DESARA MESH MODEL: CAL-DS01

K101169 · Caldera Medical, Inc. · OTN · May 20, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K101169
• Device Name: DESARA MESH MODEL: CAL-DS01
• Applicant: Caldera Medical, Inc.
• Product Code: OTN · General, Plastic Surgery
• Decision Date: May 20, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Desara Mesh 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.

Device Story

Desara Mesh Sling is a sterile, single-use pubourethral sling; used to provide pelvic support for treatment of stress urinary incontinence, mixed incontinence, and vaginal vault prolapse. Device consists of monofilament polypropylene yarn knitted into mesh; includes integral sleeves and sutures to assist surgeon during placement; sleeves and sutures are removed post-placement. Used in clinical settings by surgeons. Device provides mechanical support to the urethra to address hypermobility or intrinsic sphincter deficiency, potentially improving patient continence.

Clinical Evidence

Bench testing, cadaver lab, and validation testing performed. Biocompatibility testing conducted in accordance with ISO 10993 standards with passing results.

Technological Characteristics

Monofilament polypropylene yarn knitted into mesh. Sterile, single-use. Includes integral sleeves and sutures for placement. Biocompatibility per ISO 10993.

Indications for Use

Indicated for females with Genuine Stress Urinary Incontinence (SUI) or mixed incontinence resulting from urethral hypermobility 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

• Desara Mesh Sling (K072456)

Submission Summary (Full Text)

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### 510(k) Summarv

| Date of Summary: | July 29, 2013 |
|------------------|---------------|
|------------------|---------------|

Submitted by:

| Submitter: | Caldera Medical, Inc. |
|------------|-----------------------------------------------|
| Address: | 5171 Clareton Drive<br>Agoura Hills, CA 91301 |
| Contact: | Vicki Gail, Manger QA/RA |
| Phone: | [phone] x 102 |
| Fax: | [phone] |

Device Name:

| Device Name: | Surgical Mesh (878.3300) |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Desara Mesh Sling |
| Common Name: | Surgical Mesh |
| Device Class: | Class II, Product Code OTN, 21 CFR 878.3300,<br>Gynecologic, For Stress Urinary Incontinence, Female,<br>Obstetrics/Gynecology Panel |
| Predicate Device: | Desara Mesh Sling. K072456. Caldera Medical. Inc. |

#### Description of Device:

The Desara Mesh Sling is a sterile, single-use pubourethral sling used to provide support in the pelvic region to treat stress urinary incontinence, mixed incontinence, and vaginal vault prolapse. The device is manufactured out of a monofilament polypropylene yarn, which is knitted into a mesh. The device has integral sleeves and sutures to assist the surgeon in placement of the device. The sleeves and sutures are removed after placement of the device.

#### Intended Use of Device:

The Desara Mesh 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.

#### Technological Characteristics

The new Desara Mesh is a modification of the predicate mesh device, with the same intended use and does not change the fundamental scientific technology as the predicate device.

## Performance Data Summary

The biocompatibility tests conducted for the new Desara mesh were selected in accordance to ISO 10993, Biological Evaluation of Medical Devices Part I: Evaluation and Testing standards and all test results were passing.

Confidential

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In accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh, the results of bench, cadaver lab and validation testing has shown the new Desara Mesh device to be substantially equivalent to the predicate device.

Summary of Substantial Equivalence

The new Desara mesh is safe and effective for its intended use and is substantially equivalent to the predicate device, Desara mesh, also a product of Caldera Medical.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract symbol resembling a person with outstretched arms. The symbol is positioned to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

September 13, 2013

Caldera Medical, Inc. % Vicki Gail Quality and Operations Manager 28632 Roadside Drive. Suite 260 Agoura Hills, CA 91301

K101169 Re: Trade/Device Name: Desara® Mesh Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated (Date on orig SE ltr): April 23, 2010 Received (Date on orig SE Itr): April 26, 2010

Dear Vicki Gail,

This letter corrects our substantially equivalent letter of May 20, 2010.

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

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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 tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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,

# Herbert P. Lerner -S

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

510(k) Number (if known): K101169

Device Name: Desara® Mesh

# Indications for Use:

The Desara® Mesh 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.

Image /page/4/Picture/5 description: The image shows the text "Prescription Use (21 CFR 801 Subpart D)" with a box next to it that has been marked with an "X". The text indicates that the product is intended for prescription use and is subject to the regulations outlined in Title 21, Code of Federal Regulations, Part 801, Subpart D. The presence of the "X" in the box suggests that this option has been selected or indicated.

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

# 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 2013.09.13 13:31:56 -04/00'

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Desara Mesh 510(k) #K101169 Add To File

Confidential