GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System

K181151 · ETHICON, Inc. · PWJ · Aug 10, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K181151
• Device Name: GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System
• Applicant: ETHICON, Inc.
• Product Code: PWJ · Obstetrics/Gynecology
• Decision Date: Aug 10, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4910
• Device Class: Class 2

Intended Use

The Gynecare TVT ABBREVO™ Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT ABBREVO™ device. The Gynecare TVT™ Obturator Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT™ Obturator device.

Device Story

Device consists of stainless steel helical passers with plastic handles and stainless steel winged guide; used as surgical instrumentation to facilitate placement of suburethral sling implants. Passers are provided pre-assembled to the implant assembly; winged guide facilitates consistent passage through dissection tract. Used in clinical/surgical setting by physicians during urogynecologic procedures. Output is physical guidance of surgical mesh placement; aids surgeon in achieving correct anatomical positioning of sling to treat stress urinary incontinence. Benefits patient by enabling precise, consistent delivery of incontinence treatment device.

Clinical Evidence

Bench testing only. Testing included sterilization validation, package integrity, dimensional and mechanical performance, biocompatibility (cytotoxicity, sensitization, irritation), and shelf-life. Results confirmed devices are sterile (SAL 10^-6), biocompatible, and possess sufficient mechanical performance for intended use.

Technological Characteristics

Materials: stainless steel, polycarbonate. Form factor: curved wire passers with plastic handles and winged guide accessory. Principle: mechanical surgical instrumentation for mesh delivery. Sterilization: validated method to SAL 10^-6.

Indications for Use

Indicated for use as surgical instrumentation to aid in the placement of GYNECARE TVT ABBREVO™ and GYNECARE TVT™ Obturator suburethral sling devices in women.

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 ABBREVO™ Continence System (K100936)
• GYNECARE TVT Obturator Continence System (K033568)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

August 10, 2018

Ethicon, Inc. Debbie Fazen, Ph.D. Senior RA Program Lead Route 22 West Somerville, NJ 08876

Re: K181151

Trade/Device Name: GYNECARE TVT ABBREVO™ and GYNECARE TVT™ Obturator Helical Passers and Atraumatic Winged Guide Regulation Number: 21 CFR& 884.4910 Regulation Name: Specialized Surgical Instrumentation for use with Urogynecologic Surgical Mesh Regulatory Class: II Product Code: PWJ Dated: July 11, 2018 Received: July 12, 2018

Dear Debbie Fazen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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,

Signature

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) K181151

Device Name

GYNECARE TVT ABBREVO™ and GYNECARE TVT™ Obturator Helical Passers and Atraumatic Winged Guide

Indications for Use (Describe)

The Gynecare TVT ABBREVO™ Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT ABBREVO™ device.

The Gynecare TVT™ Obturator Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT™ Obturator device.

| 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) |

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# 510(k) Summary

| 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: | Debbie Fazen<br>Manager, Regulatory Affairs<br>Ph: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | August 9, 2018 |
| Device Trade Names: | GYNECARE TVT ABBREVO™ and GYNECARE TVT™<br>Obturator Helical Passers and Atraumatic Winged Guide |
| Common Names: | Specialized urogynecological surgical mesh instrumentation |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 884.4910 – Specialized surgical instrumentation for use<br>with urogynecologic surgical mesh |
| Product Code: | PWJ (instrumentation, surgical mesh, urogynecologic, stress<br>urinary incontinence) |

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### Predicate Devices:

| Device | Company | Product<br>Code | 510(k)<br>Number |
|---------------------------------------------------------------------------------------------------|---------------|-----------------|------------------|
| GYNECARE<br>TVT<br>ABBREVO<br>TM<br>Continence<br>System (Helical<br>Passers and<br>Winged Guide) | Ethicon, Inc. | OTN | K100936 |
| GYNECARE<br>TVT Obturator<br>Continence<br>System (Helical<br>Passers and<br>Winged Guide) | Ethicon, Inc. | OTN | K033568 |

The predicate devices have not been subject to a design related recall.

### Device Description

The GYNECARE TVT ABBREVO™ Continence System is intended for use in women as a suburethral sling for the treatment of SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The GYNECARE TVT™ Obturator System is intended to be used in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Helical Passers are two stainless steel, curved wire passers with plastic handles that are designed to deliver the GYNECARE TVT ABBREVO™ & GYNECARE TVT™ Obturator Implant. The Helical Passers are provided as left and right units, pre-assembled to the GYNECARE TVT ABBREVO™ & GYNECARE TVT™ Obturator Implant Assembly.

The Winged Guide is a stainless steel accessory instrument that facilitates consistent passage of the GYNECARE TVT ABBREVO™ & GYNECARE TVT™ Obturator Implant Assembly through the dissection tract.

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| Device &<br>Predicate<br>Device(s): | K181151 | K100936 (TVT Abbrevo) | K033568 (TVT Obturator) |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Device<br>Characteristics | | | |
| Indication<br>for Use | The GYNECARE<br>TVT ABBREVOTM<br>Helical Passers and<br>Atraumatic Winged<br>Guide are intended to<br>aid in the placement<br>of the GYNECARE<br>TVT ABBREVOTM<br>device.<br>The GYNECARE<br>TVTTM Obturator<br>Helical Passers and<br>Atraumatic Winged<br>Guide are intended to<br>aid in the placement<br>of the GYNECARE<br>TVTTM Obturator<br>device. | The GYNECARE TVT<br>ABBREVOTM Continence<br>System is intended for use in<br>women as a suburethral sling<br>for the treatment of stress<br>urinary incontinence (SUI)<br>resulting from urethral<br>hypermobility and/or intrinsic<br>sphincter deficiency. | The GYNECARE TVT<br>Obturator device is<br>intended to be used in<br>women as a sub-urethral<br>sling for the treatment of<br>stress urinary<br>incontinence (SUI)<br>resulting from urethral<br>hypermobility and/or<br>intrinsic sphincter<br>deficiency. |
| Operating<br>principle | Aid in the placement of<br>surgical mesh | Treatment of women with<br>stress urinary incontinence | Treatment of women<br>with stress urinary<br>incontinence |
| Patient contact<br>durations | < 24 hours (tissue/bone) | Permanent (tissue/bone) | Permanent<br>(tissue/bone) |
| Device Design | Instrumentation | Mesh | Mesh |
| Device<br>Materials | Stainless steel,<br>polycarbonate | Woven polypropylene | Woven polypropylene |

## Comparison of Indication for Use and Technological Characteristics

The indications for use statements for the subject device and the predicate device are not identical, as the predicate device is a surgical mesh that is indicated for stress urinary incontinence. The intended use of the subject and predicate device is the same, as the subject device is an accessory to a 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, shelflife/reprocessing, labeling, and sterilization) published in the final order reclassifying

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### Summary of Performance Testing

The following performance tests were completed on the subject devices:

- Sterilization validation ●
- . Package integrity
- Dimensional and mechanical performance ●
- . Biocompatibility
- Cytotoxicity O
- Sensitization O
- Irritation o
- 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, and have a validated shelf life.

### 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.