Met specifications; same as predicate.
	Burst strength	Met specifications; same as predicate.
	Pore size	Met specifications; same as predicate.
	Mesh thickness	Met specifications; same as predicate.
	Surface finish inspection	Met specifications; same as predicate.
Shelf Life	Aging study (5 years accelerated)	Continues to meet specifications.
	Real-time aging study (5 years)	In progress to support data.
Sterilization Residuals	Ethylene Oxide Residual Analysis	Within limits specified in I.S. EN ISO 10993-7: 2008.
Microbiological	Bioburden testing	Met Proxy Biomedical Ltd. acceptance criteria.
	Pyrogen testing (LAL method)	Met all acceptance criteria.
Biocompatibility	Cytotoxicity	Conformance with requirements per I.S. EN ISO 10993-1: 2009.
	Irritation	Conformance with requirements per I.S. EN ISO 10993-1: 2009.
	Sensitization	Conformance with requirements per I.S. EN ISO 10993-1: 2009.
	Chemical characterization of alternative polypropylene resin	Conformance with requirements per I.S. EN ISO 10993-1: 2009.
Chemical Analysis	Chemical constitution	Comparable.

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 specific sample sizes for each mechanical, microbiological, or chemical test. It generally refers to "VitaMESH™ units manufactured using an alternative polypropylene resin." The provenance is implied to be from Proxy Biomedical Ltd. in Ireland, as they are the submitter and manufacturer. The studies are prospective in the sense that they were conducted specifically for this submission to assess the performance of the device with the new material.

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. The device under review is a surgical mesh, not an AI or diagnostic imaging device that requires expert interpretation for ground truth establishment. The evaluation relies on laboratory and in-vitro testing against established international standards and internal specifications.

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

This section is not applicable. As this is a physical medical device, there is no need for adjudication methods typically used in diagnostic studies involving human readers. The performance is objectively measured through standardized lab tests.

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 section is not applicable. The device is a surgical mesh, not an AI-assisted diagnostic tool. Therefore, MRMC studies and assessment of human reader improvement with AI assistance are irrelevant to this submission.

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

This section is not applicable. This is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.

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

The "ground truth" for this device's performance is based on:

Industry Standards: I.S. EN ISO 10993-7: 2008 for Ethylene Oxide Sterilization Residuals and I.S. EN ISO 10993-1: 2009 for Biocompatibility.
Internal Specifications: Proxy Biomedical Ltd.'s own established acceptance criteria for various tests (e.g., bioburden, mechanical properties).
Comparison to Predicate Device: The primary ground truth is the performance and characteristics of the legally marketed predicate device (VitaMESH™ Macroporous PP Surgical Mesh, K060520) which the new device aims to be substantially equivalent to.

8. The sample size for the training set

This section is not applicable. There is no "training set" in the context of this traditional medical device submission. Machine learning models use training sets, but this is a physical product evaluated through laboratory testing.

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

This section is not applicable for the same reasons as point 8.

Summary

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April 30, 2018

Proxy Biomedical Ltd. % Elaine Duncan President Paladin Medical, Inc. P.O. Box 560 Stillwater, Minnesota 55082

Re: K172636

Trade/Device Name: VitaMESH Macroporous PP Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: March 26, 2018 Received: March 27, 2018

Dear Elaine Duncan:

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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172636

Device Name

VITAMESH™ MacroPorous PP Surgical Mesh

Indications for Use (Describe)

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

Prescription Use (Ref. 21 CFR 201 Subpart D)	☒
Over-The-Counter Use (Ref. 21 CFR 201 Subpart C)	□

Prescription Use (Part 21 CFR 801 Subpart D)

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

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SUBMITTER:

K172636, pg. 1 of 4

Submitted on behalf of:

Proxy Biomedical Ltd.
Coilleach
Spiddal
Galway
Ireland
Contact Person	Adrienne Tierney
Phone	353 (0)91 896934
Email	Adrienne.Tierney@proxybiomedical.com

by:

	Elaine Duncan, M.S.M.E., RAC
	President, Paladin Medical, Inc.
	PO Box 560
	Stillwater, MN 55082
Telephone:	715-549-6035
Fax:	715-549-5380

CONTACT PERSON for SUBMISSION: Elaine Duncan

DATE PREPARED:

August 29, 2017

Device Trade Name	VitaMESH™ Macroporous PP Surgical Mesh
Common Name	Surgical Mesh
Classification reference	21 CFR 878.3300
Regulatory Class	II
Product Code	FTL
Predicate Device Name	VitaMESH™ Macroporous PP Surgical Mesh
Device 510(k) number	K060520

DEVICE DESCRIPTION:

The basis for this Traditional 510(k) submission is a material supplier change to the VitaMESH™ Macroporous PP Surgical Mesh. The synthetic mesh is constructed of knitted filaments of an alternative polypropylene resin. This material change does not affect the device description (or the device description on the package and instructions for use.) The proposed VitaMESH™ with the material supplier change is knitted by the same process as the predicate VitaMESH™, which interlinks each fiber junction and which provides for elasticity in both directions are.

