IVS TUNNELLER DEVICES

K073164 · Covidien UK Manufacturing, Ltd. · FTL · Mar 5, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073164
• Device Name: IVS TUNNELLER DEVICES
• Applicant: Covidien UK Manufacturing, Ltd.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Mar 5, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IVS Tunneller™ Intra-Vaginal Sling placement device is intended to be used in females to position a polypropylene mesh for the treatment of genuine stress urinary incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency, and vaginal vault prolapse. The Obturator IVS Tunneller™ Intra-Vaginal Sling placement device is intended to be used in females to position a polypropylene mesh for the treatment of genuine stress urinary incontinence (SUI) and for mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

Device Story

The IVS Tunneller™ and Obturator IVS Tunneller™ are surgical instruments used to position polypropylene mesh tape for treating female urinary incontinence and vaginal vault prolapse. The device consists of a curved stainless steel introducer with a delta wing polypropylene handle, a polypropylene stylette with an eyelet for threading the mesh, and a non-absorbable, porous polypropylene mesh tape. During surgery, the introducer creates a pathway; the stylette's atraumatic conical tip performs blunt tissue dissection and muscle deflection. The mesh is threaded through the stylette eyelet and positioned to support the urethra or vaginal vault. The device is used by surgeons in a clinical/OR setting. The mesh remains in the patient to provide structural support, potentially alleviating incontinence symptoms or prolapse.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Components: stainless steel introducer, polypropylene stylette, polypropylene mesh tape. Materials evaluated per ISO 10993-1. Sterile, single-use, non-absorbable surgical mesh. Mechanical blunt dissection principle.

Indications for Use

Indicated for females with genuine stress urinary incontinence (SUI), mixed incontinence due to urethral hypermobility or intrinsic sphincter deficiency, and vaginal vault prolapse (IVS Tunneller version only).

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

• IVS Tunneller™ Intra-Vaginal Sling (K010035)
• Parietene® Polypropylene Mesh (K991400)
• Surgipro™ Polypropylene Surgical Mesh (K915526)

Submission Summary (Full Text)

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K073164
(pg 1 of 2)

### 510(k) Summary of Safety and Effectiveness

| SUBMITTER: | Covidien UK Manufacturing Ltd.<br>20 Garryduff Road, Ballymoney<br>County Antrim, Ireland BT53 7AP<br>Phone: [phone] |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Sharon Alexander<br>Senior Associate, Regulatory Affairs<br>Covidien<br>60 Middletown Avenue<br>North Haven, CT 06473 USA<br>Phone: [phone] |
| DATE PREPARED: | March 4, 2008 |
| | MAR - 5 2008 |
| TRADE/PROPRIETARY NAME: | IVS Tunneller™ Device |
| COMMON/USUAL NAME: | Intra-Vaginal Sling Placement Device |
| CLASSIFICATION NAME: | Mesh, Surgical, Polymeric |
| PREDICATE DEVICE(S): | IVS Tunneller™ Intra-Vaginal Sling (K010035)<br>Parietene® Polypropylene Mesh (K991400)<br>Surgipro™ Polypropylene Surgical Mesh (K915526) |
| DEVICE DESCRIPTION: | The IVS Tunneller™ Intra-Vaginal Sling placement device is<br>comprised of three components: a stainless steel introducer or outer<br>sheath, a polypropylene stylette, and a polypropylene mesh tape. The<br>introducer is a curved stainless steel tube with a delta wing<br>polypropylene handle, which is used to create a pathway for the<br>correct placement of the polypropylene mesh tape. The polypropylene<br>stylette has an eyelet for threading the polypropylene mesh tape and<br>an atraumatic conical tip which allows for blunt tissue dissection and<br>muscle deflection during the passage of the introducer. The<br>polypropylene mesh tape is a non-absorbable, inert, porous, surgical<br>mesh tape, created from either monofilament or multifilament yarns,<br>and is supplied sterile. |
| INTENDED USE: | The IVS Tunneller™ Intra-Vaginal Sling placement device is intended<br>to be used in females to position a polypropylene mesh for the<br>treatment of genuine stress urinary incontinence (SUI), mixed<br>incontinence resulting from urethral hypermobility or intrinsic sphincter<br>deficiency, and vaginal vault prolapse. |
| TECHNOLOGICAL<br>CHARACTERISTICS: | The fundamental scientific technology of the IVS Tunneller™<br>Intra-Vaginal Sling placement device is substantially equivalent to the<br>predicate IVS Tunneller™ device. |
| MATERIALS: | All components of the IVS Tunneller™ Intra-Vaginal Sling placement<br>device have been evaluated in accordance with ISO Standard 10993-<br>1. |
| PERFORMANCE DATA: | The performance of the subject IVS Tunneller™ device is<br>substantially equivalent to the currently marketed predicate IVS<br>Tunneller™ device. |

