Polyform Synthetic Mesh

K171271 · Boston Scientific Corporation · OTO · Dec 15, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K171271
• Device Name: Polyform Synthetic Mesh
• Applicant: Boston Scientific Corporation
• Product Code: OTO · General, Plastic Surgery
• Decision Date: Dec 15, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Polyform Syntheic Mesh is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor via an abdominal approach, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

Device Story

Polyform Synthetic Mesh is a surgical implant consisting of monofilament polypropylene fibers knitted into a rectangular sheet. Available in 10x15 cm and 15x20 cm sizes, the mesh is intended for use by surgeons during abdominal procedures to provide mechanical support or bridge fascial defects in the pelvic floor. The device is supplied sterile in a single-use pouch; surgeons cut the mesh to the required size and shape intraoperatively to match the patient's specific anatomical needs. It functions as a permanent implant to reinforce weakened tissue.

Clinical Evidence

No clinical data provided. The submission is a modification to the instructions for use; no performance testing was required.

Technological Characteristics

Monofilament polypropylene fibers knitted into a sheet. Rectangular form factor (10x15 cm or 15x20 cm). Single-use, sterile, supplied in Tyvek/Mylar pouch. Identical to predicate device.

Indications for Use

Indicated for patients requiring tissue reinforcement and stabilization of pelvic floor fascial structures via abdominal approach for surgical treatment of fascial defects.

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

• Polyform™ Synthetic Mesh (K051245)

Submission Summary (Full Text)

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December 15, 2017

Boston Scientific Corporation Elizabeth Renken Principal Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752

Re: K171271

> Trade/Device Name: Polyform™ Synthetic Mesh Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: OTO Dated: November 10, 2017 Received: November 15, 2017

Dear Elizabeth Renken:

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.

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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); 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,

Image /page/1/Picture/6 description: The image shows the text "Benjamin R. Fisher -S". The text is written in a clear, sans-serif font and is horizontally aligned. The background of the image is plain and does not contain any other elements.

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K171271

Device Name Polyform™ Synthetic Mesh

Indications for Use (Describe)

Polyform Syntheic Mesh is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor via an abdominal approach, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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### 510(k) Summary for Polyform™ Synthetic Mesh

### K171271

#### Date of Summary: December 14, 2017

#### A. Sponsor

Boston Scientific Corporation Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01752

#### B. Contact

Elizabeth Renken Principal Specialist, Regulatory Affairs 508-683-6746 [e-mail]

Or

Lisa Sullivan Sr. Manager, Regulatory Affairs 508-683-4745 [e-mail]

#### C. Device Information

| Trade name: | Polyform™ Synthetic Mesh |
|----------------------|------------------------------------------------------------------------------------------------------------------|
| Common/usual name: | Surgical Mesh |
| Classification Name: | Surgical Mesh (21 CFR 878.3300) |
| Class: | II |
| Product Code: | OTO – Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal and Uterine Prolapse, Trasabdominally Placed |
| Predicate: | Polyform™ Synthetic Mesh (K051245) |

The predicate device has not been subject to a design related recall.

#### E. Device Description

The subject device consists of monofilament polypropylene fibers knitted into a sheet. It is rectangular in shape and available in two sizes, 10 x 15 cm and 15 x 20 cm. Surgeons implanting the subject device cut the mesh to the size and shape needed for an individual patient. The subject device is single use only, supplied sterile, and individually packaged in a Tyvek/Mylar pouch. The subject and predicate device are identical.

#### F. Indications for Use

Polyform Synthetic Mesh is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor via an abdominal approach, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

The subject and predicate device have the same intended use.

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### G. Technological Characteristics

The subject and predicate device are identical; and accordingly, they have the same technological characteristics.

## H. Performance Summary

The Polyform Synthetic Mesh submitted herein is a modification of the predicate mesh device, Polyform Synthetic Mesh (K051245). The modification is an update to the device instructions for use packaged with the product. No performance data are needed to support the modifications to the instructions for use.

### I. Substantial Equivalence

The proposed Polyform Synthetic Mesh is substantially equivalent to the predicate device.