NEEDLELESS SLING

K063136 · Specialities Remeex International, S.L. · PAH · Dec 19, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K063136
• Device Name: NEEDLELESS SLING
• Applicant: Specialities Remeex International, S.L.
• Product Code: PAH · General, Plastic Surgery
• Decision Date: Dec 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The NEEDLELESS SLING is indicated for the treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency

Device Story

Needleless Sling is a surgical mesh device for treating female stress urinary incontinence. Device consists of a mesh sling placed under the urethra; functions by providing pubourethral support to limit urethral descent and create fibrosis. Sling is adjustable during and immediately after surgical intervention to achieve continence. Used by surgeons in clinical settings. Provides mechanical support to the mid-urethra to restore continence in patients with urethral hypermobility or intrinsic sphincter deficiency.

Clinical Evidence

Bench testing only; verification testing confirmed product meets established performance requirements.

Technological Characteristics

Surgical mesh for pubourethral support; polymeric material; form, fit, and function equivalent to predicate mesh systems.

Indications for Use

Indicated for female patients 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 Tension-Free Vaginal Tape System (K012628)
• Gynecare TVT Secur System (K052401)

Submission Summary (Full Text)

{0}------------------------------------------------

510K(k) SUMMARY

510K Notification

SUBMITTER:

Specialities Remeex International, s.I. C/Tren De Baix, 55 Gaixos Terrassa Barcelona, Spain 08223

DATE PREPARED:

DEVICE NAME:

October 12th 2006

DEC 1 9 2006

NEEDLELESS SLING

CLASSIFICATION NAMES:

PREDICATE DEVICES:

Mesh, Surgical, Polymeric

1. GYNECARE TENSION FREE VAGINAL TAPE SYSTEM 2. GYNECARE TVT SECUR SYSTEM

# Device Description:

The NEEDLELESS SLING is included in the sling techniques for the treatment of female stress urinary incontinence. This device is a vaginal sling that permits for the regulation of continence in the female incontinent patient. This system uses a mesh sling, placed under the urethra, that can be regulated during the intervention and just after it to achieve continence. The sling is passed through the endopelvic fascia, creating a fibrosis that supports the mid urethra as a limitation to its descending and thus providing continence.

### Predicate Devices:

There has been a device previously cleared by the FDA in the following 510(K) Notifications indicated as a pubourethral sling for the treatment of female stress urinary incontinence:

| Device | 510(k) Document<br>Number | Date Cleared | Indications |
|----------------------------------------------|---------------------------|--------------|--------------------------------|
| Gynecare Tension-Free<br>Vaginal Tape System | K012628 | 10/26/2001 | Female Urinary<br>Incontinence |
| Gynecare TVT Secur<br>System | K052401 | 11/28/2005 | Female Urinary<br>Incontinence |

Technologically, both the proposed and predicate devices are the same (i.e. both are meshes that provide pubourethral support) and are indicated for the treatment of female urinary incontinence. Any differences between the two devices do not raise new questions of safety and effectiveness.

000090

{1}------------------------------------------------

K@ 3136
page 2 of 2

## Intended Use:

## NEEDLELESS SLING Indications:

The NEEDLELESS SLING is indicated for the treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency

### Technological Characteristics:

Technologically, both the new device and the predicate device are the same (i.e. both are meshes that provide pubourethral support). The form, fit, function and method of operation are similar Any differences between the two devices do not raise new questions of safety and effectiveness

#### Performance Data:

Results of verification testing indicates that the product meets the established performance requirements

#### Conclusions:

Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the proposed device is substantially equivalent to the existing legally marketed device under the Federal Food, Drug and Cosmetic Act.

CONFIDENTIAL

000091

{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 eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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

Specialities Remeex International S.L. % Mr. Jeffrey R. Shideman President International Medical Products Corporation 7307 Glouchester Drive EDINA MN 55435

SEP 2 8 2012

Re: K063136 Trade/Device Name: NEEDLESS SLING Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAH Dated: October 12, 2006 Received: November 7, 2006

Dear Mr. Shideman:

This letter corrects our substantially equivalent letter of December 19, 2006.

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 (OS) 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/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

{4}------------------------------------------------

Indications for Use 510(k) Number (if known): KO63136

Device Name: NEEDLELESS SLING

Indications for Use:

The NEEDLELESS SLING is indicated for the treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/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 OF NEEDED)

Concurrence of CDRH2 Office of Device Evaluation (ODE)

Plo

(Division Sign-Of: Division of Gener 1, Restorative, and Neurological Devices

Page of

**510(k) Number** K0603136

CONFIDENTIAL

000005