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 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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called Polyform™ Synthetic Mesh. It is a letter from the FDA to Boston Scientific Corporation, dated December 15, 2017, confirming that the device has been determined to be substantially equivalent to a legally marketed predicate device.

Based on the provided document, here's an analysis of the acceptance criteria and study information:

Key Takeaway: The submission for the Polyform™ Synthetic Mesh is based on substantial equivalence to a predicate device (K051245), not on a new performance study that establishes design-specific acceptance criteria for the new device. The "modification" for the current submission is an update to the device's Instructions For Use (IFU), and the document explicitly states: "No performance data are needed to support the modifications to the instructions for use."

Therefore, many of the typical questions regarding acceptance criteria and performance studies for a new device's design are not applicable in this 510(k) summary. The acceptance criteria here would primarily relate to the demonstration of identical or highly similar technological characteristics and intended use to the predicate device.

Analysis based on the provided document:

A table of acceptance criteria and the reported device performance:

Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Device Performance
Material Composition: Must be identical or substantially similar to predicate.	The subject device consists of "monofilament polypropylene fibers knitted into a sheet," which is implicitly identical or substantially equivalent to the predicate, as the document states "The subject and predicate device are identical."
Physical Form/Design: Must be identical or substantially similar to predicate.	"It is rectangular in shape and available in two sizes, 10 x 15 cm and 15 x 20 cm." This is implicitly identical or substantially equivalent to the predicate, as the document states "The subject and predicate device are identical."
Sterility: Must be supplied sterile.	"The subject device is single use only, supplied sterile, and individually packaged in a Tyvek/Mylar pouch." (Implicitly meets standard sterility requirements, consistent with predicate).
Intended Use/Indications: Must be identical to predicate.	"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 document explicitly states: "The subject and predicate device have the same intended use."
Technological Characteristics: Must be identical or substantially similar to predicate.	"The subject and predicate device are identical; and accordingly, they have the same technological characteristics."
Performance Data: No new performance data needed for the specific modification.	"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." This explicitly states that no new performance data was required for this specific submission due to the nature of the change (IFU update). The original predicate device's clearance would have been based on its own performance data or substantial equivalence at that time.
Predicate Device History: Predicate not subject to design-related recall.	"The predicate device has not been subject to a design related recall."

Sample sizes used for the test set and the data provenance:
- Not Applicable. The submission is not based on a new performance study requiring a test set for design validation. It relies on the substantial equivalence to a predicate device, and the specific modification (IFU update) did not necessitate new performance data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No new test set requiring expert ground truth establishment was conducted for this 510(k) submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No new test set requiring adjudication was conducted for this 510(k) submission.
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 device is a surgical mesh, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is not relevant.
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 software.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable for this specific 510(k) submission. The "ground truth" for this submission hinges on the established safety and efficacy of the predicate device, and the demonstration that the subject device is identical to it, with only a change to the Instructions For Use. The original predicate clearance (K051245) would have relied on its own data or prior predicate, which might have included various types of evidence.
The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI or machine learning algorithm requiring a training set.
How the ground truth for the training set was established:
- Not Applicable. (See point 8)

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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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)

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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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 Elizabeth.Renken@bsci.com

Lisa Sullivan Sr. Manager, Regulatory Affairs 508-683-4745 Lisa.Sullivan@bsci.com

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

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.

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.