(117 days)
The Advantage System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Advantage surgical mesh during urogynaecological procedures.
The Advantage Fit System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Advantage Fit surgical mesh during urogynaecological procedures.
The Lynx System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Lynx surgical mesh during urogynaecological procedures.
The Solyx SIS Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Solyx SIS surgical mesh during urogynaecological procedures.
The Obtryx (Curved) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx surgical mesh during urogynaecological procedures.
The Obtryx (Halo) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx surgical mesh during urogynaecological procedures.
The Obtryx II (Curved) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx II surgical mesh during urogynaecological procedures.
The Obtryx II (Halo) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx II surgical mesh during urogynaecological procedures.
The subject devices are not sold individually and are only offered packaged as part of a surgical mesh system. Device descriptions specific to each delivery device are italicized below within each existing system description.
Advantage™ System and Advantage Fit™ System: The disposable delivery device 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 transvaginal placement.
Lynx™ System: The disposable delivery device consists of a handle with a curved needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for suprapubic placement.
Solyx™ SIS System: The disposable delivery device consists of a handle, a stainless steel shaft and a deployment mechanism. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for placement into the obturator internus muscle.
Obtryx™ System (Curved & Halo): The disposable delivery devices consist of a handle with a stainless steel needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for placement through the obturator foramen.
Obtryx™ II System (Curved & Halo): The disposable delivery devices consist of a handle with a stainless steel needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for placement through the obturator foramen.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is present and noting what is absent as per your request.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or corresponding reported device performance values in a table format for a diagnostic or AI device. Instead, it details that the device met "applicable design and performance requirements" and various "special controls."
However, we can infer the types of performance aspects that were evaluated:
| Performance Aspect | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Sterilization | Meet established sterilization validation standards. | Validation demonstrated successful sterilization. |
| Package Integrity | Maintain integrity after real-time aging (dye penetration, seal strength, visual inspection). | Demonstrated integrity after real-time aging. |
| Dimensional | Meet specified dimensional tolerances. | Dimensions met defined specifications. |
| Functional | Perform intended functions (e.g., aid in insertion, placement, fixation, anchoring). | Functional tests demonstrated sufficient mechanical performance for intended use. |
| Distribution Challenge | Packaging protects device during distribution. | Packaging maintained integrity during distribution challenge. |
| Biocompatibility | No significant adverse biological reactions (cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity). | Demonstrated to be biocompatible. |
| Shelf-life | Maintain performance and integrity for specified duration (3 years). | Supports a three-year shelf life. |
2. Sample size used for the test set and the data provenance
The document does not provide information on specific sample sizes for test sets, nor does it detail the data provenance (e.g., country of origin, retrospective/prospective) for any performance data. The tests described are related to device engineering and material performance, not clinical data or diagnostic accuracy.
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 and not provided as the submission is for a surgical delivery device, not a diagnostic device requiring expert interpretation for ground truth establishment. The "performance testing" described is for mechanical, material, and sterility validation.
4. Adjudication method for the test set
This information is not applicable and not provided for the same reasons as point 3.
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 and not provided as the device is a surgical delivery tool, not an AI-assisted diagnostic or interpretation system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided as the device is a physical surgical delivery tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" in the context of diagnostic or AI performance is not applicable here. For the engineering and biocompatibility tests, the "truth" is established by adherence to recognized standards, test methodologies, and objective measurements (e.g., sterility validation protocols, mechanical stress limits, chemical analysis for biocompatibility).
8. The sample size for the training set
This information is not applicable and not provided as the device is a physical surgical instrument and does not involve AI or machine learning models that require a "training set."
9. How the ground truth for the training set was established
This information is not applicable and not provided for the reasons stated in point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 20, 2017
Anand Patel Regulatory Affairs Specialist II 100 Boston Scientific Way Marlborough, MA 01752
Re: K172565
Trade/Device Name: Advantage™ System Delivery Device, Advantage Fit™ System Delivery Device. Lynx™ System Delivery Device. Solyx™ SIS Delivery Device. Obtryx™ (Curved) Delivery Device, Obtryx™ (Halo) Delivery Device, Obtryx™ II (Curved) Delivery Device, Obtryx™ II (Halo) Delivery Device Regulation Number: 21 CFR§ 884.4910 Regulation Name: Specialized Surgical Instrumentation for use with Urogynecologic Surgical Mesh Regulatory Class: II Product Code: PWJ Dated: November 17, 2017 Received: November 20, 2017
Dear Anand Patel:
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.
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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); 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.
