(118 days)
The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from 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 blue knitted polypropylene monofilament fiber mesh body implant, association loops, dilator legs, sleeves, leader loops, center tab and lead. The proposed sling is packaged with (2) delivery devices (Halo or Curved) which 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.
The provided 510(k) summary for the Obtryx II System does not contain information about acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/ML medical device.
This document describes a traditional 510(k) for a surgical mesh (Obtryx II System) used for stress urinary incontinence. The approval is based on "substantial equivalence" to predicate devices (Advantage, Advantage Fit & Lynx Systems, Obtryx, Prefyx Systems) through non-clinical testing, rather than a clinical study with defined performance acceptance criteria.
Therefore, many of the requested details are not applicable or cannot be extracted from this specific 510(k) document.
Here's a breakdown of the information that is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Not Explicitly Stated but Inferred) | Reported Device Performance |
|---|---|
| Material Properties: Suitable for intended use | Device meets predetermined specifications. Test results demonstrate suitability. |
| Biocompatibility: Meet EN ISO 10993-1 | Device is biocompatible for its intended use. Test results demonstrate compliance. |
| Bench Testing: Meet performance specifications | Device meets predetermined specifications. Test results demonstrate acceptable performance for clinical use. |
| Substantial Equivalence to Predicates (K020110 & K040787): | The proposed sling is "as safe, as effective, and performs as well as the predicate devices" in terms of intended use, technological characteristics (mesh design and material), and performance characteristics tested. |
Explanation: The document states that "Material testing was performed to demonstrate that the material properties are suitable for the intended use," "Bench testing was performed to demonstrate that the device as manufactured meets performance specifications," and "Biocompatibility testing was performed... and results demonstrate that the device is biocompatible for its intended use." These imply that acceptance criteria were met, but the specific numerical targets or thresholds are not disclosed in this summary. The primary "acceptance criteria" for this 510(k) path is demonstrating substantial equivalence to already approved predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. This 510(k) relies on non-clinical (material, bench, biocompatibility) testing and comparison to predicate devices, not human subject testing with a "test set" in the context of an AI/ML algorithm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This information pertains to studies establishing ground truth for diagnostic or prognostic AI/ML algorithms. This document describes a surgical mesh, not a diagnostic algorithm.
4. Adjudication Method for the Test Set:
- Not Applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is relevant for diagnostic imaging AI tools comparing human performance with and without AI assistance. This document describes a physical medical device (surgical mesh).
6. Standalone Performance Study (Algorithm Only):
- Not Applicable. There is no "algorithm" in the context of an AI/ML system to evaluate for this surgical mesh device.
7. Type of Ground Truth Used:
- For non-clinical testing, the "ground truth" would be the established engineering specifications for material properties, biocompatibility standards (e.g., EN ISO 10993-1), and device performance specifications.
- For substantial equivalence, the "ground truth" is established by the safety and effectiveness of the legally marketed predicate devices.
8. Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device that uses a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. See point 8.
In summary: The Obtryx II System gained 510(k) clearance based on demonstrating substantial equivalence to existing predicate devices through comprehensive non-clinical testing (material, bench, and biocompatibility). This approval pathway does not require the types of clinical studies, expert-adjudicated test sets, or AI/ML algorithm performance metrics that your questions typically address.
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K121754
PAGE 1 OF 2
510(k) Summary for Blue SUI Sling
A. Sponsor
Boston Scientific Corporation Urology and Gynecology Division 100 Boston Scientific Way Marlborough, MA 01756
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
Obtryx II System Tradename: Common/usual name: Surgical Mesh Classification Name: OTN - Mesh, Surgical, Synthetic, Urogynecologic, for Stress Urinary Incontinence, Female, Multi-Incision 21 CFR 878.3300, Class II
D. Predicate Device(s)
| Tradename: | Advantage , Advantage Fit & Lynx SystemsObtryx, Prefyx Systems |
|---|---|
| Common/usual name: | Surgical Mesh |
| Classification Name: | FTL- Mesh, Surgical, Polymeric21 CFR 878.3300, Class II |
| Premarket Notification: | Boston Scientific Corporation,■ K020110■ K040787 |
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 blue knitted polypropylene monofilament fiber mesh body implant, association loops, dilator legs, sleeves, leader loops, center tab and lead.
Traditional 510(k) Obtryx II System
OCT 10 2012
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K121754
PAGE 2 OF 2
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The proposed sling is packaged with (2) delivery devices (Halo or Curved) which 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 hypermobility and/or intrinsic sphincter deficiency.
G. Technological Characteristics
The proposed sling has the same and/or equivalent technological characteristics (i.e. mesh design and mesh material) as the predicates K020110 & K040787.
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.
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 performance 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 Obtryx II System is substantially equivalent to the identified predicate devices in terms of intended, use , safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 10 2012
Ms. Janet A. McGrath Principal Specialist Global Regulatory Affairs Boston Scientific Corporation 100 Boston Scientific Way, M21 MARLBOROUGH MA 01752
Re: K121754
Trade/Device Name: Obtryx II System Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: September 19, 2012 Received: September 20, 2012
Dear Ms. McGrath:
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.
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
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Benjamin K. Evanko
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
Indications for Use Statement
510(k) Number (if Known): _KlZ|75L
Device Name: Obtryx II System
Indications For Use:
The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from 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)
(Division Sign-Off)
09 Oct 2012
oductive, Gastro-Renal, and
Traditional 510(k) Obtryx II System
§ 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.