(30 days)
Not Found
No
The device description focuses on the physical components of a surgical mesh and delivery system, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies described are bench testing and usability evaluations, not studies of algorithmic performance.
Yes
The device is intended for use as a suburethral sling for the treatment of female stress urinary incontinence, which is a medical condition. The mesh implant is placed in the body to address this condition.
No
The provided text clearly states that the devices (mesh implant and delivery systems) are intended for treatment (e.g., suburethral sling for stress urinary incontinence) and as an aid in insertion/placement during surgical procedures, not for diagnosis.
No
The device description explicitly details physical components such as mesh implants, delivery devices with needles and handles, sleeves, dilators, and loops. There is no mention of software as a component of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a suburethral sling and delivery system for the treatment of female stress urinary incontinence. This is a surgical implant and its associated tools, used in vivo (within the body) during a surgical procedure.
- Device Description: The description details a mesh implant, delivery devices with needles, sleeves, dilators, and loops. These are all physical components designed for surgical insertion and placement within the body.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of bodily specimens.
The device is a surgical implant and delivery system, not a diagnostic tool used with bodily fluids or tissues in vitro.
N/A
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.
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.
Product codes
OTN
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urethra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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.
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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 (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.
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.
| 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 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
Or
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 urinary |
| incontinence, 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 urinary |
| incontinence, 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 urinary |
| incontinence, retropubic or transobturator | |
| Regulation Number: | 21 CFR §878.3300 |
| Regulation Name: | Surgical Mesh |
| Classification: | Class II |
| Product Code: | OTN |
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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 System |
| Advantage Fit Ultra System | |
| Lynx 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
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.
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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.
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 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.
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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.