(281 days)
The GYNECARE TVT™ Reusable Introducer is a reusable device intended to aid in the placement of the GYNECARE TVT Device retropubically.
The GYNECARE TVT™ Reusable Rigid Catheter Guide is a reusable device intended to facilitation of the urethra and bladder neck during the placement of the GYNECARE TVT Device and GYNECARE TVT EXACT Continence System.
The GYNECARE TVT EXACT™ Continence System Trocar is a single use device intended to aid in the placement of the GYNECARE TVT EXACT Continence System retropubically.
The subject devices include the following components:
GYNECARE TVT™ Reusable Introducer
GYNECARE TVTTM Reusable Rigid Catheter Guide
GYNECARE TVT EXACT™ Continence System Trocar
The subject devices are intended to be used with the GYNECARE TVT™ Device and GYNECARE TVT EXACT™ Continence System intended to treat stress urinary incontinence.
GYNECARE TVT™ Reusable Introducer
The GYNECARE TVT™ Introducer is provided non-sterile and is reusable. The Introducer is made of stainless steel. It consists of two parts, a handle and an inserted threaded metal shaft. The Introducer is intended to facilitate the passage of the GYNECARE TVT™ Device from the vagina to the abdominal skin. It is connected and fixed to the threaded end of the shaft, prior to inserting the needle with the tape.
GYNECARE TVT™ Reusable Rigid Catheter Guide
The GYNECARE TVT™ Rigid Catheter Guide is a non-sterile reusable instrument intended to facilitate the identification of the urethra and the bladder neck during the surgical procedure. It is inserted into a Folev catheter (recommended size 18 French) positioned in the urethra. To facilitate insertion, it can be lubricated with gel.
GYNECARE TVT EXACT™ Continence System Trocar
The GYNECARE TVT EXACT™ Continence System Trocar consists of the stainless steel Trocar Shaft and the plastic Trocar Handle. The Trocar Shaft is designed to fit inside the white Trocar Sheaths on the GYNECARE TVT EXACT™ Continence System Implant / Trocar Sheath Assembly, and is used to position the GYNECARE TVT EXACT™ Continence System Implant in the patient from a vaginal incision up through the abdominal wall.
This document describes a 510(k) premarket notification for reusable surgical instruments (GYNECARE TVT™ Reusable Introducer, GYNECARE TVT™ Reusable Rigid Catheter Guide) and a single-use instrument (GYNECARE TVT EXACT™ Continence System Trocar), which are accessories for urogynecologic surgical mesh systems. The submission asserts substantial equivalence to predicate devices (K974098 and K132054).
Here's an analysis of the acceptance criteria and supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail threshold manner for performance. Instead, it lists the types of performance tests conducted and concludes that the devices meet the requirements, implying that the results of these tests were considered acceptable.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Purity/Sterilization: | |
| Sterilization Validation | Sterile to an SAL for 10^-6 |
| Material/Biocompatibility: | |
| Biocompatibility | Biocompatible (Cytotoxicity, Sensitization, Irritation tests successful) |
| Functionality/Durability: | |
| Dimensional and Mechanical Performance | Sufficient mechanical performance for intended use |
| Reprocessing Validation (Reusable devices only) | Can be adequately reprocessed |
| Package Integrity | Adequate |
| Shelf Life | Validated shelf life |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify the sample sizes used for any of the performance tests (e.g., how many devices were tested for mechanical performance, sterilization, or reprocessing).
The data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. These were likely conducted in a controlled laboratory environment by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This type of information is not applicable to the performance characteristics studied for these medical instruments. The "ground truth" for mechanical performance, sterility, or biocompatibility is established through objective laboratory testing and industry standards, not through expert consensus on interpretation, as might be the case for an AI diagnostic device.
4. Adjudication Method for the Test Set:
This is not applicable as the tests relate to objective engineering and biological performance characteristics, not subjective clinical interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. These devices are surgical instruments, not diagnostic tools that would directly assist human readers in interpreting images or data. Therefore, the concept of "effect size of how much human readers improve with AI vs. without AI assistance" is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, a standalone performance study in the context of an algorithm is not applicable. These are physical medical devices, not software algorithms.
7. The type of ground truth used:
The "ground truth" for these tests would be established by:
- Sterilization Validation: Demonstrated sterility to a specified Sterility Assurance Level (SAL) through objective microbiological testing.
- Mechanical Performance: Adherence to engineering specifications and relevant industry standards for strength, durability, and dimensional accuracy, measured objectively.
