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 Description

The Caldera Desara Mesh is 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 sleeve and sutures to assist the surgeon in placement of the device. The sleeve and sutures are removed after placement of the device.

AI/ML Overview

Here's the analysis of the provided text regarding the CALDERA DESARA 510(K) SUMMARY.

The provided text does NOT contain information about any acceptance criteria, device performance studies, or clinical trial data. It is a regulatory submission for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical effectiveness data.

Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone studies, or ground truth details.

The document primarily describes:

Device Name: Desara Mesh
Applicant: Caldera Medical, Inc.
Intended Use: In females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI) and mixed incontinence.
Predicate Device: Caldera T-Sling (K050516)
Technological Characteristics: States the Desara device has the same materials and design as the Caldera T-Sling, with minor changes related to suppliers and mesh configuration.
Regulatory Status: 510(k) clearance (K072456) as a Class II device (Surgical Mesh, Product Code OTN).

To answer your prompt fully, I would need a different type of document, such as a clinical study report or a more detailed summary of clinical data that would typically be associated with a PMA (Premarket Approval) application or a 510(k) that included specific performance testing.

Summary

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CALDERA DESARA 510(K) SUMMARY

Date of Summary:	July 29, 2013
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l. Applicant: Caldera Medical, Inc. 5171 Clareton Drive Agoura Hills. CA 91301 Tel: (805) 879-6555 Fax: (818) 879-6556
- Christine Emanuel Contact: Caldera Medical, Inc. 28632 Roadside Drive, Suite 260 Agoura Hills, CA 91301 Tel: (866) 422-5337 Fax: (818) 879-6556 cemanuel@west.net
Surgical Mesh (878.3300) 2. Device Name: Trade Name: Desara Common Name: Surgical Mesh Class II. Product Code OTN, 21 CFR 878.3300, Device Class: Gynecologic, For Stress Urinary Incontinence, Female, Obstetrics/Gynecology Panel
Caldera T-Sling, K050516, Feb 3, 2006 3. Predicate Device

4. Description of Device

The Desara Mesh device is a modification to the Caldera T-Sling, used for the same Indications for Use and manufactured out of the same mesh material, a monofilament polypropylene mesh

5. 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.

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6. Summary of Technological Characteristics

The Caldera Desara device has the same materials and design as the Caldera T-Sling and has the same technological characteristics. The changes to the Desara Mesh are minor and are primarily related to changes in suppliers as well as minor changes to mesh configuration.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

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

September 13, 2013

Caldera Medical, Inc. % Mara Korsunsky Quality Assurance and Regulatory Affairs Manager 28632 Roadside Drive, Suite 260 Agoura Hills, CA 91301

K072456 Re:
Trade/Device Name: Desara™ Implant Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated (Date on orig SE ltr): April 7, 2008 Received (Date on orig SE Itr): April 8, 2008

Dear Mara Korsunsky,

This letter corrects our substantially equivalent letter of May 8, 2008.

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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Page 2 - Mara Korsunsky

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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): K072456

Device Name: Desara® Mesh

Indications for Use:

Image /page/4/Picture/5 description: The image shows the words "Prescription Use (21 CFR 801 Subpart D)" with a box to the right of the words "Prescription Use". There is an "X" in the box, indicating that the prescription use option has been selected. The text is in black font and the box is outlined in black.

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

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Confidential

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
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.(b)
Classification. Class II.