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K073164 Response

March 4, 2008

のおいたいですが、2006年には、2005年には、2005年には、2005年には、2005年には、100%、2005年に、100%、2005年に、1700年、2002

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K073164
(pg 1 of 2)

## 510(k) Summary of Safety and Effectiveness

| SUBMITTER: | Covidien UK Manufacturing Ltd.<br>20 Garryduff Road, Ballymoney<br>County Antrim, Ireland BT53 7AP<br>Phone: [phone] |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Sharon Alexander<br>Senior Associate, Regulatory Affairs<br>Covidien<br>60 Middletown Avenue<br>North Haven, CT 06473 USA<br>Phone: [phone] |
| DATE PREPARED: | March 4, 2008 |
| TRADE/PROPRIETARY NAME: | Obturator IVS Tunneller™ Device |
| COMMON/USUAL NAME: | Intra-Vaginal Sling Placement Device |
| CLASSIFICATION NAME: | Mesh, Surgical, Polymeric |
| PREDICATE DEVICE(S): | IVS Tunneller™ Intra-Vaginal Sling (K010035)<br>Parietene® Polypropylene Mesh (K991400)<br>Surgipro™ Polypropylene Surgical Mesh (K915526) |
| DEVICE DESCRIPTION: | The Obturator IVS Tunneller™ Intra-Vaginal Sling placement device<br>is comprised of three components: a stainless steel introducer or<br>outer sheath, a polypropylene stylette, and a polypropylene mesh<br>tape. The introducer is a curved stainless steel tube with a delta wing<br>polypropylene handle, which is used to create a pathway for the<br>correct placement of the polypropylene mesh tape. The polypropylene<br>stylette has an eyelet for threading the polypropylene mesh tape and<br>an atraumatic conical tip which allows for blunt tissue dissection and<br>muscle deflection during the passage of the introducer. The<br>polypropylene mesh tape is a non-absorbable, inert, porous, surgical<br>mesh tape, created from either monofilament or multifilament yarns,<br>and is supplied sterile. |
| INTENDED USE: | The Obturator IVS Tunneller™ Intra-Vaginal Sling placement device<br>is intended to be used in females to position a polypropylene mesh for<br>the treatment of genuine stress urinary incontinence (SUI) and for<br>mixed incontinence resulting from urethral hypermobility or intrinsic<br>sphincter deficiency. |
| TECHNOLOGICAL<br>CHARACTERISTICS: | The fundamental scientific technology of the Obturator IVS<br>Tunneller™ Intra-Vaginal Sling placement device is substantially<br>equivalent to the predicate IVS Tunneller™ device. |
| MATERIALS: | All components of the Obturator IVS Tunneller™ Intra-Vaginal Sling<br>placement device have been evaluated in accordance with ISO<br>Standard 10993-1. |
| PERFORMANCE DATA: | The performance of the subject Obturator IVS Tunneller™ device is<br>substantially equivalent to the currently marketed predicate IVS<br>Tunneller™ device. |

:

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March 4, 2008

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 5 2008

Covidien UK Manufacturing Ltd. % Covidien Ms. Sharon Alexander Senior Associate, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473

Re: K073164

Trade/Device Name: Obturator IVS Tunneller™ Intra-Vaginal Sling Placement Device Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: February 21, 2008 Received: February 22, 2008

Dear Ms. Alexander:

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 application (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 such 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Ms. Sharon Alexander

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Presmarket, Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html.

Sincerely vours.

Mark M. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 2073164

#### Indications For Use

510(k) Number (if known): K073164

Device Name: IVS Tunneller™ Intra-Vaginal Sling Placement Device

Indications For Use:

The IVS Tunneller™ Intra-Vaginal Sling placement device is intended to be used in females to position a polypropylene mesh for the treatment of genuine stress urinary incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency, and vaginal vault prolapse.

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)

Neil R. Gelman for man

Division of General. Restorative. and Neurological Devices

510(k) Number

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K073164
(pg 2 of 2)

### Indications For Use

510(k) Number (if known): K073164

Device Name: Obturator IVS Tunneller™ Intra-Vaginal Sling Placement Device

Indications For Use:

The Obturator IVS Tunneller™ Intra-Vaginal Sling placement device is intended to be used in females to position a polypropylene mesh for the treatment of genuine stress urinary incontinence (SUI) and for mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

Prescription Use X (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)

Nehardl for mxm
(Division Sign Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K073164