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 Desara Mesh 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, tips and sutures to assist the surgeon in placement of the device. The sleeves, tips and sutures are removed after placement of the device.

AI/ML Overview

Here's an analysis of the provided text regarding the Desara Mesh, focusing on the acceptance criteria and study details:

Device: Desara Mesh (Surgical Mesh)

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary for a premarket notification, not a detailed study report with specific acceptance criteria and performance metrics. Therefore, explicit, quantifiable acceptance criteria and their corresponding reported device performance values are not present in the text.

Instead, the document states:

Aspect	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Passed all testing requirements	"The mesh material has passed all testing requirements for biocompatibility"
Performance	Passed all testing requirements	"The mesh material has passed all testing requirements for ... performance"
Shelf life	Passed all testing requirements	"The mesh material has passed all testing requirements for ... shelf life"
Sterilization	Passed all testing requirements	"The mesh material has passed all testing requirements for ... sterilization"
Validation Testing	Passed all testing criteria	"The Desara Mesh material has been subjected to cadaver labs, bench and validation testing and has passed all testing criteria."
Substantial Equivalence	Safe and effective for intended use, equivalent to predicate device	"The Desara Mesh is safe and effective for its intended use and is substantially equivalent to the predicate device, Desara Mesh, K101169"

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify sample sizes for any test sets. It mentions "cadaver labs, bench and validation testing" but provides no details on the number of cadavers, bench test units, or any other data points.

The data provenance is also not specified beyond the tests being conducted for the manufacturer (Caldera Medical, Inc.). It's unclear if the data is retrospective or prospective, or the country of origin.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not present in the document. The type of testing mentioned (biocompatibility, performance, shelf life, sterilization, cadaver labs, bench, validation) does not typically involve expert consensus to establish a "ground truth" in the way, for example, image-based diagnostic studies do. These are primarily engineering and biological safety tests.

4. Adjudication Method for the Test Set

This information is not present as the nature of the testing described (biocompatibility, engineering tests) does not typically involve expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done or mentioned. This type of study is more relevant for diagnostic AI devices where human performance with and without AI assistance is being evaluated. The Desara Mesh is a surgical implant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

No, a standalone (algorithm only) performance study was not done or mentioned. This is not applicable to a surgical mesh device. The performance mentioned refers to the physical and biological properties of the mesh itself, not an algorithm.

7. The Type of Ground Truth Used

Based on the types of tests described, the "ground truth" would be established by:

Biocompatibility: Adherence to established ISO standards and testing protocols (e.g., cytotoxicity, sensitization, irritation based on biological responses).
Performance: Measured physical properties (e.g., tensile strength, pore size, elasticity) against pre-defined engineering specifications.
Shelf life: Stability of the material over time under simulated or real-time aging conditions, meeting pre-defined criteria.
Sterilization: Demonstrated sterility assurance level (SAL) against established standards.
Cadaver Labs: Likely involved successful surgical placement and observation of anatomical interaction within the cadaveric model, following predefined procedural success criteria.
Bench Testing: Objective measurements against engineering specifications.
Validation Testing: Confirmation that the device meets its design requirements.

These are objective, measurable outcomes rather than expert consensus on a diagnostic finding or pathology.

8. The Sample Size for the Training Set

This information is not present. The Desara Mesh is a physical medical device, not an AI or algorithmic device that requires a "training set" in the computational sense. The "development" process for such a device would involve material science, engineering design, and fabrication, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" in the context of an AI device. For a physical device like a surgical mesh, the "ground truth" during its development and testing phases would be based on established engineering principles, material science properties, biological safety standards, and predefined performance specifications.

Summary

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510(k) Summary

Date of Summary:	July 29, 2013
Applicant:	Caldera Medical, Inc.5171 Clareton DriveAgoura Hills, CA 91301P (818) 879-6555F (818) 879-6556
Contact:	Vicki GailQuality and Operations ManagerP (818) 483-7602F (818) 736-9083E vgail@calderamedical.com
Device Name:	Surgical Mesh (878.3300)
Device Class:	Class II, Product Code OTN, 21 CFR 878.3300, Gynecologic, ForStress Urinary Incontinence, Female, Obstetrics/GynecologyPanel
Trade Name:	Desara Mesh
Common Name:	Surgical Mesh
Predicate Device:	Desara Mesh , K101169

Description of 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.

Summary of Technological Characteristics

The Desara Mesh contains a change in the tip resin material only. The Desara Mesh and the predicate mesh are comprised of the same knit pattern, mesh and other component materials. The Desara Mesh is the same shape and size as the predicate mesh. The Desara Mesh has the same intended use and does not change the fundamental scientific technology of the predicate device.

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Performance Summary

The Desara Mesh is produced from the same mesh material as the predicate device, Desara Mesh, #K101169, also a product of Caldera Medical. The mesh material has passed all testing requirements for biocompatibility, performance, shelf life and sterilization. The Desara Mesh material has been subjected to cadaver labs, bench and validation testing and has passed all testing criteria.

Summary of Substantial Equivalence

The Desara Mesh is safe and effective for its intended use and is substantially equivalent to the predicate device, Desara Mesh, K101169, also a product of Caldera Medical.

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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 is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings outstretched in a swooping motion.

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 5171 Clareton Drive Agoura Hills, CA 91301

Re: K112609 Trade/Device Name: Desara® Mesh Regulation Number: 21 CFR8 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated (Date on orig SE Itr): September 7, 2011 Received (Date on orig SE ltr): September 8, 2011

Dear Vicki Gail,

This letter corrects our substantially equivalent letter of September 30, 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 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. Iisting 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 - Vicki Gail

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): K112609

Device Name: Desara® Mesh

Indications for Use:

Prescription Use(21 CFR 801 Subpart D)	X
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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.