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.

AI/ML Overview

The provided document is a 510(k) summary for surgical instrumentation and describes performance testing for those instruments, not for an AI/ML device. Therefore, it does not contain information about acceptance criteria or studies related to AI/ML device performance.

The document discusses the following types of performance testing for the GYNECARE TVT ABBREVO™ and GYNECARE TVT™ Obturator Helical Passers and Atraumatic Winged Guide:

Sterilization validation: To demonstrate the devices are sterile to an SAL of 10^-6.
Package integrity: To ensure the sterility of the packaged devices.
Dimensional and mechanical performance: To confirm the instruments meet design specifications and can withstand intended use.
Biocompatibility: Including cytotoxicity, sensitization, and irritation tests to ensure the materials are safe for patient contact.
Shelf life: To validate the stability and performance of the devices over their intended storage period.

The document concludes that the subject devices are substantially equivalent to their predicate devices and meet the special controls outlined in 21 CFR 884.4910.

Since this document does not pertain to an AI/ML device, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML performance.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 UrologyA Division of Ethicon, Inc. a Johnson & Johnson companyP.O. Box 151Route 22 WestSomerville, NJ 08876-0151
Contact Person:	Debbie FazenManager, Regulatory AffairsPh: (908) 218-3196Fax: (908) 218-2595Email: Dfazen@its.jnj.com
Date Prepared:	August 9, 2018
Device Trade Names:	GYNECARE TVT ABBREVO™ and GYNECARE TVT™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 usewith urogynecologic surgical mesh
Product Code:	PWJ (instrumentation, surgical mesh, urogynecologic, stressurinary incontinence)

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Predicate Devices:

Device	Company	ProductCode	510(k)Number
GYNECARETVTABBREVOTMContinenceSystem (HelicalPassers andWinged Guide)	Ethicon, Inc.	OTN	K100936
GYNECARETVT ObturatorContinenceSystem (HelicalPassers andWinged 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.

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Device &PredicateDevice(s):	K181151	K100936 (TVT Abbrevo)	K033568 (TVT Obturator)
General DeviceCharacteristics
Indicationfor Use	The GYNECARETVT ABBREVOTMHelical Passers andAtraumatic WingedGuide are intended toaid in the placementof the GYNECARETVT ABBREVOTMdevice.The GYNECARETVTTM ObturatorHelical Passers andAtraumatic WingedGuide are intended toaid in the placementof the GYNECARETVTTM Obturatordevice.	The GYNECARE TVTABBREVOTM ContinenceSystem is intended for use inwomen as a suburethral slingfor the treatment of stressurinary incontinence (SUI)resulting from urethralhypermobility and/or intrinsicsphincter deficiency.	The GYNECARE TVTObturator device isintended to be used inwomen as a sub-urethralsling for the treatment ofstress urinaryincontinence (SUI)resulting from urethralhypermobility and/orintrinsic sphincterdeficiency.
Operatingprinciple	Aid in the placement ofsurgical mesh	Treatment of women withstress urinary incontinence	Treatment of womenwith stress urinaryincontinence
Patient contactdurations	< 24 hours (tissue/bone)	Permanent (tissue/bone)	Permanent(tissue/bone)
Device Design	Instrumentation	Mesh	Mesh
DeviceMaterials	Stainless steel,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.

Regulation Number and Section

§ 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.