INDICATION FOR USE:

VitaMESH™ Macroporous PP Surgical Mesh is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.

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510(k) SUMMARY

BASIS FOR SUBSTANTIAL EQUIVALENCE

K172636, pg. 2 of 4

The predicate VitaMESH™ Macroporous PP Surgical Mesh which was cleared under 510(k) number K060520 is a non-absorbable, synthetic mesh, constructed of knitted filaments of polypropylene. As shown in this submission, the VitaMESH™ with the resin change is the same product as the predicate. The following demonstrates substantial equivalence.

Comparison of VitaMESH™ with alternative material device to predicate device

Characteristic	VitaMESH™	VitaMESH™
	Proposed	Predicate
510(K)	K172636	K060520
Material: Chemically,Physically, and Biologicallyequivalent.	Alternative Polypropylene	Polypropylene

There have been no changes made to the fiber extrusion process.
No changeshave been made to the manufacturing process (including sterilization) of the finished mesh device.
. There is no change to the proposed clinical use of the device.
. No changes have been made to the sterilization method of this device.
There is no change to the packaging shelf life qualification as a result of this material change to VitaMESH™.
. The product catalogue range has increased since the original VitaMESH™ submission. The current product sizes are still within the original range of the predicate. . Minor changesto the packaging and labelling since the original submission for the predicate are unrelated to the material change and are summarized in the submission for information only

PERFORMANCE DATA:

The proposed VitaMESH™ has been manufactured with an alternative polypropylene resin to the predicate VitaMESH™ cleared under 510(k) number K060520. This alternative polypropylene has been shown to be substantial equivalent to the polypropylene used in the manufacturing of the predicate. This change was necessitated by the discontinuation of the original raw material polypropylene resin by the supplier. The following evaluations were provided in support of the substantial equivalence determination:

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510(k) SUMMARY

K172636, pg. 3 of 4

Mechanical testing: The change of polypropylene used for manufacturing of VitaMESH™ does not introduce new risks to mechanical performance as shown by testing. All device specifications for the proposed VitaMESH™ are the same as for the predicate VitaMESH™. Mechanical testing and visual performance testing was performed on VitaMESH™ units manufactured using an alternative polypropylene resin to the predicate. This testing included:

Aerial density
Device stiffness
Tensile strength
Suture pullout strength
Tear resistance
Burst strength
Pore size
Mesh thickness
Surface finish inspection

For product shelf life qualification, an aging study demonstrates that VitaMESH™ manufactured with the alternative polypropylene continues to meet specifications after 5 years accelerated aging both in physical characterization and performance testing. Additionally, a 5 year Real time aging study is in progress to support the above data.

Ethylene Oxide Residual Analysis: Ethylene oxide and ethylene chlorohydrin levels were found to be within limits specified in I.S. EN ISO 10993-7: 2008 'Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals (ISO 10993-7: 2008)'.

Microbiological Testing: A microbiological evaluation was conducted to mitigate against any risks identified in changing from the fibre extruded with the original polypropylene of the predicate to the Bioburden testing carried out on the VitaMESH™ devices manufactured alternative polypropylene. with the alternative polypropylene met Proxy Biomedical Ltd. acceptance criteria. Routine pyrogen testing carried out on the VitaMESH™ devices manufactured with the alternative polypropylene using Linulus Amoebocyte Lysate (LAL) method met all acceptance criteria.

Biocompatibility testing: The change of polypropylene used for manufacturing of the device does not introduce new risks to biological safety. Conformance with biocompatibility requirements is shown in this submission.

The biocompatibility evaluation for the VitaMESH™ Macroporous PP Surgical Mesh manufactured using an alternative polypropylene resin to the predicate was conducted in accordance with I.S. EN

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510(k) SUMMARY

K172636, pg. 4 of 4

ISO 10993-1: 2009 'Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process'. Testing included Cytotoxicity, irritation, sensitization, and chemical characterization of alternative polypropylene resin..

Chemical analysis: Testing demonstrated comparable chemical constitution.

CONCLUSIONS:

Mechanical test data and the determination of biocompatibility as well as chemical characterization demonstrates that the VitaMESH™ Macroporous PP Surgical Mesh manufactured using the alternative polypropylene performs as intended use conditions. In additon, VitaMESH™ devices manufactured using the alternative polypropylene proposed in this substantially equivalent to the predicate device.

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.