(87 days)
Not Found
No
The device description and intended use focus on physical components (mesh, introducers, guides, passers) and their mechanical function in surgical procedures. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
Yes
The devices are explicitly intended for the "treatment" of Stress Urinary Incontinence (SUI) and related conditions, which directly indicates a therapeutic purpose.
No
These devices are intended for the treatment of Stress Urinary Incontinence by acting as a sling or aiding in the placement of the sling, not for diagnostic purposes.
No
The device description explicitly details physical components made of materials like polypropylene mesh, stainless steel, and plastic, indicating it is a hardware-based medical device system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "pubo-urethral sling" or "sub-urethral sling" for the "treatment of Stress Urinary Incontinence (SUI)". This describes a surgical implant and associated instruments used to physically support anatomical structures.
- Device Description: The device description details the materials (polypropylene mesh, stainless steel) and components (tape, sheaths, needles, introducers, guides, etc.) which are consistent with surgical devices used for implantation and placement.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant and its associated tools.
N/A
Intended Use / Indications for Use
The GYNECARE TVT Device is intended to be used as a pubo-urethral sling for treatment of Stress Urinary Incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Introducer and Rigid Catheter Guide are available separately and are intended to facilitate in the placement of the GYNECARE TVT Device.
The GYNECARE TVT Introducer is a reusable device intended to aid in the placement of the GYNECARE TVT Device retropubically.
The GYNECARE TVT 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 Device is intended to be used as a pubo-urethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Introducer and Rigid Catheter Guide are available separately and GYNECARE TVT Abdominal Guides and Couplers are included in each kit.
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 EXACT Continence System is intended to be used as a pubo-urethral sling for treatment of female Stress Urinary Incontinence, resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
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.
The GYNECARE TVT 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 EXACT Continence System.
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.
The GYNECARE TVT Obturator Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT Obturator Device.
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 ABBREVO Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT ABBREVO Device.
Product codes (comma separated list FDA assigned to the subject device)
OTN, PWJ
Device Description
GYNECARE TVT™ Device is a sterile single use device, consisting of one piece of undyed or blue (up to 0.28 weight percent phthalocyanine blue, Color Index number 74160) PROLENE™ Polypropylene Mesh (tape) approximately 1/2 inch x 18 inches (1.1 cm x 45 cm), covered by clear plastic Sheaths overlapping in the middle, and held between two stainless steel needles bonded to the mesh and sheath with plastic collars.
PROLENE Polypropylene Mesh is constructed of knitted filaments of extruded polypropylene strands identical in composition to that used in PROLENE™ Polypropylene Nonabsorbable Surgical Sutures. The mesh is approximately 0.027 inches (0.7 mm) thick. PROLENE Mesh is knitted by a process which interlinks each fiber junction.
GYNECARE TVT™ Reusable Introducer (available separately) 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™ Rigid Catheter Guide (available separately) is a non-sterile reusable stainless-steel instrument intended to facilitate the identification of the urethra and the bladder neck during the placement of the GYNECARE TVT Device and the GYNECARE TVT EXACT Continence System. It is inserted into a Foley catheter (recommended size 18 French) positioned in the bladder via the urethra.
GYNECARE TVT™ Abdominal Guide is a sterile disposable instrument intended to facilitate the passage of the GYNECARE TVT Device. Two Abdominal Guides are included in each kit with the GYNECARE TVT Couplers.
GYNECARE TVT™ Coupler is a sterile disposable polypropylene connector used to connect the GYNECARE TVT Abdominal Guide to the GYNECARE TVT Needle. Two couplers are included in each kit with Abdominal Guides.
GYNECARE TVT EXACT™ Continence System is a sterile, single patient use procedure kit consisting of:
A. GYNECARE TVT EXACT Continence System Trocar Sheath / Implant Assembly
The GYNECARE TVT EXACT™ Continence System Trocar Sheath / Implant Assembly consists of one piece of blue (up to 0.28 weight percent phthalocyanine blue, Color Index number 74160) PROLENE™ Polypropylene Mesh (Implant) approximately 1/2 inch x 18 inches (1.1 cm x 45 cm), covered by clear plastic Sheaths and overlapping in the middle, and held between two white Trocar Sheaths, which are bonded to the Implant and Implant Sheath. PROLENE Propylene Mesh is constructed of knitted filaments of extruded polypropylene strands identical in composition to that used in PROLENE™ Polypropylene Nonabsorbable Surgical Sutures. The Implant is approximately 0.027 inches (0.7 mm) thick. PROLENE Mesh is knitted by a process which interlinks each fiber junction.
