(90 days)
OTN
Not Found
No
The description focuses on the physical components and surgical procedure of a mesh sling device, with no mention of AI or ML capabilities.
Yes
The device is intended for the treatment of stress urinary incontinence, which is a medical condition, making it a therapeutic device.
No
The device is described as a surgical implant (pubourethral sling) used for treatment, not for diagnosis. Its components and intended use clearly indicate a therapeutic rather than a diagnostic purpose.
No
The device description clearly outlines physical components made of polypropylene mesh, polyethylene, and stainless steel, indicating it is a hardware device, not software-only.
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 (SUI) by acting as a pubourethral sling. This is a surgical procedure performed on the patient's body.
- Device Description: The device is a surgical implant (mesh) and associated instruments used during surgery.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide diagnostic information. IVDs are used to diagnose, monitor, or screen for diseases or conditions by analyzing these types of samples.
The device is a surgical device used for treatment, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The TVT device is a sterile, single-use device 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 and Rigid Catheter Guide accessories are intended to facilitate placement of the TVT device. The accessories, available separately, are provided non-sterile and are reusable.
Product codes
OTN
Device Description
The Tension Free Vaginal Tape (TVT) System is comprised of three components; the device (TVT device) and its accessories (TVT Introducer and TVT Rigid Catheter Guide). Each is available separately for use at the surgical site. The TVT device is composed of PROLENE polypropylene mesh (tape). The mesh is covered with a polyethylene sheath with a slit in the middle. Both the mesh and sheath are attached to two (2) stainless steel needles. The TVT Introducer (accessory) is made of stainless steel. It is composed of three (3) parts; handle, threaded staft and rubber O-ring. The introducer functions to facilitate passage of the TVT device from the vagina to the abdominal skin. The TVT Rigid Catheter Guide is made of stainless steel and used to add rigidity to the Foley Catheter during the surgical procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pubourethral
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 clinical evaluations were used to show that the TVT System functioned as clinically intended. Sufficient data has been gathered from clinical testing to assess that the TVT System performs as clinically intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ProteGen Sling Collagen Impregnated Material
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
.���:
K974098
JAN 28 1998
SECTION 7
SUMMARY OF SAFETY AND EFFECTIVENESS
| 510(k) 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. 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. | |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| | New Device
Name: | Tension Free Vaginal Tape (TVT) System |
| | Predicate Device
Name: | ProteGen Sling Collagen Impregnated Material |
| | 510(K) SUMMARY | |
| Device Description | The Tension Free Vaginal Tape (TVT) System is comprised of three
components; the device (TVT device) and its accessories (TVT
Introducer and TVT Rigid Catheter Guide). Each is available separately
for use at the surgical site. The TVT device is composed of PROLENE
polypropylene mesh (tape). The mesh is covered with a polyethylene
sheath with a slit in the middle. Both the mesh and sheath are attached
to two (2) stainless steel needles. The TVT Introducer (accessory) is
made of stainless steel. It is composed of three (3) parts; handle,
threaded staft and rubber O-ring. The introducer functions to facilitate
passage of the TVT device from the vagina to the abdominal skin. The
TVT Rigid Catheter Guide is made of stainless steel and used to add
rigidity to the Foley Catheter during the surgical procedure. | |
| Intended Use | The TVT device is intended to be used as 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 | The TVT device is a sterile, single-use device intended to be
used as a pubourethral sling indicated for treatment of stress urinarv
incontinence, for female urinary incontinence resulting from urethral
hypermobility and/or intrinsic sphincter deficiency. The TVT Introducer
and Rigid Catheter Guide accessories are intended to facilitate
placement of the TVT device. The accessories, available separately, are
provided non-sterile and are reusable. | |
| Technological
Characteristics | Technologically both the new device and predicate device are the
same (i.e. both are meshes that provide pubourethral support).
Additionally, both devices utilize accessories for use in the surgical
procedure. Any differences between the two devices do not raise new
questions of safety and effectiveness. | |
| Performance Data | Results of clinical evaluations were used to show that the TVT System
functioned as clinically intended. Sufficient data has been gathered
from clinical testing to assess that the TVT System performs as
clinically intended. | |
| Conclusions | Based on the 510(k) summaries and 510(k) statements (21 CFR 807)
and the information provided herein, we conclude that the modified
device is substantially equivalent to the existing legally marketed device
under the Federal Food, Drug and Cosmetic Act. | |
| Contact | Gregory R. Jones
Director
Regulatory Affairs
ETHICON, Inc.
Rt. #22 West
Somerville, NJ 08876-0151 | |
| Date | October 28, 1997 | |
Continued on next page
1
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
Tension Free Vaginal Tape (TVT) System
ETHICON, Inc.
:44:
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of what appears to be an abstract human figure or symbol, possibly representing health or well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Gregory R. Jones Director, Regulatory Affairs Ethicon, Inc. P.O. Box 151 SOMERVILLE NJ 08876
SEP 2 8 2012
Re: K974098 Trade/Device Name: Tension Free Vaginal Tape (TVT) System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: October 29, 1997 Received: October 30, 1997
Dear Mr. Jones:
This letter corrects our substantially equivalent letter of January 28, 1998.
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 (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/CDRH0ffices/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Benjamin R. Fuchs
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
.
.
INDICATION FOR USE
510(k) Number (if known):
Device Name:
Indications for Use:
Tension Free Vaginal Tape (IVI) System
The TVT device is a sterile, single-use device 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 and Rigid Catheter Guide accessories are intended to facilitate placement of the TVT device. The accessories, available separately, are provided nonsterile and are reusable.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | OR Over-The Counter Use |
|---|---|
| ------------------------------------------ | ----------------------------------------------- |
(Optional Format 1-2-9G)
| (Division Sign-Off) | |
|---|---|
| Device | |
| 510(k) Number | K974020 |
Tension Free Vaginal Tape (TVT) System ETHICON, Inc.