KIM

K103022 · Neomedic International S.L. · OTN · Dec 20, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K103022
• Device Name: KIM
• Applicant: Neomedic International S.L.
• Product Code: OTN · General, Plastic Surgery
• Decision Date: Dec 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

KIM (Knotless Incontinence Mesh) is a surgical mesh kit for treatment of female stress urinary incontinence resulting from urethral hyper mobility and / or intrinsic sphincter deficiency.

Device Story

KIM is a sterile, single-use surgical mesh kit for treating female stress urinary incontinence. The device consists of a monofilament polypropylene mesh sling with attached polypropylene traction threads and stainless steel/POM passers. Used by surgeons in a clinical setting, the device is delivered via a trans-obturator 'out-inside' approach. Passers guide the mesh through the obturator foramens; traction threads facilitate attachment and are removed post-placement. The surgeon adjusts the sling tension to provide urethral support. The device provides a mechanical scaffold to support the urethra, addressing hypermobility or sphincter deficiency.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included sterilization validation (bioburden, ETO residuals, SAL), packaging integrity, biocompatibility (cytotoxicity, implantation, sensitization, genotoxicity, acute systemic toxicity, irritation, haemolysis, pyrogenicity), and mechanical testing (suture pullout, tensile strength, tear resistance, pore size, thickness, density, porosity).

Technological Characteristics

Materials: Monofilament polypropylene mesh, polypropylene traction threads, POM transition cones, stainless steel AISI 303/POM passers. Mesh properties: 0.14 mm monofilament diameter, 180N tensile strength, 1.45 mm pore size, 0.45 mm thickness, 59.8 g/m2 density, 52% porosity. Sterilization: Ethylene oxide (ETO). Form factor: Surgical mesh kit with passers for trans-obturator delivery.

Indications for Use

Indicated for female patients with stress urinary incontinence 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 TVT Obturator System (K033568)
• Boston Scientific Surgical Mesh (K081275)
• Desara Mesh Sling Model CALD-DS01 (K072456)
• GMD Universal Sling Model Product Code 1010 and 1020 (K083471)
• I-Stop Mid-Urethral Sling (K052175)

Submission Summary (Full Text)

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DEC 2 0 2011 510(K) Supplement KIM K103022 12/19/2011

| DIMA | KIM (Knotless<br>Incontinence Mesh) | K103022 |
|------|-------------------------------------|---------|
|------|-------------------------------------|---------|

#### 510K Summary:

| SUBMITTER: | Neomedic International, S.L.<br>C/ Maestrat 41-43 1º<br>08225 Terrassa (Barcelona)<br>Spain |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| US Contact Person: | Dr. Jeffrey R. Shideman<br>Telephone: [phone] |
| DATE PREPARED:<br>DEVICE NAME: | December 15th, 2011<br>KIM (Knotless Incontinence Mesh) |
| CLASSIFICATION<br>NAMES:<br>PREDICATE DEVICES: | Mesh, Surgical, Polymeric<br>K033568 Gynecare TVT Obturator System<br>K081275 Boston Scientific Surgical Mesh<br>K072456 Desara Mesh Sling Model CALD-DS01<br>K083471 GMD Universal Sling Model Product Code 1010 and<br>1020<br>K052175 I-Stop Mid-Urethral Sling |

#### Device Description:

KIM (Knotless Incontinence Mesh) is a sterile, single use surgical mesh kit for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

KIM (Knotless Incontinence Mesh) is composed by a monofilament polypropylene mesh sling and two passers used to pass the sling through the obturator foramens.

Polypropylene monofilament traction threads are fixed at each end of the mesh to facilitate the attachment of the passers to the mesh.

The passers are used to deliver the sling via the trans-obturator "out-inside" approach.

The traction threads are removed after placement of the sling.

When placing the mesh, the sling can be adjusted by the surgeon to leave the mesh flat under the urethra, at the proper tension providing extra support to the urethra.

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# Description of material components and physical properties:

| Component | Material |
|---------------------------------|---------------------------------|
| Monofilament polypropylene mesh | Polypropylene monofilament |
| Traction threads | Polypropylene monofilament |
| Transition cones | POM |
| Passers | Stainless steel AISI 303<br>POM |

| Component | Properties |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Monofilament polypropylene mesh | Knitted mesh<br>Monofilament diameter = 0.14 mm<br>Tensile break strength = 180±20 Newton<br>Pore size = 1.45±0.40 mm<br>Thickness = 0.45±0.05 mm<br>Density = 59.8 g/m2<br>Porosity = 52.00 % |
| Traction threads | USP 0 |
| Transition cones | Diameter: 4 mm<br>Length: 10 mm |
| Passers | Passers diameter = 4 mm |

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.

