IVS TUNNELLER DEVICES

• K Number: K073164
• Device Name: IVS TUNNELLER DEVICES
• Manufacturer: COVIDIEN UK MANUFACTURING LTD
• Date Cleared: 2008-03-05 ( 117 days)
• Product Code: FTL
• Regulation Number: 878.3300

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 Description

The IVS Tunneller™ Intra-Vaginal Sling placement device is comprised of three components: a stainless steel introducer or outer sheath, a polypropylene stylette, and a polypropylene mesh tape. The introducer is a curved stainless steel tube with a delta wing polypropylene handle, which is used to create a pathway for the correct placement of the polypropylene mesh tape. The polypropylene stylette has an eyelet for threading the polypropylene mesh tape and an atraumatic conical tip which allows for blunt tissue dissection and muscle deflection during the passage of the introducer. The polypropylene mesh tape is a non-absorbable, inert, porous, surgical mesh tape, created from either monofilament or multifilament yarns, and is supplied sterile. The Obturator IVS Tunneller™ Intra-Vaginal Sling placement device is comprised of three components: a stainless steel introducer or outer sheath, a polypropylene stylette, and a polypropylene mesh tape. The introducer is a curved stainless steel tube with a delta wing polypropylene handle, which is used to create a pathway for the correct placement of the polypropylene mesh tape. The polypropylene stylette has an eyelet for threading the polypropylene mesh tape and an atraumatic conical tip which allows for blunt tissue dissection and muscle deflection during the passage of the introducer. The polypropylene mesh tape is a non-absorbable, inert, porous, surgical mesh tape, created from either monofilament or multifilament yarns, and is supplied sterile.

Predicate Devices

K010035, K991400, K915526

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance summary focus on mechanical components and surgical technique, with no mention of AI or ML.

Therapeutic

No
The device is described as a "placement device" for positioning a mesh to treat conditions, not as a device that directly provides therapy itself.

Diagnostic

No

The device is described as a "placement device" for "positioning a polypropylene mesh" for surgical treatment, indicating its function is therapeutic, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description explicitly lists physical components made of stainless steel and polypropylene, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly describes a surgical procedure to position a mesh for treating conditions like stress urinary incontinence and vaginal vault prolapse. This is a therapeutic intervention performed in vivo (within the body).
• Device Description: The device components (introducer, stylette, mesh tape) are designed for surgical implantation and tissue manipulation, not for analyzing samples in vitro (outside the body).
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostic testing.

IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used for treatment.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

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.

Product codes (comma separated list FDA assigned to the subject device)

FTL

Device Description

The IVS Tunneller™ Intra-Vaginal Sling placement device is comprised of three components: a stainless steel introducer or outer sheath, a polypropylene stylette, and a polypropylene mesh tape. The introducer is a curved stainless steel tube with a delta wing polypropylene handle, which is used to create a pathway for the correct placement of the polypropylene mesh tape. The polypropylene stylette has an eyelet for threading the polypropylene mesh tape and an atraumatic conical tip which allows for blunt tissue dissection and muscle deflection during the passage of the introducer. The polypropylene mesh tape is a non-absorbable, inert, porous, surgical mesh tape, created from either monofilament or multifilament yarns, and is supplied sterile.

The Obturator IVS Tunneller™ Intra-Vaginal Sling placement device is comprised of three components: a stainless steel introducer or outer sheath, a polypropylene stylette, and a polypropylene mesh tape. The introducer is a curved stainless steel tube with a delta wing polypropylene handle, which is used to create a pathway for the correct placement of the polypropylene mesh tape. The polypropylene stylette has an eyelet for threading the polypropylene mesh tape and an atraumatic conical tip which allows for blunt tissue dissection and muscle deflection during the passage of the introducer. The polypropylene mesh tape is a non-absorbable, inert, porous, surgical mesh tape, created from either monofilament or multifilament yarns, and is supplied sterile.

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

Prescription Use

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)

The performance of the subject IVS Tunneller™ device is substantially equivalent to the currently marketed predicate IVS Tunneller™ device.

