(101 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or related concepts.
No.
The device (Helical Passers and Winged Guide) is an accessory instrument intended to aid in the placement of another device (GYNECARE TVT ABBREVO™ or GYNECARE TVT™ Obturator device), which itself is likely the therapeutic device (an implant). The described device is not directly involved in treating or preventing a disease or condition.
No
The device is described as an aid for placing another medical device (GYNECARE TVT ABBREVO™ & GYNECARE TVT™ Obturator Implant). Its description focuses on mechanical function (curved wire passers, accessory instrument for consistent passage), and the performance studies listed are related to sterility, mechanical performance, and biocompatibility, not diagnostic capabilities.
No
The device description explicitly details physical components made of stainless steel and plastic, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aid in the placement of the GYNECARE TVT ABBREVO™ device" and "aid in the placement of the GYNECARE TVT™ Obturator device." This describes a surgical instrument used to facilitate the implantation of another medical device.
- Device Description: The description details stainless steel instruments (passers and a guide) designed to deliver an implant. This aligns with surgical tools, not devices used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, or providing diagnostic information. The device's function is purely mechanical and procedural.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes
PWJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance tests were completed on the subject devices:
- Sterilization validation
- Package integrity
- Dimensional and mechanical performance
- Biocompatibility
- Cytotoxicity
- Sensitization
- 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, and have a validated shelf life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
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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3
510(k) Summary
| Submitter: | Ethicon Women's Health and Urology
A Division of Ethicon, Inc. a Johnson & Johnson company
P.O. Box 151
Route 22 West
Somerville, NJ 08876-0151 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Debbie Fazen
Manager, Regulatory Affairs
Ph: (908) 218-3196
Fax: (908) 218-2595
Email: 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 use
with urogynecologic surgical mesh |
| Product Code: | PWJ (instrumentation, surgical mesh, urogynecologic, stress
urinary incontinence) |
4
Predicate Devices:
| Device | Company | Product
Code | 510(k)
Number |
|---------------------------------------------------------------------------------------------------|---------------|-----------------|------------------|
| GYNECARE
TVT
ABBREVO
TM
Continence
System (Helical
Passers and
Winged Guide) | Ethicon, Inc. | OTN | K100936 |
| GYNECARE
TVT Obturator
Continence
System (Helical
Passers and
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.
5
| Device &
Predicate
| Device(s): | K181151 | K100936 (TVT Abbrevo) | K033568 (TVT Obturator) |
|---|---|---|---|
| General Device | |||
| Characteristics | |||
| Indication | |||
| for Use | The GYNECARE | ||
| TVT ABBREVOTM | |||
| Helical Passers and | |||
| Atraumatic Winged | |||
| Guide are intended to | |||
| aid in the placement | |||
| of the GYNECARE | |||
| TVT ABBREVOTM | |||
| device. | |||
| The GYNECARE | |||
| TVTTM Obturator | |||
| Helical Passers and | |||
| Atraumatic Winged | |||
| Guide are intended to | |||
| aid in the placement | |||
| of the GYNECARE | |||
| TVTTM Obturator | |||
| device. | The GYNECARE TVT | ||
| ABBREVOTM Continence | |||
| System is intended for use in | |||
| women as a suburethral sling | |||
| for the treatment of stress | |||
| urinary incontinence (SUI) | |||
| resulting from urethral | |||
| hypermobility and/or intrinsic | |||
| sphincter deficiency. | The GYNECARE TVT | ||
| Obturator device 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. | |||
| Operating | |||
| principle | Aid in the placement of | ||
| surgical mesh | Treatment of women with | ||
| stress urinary incontinence | Treatment of women | ||
| with stress urinary | |||
| incontinence | |||
| Patient contact | |||
| durations |