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.

Device Description

The Advantage Ultra System is a sterile, single-use system consisting of one delivery device and one 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 is packaged with the Advantage™ System Delivery Device previously cleared via K172565. 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 is a sterile, single-use system consisting of one delivery device and one 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 Fit Ultra System is packaged with the Advantage Fit™ System Delivery Device previously cleared via K172565. 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 Lynx Ultra System is a sterile, single-use system consisting of two delivery devices and one 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. The Lynx Ultra System is packaged with two Lynx System Delivery Devices previously cleared via K172565. 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.

AI/ML Overview

The provided text describes the 510(k) summary for the Advantage™ Ultra System, Advantage Fit™ Ultra System, and Lynx™ Ultra System, which are surgical meshes for treating female stress urinary incontinence. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study or a standalone algorithm performance study.

Therefore, the information required for "a table of acceptance criteria and the reported device performance" and the details of a study proving those criteria are not explicitly present in the provided text in the way one might expect for a typical performance validation study with specific metrics like sensitivity, specificity, or accuracy for an AI/CADe device.

However, based on the provided text, the closest interpretations for acceptance criteria and the "study" demonstrating their fulfillment are related to performance testing to ensure the device functions as intended and meets specifications compared to its predicates.

Here's an analysis based on the available information:

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

The document does not provide a table with specific quantitative acceptance criteria (e.g., minimum tensile strength value) explicitly alongside reported performance results. Instead, it broadly states that performance testing was conducted, and the results "demonstrate that the proposed products function as intended and meet specification requirements."

Acceptance Criteria Category	Reported Device Performance (Summary)
Functional & Mechanical
Dimensional Tests	Products function as intended and meet specification requirements.
Tensile Strength Tests	Products function as intended and meet specification requirements.
Full Functional Tests	Products function as intended and meet specification requirements.
Usability
User Evaluations	Products function as intended and meet specification requirements.
Packaging & Sterility
Packaging Tests	Products function as intended and meet specification requirements.
Sterility	Products function as intended and meet specification requirements.
Biocompatibility
Biocompatibility Testing	All patient contacting materials meet applicable biocompatibility standards per ISO 10993-1:2018 and FDA Guidance.
Shelf Life
Accelerated Aging (13 months)	Performance testing on non-aged and accelerated aged samples supports a 1-year shelf life.

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 specify the sample sizes for the performance tests (dimensional, tensile, functional, user evaluations, packaging, sterility, biocompatibility). It also does not mention the data provenance in terms of country of origin or whether a retrospective or prospective study was conducted for establishing clinical performance (as this submission is focused on substantial equivalence based on materials and design, not clinical outcomes from a trial). The "samples" referred to are likely physical devices or components of the device itself (non-aged and accelerated aged for shelf life testing).

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 information is not applicable and not provided in the document. The performance tests described (dimensional, tensile, functional, biocompatibility, sterility) are technical evaluations of the device's physical properties and safety, not assessments requiring expert "ground truth" in a clinical diagnostic sense. "User evaluations" are mentioned, which would involve experts (e.g., surgeons or medical professionals) interacting with the device, but the number and qualifications are not detailed.

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

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or studies involving human interpretation (e.g., radiology reads) to establish ground truth or handle discrepancies, neither of which is described as part of the performance testing for this surgical mesh.

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 is not applicable as the device is a surgical mesh, not an AI/CADe system for diagnostic imaging interpretation. Therefore, no MRMC study or AI-related effectiveness details are provided.

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

This is not applicable as the device is a surgical mesh, not an algorithm.

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

For the performance testing, the "ground truth" would be the established engineering specifications, material standards (e.g., ISO 10993-1:2018 for biocompatibility), and regulatory requirements for sterility and packaging integrity. These are objective measures and standards rather than clinical "ground truth" derived from patient data or expert consensus on a diagnosis.

8. The sample size for the training set

This is not applicable as the device is a physical surgical mesh, not an AI model requiring a training set.

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

This is not applicable as the device is a physical surgical mesh, not an AI model.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. The logos are simple and professional in appearance.

August 6, 2021

Boston Scientific Corporation % Brooke Cuddy Principal Regulatory Affairs Specialist Boston Scientific 100 Boston Scientific Way Marlborough, MA 01752

Re: K211223

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

Dear Brooke Cuddy:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 21, 2021. Specifically, FDA is updating this SE Letter with an update to the contact zip code as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jessica K. Nguyen, Ph.D., OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, Jessica. Nguyen@fda.hhs.gov.

Sincerely,

Jessica K. Nguyen -S

Jessica K. 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

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Image /page/1/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, which features a stylized human figure. To the right of that is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue box, followed by the full name of the agency in blue text.

July 21, 2021

Boston Scientific Corporation % Brooke Cuddy Principal Regulatory Affairs Specialist Boston Scientific 100 Boston Scientific Wav Marlborough, MA 01564

Re: K211223

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: April 23, 2021 Received: April 26, 2021

Dear Brooke Cuddy:

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.

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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 (QS) 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).

Sincerely.

