(74 days)
Not Found
Not Found
No
The device description and intended use focus on a physical surgical implant and its accessories, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a pubourethral sling for the treatment of stress urinary incontinence (SUI), which directly addresses a medical condition.
No
Explanation: The device is described as a "pubourethral sling" and a "tape" composed of mesh, intended for the treatment of stress urinary incontinence by providing support. It does not perform any diagnostic functions like measuring, identifying, or analyzing conditions.
No
The device description clearly outlines physical components made of polypropylene mesh, stainless steel, and polyethylene, indicating it is a hardware device used in a surgical procedure.
Based on the provided text, 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 in vivo (within the body).
- Device Description: The device is a physical implant (mesh) and surgical tools (introducer, catheter guide, abdominal guides). These are used during a surgical procedure, not for testing samples in vitro (outside the body).
- No mention of testing biological samples: The description does not involve analyzing blood, urine, tissue, or any other biological sample to diagnose a condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a surgical implant and associated tools used to physically correct a condition.
N/A
Intended Use / Indications for Use
The TVT device is intended to be used as a pubourethral sling Indicated for treatment of stress urinary incontinence (SUI) for moreated for a cannontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The TVT Introducer, Rigid and of millions and TVT Abdominal Guides and Couplers are accessories intended to facilitate placement of the TVT device.
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 and TVT Abdominal Guides and Couplers). Each is available separately for use at the surgical site. The TVT device is composed of unpigmented or blue pigmented 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 shaft 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. The TVT AA (Accessory) Abdominal Guide is made of stainless steel and the couplers are made from polypropylene.
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)
Results of bench testing and preclinical evaluations were used to show that the TVT System functioned as clinically intended and have the same product properties.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
K012628
OCT 2 6 2001
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. |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Modified
Device Name: | GYNECARE Tension Free Vaginal Tape (TVT)
System with Accessories
TVT Reusable Introducer
TVT Reusable Rigid Catheter Guide
TVT-AA Abdominal Guides and Couplers |
| Predicate
Device Name: | GYNECARE Tension Free Vaginal Tape (TVT)
System with Accessories
TVT Reusable Introducer
TVT Reusable Rigid Catheter Guide
Cook OB/GYN Stamey Needle |
| 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 and TVT
Abdominal Guides and Couplers). Each is available separately for
use at the surgical site. The TVT device is composed of
unpigmented or blue pigmented 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
shaft 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.
The TVT AA (Accessory) Abdominal Guide is made of stainless
steel and the couplers are made from polypropylene. |
| Intended Use | The TVT device is intended to be used as a pubourethral sling for
treatment of stress urinary incontinence (SUI). |
| Indications
Statement | The TVT device is 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, Rigid
Catheter Guide and TVT abdominal Guides and Couplers
accessories are intended to facilitate placement of the TVT device. |
| Technological
Characteristics | Technologically both the modified TVT Blue device and the
currently marketed predicate device are the same. The TVT-AA
Abdominal Guides and Couplers is an accessory that may be used
with the modified device or the modified device to facilitate an
abdominal approach for the placement of the TVT mesh. |
| Performance Data | Results of bench testing and preclinical evaluations were used to
show that the TVT System functioned as clinically intended and
have the same product properties. |
| 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 of Regulatory Affairs & Quality Assurance
GYNECARE
A Division of ETHICON, Inc.
Rt. #22 West
Somerville, NJ 08876-0151 |
| Date | August 9, 2001 |
Continued on next page
1
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
August 9, 2001
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three flowing lines that form the shape of a person's head and torso. The figure is positioned to the right of a circular emblem that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Gregory R. Jones Director of Regulatory Affairs and Quality Assurance Gynecare Division of Ethicon P.O. Box 151 SOMERVILLE NJ 08876
SEP 28 2012
Re: K012628
Trade/Device Name: GYNECARE Tension-Free Vaginal Tape (TVT) Blue System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: August 9, 2001 Received: August 13, 2001
Dear Mr. Jones:
This letter corrects our substantially equivalent letter of October 26, 2001.
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/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 (TVT) Blue System
The TVT device is intended to be used as a pubourethral sling Indicated for treatment of stress urinary incontinence (SUI) for moreated for a cannontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The TVT Introducer, Rigid and of millions and TVT Abdominal Guides and Couplers are accessories intended to facilitate placement of the TVT device.
K0126
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The Counter Use Prescription Use OR (Per 21 CFR 801.109) (Optional Format 1-2-9G) (Division Sign-Off) Division of General, Restorative and Neurological Devices Modified TVT Blue and TVT-AA 510(k) Number_ _ 01262
i
ና ምጥ፣ የተጣጥለ ነ
חוץ וייחי וי ויי
:::