SUPRIS RETROPUBIC SLING SYSTEM

K111233 · Coloplast A/S · OTN · Jun 24, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K111233
• Device Name: SUPRIS RETROPUBIC SLING SYSTEM
• Applicant: Coloplast A/S
• Product Code: OTN · General, Plastic Surgery
• Decision Date: Jun 24, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Supris Retropubic Sling System is an implantable, suburethral, support tape indicated for the surgical treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The sling is placed retropubically using two disposable introducers using either a "top down" or "bottom up" surgical approach

Device Story

Supris Retropubic Sling System is a permanent, synthetic, sub-urethral support tape; constructed from knitted monofilament polypropylene. Device includes disposable needles/introducers for surgical placement. Used in clinical settings by surgeons to treat female stress urinary incontinence. Sling placed retropubically via either "top-down" or "bottom-up" surgical approach. Low-elasticity mesh structure provides resistance to traction and facilitates tissue colonization for long-term support. Device provides mechanical support to the urethra to restore continence.

Clinical Evidence

No clinical trials were conducted for this specific submission. Safety and effectiveness of the top-down versus bottom-up surgical approaches were evaluated via a review of published scientific literature on similar tension-free retropubic female urinary incontinence slings. The literature review concluded that both approaches are comparable regarding risks and adverse events.

Technological Characteristics

Material: Knitted monofilament polypropylene. Form factor: Sub-urethral support tape with disposable introducers. Principle: Mechanical support/tension-free sling. Sterilization: Not specified. Connectivity: None.

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

• Mentor Aris TM Suprapubic Surgical Kit (K053296)

Submission Summary (Full Text)

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# K111233

### 510(k) Summary

## JUN 2 4 25/11

| Submitter: | Coloplast A/S |
|----------------------|--------------------------------------------------------------|
| Address | Holtedam 1<br>3050 Humlebaek, Denmark<br>[phone] |
| Company Contact: | Tim Crabtree<br>Regulatory Affairs Manager |
| Date Prepared: | June 14, 2011 |
| Device Name: | Supris® Retropubic Sling System |
| Common Name: | Surgical mesh |
| Classification Name: | Surgical mesh, polymeric |
| Classification: | 21 CFR §878.3300 |
| Product Code: | OTN, FTL |
| Predicate Devices: | Mentor Aris ^TM Suprapubic Surgical Kit<br>K053296 |

Description of Device: The Supris Retropubic Sling System is a permanent, synthetic sub-urethral sling that is provided with disposable needles in the system. The Supris sling is made from knitted monofilament polypropylene and has low elasticity. This structure gives the Supris sling resistance to traction, allows for tissue colonization and facilitates positioning during surgery.

Intended Use: The Supris Retropubic Sling System is an implantable, suburethral, support tape indicated for the surgical treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The sling is placed retropubically using two disposable introducers using either a "top down" or "bottom up" surgical approach

Purpose of Submission: Name change and labeling update with the description of bottom-up approach surgical approach.

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Comparison of Surgical Approaches: The Supris Retropubic Sling System has not been evaluated in any clinical trial to compare the safety and effectiveness of the top-down vs. the bottom-up surgical approaches. The safety and effectiveness of both the top-down and the bottom-up approaches were evaluated based on a review of published scientific literature on other tension-free retropubic female urinary incontinence slings. The results of this review determined that both approaches are comparable in terms of risks and the occurrence of related adverse events. Additionally, the literature also cited that that either approach is used based on surgeon preference and medical specialty.

Substantial Equivalence: The changes cited in this submission do not affect substantial equivalence established in the original submission.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is composed of three curved lines that suggest the feathers and body of the bird.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20995-0002

Coloplast A/S Mr. Tim Crabtree Regulatory Affairs Manager c/o Coloplast Corp. 1601 West River Road North MINNEAPOLIS MN 55411

JUN 2 4 2011

Re: K111233

> Trade Name: SUPRIS® Retropubic Sling System Regulation Number: 21 CFR §878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product code: OTN Dated: June 14, 2011 Received: June 15, 2011

Dear Mr. Crabtree:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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

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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" (21CFR 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,

Huchal Lemur MD

erbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

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## 510(k) Number (if known): ≤ | | 2 ≥ 3

## Device Name: Supris® Sling System

Indications for Use: The Supris Retropubic Sling System is an implantable, suburethral, support tape indicated for the surgical treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The sling is placed retropubically using two disposable introducers using either a "top down" or "bottom up" surgical approach

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Offige of Derice Evaluation (ODE)-

Hecht Kemer

(Division Sign-om)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K111233