GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar

K173019 · ETHICON, Inc. · PWJ · Jul 6, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K173019
• Device Name: GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar
• Applicant: ETHICON, Inc.
• Product Code: PWJ · Obstetrics/Gynecology
• Decision Date: Jul 6, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4910
• Device Class: Class 2

Intended 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 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.

Device Story

Subject devices are surgical instruments used to assist in the placement of urogynecologic mesh systems (GYNECARE TVT and TVT EXACT) for stress urinary incontinence treatment. The Reusable Introducer (stainless steel) facilitates passage of the TVT device from the vagina to the abdominal skin. The Reusable Rigid Catheter Guide (inserted into a Foley catheter) aids in identifying the urethra and bladder neck. The TVT EXACT Trocar (stainless steel shaft, plastic handle) positions the implant from a vaginal incision through the abdominal wall. These devices are used in a surgical setting by physicians. They do not treat incontinence directly but act as mechanical accessories to ensure correct placement of the therapeutic mesh. Benefits include precise surgical navigation and placement of the continence system.

Clinical Evidence

Bench testing only. Testing included sterilization validation, reprocessing validation, package integrity, dimensional and mechanical performance, biocompatibility (cytotoxicity, sensitization, irritation), and shelf-life testing. Results confirmed devices are sterile, biocompatible, mechanically sufficient, and reusable components can be adequately reprocessed.

Technological Characteristics

Materials: Stainless steel, polycarbonate. Design: Manual surgical instrumentation. Reusable components (Introducer, Catheter Guide) require reprocessing; Trocar is single-use. Sterilization: Validated to SAL 10^-6. Connectivity: None. Software: None.

Indications for Use

Indicated for use in female patients undergoing surgical placement of urogynecologic mesh for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• GYNECARE TVT™ Tension Free Vaginal Tape (TVT System) (K974098)
• GYNECARE TVT EXACT™ Continence System (K132054)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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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Image /page/3/Picture/0 description: The image shows the logo for Ethicon, a Johnson & Johnson company. The word "ETHICON" is written in large, red, sans-serif letters. Below the company name, in a smaller, cursive font, is the text "a Johnson & Johnson company."

# 510(k) Summary – K173019

| Submitter: | Ethicon Women's Health and Urology<br>A Division of Ethicon, Inc. a Johnson & Johnson company<br>P.O. Box 151<br>Route 22 West<br>Somerville, NJ 08876-0151 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Melina Escobar<br>Regulatory Affairs Specialist<br>Ph: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | July 5, 2018 |
| Device Trade Names: | GYNECARE TVT™ Reusable Introducer<br>GYNECARE TVT™ Reusable Rigid Catheter Guide<br>GYNECARE TVT EXACT™ Continence System Trocar |
| Common Name: | Specialized urogynecologic surgical mesh instrumentation |
| Regulation Name: | Specialized surgical instrumentation for use with urogynecologic<br>surgical mesh |
| Regulation Number: | 21 CFR 884.4910 |
| Regulatory Class: | II |
| Product Code: | PWJ (instrumentation, surgical mesh, urogynecologic, stress<br>urinary incontinence) |
| Predicate Device: | GYNECARE TVT™ Tension Free Vaginal Tape (TVT System)<br>Ethicon, Inc., 510(k) K974098<br>GYNECARE 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 and<br>Predicate Devices | K173019 | K974098 | K132054 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use<br>Statement | The GYNECARE<br>TVTTM Reusable<br>Introducer is a<br>reusable device<br>intended to aid in the<br>placement of the<br>GYNECARE TVT<br>Device<br>retropubically.<br>The GYNECARE<br>TVTTM Reusable<br>Rigid Catheter Guide<br>is a reusable device<br>intended to facilitate<br>the identification of<br>the urethra and<br>bladder neck during<br>the placement of the<br>GYNECARE TVT<br>Device and<br>GYNECARE TVT<br>EXACT Continence<br>System.<br>The GYNECARE<br>TVT EXACTTM<br>Continence System<br>Trocar is a single use<br>device intended to aid<br>in the placement of<br>the GYNECARE<br>TVT EXACT<br>Continence System<br>retropubically. | The TVT device is a<br>sterile, single-use<br>device intended to be<br>used as a<br>pubourethral sling<br>indicated for<br>treatment of stress<br>urinary incontinence<br>(SUI), for female<br>urinary incontinence<br>resulting from<br>urethral<br>hypermobility and/or<br>intrinsic sphincter<br>deficiency. The TVT<br>Introducer and Rigid<br>Catheter Guide<br>accessories are<br>intended to facilitate<br>placement of the<br>TVT device. The<br>accessories, available<br>separately, are<br>provided non-sterile<br>and are reusable. | The GYNECARE<br>TVT EXACTTM<br>Continence System is<br>intended to be used as<br>a pubourethral sling<br>for treatment of<br>female stress urinary<br>incontinence,<br>resulting from<br>urethral<br>hypermobility and/or<br>intrinsic sphincter<br>deficiency. |
| Operating principle | Aid in the placement<br>of surgical mesh | Treatment of women<br>with stress urinary<br>incontinence | Treatment of women<br>with stress urinary<br>incontinence |

The following table compares the subject and predicate device.

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| Patient contact<br>durations | < 24 hours<br>(tissue/bone) | Permanent<br>(tissue/bone) | Permanent<br>(tissue/bone) |
|------------------------------|-----------------------------------|----------------------------|----------------------------|
| Device Design | Instrumentation | Mesh | Mesh |
| Device Materials | Stainless steel,<br>polycarbonate | Woven<br>polypropylene | Woven<br>polypropylene |

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.