(16 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 with association loops, mesh sleeve and center tab.
The provided text is a 510(k) summary for a surgical mesh device, the Obtryx™ System and Prefyx PPSTM System. It explicitly states that no clinical testing was required or performed to prove the device meets acceptance criteria. Instead, the device's substantial equivalence to a predicate device (AdvantageTM, Advantage FitTM System & LynxTM Systems) was established through non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since no clinical testing was performed, there are no specific clinical acceptance criteria or reported device performance metrics in the document. The document primarily focuses on demonstrating equivalence to a predicate device through non-clinical means.
| Acceptance Criteria (from predicate device) | Reported Device Performance |
|---|---|
| Intended Use | Identical |
| Technological Characteristics | Identical |
| Performance Characteristics | Identical (based on non-clinical testing) |
| Biocompatibility | Identical (based on non-clinical testing) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. No clinical test set was used.
- Data Provenance: Not applicable. The document refers to "testing results of the material, biocompatibility, bench testing" for the non-clinical assessment, but does not specify the origin of any data, if any external data was used for comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical test set requiring expert ground truth was used.
4. Adjudication method for the test set
- Not applicable. No clinical test set requiring adjudication was used.
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
- Not applicable. This device is a surgical mesh, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.
6. 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.
7. The type of ground truth used
- Not applicable in the context of clinical performance evaluation. The "ground truth" for demonstrating substantial equivalence was the performance, biocompatibility, and intended use of the legally marketed predicate device, as assessed through non-clinical testing.
8. The sample size for the training set
- Not applicable. This device is a surgical mesh and does not involve AI or machine learning models that require training sets.
9. How the ground truth for the training set was established
- Not applicable. As noted above, there is no training set for this device.
Justification for the above responses from the text:
The key section is H. Substantial Equivalence and 1. Non-Clinical Testing:
- "The surgical mesh is identical to currently marketed surgical mesh in terms of performance characteristics, biocompatibility, and intended use. Therefore, testing was not required to be repeated on the surgical mesh."
- "Conclusion: Based on testing results of the material, biocompatibility, bench testing, and the proposed device labeling, the device is substantially equivalent to the identified predicate device in terms of intended use..."
This clearly indicates that no new clinical studies or clinical performance data specific to this device were generated or provided in the 510(k) submission. The substantial equivalence was established through non-clinical means by demonstrating its identity to a predicate device.
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Boston Scientific Corporation
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: Obtryx™ System (Halo or Curved) and Prefyx PPSTM System Common/usual name: Surgical Mesh Classification Name: OTN - Mesh, Surgical, Polymeric 21 CFR 878.3300, Class II
D. Predicate Device(s)
| Tradename: | AdvantageTM, Advantage FitTM System & LynxTMSystems |
|---|---|
| Common/usual name: | Surgical Mesh |
| Classification Name: | OTN- Mesh, Surgical, Polymeric21 CFR 878.3300, Class II |
| Premarket Notification: | Boston Scientific Corporation,K020110 |
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 with association loops, mesh sleeve and center tab.
Addition of documentation for Special 510(k) K040787 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).
Two (2) delivery devices (Halo or Curved) are used in conjunction with the mesh assembly to place the mesh implant. Each of the delivery devices consist of a polymer handle and a stainless steel needle which extends from the handle. The tip of the needle has a slot which is used to attach the association loop of the mesh assembly
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 and the materials of the surgical mesh are identical to the predicate device.
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 devices.
1. Non-Clinicial Testing
The surgical mesh is identical to currently marketed surgical mesh in terms of performance characteristics, biocompatibility, and intended use. Therefore, testing was not required to be repeated on the surgical mesh.
Conclusion:
Based on testing results of the material, biocompatiblity, bench testing, and the proposed device labeling, the device is substantially equivalent to the identified predicate device in terms of intended use, 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 Special 510(k) K040787 Surgical Mesh April 11, 2013
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol resembling a bird or a wing-like shape, composed of curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
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 % Janet A. McGrath Regulatory Affairs Specialist One Boston Scientific Place Natick, MA 01760
Re: K040787
Trade/Device Name: Obtryx™ System (Halo or Curved) and Prefyx PPSTM System Regulation Number: 21 CFR$ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated (Date on orig SE ltr): March 24, 2004 Received (Date on orig SE ltr): April 1, 2004
Dear Janet A. McGrath,
This letter corrects our substantially equivalent letter of April 14, 2004.
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 - Janet A. McGrath
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): K040787
Device Name: Obtryx™ System (Halo or Curved) and Prefyx PPSTM 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)
Herbe
§ 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.