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Charles Viviano -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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Indications for Use
510(k) Number (if known) K172565
Device Name
Advantage™ System Delivery Device, Advantage Fif™ System Delivery Device, Lynx™ System Delivery Device, Solyx™ SIS Delivery Device, Obtryx™ (Curved) Delivery Device, Obtryx™ (Halo) Delivery Device, Obtryx™ II (Curved) Delivery Device, Obtryx™ II (Halo) Delivery Device
Indications for Use (Describe)
The Advantage System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Advantage surgical mesh during urogynaecological procedures.
The Advantage Fit System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Advantage Fit surgical mesh during urogynaecological procedures.
The Lynx System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Lynx surgical mesh during urogynaecological procedures.
The Solyx SIS Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Solyx SIS surgical mesh during urogynaecological procedures.
The Obtryx (Curved) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx surgical mesh during urogynaecological procedures.
The Obtryx (Halo) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx surgical mesh during urogynaecological procedures.
The Obtryx II (Curved) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx II surgical mesh during urogynaecological procedures.
The Obtryx II (Halo) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx II surgical mesh during urogynaecological 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) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K172565
A. Date Prepared
December 20, 2017
B. Sponsor
Boston Scientific Corporation Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01752
C. Contact
Anand Patel Regulatory Affairs Specialist II 508-683-5320 anand.patel@bsci.com
Or
Lauren Russo Regulatory Affairs Manager 508-683-4707 lauren.russo@@bsci.com
D. Device Name(s)
Trade name: Advantage™ System Delivery Device Common/usual name: Delivery Devices Regulation Number: 21 CFR 884.4910 Regulation Name: Specialized Surgical Instrumentation for Use with Urogynecologic Surgical Mesh Classification: Class II Product Code: PWJ (instrumentation, surgical mesh, urogynecologic, stress urinary incontinence)
Trade name: Advantage™ Fit System Delivery Device Common/usual name: Delivery Devices Regulation Number: 21 CFR 884.4910 Regulation Name: Specialized Surgical Instrumentation for Use with Urogynecologic Surgical Mesh Classification: Class II Product Code: PWJ (instrumentation, surgical mesh, urogynecologic, stress urinary incontinence)
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Trade name: Lynx™ System Delivery Device Common/usual name: Delivery Devices Regulation Number: 21 CFR 884.4910 Regulation Name: Specialized Surgical Instrumentation for Use with Urogynecologic Surgical Mesh Classification: Class II Product Code: PWJ (instrumentation, surgical mesh, urogynecologic, stress urinary incontinence)
Trade name: SolyxTM SIS Delivery Device
Common/usual name: Delivery Devices Regulation Number: 21 CFR 884.4910 Regulation Name: Specialized Surgical Instrumentation for Use with Urogynecologic Surgical Mesh Classification: Class II Product Code: PWJ (instrumentation, surgical mesh, urogynecologic, stress urinary incontinence)
Trade name: Obtryx™ (Curved) Delivery Device)
Common/usual name: Delivery Devices Regulation Number: 21 CFR 884.4910 Regulation Name: Specialized Surgical Instrumentation for Use with Urogynecologic Surgical Mesh Classification: Class II Product Code: PWJ (instrumentation, surgical mesh, urogynecologic, stress urinary incontinence)
Trade name: ObtryxTM (Halo) Delivery Device
Common/usual name: Delivery Devices Regulation Number: 21 CFR 884.4910 Regulation Name: Specialized Surgical Instrumentation for Use with Urogynecologic Surgical Mesh Classification: Class II Product Code: PWJ (instrumentation, surgical mesh, urogynecologic, stress urinary incontinence)
Trade name: Obtryx™ II (Curved) Delivery Device Common/usual name: Delivery Devices Regulation Number: 21 CFR 884.4910 Regulation Name: Specialized Surgical Instrumentation for Use with Urogynecologic Surgical Mesh Classification: Class II Product Code: PWJ (instrumentation, surgical mesh, urogynecologic, stress urinary incontinence)
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Trade name: Obtryx™ II (Halo) Delivery Device Common/usual name: Delivery Devices Regulation Number: 21 CFR 884.4910 Regulation Name: Specialized Surgical Instrumentation for Use with Urogynecologic Surgical Mesh Classification: Class II Product Code: PWJ (instrumentation, surgical mesh, urogynecologic, stress urinary incontinence)
E. Predicate Device(s)
Trade name: Advantage™ System, Advantage Fit™ System, Lynx™ System Common/usual name: Surgical Mesh Regulation Number: 21 CFR 878.3300 Classification: Class II Product Code: OTN Premarket Notification: Boston Scientific, K020110
Trade name: Solyx™ SIS System Common/usual name: Surgical Mesh Regulation Number: 21 CFR 878.3300 Classification: Class II Product Code: PAH Premarket Notification: Boston Scientific, K081275
Trade name: Obtryx™ II System (Curved & Halo) Common/usual name: Surgical Mesh Regulation Number: 21 CFR 878.3300 Classification: Class II Product Code: OTN Premarket Notification: Boston Scientific, K121754
The predicate devices have not been subject to a design-related recall.
