The mesh implant is intended for use as a suburethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Advantage Ultra System and the Advantage Fit Ultra System delivery devices are intended for use as an aid in insertion, placement, fixation, and anchoring of the Advantage Ultra surgical mesh during urogynecological procedures.

Lynx Ultra System

The mesh implant is intended for use as a suburethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Lynx Ultra System delivery device is intended for use as an aid in insertion, placement, fixation, and anchoring of the Lynx Ultra surgical mesh during urogynecological procedures.

Device Description

Advantage Ultra System and Advantage Fit Ultra System

The Advantage Ultra System and the Advantage Fit Ultra System are sterile, single-use systems each consisting of one delivery device and one blue mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. The two dilators at the distal ends of the mesh assembly are designed to be placed over the needle end of the delivery device.

The Advantage Ultra System and the Advantage Fit Ultra Systems are each packaged with their respective delivery device (Advantage Ultra or Advantage Fit Ultra delivery device). This is a single-use disposable delivery device that consists of a handle with a curved needle and a pusher component. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for retropubic placement.

The Advantage Fit Ultra System includes the same mid-urethral mesh implant as the Advantage Ultra System but differs in the design of the dilators and delivery devices. The needle portion of the Advantage Fit Ultra delivery device has a smaller outer diameter and a smaller bend radius and is offered to provide physicians with surgical options. The Advantage Fit Ultra dilators also have a smaller diameter to accommodate for the different needle size.

Lynx Ultra System

The Lynx Ultra System is a sterile, single-use system consisting of two delivery devices and one blue mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. At the distal ends of the mesh assembly there are association loops designed to be placed in the needle slot of the distal end of a delivery device.

AI/ML Overview

This document is a 510(k) summary for the Advantage™ Ultra System, Advantage Fit™ Ultra System, and Lynx™ Ultra System, surgical mesh devices for treating female stress urinary incontinence. The core of this submission is to demonstrate that these devices are substantially equivalent to previously cleared predicate devices (K211223). The primary change in these new submissions is related to procedural steps in the electronic Instructions for Use (eIFU), specifically regarding the release and removal of disposable components of the mesh assembly.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are focused on ensuring that the changes (eIFU modifications) do not negatively impact safety or effectiveness, and that the device remains substantially equivalent to its predicate. There isn't a traditional performance study proving clinical efficacy against a disease endpoint, as this is a 510(k) submission for substantial equivalence.

Here's an interpretation of your request based on the provided document:

Acceptance Criteria and Device Performance (in the context of a 510(k) for eIFU changes)

Since the document explicitly states "there are no changes to the intended use or indications for use, design, materials, sterilization, technological and performance characteristics, or principle of operation," the acceptance criteria are implicitly tied to demonstrating that the eIFU modifications do not introduce new safety or effectiveness concerns and allow the device to function as intended.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implicit)	Reported Device Performance
1. User Needs Met: All user needs impacted by eIFU modifications are adequately addressed.	Design Validation: "objective evidence that all user needs impacted by the eIFU modifications were met and overall performance for the intended clinical use was acceptable."
2. Functionality Maintained: Ultra Products continue to function as intended with the new eIFU.	Summative Usability Evaluation: Demonstrated that "the Ultra Products continue to function as intended."
3. No New Safety/Effectiveness Issues: eIFU changes do not introduce new issues of safety or effectiveness compared to predicate devices.	Summative Usability Evaluation: Demonstrated that the Ultra Products "do not raise new issues of safety or effectiveness compared to the predicate devices."Overall Conclusion: "concluded that the proposed Ultra Products are substantially equivalent to the established predicate devices."

Study Details

The studies performed are "Performance bench testing" in the form of "Design Validation" and a "Summative Usability Evaluation."

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the exact number of participants (users) or instances for the "Design Validation" and "Summative Usability Evaluation." It refers generally to "performance bench testing."
- Data Provenance: Not specified, but "bench testing" typically implies laboratory or simulated environments, not patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the sense of clinical "ground truth" (e.g., pathology, outcomes). The "ground truth" here is the successful and safe use of the device according to the eIFU. The design validation and usability studies themselves aim to verify this by testing user interaction and performance. The document does not specify the number or qualifications of evaluators/experts involved in conducting or assessing these bench tests.
Adjudication method for the test set:
- Not explicitly stated. For bench testing and usability studies, adjudication might involve expert review of test results, error analysis, and user feedback, but no specific method like "2+1" or "3+1" is mentioned.
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 is not an AI/imaging device. The study type is bench testing and usability evaluation for a surgical mesh delivery system with modified instructions for use.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a medical device (surgical mesh and delivery system), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this submission's studies is the successful and safe operation of the device according to the updated eIFUs. This is assessed via controlled testing environments (bench testing) and usability studies, rather than clinical endpoints, pathology, or outcomes data, as this 510(k) specifically addresses changes to the instructions for use, not the fundamental device design or clinical performance.
The sample size for the training set:
- Not applicable. This is not a machine learning/AI device, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable (as above).

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

June 29, 2023

Boston Scientific Corporation Jotham Moon Senior Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752

Re: K231549

Trade/Device Name: Advantage™ Ultra System, Advantage Fit™ Ultra System, Lynx™ Ultra System Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: OTN Dated: May 26, 2023 Received: May 30, 2023

Dear Jotham Moon:

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.

