(88 days)
The GYNECARE TVT SECUR* device is intended for use 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 SECUR* device is a sterile, single patient use device, consisting of one piece of undyed or blue (Phtalocyanine blue, Color index Number 74160) PROLENE* polypropylene mesh (tape) approximately 1.1cm x 8.0cm (approximately ½ x 4 inches). The ends of the device will be sandwiched between pieces of fleece made of polyglactin 910/polydioxanone coated with polydioxanone film. The coated ends are added to facilitate passage (stiffens the ends) and placement (tactile feel for the surgeon) of the mesh implant. Two curved, stainless steel, single use introducers are used to deliver the implant. The introducers are supplied fixed to the implant via a wire through the coated ends and inserters. TVT SECUR is designed to accommodate two surgical techniques: the “Hammock approach” and the “U approach”. The GYNECARE TVT Universal System is a less invasive 'exit less' device which will enable the physician to perform a suburethal sling procedure placing the mesh under the mid urethra without either the delivery device or the implant exiting the skin.
Here's an analysis of the provided text regarding the GYNECARE TVT SECUR System, focusing on acceptance criteria and supporting studies.
Note: The provided text is a 510(k) summary for a medical device (GYNECARE TVT SECUR* System). This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial results with specific acceptance criteria and performance metrics for a novel technology. Therefore, much of the requested information (like specific sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or detailed standalone performance) is not present in this document. The "Performance Data" section in such summaries typically refers to bench testing and verification, not clinical studies in the way one might expect for an AI/software device.
Acceptance Criteria and Device Performance for GYNECARE TVT SECUR System
Based on the provided 510(k) summary, the device is a medical implant intended for the treatment of stress urinary incontinence, not an AI or imaging device with performance metrics like sensitivity/specificity. The "acceptance criteria" here are focused on demonstrating that the modified device is substantially equivalent to existing, legally marketed predicate devices, and that it meets established engineering performance requirements.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from 510(k) context) | Reported Device Performance (as stated or inferred) |
|---|---|---|
| Substantial Equivalence | - Same intended use as predicate device.- Similar technological characteristics (form, fit, function, method of operation). | - Intended Use: "A pubourethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency." (Matches predicate's likely intended use).- Technological Characteristics: "The modified device has the same technological characteristics as the predicate device. The form, fit, function and method of operation are similar." |
| Performance Requirements (Bench/Verification Testing) | - Device meets established engineering and material specifications relevant to its function as a sub-urethral sling (e.g., material strength, dimensions, sterility, appropriate introducer function). | - "Results of verification testing indicates that the product meets the established performance requirements." (Specific numerical results are not provided in this summary). |
| Safety | - Material biocompatibility.- Sterility assurance.- Mechanical integrity under expected physiological loads. | - Not explicitly detailed in summary, but assumed to be demonstrated through material safety data and verification testing showing no new safety concerns compared to predicate. |
| Effectiveness (Implied) | - Performs its intended function (support of the urethra to treat SUI). | - Implied by substantial equivalence to predicate devices which are already accepted as effective for SUI treatment. No new clinical effectiveness data presented beyond comparison to predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of a typical clinical "test set" for performance evaluation described for an AI device. The 510(k) refers to "verification testing," which is usually bench (laboratory) testing of materials and device components. There is no mention of a human test set in the clinical evaluation sense.
- Data Provenance: Not applicable. The "verification testing" would be conducted internally by the manufacturer or a contract lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. This summary does not describe a clinical study requiring expert consensus for ground truth.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication method: Not applicable. This summary does not describe a clinical study requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done for this device, as it is a surgical implant and not an imaging or diagnostic AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance Study: Not applicable. This is not an algorithm-only device. The "performance data" refers to bench testing of the physical device.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the "verification testing," the ground truth would be based on engineering specifications, material properties, and established test methodologies (e.g., tensile strength measurements, dimensional accuracy, sterilization efficacy). For the substantial equivalence argument, the "ground truth" is the performance and safety profile of the predicate device.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/machine learning model that requires a training set in that sense.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable.
