Who is the manufacturer of GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM?

Gynecare Center filed the 510(k) submission for GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM (K012628).

What is the FDA product code for GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM?

OTN. It is classified under 21 CFR 878.3300 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM?

GYNECARE Tension Free Vaginal Tape (TVT) System with Accessories (K012628); Cook OB/GYN Stamey Needle.

Who can help prepare an FDA 510(k) submission like GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM

K012628 · Gynecare Center · OTN · Oct 26, 2001 · General, Plastic Surgery

Device Facts

Record ID	K012628
Device Name	GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM
Applicant	Gynecare Center
Product Code	OTN · General, Plastic Surgery
Decision Date	Oct 26, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.3300
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The TVT device is intended to be used as a pubourethral sling for treatment of stress urinary incontinence (SUI).

Device Story

Pubourethral sling system for stress urinary incontinence (SUI) treatment; consists of polypropylene mesh tape (unpigmented or blue) with polyethylene sheath, attached to stainless steel needles. Accessories include stainless steel introducer, rigid catheter guide, abdominal guides, and polypropylene couplers. Used in surgical setting by physicians to facilitate tape placement from vagina to abdominal skin. Provides mechanical support to urethra to treat hypermobility or intrinsic sphincter deficiency.

Clinical Evidence

Bench testing and preclinical evaluations only; no clinical trial data presented. Testing confirmed device functionality and equivalent product properties to the predicate.

Technological Characteristics

Materials: Polypropylene mesh (PROLENE), polyethylene sheath, stainless steel needles/introducer/catheter guide, polypropylene couplers. Form factor: Pubourethral sling system with surgical accessories. Principle: Mechanical support via suburethral sling. Sterilization: Not specified.

Indications for Use

Indicated for treatment of stress urinary incontinence (SUI) in females resulting from urethral hypermobility and/or intrinsic sphincter deficiency. Accessories facilitate placement of the device.

Regulatory Classification

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.

Predicate Devices

GYNECARE Tension Free Vaginal Tape (TVT) System with Accessories (K012628)
Cook OB/GYN Stamey Needle

Related Devices

K041948 — SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS · American Medical Systems, Inc. · Aug 11, 2004
K101440 — GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012 · Generic Medical Devices, Inc. · Jun 18, 2010
K132054 — GYNECARE TVT EXACT CONTINENCE SYSTEM · ETHICON, Inc. · Aug 23, 2013
K020110 — MODIFICATION TO TRELEX MESH SURGICAL MESH · Boston Scientific · Apr 3, 2002
K201686 — GYNECARE TVT System, GYNECARE TVT with Abdominal Guides System, GYNECARE TVT Introducer and Catheter Guide, GYNECARE TVT EXACT Continence System and Trocar, GYNECARE TVT Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO Continence System and Passers and Winged Guide · ETHICON, Inc. · Sep 17, 2020

Submission Summary (Full Text)

{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 :::