VitaMESH Macroporous PP Surgical Mesh

K172636 · Proxy Biomedical , Ltd. · FTL · Apr 30, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K172636
• Device Name: VitaMESH Macroporous PP Surgical Mesh
• Applicant: Proxy Biomedical , Ltd.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Apr 30, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

VitaMESH is a nonabsorbable, synthetic surgical mesh constructed of knitted polypropylene filaments. It is used by surgeons in clinical settings to provide structural reinforcement for hernia and fascial defects. The device is implanted to support tissue during and after the wound healing process. This submission documents a change in the polypropylene resin supplier; the manufacturing process, including knitting and sterilization, remains identical to the predicate device. The mesh provides elasticity in multiple directions due to its interlinked fiber junction design. Clinical benefit is derived from the permanent mechanical support provided to the defect site, reducing the risk of recurrence. The device is provided sterile.

Clinical Evidence

Bench testing only. Evaluations included mechanical testing (areal density, stiffness, tensile strength, suture pullout, tear resistance, burst strength, pore size, thickness), 5-year accelerated aging, ethylene oxide residual analysis per ISO 10993-7, microbiological/pyrogen testing (LAL method), and biocompatibility testing (cytotoxicity, irritation, sensitization) per ISO 10993-1. Results confirmed the device meets all specifications and is equivalent to the predicate.

Technological Characteristics

Knitted polypropylene mesh; nonabsorbable. Sterilized via Ethylene Oxide. Compliant with ISO 10993-7 (residuals) and ISO 10993-1 (biocompatibility). Mechanical properties include specific areal density, stiffness, tensile strength, suture pullout strength, tear resistance, burst strength, and pore size.

Indications for Use

Indicated for patients requiring repair or reinforcement of hernia and fascial defects needing nonabsorbable implant support.

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

• VitaMESH™ Macroporous PP Surgical Mesh (K060520)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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

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

| Prescription Use (Ref. 21 CFR 201 Subpart D) | <span style="text-decoration: overline;">☒</span> |
|--------------------------------------------------|---------------------------------------------------|
| 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 | [e-mail] |

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,<br>Physically, and Biologically<br>equivalent. | 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.