B. 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.
The GYNECARE TVT™ Obturator System is a sterile, single patient use procedure kit consisting of:
A. GYNECARE TV Obturator Device
The GYNECARE TV Obturator Device consisting of one piece of undyed or blue (up to 0.28 weight percent phthalocyanine blue, Color Index 74160) PROLENE™ polypropylene mesh (tape) approximately 1/2 inch x 18 inches (1.1 cm x 45 cm), covered by clear plastic sheath overlapping in the middle. Plastic tube receptacles are attached at each end.
PROLENE Propylene Mesh is constructed of knitted filaments of extruded polypropylene strands identical in composition to that used in PROLENE Polypropylene Non-absorbable Surgical Suture. The implant is approximately 0.027 inches (0.7 mm) thick.
B. GYNECARE TVT™ Obturator Helical Passers and Atraumatic Winged Guide
GYNECARE TVT™ Obturator Helical Passers are two stainless steel, curved wire passers with plastic handles that are designed to deliver the GYNECARE TVT Obturator Device. Helical Passers are provided as left and right units, pre-assembled to the GYNECARE TVT Obturator Device.
GYNECARE TVT™ Obturator Atraumatic Winged Guide is a stainless steel accessory instrument, which facilitates the passage of the GYNECARE TVT Helical Passers through the dissection tract.
GYNECARE TVT ABBREVO™ Continence System is a sterile, single-patient use procedure kit consisting of:
A. GYNECARE TVT ABBREVO Implant Assembly
The GYNECARE TVT ABBREVO Implant Assembly consists of one piece of blue (up to 0.28 weight percent phthalocyanine blue, Color Index number 74160) PROLENE™ Polypropylene Mesh (Implant), approximately 1/2 inch x 4.7 inches (1.1 cm x 12 cm), covered by clear plastic Sheaths and held between two Helical Passer Sheaths (white polyethylene tube receptacles). The Helical Passer Sheaths are bonded to the mesh implant sheaths and the Positioning Lines (PROLENE™ Polypropylene Monofilament). PROLENE is constructed of knitted monofilaments of extruded polypropylene, identical in composition to that used in PROLENE™ Polypropylene Nonabsorbable Surgical Sutures. The Implant is approximately 0.027 inches (0.7 mm) thick.
B. GYNECARE TVT ABBREVO Placement Loop
The GYNECARE TVT ABBREVO Placement Loop is a sterile, single-patient use device consisting of a loop of PROLENE Polypropylene Monofilament with an attached polypropylene button. This loop and button are pre-assembled as part of the GYNECARE TVT ABBREVO Implant Assembly at the center of the mesh to aid in symmetric placement of the mesh.
C. GYNECARE TVT ABBREVO™ Helical Passers and Atraumatic Winged Guide
GYNECARE TVT ABBREVO™ Helical Passers are two stainless steel, curved wire passers with plastic handles that are designed to deliver the GYNECARE TVT ABBREVO Implant. The Helical Passers are provided as left and right units, pre-assembled to the GYNECARE TVT ABBREVO Implant Assembly.
GYNECARE TVT ABBREVO™ Atraumatic Winged Guide is a stainless steel accessory instrument which facilitates consistent passage of the GYNECARE TVT ABBREVO Helical Passers through the dissection tract. The Winged Guide is marked with an Insertion Zone to aid the surgeon's assessment of inserted depth. The Insertion Zone indicates a distance of 3 cm to 4 cm from the tip of the Winged Guide.
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)
No performance data are needed to evaluate these labeling changes.
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.
