GYNECARE TVT OBTURATOR SYSTEM

K033568 · ETHICON, Inc. · OTN · Dec 8, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K033568
• Device Name: GYNECARE TVT OBTURATOR SYSTEM
• Applicant: ETHICON, Inc.
• Product Code: OTN · General, Plastic Surgery
• Decision Date: Dec 8, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GYNECARE TVT Obturator 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.

Device Story

Sterile, single-patient-use pubourethral sling; consists of PROLENE polypropylene mesh tape covered by plastic sheath; medical-grade plastic tube receptacles attached to mesh ends for Helical Passer attachment. Used by surgeons via trans-obturator 'inside-out' approach; mesh delivered trans-vaginally along posterior ischiopubic ramus through obturator membrane. Provides mechanical support to urethra to treat SUI; benefits patient by restoring continence.

Clinical Evidence

Bench testing only.

Technological Characteristics

PROLENE polypropylene mesh (undyed or Phtalocyanine blue, Color index 74160); plastic sheath; medical-grade plastic tube receptacles; Helical Passers for delivery. Trans-obturator 'inside-out' delivery mechanism. Sterile, single-use.

Indications for Use

Indicated for women with stress urinary incontinence (SUI) caused by urethral hypermobility and/or intrinsic sphincter deficiency.

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 TVT device

Submission Summary (Full Text)

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## 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. |
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| MODIFIED DEVICE NAME: | GYNECARE TVT Obturator device |
| PREDICATE DEVICE NAME: | GYNECARE TVT device |
| Device Description | The GYNECARE TVT Obturator 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) covered by a plastic sheath overlapping in the middle. Medical grade plastic tube receptacles are attached at each end of the mesh to accommodate the Helical Passers. The Helical Passers come assembled to the GYNECARE TVT Obturator device and are used to deliver of the mesh implant via the trans-obturator “inside-out” approach. The “inside-out” approach delivers the mesh trans-vaginally, along the posterior ischiopubic ramus and through the obturator membrane. |
| 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 Obturator is indicated for the treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. |

GYNECARE TVT Obturator System · GYNECARE a Division of ETHICON, Inc. ປົບບໍ່ປີ່ສໍ 8

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## 510(K) SUMMARY( continued)

and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of th

| Technological<br>Characteristics | The modified device has the same technological characteristics as<br>the predicate device. The form, fit, function and method of<br>operation are similar. |
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| Performance Data | Results of verification testing indicates that the product meets the<br>established performance requirements. |
| Conclusion | Based upon the 510(k) summaries and 510(k) statements (21 CFR<br>807) and the information provided herein, we conclude that the<br>subject device is substantially equivalent to the predicate devices<br>under the Federal Food, Drug and Cosmetic Act. |
| Contact | Sean M. O'Bryan<br>Senior Project Manager, Regulatory Affairs<br>ETHICON, Inc.<br>Rt. 22 West<br>Somerville, NJ 08876-0151 |

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Date November 7, 2003

GYNECARE TVT Obturator System GYNECARE, a division of ETHICON, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle, emphasizing the department's name and national affiliation. The logo is presented in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP 2 8 2012

Mr. Sean O'Bryan Senior Project Manager, Regulatory Affairs Ethicon, Inc. Route 22 West SOMERVILLE NJ 08876

Re: K033568 Trade/Device Name: GYNECARE TVT Obturator Device Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: November 10, 2003 Received: November 13, 2003

Dear Mr. O'Bryan:

This letter corrects our substantially equivalent letter of December 8, 2003.

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 [phone] or [phone] 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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| | INDICATION FOR USE |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known): | K033568 |
| Device Name: | GYNECARE TVT Obturator device |
| Indications for Use: | The GYNECARE TVT Obturator device is intended for use in<br>women as a sub-urethral sling for the treatment of stress urinary<br>incontinence (SUI) resulting from urethral hypermobility and/or<br>intrinsic sphincter deficiency. |

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_K_633568 1

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | OR | Over-The Counter Use |
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| | | (Optional Format 1-2-9G) |

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