(272 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, sterilization, and reprocessing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The devices described are instruments (guides, introducers, and couplers) designed to facilitate the surgical placement of a separate therapeutic device (the "GYNECARE TVT™ sling") used to treat stress urinary incontinence. They do not directly confer therapeutic benefit themselves.
No
The described devices (Abdominal Guides and Couplers, Reusable Introducer, Reusable Rigid Catheter Guide) are surgical instruments designed to facilitate the placement of the GYNECARE TVT™ device (a sling for stress urinary incontinence), rather than to diagnose a condition. Their intended use is to aid in a surgical procedure, not to identify or monitor a medical condition.
No
The device description explicitly lists physical components made of stainless steel and polypropylene, and the performance studies focus on sterilization, reprocessing, mechanical performance, and biocompatibility, all indicative of hardware devices.
Based on the provided text, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly describes the devices as being used to facilitate the placement of a surgical device (the GYNECARE TVT™ sling) within the body to treat stress urinary incontinence. This is a surgical procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The descriptions detail instruments used for surgical manipulation and guidance during a procedure. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) which is the hallmark of an IVD.
- Performance Studies: The performance studies listed (sterilization, reprocessing, mechanical performance, biocompatibility, etc.) are typical for surgical instruments and implants, not for diagnostic tests.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The devices described here are surgical tools used during a procedure on the body.
N/A
Intended Use / Indications for Use
The GYNECARE TVT™ Abdominal Guides and Couplers are single use devices used to facilitate placement of the GYNECARE TVT™ device when placed in a top-down retropubic fashion (also known as an abdominal approach).
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.
Product codes (comma separated list FDA assigned to the subject device)
PWJ
Device Description
The subject devices included the following components:
GYNECARE TVT™ Reusable Introducer
GYNECARE TVT™ Reusable Rigid Catheter Guide
GYNECARE TVT™ Abdominal Guides and Couplers
The subject devices are intended to be used with the GYNECARE TVT™ sling 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 needle, via 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 Foley catheter (recommended size 18 French) positioned in the bladder via the urethra. To facilitate insertion, it can be lubricated with gel.
GYNECARE TVT™ Abdominal Guide
The GYNECARE TVT abdominal guide is a sterile disposable instrument intended to facilitate passage of the GYNECARE TVT device. Two abdominal guides are included in each kit with the GYNECARE TVT couplers.
GYNECARE TVT™ Coupler
The GYNECARE TVT coupler is a sterile disposable polypropylene connector used to connect the GYNECARE TVT abdominal quide to the GYNECARE TVT needle. Two couplers are included in each kit with abdominal quides.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra and bladder neck
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
- 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 10th, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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June 28, 2018
Ethicon, Inc Julie Tom Wing Senior Regulatory Affairs Program Lead P.O. Box 151, Route 22 West Somerville, New Jersey 08876
Re: K173162
Trade/Device Name: GYNECARE TVT™ Abdominal Guides and Couplers, GYNECARE TVT™ Reusable Introducer, GYNECARE TVT™ Reusable Rigid Catheter Guide Regulation Number: 21 CFR 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: May 29, 2018
Dear Julie Tom Wing:
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 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 (QS) regulation (21 CFR Part 820);
1
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 medical devices and radiation-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,
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) K173162
Device Name
GYNECARE TVT™ Abdominal Guides and Couplers, GYNECARE TVT™ Reusable Introducer, GYNECARE TVT™ Reusable Rigid Catheter Guide
Indications for Use (Describe)
The GYNECARE TVT™ Abdominal Guides and Couplers are single use devices used to facilitate placement of the GYNECARE TVT™ device when placed in a top-down retropubic fashion (also known as an abdominal approach).
The GYNECARE TVT™ Reusable Introducer is a reusable device intended to aid in the placement of the GYNECARE TVTTM 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.
| 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 – K173162
| 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: | Julie Tom Wing, M.S. |
| Senior Regulatory Affairs Program Lead | |
| Ph: (908) 218-5648 | |
| Fax: (908) 218-2595 | |
| Email: jtomwing@its.jnj.com | |
| Date Prepared: | June 27, 2018 |
| Device Trade Name: | GYNECARE TVT™ Abdominal Guides and Couplers |
| GYNECARE TVT™ Reusable Introducer | |
| GYNECARE TVT™ Reusable Rigid Catheter Guide | |
| Common Name: | Specialized urogynecologic surgical mesh |
| instrumentation | |
| Regulation Name: | Specialized surgical instrumentation for use with |
| urogynecologic surgical mesh | |
| Regulation Number: | 21 CFR 884.4910 |
| Regulatory Class: | II |
| Product Code: | PWJ (instrumentation, surgical mesh, urogynecologic |
| stress urinary incontinence) |
4
Predicate Device:
GYNECARE TVT™, Ethicon Women's Health and Urology, 510(k) K012628.
The predicate device has not been subject to a design related recall.
Device Description
The subject devices included the following components:
GYNECARE TVT™ Reusable Introducer
GYNECARE TVT™ Reusable Rigid Catheter Guide
GYNECARE TVT™ Abdominal Guides and Couplers
The subject devices are intended to be used with the GYNECARE TVT™ sling 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 needle, via 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 Foley catheter (recommended size 18 French) positioned in the bladder via the urethra. To facilitate insertion, it can be lubricated with gel.
GYNECARE TVT™ Abdominal Guide
The GYNECARE TVT abdominal guide is a sterile disposable instrument intended to facilitate passage of the GYNECARE TVT device. Two abdominal guides are included in each kit with the GYNECARE TVT couplers.
GYNECARE TVT™ Coupler
The GYNECARE TVT coupler is a sterile disposable polypropylene connector used to connect the GYNECARE TVT abdominal quide to the GYNECARE TVT needle. Two couplers are included in each kit with abdominal quides.
5
Indications for Use
The GYNECARE TVT™ Abdominal Guides and Couplers are single use devices used to facilitate placement of the GYNECARE TVT™ device when placed in a top-down retropubic fashion (also known as an abdominal approach).
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.
Summary of Substantial Equivalence Comparison
| Device & Predicate Device(s): | K173162 | K012628 |
|---|---|---|
| Indications for Use Statement | 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. | ||
| The GYNECARE TVT | ||
| Abdominal Guides and | ||
| Couplers are single | ||
| use devices used to | ||
| facilitate placement of | ||
| the GYNECARE TVT | ||
| Device when placed in | ||
| a top-down retropubic | ||
| fashion (also known as | ||
| an abdominal | ||
| approach). | The TVT device is | |
| intended to be used as | ||
| a pubourethral sling | ||
| indicated for treatment | ||
| of stress urinary | ||
| incontinence (SUI) for | ||
| female urinary | ||
| incontinence resulting | ||
| from urethral | ||
| hypermobility and/or | ||
| intrinsic sphincter | ||
| deficiency. The TVT | ||
| introducer, rigid | ||
| catheter guide and | ||
| TVT abdominal guides | ||
| and couplers are | ||
| accessories intended | ||
| to facilitate placement | ||
| of the TVT device. |
The following table compares the subject and predicate device.
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| Operating Principle | Aid in placement of
surgical mesh | Treatment of women
with stress urinary
incontinence |
|--------------------------|---------------------------------------------------|-----------------------------------------------------------|
| Patient Contact Duration |