K012628, K173019, K173162, K132054, K033568, K181151, K100936
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
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 17, 2020
Ethicon, Inc. Ariell Joiner Regulatory Affairs Specialist III Route 22 West Somerville, NJ 08876-0151
Re: K201686
Trade/Device Name: GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVTTM Obturator System and Passers and Winged Guide. GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide
Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: OTN, PWJ Dated: June 19, 2020 Received: June 22, 2020
Dear Ariell Joiner:
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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Sharon M. Andrews Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201686
Device Name
GYNECARE TVT™ System. GYNECARE TVT™ with Abdominal Guides System. GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide
Indications for Use (Describe)
The GYNECARE TVT Device is intended to be used as a pubo-urethral sling for treatment of Stress Urinary Incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Introducer and Rigid Catheter Guide are available separately and are intended to facilitate in the placement of the GYNECARE TVT Device.
The GYNECARE TVT Device is intended to be used as a pubo-urethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Introducer and Rigid Catheter Guide are available separately and GYNECARE TVT Abdominal Guides and Couplers are included in each kit.
The GYNECARE TVT Introducer is a reusable device intended to aid in the placement of the GYNECARE TVT Device retropubically.
The GYNECARE TVT 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 GYNECARE TVT EXACT Continence System is intended to be used as a pubo-urethral sling for treatment of female Stress Urinary Incontinence, resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
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.
The GYNECARE TVT 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 EXACT Continence System.
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.
The GYNECARE TVT Obturator Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT Obturator Device.
The GYNECARE TVT ABBREVO Continence System is intended for use in women as a sub-urethral sling for the treatment of SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The GYNECARE TVT ABBREVO Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT ABBREVO 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)
3
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4
510(k) Summary
| Submitter: | Ethicon, Inc. a Johnson & Johnson company
P.O. Box 151
Route 22 West
Somerville, NJ 08876-0151 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ariell Joiner
Regulatory Affairs Specialist
Phone: 908-218-2348
Fax: 908-218-2595
Email: ajoiner@its.jnj.com |
| Date Prepared: | September 16, 2020 |
Urogynecologic Surgical Mesh Systems and Surgical Instruments
| Device Trade Name: | GYNECARE TVTTM System
GYNECARE TVTTM with Abdominal Guides System
GYNECARE TVTTM Introducer and Catheter Guide
GYNECARE TVT EXACTTM Continence System and Trocar
GYNECARE TVTTM Obturator System and Passers and Winged Guide
GYNECARE TVT ABBREVOTM Continence System and Passers and
Winged Guide |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary
Incontinence, Retropubic Or Transobturator
Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary
Incontinence |
| Class: | II |
| Classification: | 21 CFR 878.3300 - Surgical mesh |
| Product Code: | OTN and PWJ |
| Panel: | General and Plastic Surgery Devices |
Predicate Devices:
| Device | Meshes | Instruments | ||
|---|---|---|---|---|
| Product Code | 510(k) | Product Code | 510(k) | |
| GYNECARE TVT™ Tension-free | ||||
| Vaginal Tape (TVT System) | OTN | K012628 | PWJ | K173019 |
| GYNECARE TVT™ Reusable | ||||
| Introducer | Not Applicable | |||
| (Reusable Instruments only) | PWJ | K173019 | ||
| PWJ | K173162 |
5
| Device | Meshes | Instruments | ||
|---|---|---|---|---|
| Product Code | 510(k) | Product Code | 510(k) | |
| GYNECARE TVTTM Reusable Rigid | ||||
| Catheter Guide | Not Applicable | |||
| (Reusable Instruments only) | PWJ | K173019 | ||
| PWJ | K173162 | |||
| GYNECARE TVTTM with Abdominal | ||||
| Guides Tension-Free Support for | ||||
| Incontinence System | OTN | K012628 | PWJ | K173162 |
| GYNECARE TVT EXACTTM | ||||
| Continence System | OTN | K132054 | PWJ | K173019 |
| GYNECARE TVTTM Obturator | ||||
| System | OTN | K033568 | PWJ | K181151 |
| GYNECARE TVT ABBREVOTM | ||||
| Continence System | OTN | K100936 | PWJ | K181151 |
Device Description:
GYNECARE TVT™ Tension-free Vaginal Tape System
GYNECARE TVT™ Device is a sterile single use device, consisting of one piece of undyed or blue (up to 0.28 weight percent phthalocyanine blue, Color Index number 74160) PROLENE™ Polypropylene Mesh (tape) approximately 1/2 inch x 18 inches (1.1 cm x 45 cm), covered by clear plastic Sheaths overlapping in the middle, and held between two stainless steel needles bonded to the mesh and sheath with plastic collars.
