(88 days)
Not Found
Not Found
No
The device description and intended use focus on a physical mesh implant and delivery system for surgical treatment of stress urinary incontinence. There is no mention of software, data processing, or any technology that would typically incorporate AI/ML.
Yes.
The device is intended for the treatment of stress urinary incontinence (SUI), which indicates a therapeutic purpose.
No.
The device is described as a sub-urethral sling for treating stress urinary incontinence, not for diagnosing it. It is an implantable medical device used for treatment.
No
The device description clearly details physical components such as polypropylene mesh, fleece, stainless steel introducers, and wire, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the surgical treatment of stress urinary incontinence by acting as a sub-urethral sling. This is a surgical implant procedure, not a diagnostic test performed on samples from the body.
- Device Description: The device is a surgical implant (mesh) and associated delivery tools. It does not involve the analysis of biological samples.
- No mention of diagnostic testing: The description focuses on the physical characteristics of the implant and its surgical delivery. There is no mention of analyzing blood, urine, tissue, or any other biological specimen for diagnostic purposes.
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic device used in a surgical procedure.
N/A
Intended Use / Indications for Use
A pubourethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
GYNECARE TVT SECUR* is indicated for the treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
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.
Product codes
PAH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethral region
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)
Results of verification testing indicates that the product meets the established performance requirements.
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.
Not Found
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
K052401
1/2
NOV 2 8 2005
Section 5
510(k) SUMMARY
| Statement | Information supporting claims of substantial equivalence, as
defined under the Federal Food, Drug, and Cosmetic Act,
respecting safety and effectiveness is summarized below. For the
convenience of the Reviewer, this summary is formatted in
accordance with the Agency's final rule “.... 510(k) Summaries
and 510(k) Statements .…” (21 CFR 807) and can be used to
provide a substantial equivalence summary to anyone requesting it
from the Agency.
MODIFIED DEVICE NAME:
GYNECARE TVT SECUR* System
PREDICATE DEVICE NAME:
GYNECARE TVT System and GYNECARE TVT Obturator
System |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | 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. |
GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc.
000016
1
052401$_{2/2}$
| 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. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications Statement | GYNECARE TVT SECUR* is indicated for the treatment of stress
urinary incontinence (SUI), for female urinary incontinence
resulting from urethral hypermobility and/or intrinsic sphincter
deficiency. |
| 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 Data | Results of verification testing indicates that the product meets the
established performance requirements. |
| Conclusion | Based upon the 510(k) summaries and 510(k) statements (21 CFR
807) and the information provided herein, we conclude that the
subject device is substantially equivalent to the predicate devices
under the Federal Food, Drug and Cosmetic Act. |
| Contact | Patricia M. Hojnoski, M.S.
Senior Project Manager, Regulatory Affairs
ETHICON, INC.
Rt. 22 West
Somerville, NJ 08876-0151
Phone: (908) 218-2893
Fax: (908) 218-2595 |
| Date | August 30, 2005 |
GYNECARE TVT SECUR System
GYNECARE, a division of ETHICON, Inc.
000017
2
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
3
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
4
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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