- Biocompatibility: Compliance with ISO 10993 standards, assessed through laboratory tests (e.g., cell culture for cytotoxicity, animal models for sensitization/irritation).
- Reprocessing Validation: Demonstrated effectiveness of cleaning, disinfection/sterilization, and functional integrity after multiple reprocessing cycles, verified through objective testing.
- Package Integrity: Objective tests to ensure sterile barrier integrity.
- Shelf Life: Stability and functional integrity over time, verified through accelerated aging or real-time shelf-life studies.
8. The Sample Size for the Training Set:
This concept is not applicable. These are physical medical instruments and do not involve machine learning algorithms that require training data.
9. How the Ground Truth for the Training Set was Established:
This concept is not applicable for the same reason as above (no machine learning involved).
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July 6, 2018
Ethicon Inc. Melina Escobar Regulatory Affairs Specialist Ethicon Women's Health and Urology P.O. Box 151 Route 22 West Somerville, New Jersey 08876-0151
Re: K173019
Trade/Device Name: GYNECARE TVT™ Reusable Introducer, GYNECARE TVTTM Reusable Rigid Catheter Guide, GYNECARE TVT EXACT™ Continence System Trocar Regulation Number: 21 CFR 884.4910 Regulation Name: Specialized surgical instrumentation for use with urogynecologic surgical mesh Regulatory Class: Class II Product Code: PWJ Dated: May 24, 2018 Received: June 6, 2018
Dear Melina Escobar:
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
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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 (OS) 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 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,
Michael T. Bailey -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) K173019
Device Name GYNECARE TVT™ Reusable Introducer GYNECARE TVT™ Reusable Rigid Catheter Guide GYNECARE TVT EXACT™ Continence System Trocar
Indications for Use (Describe)
The GYNECARE TVT™ Reusable Introducer is a reusable device intended to aid in the placement of the GYNECARE TVT Device retropubically.
The GYNECARE TVT™ Reusable Rigid Catheter Guide is a reusable device intended to facilitation of the urethra and bladder neck during the placement of the GYNECARE TVT Device and GYNECARE TVT EXACT Continence System.
The GYNECARE TVT EXACT™ Continence System Trocar is a single use device intended to aid in the placement of the GYNECARE TVT EXACT Continence System retropubically.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary – K173019
| Submitter: | Ethicon Women's Health and UrologyA Division of Ethicon, Inc. a Johnson & Johnson companyP.O. Box 151Route 22 WestSomerville, NJ 08876-0151 |
|---|---|
| Contact Person: | Melina EscobarRegulatory Affairs SpecialistPh: (908) 218-2583Fax: (908) 218-2595Email: mescob14@its.jnj.com |
| Date Prepared: | July 5, 2018 |
| Device Trade Names: | GYNECARE TVT™ Reusable IntroducerGYNECARE TVT™ Reusable Rigid Catheter GuideGYNECARE TVT EXACT™ Continence System Trocar |
| Common Name: | Specialized urogynecologic surgical mesh instrumentation |
| Regulation Name: | Specialized surgical instrumentation for use with urogynecologicsurgical mesh |
| Regulation Number: | 21 CFR 884.4910 |
| Regulatory Class: | II |
| Product Code: | PWJ (instrumentation, surgical mesh, urogynecologic, stressurinary incontinence) |
| Predicate Device: | GYNECARE TVT™ Tension Free Vaginal Tape (TVT System)Ethicon, Inc., 510(k) K974098GYNECARE TVT EXACT™ Continence System, Ethicon, Inc. |
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The predicate devices have not been subject to a design related recall.
Device Description
The subject devices include the following components:
GYNECARE TVT™ Reusable Introducer GYNECARE TVTTM Reusable Rigid Catheter Guide GYNECARE TVT EXACT™ Continence System Trocar
The subject devices are intended to be used with the GYNECARE TVT™ Device and GYNECARE TVT EXACT™ Continence System intended to treat stress urinary incontinence.
GYNECARE TVT™ Reusable Introducer
The GYNECARE TVT™ Introducer is provided non-sterile and is reusable. The Introducer is made of stainless steel. It consists of two parts, a handle and an inserted threaded metal shaft. The Introducer is intended to facilitate the passage of the GYNECARE TVT™ Device from the vagina to the abdominal skin. It is connected and fixed to the threaded end of the shaft, prior to inserting the needle with the tape.