The performance of the subject Obturator IVS Tunneller™ device is substantially equivalent to the currently marketed predicate IVS Tunneller™ device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

0

K073164
(pg 1 of 2)

510(k) Summary of Safety and Effectiveness

| SUBMITTER: | Covidien UK Manufacturing Ltd.
20 Garryduff Road, Ballymoney
County Antrim, Ireland BT53 7AP
Phone: [phone] |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Sharon Alexander
Senior Associate, Regulatory Affairs
Covidien
60 Middletown Avenue
North Haven, CT 06473 USA
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)
Parietene® Polypropylene Mesh (K991400)
Surgipro™ Polypropylene Surgical Mesh (K915526) |
| DEVICE DESCRIPTION: | The IVS Tunneller™ Intra-Vaginal Sling placement device is
comprised of three components: a stainless steel introducer or outer
sheath, a polypropylene stylette, and a polypropylene mesh tape. The
introducer is a curved stainless steel tube with a delta wing
polypropylene handle, which is used to create a pathway for the
correct placement of the polypropylene mesh tape. The polypropylene
stylette has an eyelet for threading the polypropylene mesh tape and
an atraumatic conical tip which allows for blunt tissue dissection and
muscle deflection during the passage of the introducer. The
polypropylene mesh tape is a non-absorbable, inert, porous, surgical
mesh tape, created from either monofilament or multifilament yarns,
and is supplied sterile. |
| 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. |
| TECHNOLOGICAL
CHARACTERISTICS: | The fundamental scientific technology of the IVS Tunneller™
Intra-Vaginal Sling placement device is substantially equivalent to the
predicate IVS Tunneller™ device. |
| MATERIALS: | All components of the IVS Tunneller™ Intra-Vaginal Sling placement
device have been evaluated in accordance with ISO Standard 10993-

1.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |
   

| PERFORMANCE DATA: | The performance of the subject IVS Tunneller™ device is
substantially equivalent to the currently marketed predicate IVS
Tunneller™ device. |

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K073164 Response

March 4, 2008

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1

K073164
(pg 1 of 2)

510(k) Summary of Safety and Effectiveness

| SUBMITTER: | Covidien UK Manufacturing Ltd.
20 Garryduff Road, Ballymoney
County Antrim, Ireland BT53 7AP
Phone: [phone] |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Sharon Alexander
Senior Associate, Regulatory Affairs
Covidien
60 Middletown Avenue
North Haven, CT 06473 USA
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)
Parietene® Polypropylene Mesh (K991400)
Surgipro™ Polypropylene Surgical Mesh (K915526) |
| DEVICE DESCRIPTION: | The Obturator IVS Tunneller™ Intra-Vaginal Sling placement device
is comprised of three components: a stainless steel introducer or
outer sheath, a polypropylene stylette, and a polypropylene mesh
tape. The introducer is a curved stainless steel tube with a delta wing
polypropylene handle, which is used to create a pathway for the
correct placement of the polypropylene mesh tape. The polypropylene
stylette has an eyelet for threading the polypropylene mesh tape and
an atraumatic conical tip which allows for blunt tissue dissection and
muscle deflection during the passage of the introducer. The
polypropylene mesh tape is a non-absorbable, inert, porous, surgical
mesh tape, created from either monofilament or multifilament yarns,
and is supplied sterile. |
| INTENDED 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. |
| TECHNOLOGICAL
CHARACTERISTICS: | The fundamental scientific technology of the Obturator IVS
Tunneller™ Intra-Vaginal Sling placement device is substantially
equivalent to the predicate IVS Tunneller™ device. |
| MATERIALS: | All components of the Obturator IVS Tunneller™ Intra-Vaginal Sling
placement device have been evaluated in accordance with ISO
Standard 10993-1. |
| PERFORMANCE DATA: | The performance of the subject Obturator IVS Tunneller™ device is
substantially equivalent to the currently marketed predicate IVS
Tunneller™ device. |

:

.

March 4, 2008

2

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

3

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

4

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

5

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