PROLENE Polypropylene Mesh is constructed of knitted filaments of extruded polypropylene strands identical in composition to that used in PROLENE™ Polypropylene Nonabsorbable Surgical Sutures. The mesh is approximately 0.027 inches (0.7 mm) thick. PROLENE Mesh is knitted by a process which interlinks each fiber junction.
GYNECARE TVT™ Reusable Introducer (available separately) 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.
6
GYNECARE TVT™ Rigid Catheter Guide (available separately) is a non-sterile reusable stainless-steel instrument intended to facilitate the identification of the urethra and the bladder neck during the placement of the GYNECARE TVT Device and the GYNECARE TVT EXACT Continence System. It is inserted into a Foley catheter (recommended size 18 French) positioned in the bladder via the urethra.
GYNECARE TVT™ with Abdominal Guides Tension-free Support for Incontinence System
GYNECARE TVT™ Abdominal Guide is a sterile disposable instrument intended to facilitate the passage of the GYNECARE TVT Device. Two Abdominal Guides are included in each kit with the GYNECARE TVT Couplers.
GYNECARE TVT™ Coupler is a sterile disposable polypropylene connector used to connect the GYNECARE TVT Abdominal Guide to the GYNECARE TVT Needle. Two couplers are included in each kit with Abdominal Guides.
GYNECARE TVT EXACT™ Continence System
GYNECARE TVT EXACT™ Continence System is a sterile, single patient use procedure kit consisting of:
A. GYNECARE TVT EXACT Continence System Trocar Sheath / Implant Assembly
The GYNECARE TVT EXACT™ Continence System Trocar Sheath / Implant Assembly consists of one piece of blue (up to 0.28 weight percent phthalocyanine blue, Color Index number 74160) PROLENE™ Polypropylene Mesh (Implant) approximately 1/2 inch x 18 inches (1.1 cm x 45 cm), covered by clear plastic Sheaths and overlapping in the middle, and held between two white Trocar Sheaths, which are bonded to the Implant and Implant Sheath. PROLENE Propylene Mesh is constructed of knitted filaments of extruded polypropylene strands identical in composition to that used in PROLENE™ Polypropylene Nonabsorbable Surgical Sutures. The Implant is approximately 0.027 inches (0.7 mm) thick. PROLENE Mesh is knitted by a process which interlinks each fiber junction.
B. 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.
GYNECARE TVT™ Obturator System
The GYNECARE TVT™ Obturator System is a sterile, single patient use procedure kit consisting
7
A. GYNECARE TVT Obturator Device
The GYNECARE TV Obturator Device consisting of one piece of undyed or blue (up to 0.28 weight percent phthalocyanine blue, Color Index 74160) PROLENE™ polypropylene mesh (tape) approximately 1/2 inch x 18 inches (1.1 cm x 45 cm), covered by clear plastic sheath overlapping in the middle. Plastic tube receptacles are attached at each end.
PROLENE Propylene Mesh is constructed of knitted filaments of extruded polypropylene strands identical in composition to that used in PROLENE Polypropylene Non-absorbable Surgical Suture. The implant is approximately 0.027 inches (0.7 mm) thick.
B. GYNECARE TVT™ Obturator Helical Passers and Atraumatic Winged Guide
GYNECARE TVT™ Obturator Helical Passers are two stainless steel, curved wire passers with plastic handles that are designed to deliver the GYNECARE TVT Obturator Device. Helical Passers are provided as left and right units, pre-assembled to the GYNECARE TVT Obturator Device.