GYNECARE TVT™ Reusable Rigid Catheter Guide
The GYNECARE TVT™ Rigid Catheter Guide is a non-sterile reusable instrument intended to facilitate the identification of the urethra and the bladder neck during the surgical procedure. It is inserted into a Folev catheter (recommended size 18 French) positioned in the urethra. To facilitate insertion, it can be lubricated with gel.
GYNECARE TVT EXACT™ Continence System Trocar
The GYNECARE TVT EXACT™ Continence System Trocar consists of the stainless steel Trocar Shaft and the plastic Trocar Handle. The Trocar Shaft is designed to fit inside the white Trocar Sheaths on the GYNECARE TVT EXACT™ Continence System Implant / Trocar Sheath Assembly, and is used to position the GYNECARE TVT EXACT™ Continence System Implant in the patient from a vaginal incision up through the abdominal wall.
Indications for Use
The GYNECARE TVT™ Reusable Introducer is a reusable device intended to aid in the placement of the GYNECARE TVT Device retropubically.
The GYNECARE TVT™ Reusable Rigid Catheter Guide is a reusable device intended to facilitate the identification of the urethra and bladder neck during the placement of the GYNECARE TVT Device and GYNECARE TVT EXACT Continence System.
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The GYNECARE TVT EXACT™ Continence System Trocar is a single use device intended to aid in the placement of the GYNECARE TVT EXACT Continence System retropubically.
Summary of Substantial Equivalence Comparison
| Device andPredicate Devices | K173019 | K974098 | K132054 |
|---|---|---|---|
| Indications for UseStatement | The GYNECARETVTTM ReusableIntroducer is areusable deviceintended to aid in theplacement of theGYNECARE TVTDeviceretropubically.The GYNECARETVTTM ReusableRigid Catheter Guideis a reusable deviceintended to facilitatethe identification ofthe urethra andbladder neck duringthe placement of theGYNECARE TVTDevice andGYNECARE TVTEXACT ContinenceSystem.The GYNECARETVT EXACTTMContinence SystemTrocar is a single usedevice intended to aidin the placement ofthe GYNECARETVT EXACTContinence Systemretropubically. | The TVT device is asterile, single-usedevice intended to beused as apubourethral slingindicated fortreatment of stressurinary incontinence(SUI), for femaleurinary incontinenceresulting fromurethralhypermobility and/orintrinsic sphincterdeficiency. The TVTIntroducer and RigidCatheter Guideaccessories areintended to facilitateplacement of theTVT device. Theaccessories, availableseparately, areprovided non-sterileand are reusable. | The GYNECARETVT EXACTTMContinence System isintended to be used asa pubourethral slingfor treatment offemale stress urinaryincontinence,resulting fromurethralhypermobility and/orintrinsic sphincterdeficiency. |
| Operating principle | Aid in the placementof surgical mesh | Treatment of womenwith stress urinaryincontinence | Treatment of womenwith stress urinaryincontinence |
The following table compares the subject and predicate device.
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| Patient contactdurations | < 24 hours(tissue/bone) | Permanent(tissue/bone) | Permanent(tissue/bone) |
|---|---|---|---|
| Device Design | Instrumentation | Mesh | Mesh |
| Device Materials | Stainless steel,polycarbonate | Wovenpolypropylene | Wovenpolypropylene |
The subject devices have different indications for use statements compared to the predicate device, as the predicate device is a surgical mesh system that is indicated to treat stress urinary incontinence. However, the intended use of the subject and predicate device is the same, because the subject devices are accessories to the predicate surgical mesh.
As described in the table above, the operating principle, patient contact, device design, and device materials are different between the subject and predicate devices. The predicate device is a surgical mesh, whereas the subject devices are used for the placement of surgical mesh. The differences between the subject and predicate device can raise different questions of safety and effectiveness, as we are comparing an accessory and parent device. However, the subject devices are accessories to the predicate devices. 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.
Summary of Performance Testing
The following performance tests were completed on the subject devices:
- Sterilization validation ●
- Reprocessing validation ●
- Package integrity
- Dimensional and mechanical performance ●
- Biocompatibility
- o Cytotoxicity
- o Sensitization
- o Irritation
- . Shelf life
The results of performance testing demonstrate the subject devices are sterile to an SAL for 106. biocompatible, have sufficient mechanical performance for their intended use, have a validated shelf life, and that the GYNECARE TVT Introducer and GYNECARE TVT Rigid Catheter Guide reusable devices can be adequately reprocessed.
Conclusion
The subject devices are substantially equivalent to the predicate device and meet 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.