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## Predicate Devices:

The following four devices have been previously cleared by the FDA in the following 510(K)

| Device | 510 (K) document number | Date Cleared | Indications |
|-------------------------------------------------------|-------------------------|-----------------|------------------------------------------|
| GYNECARE TVT OBTURATOR SYSTEM | K033568 | December 8 2003 | Treatment of Stress Urinary Incontinence |
| BOSTON SCIENTIFIC SURGICAL MESH | K081275 | August 27 2008 | Treatment of Stress Urinary Incontinence |
| DESARA MESH SLING, MODEL CALD-DS01 | K072456 | May 8 2008 | Treatment of Stress Urinary Incontinence |
| GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020 | K083471 | March 3 2009 | Treatment of Stress Urinary Incontinence |
| I-STOP MID-URETHRAL SLING | K052175 | October 17 2005 | Treatment of Stress Urinary Incontinence |

#### Intended Use:

KIM (Knotless Incontinence Mesh) is a surgical mesh kit for treatment of female stress urinary incontinence resulting from urethral hyper mobility and / or intrinsic sphincter deficiency.

#### Technological Characteristics comparison:

The KIM Surgical Mesh and the five predicate devices are substantially equivalent:

The five predicate devices are intended for the treatment of stress urinary incontinence.

The five predicate devices are monofilament polypropylene mesh slings.

The five predicate devices include accessories to aid in mesh placement.

The five predicate devices deliver the sling via the trans-obturator approach.

The five predicate devices are sterilized by ETO.

BOSTON SCIENTIFIC SURGICAL MESH and I-STOP MID-URETHRAL SLING are not covered by a plastic sheath.

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#### 510(K) Supplement KIM K103022 12/19/2011

There are differences compared to the predicate devices:

- 1.- GYNECARE TVT, DESARA MESH SLING and GMD UNIVERSAL SLING are covered by a plastic sheath.
The differences between the devices do not raise new questions on the safety and effectiveness. We consider the proposed device is substantially equivalent to the predicate devices.

#### Performance tests:

| Performance test | Test description |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization | Bioburden<br>Ethylene oxide residuals<br>Ethylene chlorohydrins residuals<br>Sterility assurance level (SAL) determination |
| Packaging | Expiration dating test |
| Biocompatibility | Cytotoxicity<br>Implantation<br>Sensitization with polar and non-polar extract<br>Genotoxicity<br>Acute systemic toxicity<br>Irritation<br>Haemolysis<br>Extractable metallic ions<br>Pyrogen test |
| Mechanical tests | Suture pullout strength<br>Tensile break strength at break<br>Tear resistance<br>Pore size<br>Thickness<br>Density<br>Porosity<br>Traction threads-mesh strength |

Results of verification testing indicate that the product meets the established performance requirements and standards.

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### 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 devices under the Federal Food, Drug and Cosmetic Act.

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Image /page/5/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is an emblem of an eagle with its wings spread, stylized to also resemble a human profile. The eagle/human figure is facing to the right.

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

Neomedic International S.L. % Jeffrey R. Shideman, Ph.D. President International Medical Products Corporation 7307 Glouchester Drive EDINA MN 55435

SEP 2 8 2012

Re: K103022 Trade/Device Name: KIM (Knotless Incontinence Mesh) Regulation Number: 21 CFR& 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: November 28, 2011 Received: December 1, 2011

Dear Dr. Shideman:

This letter corrects our substantially equivalent letter of December 20, 2011.

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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Rechis

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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# Indications for Use

510(k) Number (if known): K103022

Device Name: KIM (Knotless Incontinence Mesh)

Indications for Use:

KIM (Knotless Incontinence Mesh) is a surgical mesh kit for treatment of female stress urinary incontinence resulting from urethral hyper mobility and / or intrinsic sphincter deficiency

Prescription Use X (Part 2) 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 CDRH, Office of Device Evaluation (ODE)

Signature

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ductive, Gastro-Renal, and