{1}------------------------------------------------

Page

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 medical devices and radiation-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).

Sincerelv.

Angel A. Soler-garcia -S

for

Jessica Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K231549

Device Name Advantage™ Ultra System Advantage Fit™ Ultra System Lynx™ Ultra System

Indications for Use (Describe)

Advantage Ultra System and Advantage Fit Ultra System

The mesh implant is intended for use as a suburethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Lynx Ultra System

The mesh implant is intended for use as a suburethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Lynx Ultra System delivery device is intended for use as an aid in insertion, placement, fixation, and anchoring of the Lynx Ultra surgical mesh during urogynecological procedures.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary for Advantage Ultra, Advantage Fit Ultra, and Lynx Ultra Systems

Date Prepared: June 29, 2023

A. Submitter

Boston Scientific Corporation Urology Division 100 Boston Scientific Way Marlborough, MA 01752

B. Contacts

Jotham Moon Senior Regulatory Affairs Specialist 508-683-4208 Jotham.Moon@bsci.com

Brooke Cuddy Principal Regulatory Affairs Specialist 508-683-6434 Brooke.Cuddy@bsci.com

C. Device Names

Trade name:	Advantage™ Ultra System
Model Number:	M0068502060
Common/Usual Name:	Mesh, surgical, synthetic, urogynecologic, for stress urinaryincontinence, retropubic or transobturator
Regulation Number:	21 CFR §878.3300
Regulation Name:	Surgical Mesh
Classification:	Class II
Product Code:	OTN
Trade name:	Advantage Fit™ Ultra System
Model Number:	M0068502160
Common/Usual Name:	Mesh, surgical, synthetic, urogynecologic, for stress urinaryincontinence, retropubic or transobturator
Regulation Number:	21 CFR §878.3300
Regulation Name:	Surgical Mesh
Classification:	Class II
Product Code:	OTN
Trade name:	Lynx™ Ultra System
Model Number:	M0068503060
Common/Usual Name:	Mesh, surgical, synthetic, urogynecologic, for stress urinaryincontinence, retropubic or transobturator
Regulation Number:	21 CFR §878.3300
Regulation Name:	Surgical Mesh
Classification:	Class II
Product Code:	OTN

{4}------------------------------------------------

D. Predicate Devices

For purposes of establishing substantial equivalence, the proposed Ultra Products were compared to the predicate devices shown in the table below. The predicate devices have not been subject to a design-related recall.

	Predicate Devices
Device Trade Name:	Advantage Ultra SystemAdvantage Fit Ultra SystemLynx Ultra System
Regulation Name:	Surgical Mesh
Regulation Number:	21 CFR §878.3300
Classification:	Class II
Product Code:	OTN
510(k) Submitter/Holder:	Boston Scientific Corporation, Marlborough, MA
510(k) #/ Clearance Date	K211223 / Cleared July 21, 2021

Predicate Devices for Establishing Substantial Equivalence

E. Device Description

Advantage Ultra System and Advantage Fit Ultra System

Lynx Ultra System

{5}------------------------------------------------

The Lynx Ultra System is packaged with two Lynx System delivery devices. Each is a single-use disposable delivery device that consists of a handle with a curved needle with a needle slot for connection to the mesh assembly. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for suprapubic placement.

F. Intended Use/Indications for Use

Advantage Ultra System and Advantage Fit Ultra System

The mesh implant is intended for use as a suburethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Lynx Ultra Svstem

The mesh implant is intended for use as a suburethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Lynx Ultra System delivery device is intended for use as an aid in insertion, placement, fixation, and anchoring of the Lynx Ultra surgical mesh during urogynecological procedures.

G. Operating Principle

The mesh sling acts as a backboard to support the urethra during stress and straining events to prevent urine leakage.

H. Comparison of Key Technological/Performance Characteristics

The proposed Ultra Products are identical to the predicate devices cleared via K211223 in many aspects, as there are no changes to the intended use or indications for use, design, materials, sterilization, technological and performance characteristics, or principle of operation. The changes that are the subject of this premarket notification are limited to procedural steps within the Ultra Products' electronic Instructions for Use (eIFU)s. These changes modify the instructions and provide additional clarification related to release and removal of the disposable components of the mesh assembly. These changes impact the user interface by modifying the user workflow.

I. Substantial Equivalence

A direct comparison of key characteristics demonstrates that Ultra Products are substantially equivalent to the predicate devices in terms of intended use, principle of operation, technological and performance characteristics.

J. Performance Testing

Performance bench testing was conducted in the form of Design Validation and Summative Usability Evaluation to evaluate the eIFU modifications. The Design Validation provided objective evidence that all user needs impacted by the elFU modifications were met and overall performance for the intended clinical use was acceptable. The Summative Usability Evaluation demonstrated that the Ultra Products continue to function as intended and do not raise new issues of safety or effectiveness compared to the predicate devices.

{6}------------------------------------------------

K. Conclusion

Based on the intended use/indications for use, comparison of key technological characteristics, and performance testing presented in this submission, it is concluded that the proposed Ultra Products are substantially equivalent to the established predicate devices.

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.