Andrew C. Durfor -S

For Jessica K. 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

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Indications for Use

510(k) Number (if known) K211223

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

Indications for Use (Describe)

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.

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

X 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 Advantage Ultra, Advantage Fit Ultra, and Lynx Ultra Systems

Date Prepared: April 22 2021

A. Submitter

Boston Scientific Corporation Urology and Pelvic Health Division 100 Boston Scientific Way Marlborough, MA 01752

B. Contacts

Rachel Nankervis Regulatory Affairs Specialist II 508-683-4755 Rachel.Nankervis@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

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Classification:	Class I
Product Code:	OTN

D. Predicate Devices

For purposes of establishing 'substantial equivalence', the proposed Ultra products were compared to the predicate devices shown in the table below.

	Primary Predicate(Predicate A)	Secondary Predicate(Predicate B)
Device Trade Name:	Advantage SystemAdvantage Fit SystemLynx System	Obtryx II System
Regulation Name:	Surgical Mesh	Surgical Mesh
Regulation Number:	21 CFR §878.3300	21 CFR §878.3300
Classification:	Class II	Class II
Product Code:	OTN	OTN
510(k) Submitter/Holder:	Boston Scientific Corporation,Marlborough, MA	Boston Scientific Corporation,Marlborough, MA
510(k) #/	K020110	K121754
Clearance Date	Cleared April 3, 2002	Cleared October 10, 2012

Predicate Devices for Establishing 'Substantial Equivalence'

E. Device Descriptions

Advantage Ultra System

The Advantage Ultra System is packaged with the Advantage™ System Delivery Device previously cleared via K172565. 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.

Advantage Fit Ultra System

The Advantage Fit Ultra System is packaged with the Advantage Fit™ System Delivery Device previously cleared via K172565. This is a single-use disposable delivery device that consists of a

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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.

Lynx Ultra System

The Lynx Ultra System is packaged with two Lynx System Delivery Devices previously cleared via K172565. 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

The proposed Ultra products Intended Use/Indications for use statement is as follows:

"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 Intended Use statement is identical to that of Predicate A and Predicate B, except for the addition of the word "female". The female patient population was implied but not explicitly stated in the predicate device labeling. The explicitly stated patient population in the Intended Use/Indications for Use statement for the proposed Ultra products are equivalent to both Predicate A and Predicate B and does not affect the safety and effectiveness of the devices.

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 Ultra products are identical, equivalent or similar to both Predicate A (K020110) and Predicate B (K121754) devices in terms of technological characteristics and fundamental design.

As compared to Predicate A, the Ultra products' mesh implant component and placement route are identical. The proposed Ultra products and Predicate A have technological differences that are limited solely to the mesh assembly components (disposable, non-implantable) and the corresponding operational instructions related to these modified components. The proposed Ultra products' disposable mesh assemblies leverage the fundamental technologies used in Predicate B. The primary differences between the Ultra products and Predicate B are the mesh implant length and the placement route.

The following is a summary of the technological characteristics of the proposed Ultra devices compared to the legally marketed predicate devices, including a list of the technological differences:

Equivalent Intended Use (Predicates A and B)

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Identical environment of use (healthcare facility/hospital) (Predicates A and B) ●
Identical permanent mesh implant component (Predicate A)
Identical sterilization method (ethylene oxide) (Predicates A and B) ●
Identical placement routes of implant (Predicate A) ●
Identical procedural steps ●
- Insertion and placement of the mesh implant (Predicate A) o
- O Removal of the mesh assembly after mesh implant is placed (Predicate B)
. Identical delivery devices (Predicate A and B - delivery devices cleared via K172565)
Similar design and fundamental technology of the mesh assemblies (Predicate B), with ● the following minor modifications that do not raise new questions of safety and effectiveness
- o Sleeves- material formulation and increased length
- Center tab- colorant O
- Center tab lead- secondary resin supplier O
- Leader loops- increased length O

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, technological and performance characteristics.

J. Biocompatibility

The Ultra products' mesh implants, mesh assemblies, and delivery devices are all patientcontacting components. The mesh slings are categorized as implants components that contact tissue/bone for a permanent duration (> 30 days). The mesh assemblies and delivery devices are categorized as externally communicating components that contact tissue/bone for limited duration (< 24 hours). Biocompatibility testing demonstrates that all patient contacting materials meet applicable biocompatibility standards per ISO 10993-1:2018 and the FDA Guidance Use of International Standard ISO 10993-1 "Biological evaluation of medical devices. Evaluation and testing within a risk management process."

K. Performance Testing

Performance testing was conducted on non-aged samples that were accelerated aged for the equivalent of 13 months, in order to support a 1-year shelf life. The performance tests completed to demonstrate that the Ultra products function as intended include:

. Dimensional tests
Tensile strength tests ●
Full functional tests ●
- User evaluations o
- O Packaging tests
- Biocompatibility O
- Sterility O

The results of performance testing demonstrate that the proposed products function as intended and meet specification requirements, which were established considering anticipated conditions of use, for the stated shelf life.

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L. 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 predicates.

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.