T-SLING

K050516 · Herniamesh S.R.L. · OTN · Feb 3, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K050516
• Device Name: T-SLING
• Applicant: Herniamesh S.R.L.
• Product Code: OTN · General, Plastic Surgery
• Decision Date: Feb 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The T-Sling is intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency, and vaginal vault prolapse.

Device Story

T-Sling is a sterile, single-use pubourethral sling; constructed from monofilament polypropylene warp-knitted into composite mesh. Device used by physicians in clinical settings to treat female stress urinary incontinence (SUI) and vaginal vault prolapse. Mesh positioned to provide support to urethra; intended to correct urethral hypermobility or intrinsic sphincter deficiency. Device functions as a mechanical implant; no electronic or software components.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Monofilament polypropylene mesh; warp-knitted composite construction; sterile; single-use; mechanical implant.

Indications for Use

Indicated for females with Genuine Stress Urinary Incontinence (SUI), mixed incontinence due to urethral hypermobility or intrinsic sphincter deficiency, and vaginal vault prolapse.

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

• Herniamesh T-Sling (K020652)
• Tyco Healthcare IVS Tunneller (K010035)
• Ethicon TVT (K012628)

Submission Summary (Full Text)

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### Caldera Medical, Inc. T-Sling K020216 2 510(k) Summary

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#### FEB # 2006

| | FEB 3 2006 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | January 19, 2006 |
| Applicant: | Bryon L. Merade, CEO<br>Caldera Medical, Inc.<br>28632 Roadside Drive, Suite 260<br>Agoura Hills, CA 91301<br>Tel: [phone] Fax: [phone] |
| Contact: | Marla Kengen, Project Leader<br>Caldera Medical, Inc.<br>28632 Roadside Drive, Suite 260<br>Agoura Hills, CA 91301<br>Tel: [phone] Fax: [phone]<br>[e-mail] |
| Device Name: | Surgical Mesh (878.3300) |
| Trade Name: | T-Sling |
| Common Name: | Surgical Mesh |
| Classification: | Class II |
| Predicate Devices: | Herniamesh T-Sling - K020652<br>Tyco Healthcare IVS Tunneller - K010035<br>Ethicon TVT - K012628 |
| Device Description: | The T-Sling is made of monofilament polypropylene<br>warp knitted into composite mesh construction. The T-<br>Sling is a sterile, single-use pubourethral sling for the<br>treatment of stress urinary incontinence (SUI). |
| Indications for Use: | The T-Sling is intended to be used in females to position<br>a mesh for the treatment of Genuine Stress Urinary<br>Incontinence (SUI), mixed incontinence resulting from<br>urethral hypermobility or intrinsic sphincter deficiency,<br>and vaginal vault prolapse. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

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

April 11, 2014

Marla Kengen Project Leader Caldera Medical, Inc. 28632 Roadside Drive, Suite 260 Agoura Hills, California 91301

Re: K050516

Trade/Device Name: T-Sling Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OTN Dated (Date on orig SE ltr): November 28, 2005 Received (Date on orig SE ltr): December 19, 2005

Dear Marla Kengen:

This letter corrects our substantially equivalent letter of February 3, 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 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.

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#### Page 2 - Marla Kengen

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 (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 contact 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. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/2/Picture/7 description: The image shows the text "Herbert P. Lerner - S". The text is written in a bold, sans-serif font. The letters "FDA" are superimposed on the text, with the letters being in a stylized, geometric font. The letters "FDA" are also outlined in black.

for 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 Form

510(k) Number (if known) K050516

Device Name: T-Sling

Indications For Use:

The T-sling is intended to be used in females to position a polypropylene mesh for treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

## Herbert P. Lerner -S 2014.03.27 13:33:36 -04'00'

Prescription Use x

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

HERNIAMESH SRL Sede legale Via Fratelli Meliga 1/C - 10034 Chivasso (TO) Cap. Soc. € 98.800 i.v. - P.I. 02791540616 - C. F. 02245180613 -N. Iscrizione Rea Torino TO-960622 Tel. [phone] - fax [phone] Mall: [e-mail] - Mail certificata: [e-mail] - Sito internet www.herniamesh.com