GYNECARE TVT™ Obturator Atraumatic Winged Guide is a stainless steel accessory instrument, which facilitates the passage of the GYNECARE TVT Helical Passers through the dissection tract.
GYNECARE TVT ABBREVO™ Continence System
GYNECARE TVT ABBREVO™ Continence System is a sterile, single-patient use procedure kit consisting of:
A. GYNECARE TVT ABBREVO Implant Assembly
The GYNECARE TVT ABBREVO Implant Assembly consists of one piece of blue (up to 0.28 weight percent phthalocyanine blue, Color Index number 74160) PROLENE™ Polypropylene Mesh (Implant), approximately 1/2 inch x 4.7 inches (1.1 cm x 12 cm), covered by clear plastic Sheaths and held between two Helical Passer Sheaths (white polyethylene tube receptacles). The Helical Passer Sheaths are bonded to the mesh implant sheaths and the Positioning Lines (PROLENE™ Polypropylene Monofilament). PROLENE is constructed of knitted monofilaments of extruded polypropylene, identical in composition to that used in PROLENE™ Polypropylene Nonabsorbable Surgical Sutures. The Implant is approximately 0.027 inches (0.7 mm) thick.
B. GYNECARE TVT ABBREVO Placement Loop
The GYNECARE TVT ABBREVO Placement Loop is a sterile, single-patient use device consisting of a loop of PROLENE Polypropylene Monofilament with an attached polypropylene button. This loop and button are pre-assembled as part of the GYNECARE TVT ABBREVO Implant Assembly at the center of the mesh to aid in symmetric placement of the mesh.
of:
8
C. GYNECARE TVT ABBREVO™ Helical Passers and Atraumatic Winged Guide
GYNECARE TVT ABBREVO™ Helical Passers are two stainless steel, curved wire passers with plastic handles that are designed to deliver the GYNECARE TVT ABBREVO Implant. The Helical Passers are provided as left and right units, pre-assembled to the GYNECARE TVT ABBREVO Implant Assembly.
GYNECARE TVT ABBREVO™ Atraumatic Winged Guide is a stainless steel accessory instrument which facilitates consistent passage of the GYNECARE TVT ABBREVO Helical Passers through the dissection tract. The Winged Guide is marked with an Insertion Zone to aid the surgeon's assessment of inserted depth. The Insertion Zone indicates a distance of 3 cm to 4 cm from the tip of the Winged Guide.
Indications for Use:
The GYNECARE TVT Device is intended to be used as a pubo-urethral sling for treatment of Stress Urinary Incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Introducer and Rigid Catheter Guide are available separately and are intended to facilitate in the placement of the GYNECARE TVT Device.
The GYNECARE TVT Introducer is a reusable device intended to aid in the placement of the GYNECARE TVT Device retropubically.
The GYNECARE TVT 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 Device is intended to be used as a pubo-urethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Introducer and Rigid Catheter Guide are available separately and GYNECARE TVT Abdominal Guides and Couplers are included in each kit.
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 EXACT Continence System is intended to be used as a pubo-urethral sling for treatment of female Stress Urinary Incontinence, resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
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.
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The GYNECARE TVT 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 EXACT Continence System.
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.
The GYNECARE TVT Obturator Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT Obturator Device.
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 ABBREVO Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT ABBREVO Device.
The subject devices and their respective predicate devices have the same intended use.
Summary of Technological Characteristics:
The subject devices and their respective predicate devices are identical and therefore have the same technological characteristics.
Substantial Equivalence Discussion:
The subject devices differ from their respective predicate devices only in the labeling (Instructions for Use). The Instructions for Use of the subject devices have been revised to meet the new European Union (EU) Medical Device Regulation (MDR) requirements and include new sections to the Instructions or Use and clarifications throughout various existing sections of the Instructions for Use including additional warnings, adverse events, safety information, and information to be conveyed to patients. There are also minor clarifications to the Indications and Contraindications statements, and no changes to the single-use and reusable designations and patient populations. No performance data are needed to evaluate these labeling changes.
Conclusion:
Based on the intended use, fundamental scientific technology, and technological characteristics, the subject devices are substantially equivalent to their respective predicate devices.