I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000

K052175 · Uroplasty, Inc. · OTN · Oct 17, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052175
• Device Name: I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000
• Applicant: Uroplasty, Inc.
• Product Code: OTN · General, Plastic Surgery
• Decision Date: Oct 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The I-STOP Mid-Urethral Sling is intended for the treatment of female stress urinary incontinence (SUI) due to urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

Device Story

I-STOP Mid-Urethral Sling is a surgical mesh device for treating female stress urinary incontinence. Device consists of non-resorbable polypropylene mesh, polyethylene clips, stainless steel implantation needles, and polycarbonate needle handles. Surgeon implants mesh via retropubic (transvaginal or suprapubic) or transobturator (outside-in or inside-out) approaches to provide urethral support. Device is single-use and EtO sterilized. Clinical benefit includes restoration of urethral support to address incontinence.

Clinical Evidence

Clinical experience demonstrated the device functions as intended. Additional biocompatibility testing was performed to support the safety profile.

Technological Characteristics

Non-resorbable polypropylene mesh; stainless steel implantation needles; polycarbonate needle handles. EtO sterilized; single-use. Mechanical support device; no software or energy source.

Indications for Use

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

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

• Tension Free Vaginal Tape (TVT) System; Ethicon, Inc. (K974098)

Submission Summary (Full Text)

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Uroplasty, Inc. Premarket Notification [510(k)] Submission I-STOP™ Mid-Urethral Sling

OCT 1 7 2005

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K052175

## Section 8: 510(k) Summary

| Date Prepared | August 9, 2005 |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| New Device Name | I-STOP™ Mid-Urethral Sling |
| Predicate Device | Tension Free Vaginal Tape (TVT) System; Ethicon, Inc. (K974098) |
| Contact | Uroplasty, Inc.<br>2718 Summer Street NE<br>Minneapolis, MN 55413-2820<br>Telephone: [phone], Facsimile: [phone]<br>[e-mail] |

#### Intended Use

The I-STOP Mid-Urethral Sling is intended for the treatment of female stress urinary incontinence (SUI) due to urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

### Device Description

The I-STOP Device is comprised of a non-resorbable polypropylene material woven into a mesh with each end attached to a polyethylene clip, two technique-dependant stainless steel implantation needles and two polycarbonate needle handles. The device is EtO sterilized and intended for single-use only.

#### Indications Statement

The I-STOP Mid-Urethral Sling is intended for the treatment of female stress urinary incontinence due to urethral hypermobility and/or intrinsic sphincter deficiency. Four different I-STOP models allow for implantation of the I-STOP mesh via retropublic (transvaginal or suprapubic) or transobturator (outside-in or inside-out) approaches.

#### Technological Characteristics

The new and predicate devices are technologically the same; they are polypropylene meshes implanted with stainless steel needles to provide urethral support for females patients with SUI. The devices have similar implantation, sterilization, and storage requirements. In the few instances where the devices differ, no additional concerns about safety or effectiveness are raised.

## Performance

Clinical experience with the I-STOP device has demonstrated that it successfully and safely functions as intended. Additional biocompatibility testing supports the safety profile of the I-STOP Sling.

## Conclusion

The I-STOP Mid-Urethral Sling is substantially equivalent to the predicate device, the Tension Free Vaginal Tape (TVT) from Ethicon, Inc. (K974098).

CONFIDENTIAL

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

Michael Morrell, RAC Director of Regulatory Affairs SEP 2 8 2012 Uroplasty, Inc. 2718 Summer Street NE MINNEAPOLIS MN 55413

Re: K052175 Trade/Device Name: I-STOPTM Mid-Urethral Sling Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: August 9, 2005 Received: August 11, 2005

Dear Mr. Morrell:

This letter corrects our substantially equivalent letter of October 17, 2005.

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 (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/CDRH0ffices/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/Resourcesfor You/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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# PREMARKET NOTIFICATION [510(k)] SUBMISSION I-STOP" MID-URETHRAL SLING

Indication for Usc Statement

| 510(k) Number: | K052175 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| New Device Name: | I-STOP™ Mid-Urethral Sling |
| Indication for Use: | The I-STOP Mid-Urethral Sling is intended for the treatment of female<br>stress urinary incontinence (SUI) due to urethral hypermobility and/or<br>intrinsic sphincter deficiency (ISD). |

X Prescription Use (Per 21 CFR 801.109)

OR

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

(Please do not write below this line. Continue on another page if needed)

Concurrence of CDRH, Olfice of Device Evaluation (ODE)

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

510(k) Number K052175