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K052401
1/2
NOV 2 8 2005
Section 5
510(k) SUMMARY
| Statement | Information supporting claims of substantial equivalence, asdefined under the Federal Food, Drug, and Cosmetic Act,respecting safety and effectiveness is summarized below. For theconvenience of the Reviewer, this summary is formatted inaccordance with the Agency's final rule “.... 510(k) Summariesand 510(k) Statements .…” (21 CFR 807) and can be used toprovide a substantial equivalence summary to anyone requesting itfrom the Agency.MODIFIED DEVICE NAME:GYNECARE TVT SECUR* SystemPREDICATE DEVICE NAME:GYNECARE TVT System and GYNECARE TVT ObturatorSystem |
|---|---|
| Device Description | The GYNECARE TVT SECUR* device is a sterile, single patientuse device, consisting of one piece of undyed or blue(Phtalocyanine blue, Color index Number 74160) PROLENE*polypropylene mesh (tape) approximately 1.1cm x 8.0cm(approximately ½ x 4 inches). The ends of the device will besandwiched between pieces of fleece made of polyglactin910/polydioxanone coated with polydioxanone film. The coatedends are added to facilitate passage (stiffens the ends) andplacement (tactile feel for the surgeon) of the mesh implant. Twocurved, stainless steel, single use introducers are used to deliver theimplant. The introducers are supplied fixed to the implant via awire through the coated ends and inserters. TVT SECUR isdesigned to accommodate two surgical techniques: the “Hammockapproach” and the “U approach”. The GYNECARE TVTUniversal System is a less invasive 'exit less' device which willenable the physician to perform a suburethal sling procedureplacing the mesh under the mid urethra without either the deliverydevice or the implant exiting the skin. |
GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc.
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052401$_{2/2}$
| Intended Use | A pubourethral sling for treatment of stress urinary incontinence(SUI), for female urinary incontinence resulting from urethralhypermobility and/or intrinsic sphincter deficiency. |
|---|---|
| Indications Statement | GYNECARE TVT SECUR* is indicated for the treatment of stressurinary incontinence (SUI), for female urinary incontinenceresulting from urethral hypermobility and/or intrinsic sphincterdeficiency. |
| TechnologicalCharacteristics | The modified device has the same technological characteristics asthe predicate device. The form, fit, function and method ofoperation are similar. |
| Performance Data | Results of verification testing indicates that the product meets theestablished performance requirements. |
| Conclusion | Based upon the 510(k) summaries and 510(k) statements (21 CFR807) and the information provided herein, we conclude that thesubject device is substantially equivalent to the predicate devicesunder the Federal Food, Drug and Cosmetic Act. |
| Contact | Patricia M. Hojnoski, M.S.Senior Project Manager, Regulatory AffairsETHICON, INC.Rt. 22 WestSomerville, NJ 08876-0151Phone: (908) 218-2893Fax: (908) 218-2595 |
| Date | August 30, 2005 |
GYNECARE TVT SECUR System
GYNECARE, a division of ETHICON, Inc.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Patricia M. Hojnoski. M.S. Senior Project Manager, Regulatory Affairs Gynecare, A Division of Ethicon, Inc. P.O. Box 151, US Route 22 West SOMERVILLE NJ 08876
SEP 2 8 2012
Re: K052401 Trade/Device Name: GYNECARE TVT SECUR* System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAH Dated: October 25, 2005 Received: November 17, 2005
Dear Ms. Hojnoski:
This letter corrects our substantially equivalent letter of November 28, 2005.
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 (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.
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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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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Sincerely yours,
Benjamin R. Perkins
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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Kes240)
INDICATIONS FOR USE
| 510(k) Number (if known): | |
|---|---|
| Device Name: | GYNECARE TVT SECUR* System |
| Indications for Use: | The GYNECARE TVT SECUR* device is intended for use in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency. |
Prescription 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Saibare Buchur
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K052401
GYNECARE TVT SECUR System GYNECARE, a division of ETHICON. Inc.
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§ 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.