(51 days)
The GYNECARE TVT EXACT™ Continence System is intended to be used as a pubourethral sling for treatment of female Stress Urinany Incontinence, resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The GYNECARE TVT EXACT™ Continence System consists of the following sterile, single-use components: GYNECARE TVT EXACT™ Continence System Trocar and Trocar Sheath / Implant Assembly.
The GYNECARE TVT EXACT™ Continence System Trocar Sheath / Implant Assembly consists of one piece of PROLENE™ Polypropylene Mesh (Implant) approximately 1/2 inch (1.1 cm) wide, 18 inches (45 cm) long, and approximately 0.027 inches (0.7 mm) thick. The implant is covered by a clear plastic Implant Sheath and held between two white Trocar Sheaths , which are bonded to the Implant and Implant Sheath.
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.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance for GYNECARE TVT EXACT™ Continence System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Established performance requirements (for Trocar Assembly Tip Bending Strength Testing) | "Design Verification Testing Results (Trocar Assembly Tip Bending Strength Testing) indicates that modified device meets the established performance requirements." |
| No unintended impact within actual or simulated field use environments (for proposed changes to the device) | "Design Validation outcome confirms that the proposed changes do not have an unintended impact within actual or simulated field use environments in a mover consistent with the Instructions for Use of GYNECARE TVT EXACT™ and the surgeon's usual technique." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing described is "Design Verification Testing" and "Design Validation," which typically involves engineering tests rather than clinical data from human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the document. The "tests" described are related to the physical and functional aspects of the medical device (trocar assembly tip bending strength and impact of design changes in simulated or actual field use, but not specific for human outcome) and do not involve expert interpretation or ground truth establishment in the traditional sense of diagnostic or AI performance evaluation.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. This is expected given the nature of the design verification and validation tests performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not conducted as described in the provided text. The document focuses on the substantial equivalence of the modified device to a predicate device based on design verification and validation, not on evaluating human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study, in the context of an algorithm's performance without human-in-the-loop, was not conducted as described in the provided text. The device is a physical surgical implant and delivery system, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for the tests mentioned appears to be based on engineering specifications and established performance requirements for the device components (e.g., bending strength) and the intended functional outcome of the device in a simulated or actual use environment. This is not "expert consensus, pathology, or outcomes data" in the typical sense of evaluating diagnostic algorithms.
8. Sample Size for the Training Set
The document does not mention a "training set" or its sample size. This is because the device is a physical medical device, not an AI system that requires a training set for model development.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of medical device, the establishment of its "ground truth" is not applicable.
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Summary of Safety and Effectiveness
Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below.
Submitted by:
Susan Lin Manager, Regulatory Affairs Ethicon, Inc., a Johnson & Johnson Company Route 22 West, PO Box 151 Somerville, NJ 08876
AUG 2 3 2013
Name/Classification of Device:
Class II in 21 CFR § 878.3300, Surgical Mesh (OTN)
Trade Name:
GYNECARE TVT EXACT™ Continence System
Predicate Devices:
GYNECARE TVT EXACT™ Continence System (K100485), ETHICON, Inc.
Statement of Intended Use:
The GYNECARE TVT EXACT™ Continence System is intended to be used as a pubourethral sling for treatment of female Stress Urinany Incontinence, resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Device Description:
The GYNECARE TVT EXACT™ Continence System consists of the following sterile, single-use components: GYNECARE TVT EXACT™ Continence System Trocar and Trocar Sheath / Implant Assembly.
The GYNECARE TVT EXACT™ Continence System Trocar Sheath / Implant Assembly consists of one piece of PROLENE™ Polypropylene Mesh (Implant) approximately 1/2 inch (1.1 cm) wide, 18 inches (45 cm) long, and approximately 0.027 inches (0.7 mm) thick. The implant is covered by a clear plastic Implant Sheath and held between two white Trocar Sheaths , which are bonded to the Implant and Implant Sheath.
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.
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Summary of Technological Characteristics of Modified Device to Predicate Devices:
The principle of operation and fundamental scientific technology of the modified device are equivalent to the predicate device. They function in the same manner - Introducing a retropubic synthetic mesh sling in the patient from a vaginal incision to the abdominal skin that provides mid-urethral support.
Performance Data:
Design Verification Testing Results (Trocar Assembly Tip Bending Strength Testing) indicates that modified device meets the established performance requirements.
Design Validation outcome confirms that the proposed changes do not have an unintended impact within actual or simulated field use environments in a mover consistent with the Instructions for Use of GYNECARE TVT EXACT™ and the surgeon's usual technique.
Conclusions:
Based on the similarities to the predicate device identified in this submission as well as the outcome of design verification and design validationwe conclude that the modified device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 23. 2013
Ethicon, Inc. Ethicon Women's Health & Urology % Susan Lin Manager, Regulatory Affairs Route 22 West, P.O. Box 151 Somerville, NJ 08876
K132054 Re:
Trade/Device Name: Gynecare TVT Exact™ Continence System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OTN Dated: July 25, 2013 Received: July 26, 2013
Dear Susan Lin:
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
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Page 2 - Susan Lin
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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
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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510(k) Number (if known): K132054
Device Name: GYNECARE TVT EXACT™ Continence System
Indications for Use:
The GYNECARE TVT EXACT™ Continence System is intended to be used as a pubourethral sling for treatment of female Stress Urinary Incontinence, resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Prescription Use ____
(Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use ___
(Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use ________________________________ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P. Lerner -S
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K132054 510(k) Number_
§ 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.