F. Device Description
The subject devices are not sold individually and are only offered packaged as part of a surgical mesh system. Device descriptions specific to each delivery device are italicized below within each existing system description.
Advantage™ System and Advantage Fit™ System
The Advantage System and the Advantage Fit System are sterile, single use systems,
consisting of one delivery device and one mesh assembly. Each mesh assembly is comprised of a polypropylene knitted mesh protected by a disposable plastic sleeve. At the distal ends of the mesh assembly are two dilators designed to be placed over the needle end of the delivery device. The disposable delivery device consists of a handle with a curved needle, and a pusher component. The delivery device is designed to facilitate the passage of the mesh
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assembly through bodily tissues for transvaginal placement.
Lynx™ System
The Lynx System is a sterile, single use system consisting of two (2) delivery devices and one (1) mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by a disposable plastic sleeve. 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 the delivery device. The disposable delivery device consists of a handle with a curved needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for suprapubic placement.
Solyx™ SIS System
The Solyx SIS (Single Incision Sling) System is a sterile single use system consisting of one (1) delivery device and one (1) mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh with polypropylene carriers at each end of the distal mesh. The carrier is designed to be placed on the tip of the delivery device. The disposable delivery device consists of a handle, a stainless steel shaft and a deployment mechanism. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for placement into the obturator internus muscle.
Obtryx™ System (Curved & Halo)
The Obtryx Sling Systems (Curved or Halo) are sterile, single use system consisting of two (2) delivery devices and one (1) mesh assembly. Each mesh assembly is comprised of a polypropylene knitted mesh protected by a disposable plastic sleeve. 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 the delivery devices. The disposable delivery devices consist of a handle with a stainless steel needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for placement through the obturator foramen.
Obtryx™ II System (Curved & Halo)
The Obtryx II Systems (Curved or Halo) are sterile, single use system consisting of two (2) delivery devices and one (1) mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh with dilator legs and a center tab. At the distal ends of the dilator legs there are association loops designed to be placed in the needle slot of the distal end of the delivery devices. The disposable delivery devices consist of a handle with a stainless steel needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for placement through the obturator foramen.
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| Advantage™ Delivery Device | ||
|---|---|---|
| Indication forUse | K172565 (Subject Device) | K020110 (Predicate Device) |
| The Advantage System DeliveryDevice is intended for use as anaid in insertion, placement,fixation, and anchoring ofAdvantage surgical mesh duringurogynaecological procedures. | The mesh implant is intended asa suburethral sling for thetreatment of stress urinaryincontinence resulting fromurethral hypermobility and/orintrinsic sphincter deficiency. |
G. Comparison of Indications for Use with Predicate Devices
| Advantage™ Fit Delivery Device | ||
|---|---|---|
| Indication for Use | K172565 (Subject Device) | K020110 (Predicate Device) |
| The Advantage Fit System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Advantage Fit surgical mesh during urogynaecological procedures. | The mesh implant is intended as a suburethral sling for the treatment of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. |
| LynxTM Delivery Device | ||
|---|---|---|
| Indication for Use | K172565 (Subject Device) | K020110 (Predicate Device) |
| The Lynx System DeliveryDevice is intended for use as anaid in insertion, placement,fixation, and anchoring of Lynxsurgical mesh duringurogynaecological procedures. | The mesh implant is intended asa suburethral sling for thetreatment of stress urinaryincontinence resulting fromurethral hypermobility and/orintrinsic sphincter deficiency. |
| Solyx™ SIS Delivery Device | ||
|---|---|---|
| Indication for Use | K172565 (Subject Device) | K081275 (Predicate Device) |
| The Solyx SIS Delivery Device isintended for use as an aid ininsertion, placement, fixation,and anchoring of Solyx SISsurgical mesh duringurogynaecological procedures. | The mesh implant is intended asa suburethral sling for thetreatment of stress urinaryincontinence resulting fromurethral hypermobility and/orintrinsic sphincter deficiency. |
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| Obtryx™ & Obtryx™ II Delivery Device | ||
|---|---|---|
| Indication forUse | K172565 (Subject Device) | K121754 (Predicate Device) |
| The Obtryx (Curved) DeliveryDevice is intended for use as anaid in insertion, placement,fixation, and anchoring of Obtryxsurgical mesh duringurogynaecological procedures.The Obtryx (Halo) DeliveryDevice is intended for use as anaid in insertion, placement,fixation, and anchoring of Obtryxsurgical mesh duringurogynaecological procedures.The Obtryx II (Curved) DeliveryDevice is intended for use as anaid in insertion, placement,fixation, and anchoring of ObtryxII surgical mesh duringurogynaecological procedures.The Obtryx II (Halo) DeliveryDevice is intended for use as anaid in insertion, placement,fixation, and anchoring of ObtryxII surgical mesh duringurogynaecological procedures. | The mesh implant is intended asa suburethral sling for thetreatment of stress urinaryincontinence resulting fromurethral hypermobility and/orintrinsic sphincter deficiency. |
The indications for use statements for subject devices and the predicate devices are not identical, as the predicate devices are surgical mesh systems for treatment of stress urinary incontinence. The intended use of the subject and predicate devices is the same, as the subject devices are an accessory to a surgical mesh.
