(82 days)
The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The proposed sling is a sterile, single use device, consisting of a synthetic mesh sling assembly and packaged with a delivery device. The mesh assembly consists of a knitted polypropylene monofilament fiber mesh body implant, dilators, mesh sleeve and center tab.
The provided text describes a 510(k) submission for a surgical mesh, the Advantage™ System, Advantage™ Fit, and Lynx™ System. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing rather than clinical studies or acceptance criteria for a new, novel device with specific performance metrics defined by a study.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, and detailed study methods for proving device performance (like sample sizes for test/training sets, expert involvement, and MRMC studies) is not directly addressed in this type of submission.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance:
The document states that material and bench testing were done to demonstrate that the device meets performance specifications, but it does not explicitly list the acceptance criteria or specific reported performance values in a table. It generally concludes that the device "meets the predetermine specifications and is acceptable for clinical use."
| Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|
| Material properties suitable for intended use | Material testing performed, results demonstrate suitability. |
| Device manufactured meets performance specifications | Bench testing performed, results demonstrate specifications are met. |
| Biocompatible for intended use | Biocompatibility testing performed in accordance with EN ISO 10993-1, results demonstrate biocompatibility. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified. The testing is described as "Non-Clinical Testing" (material testing, bench testing, biocompatibility testing), implying laboratory or in-vitro settings, not human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the non-clinical testing described. "Ground truth" in this context typically refers to clinical diagnosis or outcome, which is not the subject of material, bench, or biocompatibility testing.
4. Adjudication method for the test set:
This information is not applicable to the non-clinical testing described. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple experts.
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 information is not applicable. An MRMC study is a clinical study format. The submission describes non-clinical testing for substantial equivalence, not a comparative effectiveness study involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical surgical mesh, not an algorithm or AI system.
7. The type of ground truth used:
This is not applicable in the traditional sense of clinical "ground truth." For material, bench, and biocompatibility testing, the "truth" is established by adherence to predefined engineering specifications, material standards, and biocompatibility protocols (e.g., EN ISO 10993-1).
8. The sample size for the training set:
This information is not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established:
This information is not applicable. There is no "training set" as this is not a machine learning or AI device.
In summary:
This 510(k) submission primarily relies on non-clinical testing (material, bench, and biocompatibility testing) to demonstrate substantial equivalence to predicate devices for a surgical mesh. The purpose is to show that the device's physical properties, performance in lab settings, and safety (biocompatibility) are comparable to already approved devices. It does not involve clinical studies with human subjects, AI algorithms, or the detailed expert-driven ground truth establishment typically required for such studies. The document states that the testing demonstrated the device met "predetermine specifications," but specific numerical acceptance criteria and results are not detailed in the provided excerpt.
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020110
510(k) Summary for Surgical Mesh
A. Sponsor
Boston Scientific Corporation Urology and Gynecology Division 100 Boston Scientific Way Marlborough, MA 01752
B. Contact
Janet A. McGrath Principal Specialist Global Regulatory Affairs 508-683-4726 or Donna Gardner Director. Regulatory Affairs 508-683-4398
C. Device Name
Tradename: Advantage™ System , Advantage Fit™ and Lynx TM System Common/usual name: Surgical Mesh Classification Name: OTN - Mesh, Surgical, Polymeric
21 CFR 878.3300, Class II
D. Predicate Device(s)
Tradename:
-
- Tension Free Vaginal Tape
-
- Trelex Mesh
-
- BioSling Bioabsorable Polymer Sling and Surgical Mesh
-
- Suspend Sling
Common/usual name: Surgical Mesh
Classification Name: OTN- Mesh, Surgical, Polymeric
21 CFR 878.3300, Class II
Premarket Notification: 1. K974098 (TVT)
E. Device Description
The proposed sling is a sterile, single use device, consisting of a synthetic mesh sling assembly and packaged with a delivery device. The mesh assembly consists of a knitted polypropylene monofilament fiber mesh body implant, dilators, mesh sleeve and center tab.
Addition of documentation for Traditional 510(k) K020110 Surgical Mesh April 11, 2013
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Accessories
The proposed sling is packaged with other legally marketed accessories (e.g., Delivery Device; Class I exempt: 876.4730 Manual gastroenterology-urology surgical instrument and accessories).
F. Intended Use
The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
G. Technological Characteristics
The intended use of the surgical mesh is equivalent to all the predicate devices listed. As stated in this 510K the materials and the technological characteristics are equivalent to the predicate Tension Free Vaginal Tape, K974098.
H. Substantial Equivalence
Utilizing FDA's Guidance for Industry and FDA Staff "Format for Traditional and Abbreviated 510(k)s" and "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh", a direct comparison of key characteristics demonstrates that the proposed sling is substantially equivalent to the predicate sling in terms of intended use, technological characteristics, and performance characteristics tested. The proposed sling is as safe, as effective, and performs as well as the predicate device.
I . Non-Clinicial Testing
Material testing was performed to demostrate that the material properites are suitable for the intended use.
Bench testing was performed to demostrate that the device as manufactured meets nerformance specifications. Test results demostrate that the device meets the predetermine specifications and is acceptable for clinical use.
Biocompatiblity testing was performed in accordance to standard EN ISO 10993-1 for each of the patient contacting materials, and results demonstrate that the device is biocompatible for its intended use.
Conclusion:
Based on material, biocompatiblity, bench testing, and the proposed device labeling, the device is substantially equivalent to the identified predicate devices previously classified under 21 CFR 878.3300 as Class II, mesh surgical, polymeric, in terms of intended use and thefore do not adversely effect safety and effectiveness.
Addition of documentation for Traditional 510(k) K020110 Surgical Mesh April 11, 2013
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 13, 2013
Boston Scientific Corporation Urology and Gynecology Division % Lorraine M. Hanley Director One Boston Scientific Place Natick, MA 01760
Re: K020110
Trade/Device Name: Advantage™ System, Advantage™ Fit System and Lynx™ System Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated (Date on orig SE ltr): January 9, 2002 Received (Date on orig SE Itr): January 11, 2002
Dear Lorraine M. Hanley,
This letter corrects our substantially equivalent letter of April 3, 2002.
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.
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Page 2 - Lorraine M. Hanley
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for 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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Boston Scientific Corporation
CONFIDENTIAL
Indications for Use Statement
510(k) Number (if Known): K020110
Device Name: Advantage™ System, Advantage™ Fit System and Lynx™ System
Indications For Use:
The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Prescription Use _ X (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herl TERLE
§ 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.