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| Device(s) | Subject Device | Predicate Device |
|---|---|---|
| K172565 | K020110K081275K121754 | |
| General Device Characteristics | ||
| Patient contact | < 24 hours (tissue/bone) | Permanent (tissue/bone) |
| OperatingPrinciple | Aid in insertion, placement,fixation, or anchoring of surgicalmesh | Sub/Mid-Uretheral mesh slingsystems for treatment of stressurinary incontinence |
| Device Design | Surgical mesh instrumentation | Surgical mesh |
| Materials | PlasticStainless steel | Polypropylene |
| Shelf-life | 3 years | 3 years |
| Sterility | EO | EO |
H. Comparison of Technological Characteristics
As discussed above, the subject devices have different technological characteristics from the predicate devices. The predicate devices are surgical mesh whereas the subject devices are used for the placement of surgical mesh. Briefly, the predicate devices differ from the subject devices as follows:
-
- Operating principle
-
- Device Design
-
- Materials
The differences between the subject devices and the predicate devices can raise different types of safety and effectiveness questions, as we are comparing an accessory and parent device. The differences in technological characteristics were evaluated through completion of special controls (performance testing, biocompatibility, shelf-life/reprocessing, labeling, and sterilization) published in the final order reclassifying urogynecologic surgical mesh instrumentation from class I to class II published on January 6, 2017.
I. Non-Clinical Performance Test Summary
The following tests were performed to demonstrate that the proposed subject devices met the applicable design and performance requirements and support a determination of substantial equivalence under the specified testing parameters. These tests include:
- Sterilization Validation
- Package integrity testing following real-time aging
- Dye Penetration O
- Seal Strength o
- Visual Inspection O
- Dimensional Tests
- . Functional Tests
- Distribution Challenge of Packaging
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- . Biocompatibility
- Cytotoxicity O
- O Sensitization
- Irritation or Intracutaneous Reactivity O
- Acute systemic toxicity O
- Shelf-life Testing ●
The results of performance testing demonstrate the subject devices are biocompatible, have sufficient mechanical performance for its intended use, and support a three-year shelf life.
J. Conclusion
The Delivery Devices for Surgical Mesh Systems are substantially equivalent and complies with the special controls outlined in 21 CFR 884.4910, Specialized surgical instrumentation for use with urogynecologic surgical mesh.
§ 884.4910 Specialized surgical instrumentation for use with urogynecologic surgical mesh.
(a)
Identification. Specialized surgical instrumentation for use with urogynecologic surgical mesh is a prescription device specifically intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures. These procedures include transvaginal pelvic organ prolapse repair, sacrocolpopexy (transabdominal pelvic organ prolapse repair), and treatment of female stress urinary incontinence. Examples of specialized surgical instrumentation include needle passers and trocars, needle guides, fixation tools, and tissue anchors. This device is not a manual gastroenterology-urology surgical instrument and accessories (§ 876.4730) or a manual surgical instrument for general use (§ 878.4800).(b)
Classification. Class II (special controls). The special controls for specialized surgical instrumentation for use with urogynecologic surgical mesh are:(1) The device must be demonstrated to be biocompatible;
(2) The device must be demonstrated to be sterile and, if reusable, it must be demonstrated that the device can be adequately reprocessed;
(3) Performance data must support the shelf life of the device by demonstrating package integrity and device functionality over the requested shelf life;
(4) Non-clinical performance testing must demonstrate that the device meets all design specifications and performance requirements, and that the device performs as intended under anticipated conditions of use; and
(5) Labeling must include:
(i) Information regarding the mesh design that may be used with the device;
(ii) Detailed summary of the clinical evaluations pertinent to use of the device;
(iii) Expiration date; and
(iv) Where components are intended to be sterilized by the user prior to initial use and/or are reusable, validated methods and instructions for sterilization and/or reprocessing of any reusable components.