Desara® Blue OV and Desara® Blue SS devices are 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

Desara® Blue OV and Desara® Blue SS devices are sterile, single-use mid-urethral slings used to provide support in the pelvic region to treat stress urinary or mixed incontinence. The devices are manufactured out of monofilament polypropylene yarn, which is knitted into a mesh. The devices have integral sleeves, tips and sutures to assist the surgeon in placement of the mesh, which are removed after placement of the device. Desara® Blue OV and Desara® Blue SS are designed to work with Caldera Medical's reusable introducers, which utilize a Universal Connection System offering surgeons the flexibility to choose their preferred surgical approach.

Desara® Blue OV incorporates an overlapping sleeve design as an alternative to the centerline sleeve gap utilized in the predicate devices, Desara® and Desara® Blue, K132069. Desara® Blue SS incorporates a shorter suture length than that of the predicate devices. Desara® and Desara Blue, K132069.

AI/ML Overview

The provided text is a 510(k) summary for medical devices, specifically surgical mesh for stress urinary incontinence. It primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing and biocompatibility assessments, rather than clinical efficacy studies involving AI. As such, the information required for a detailed AI device study (e.g., sample sizes for test and training sets, expert qualifications, MRMC studies) is not present.

However, I can extract the acceptance criteria and performance data for the mechanical and bench tests that were conducted to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

Mesh Characteristic	Acceptance Criteria (Equivalent to predicate device)	Reported Device Performance (Relative to predicate device)
Mesh Thickness	Equivalent	Equivalent
Mesh Knit Characteristics	Equivalent	Equivalent
Pore Size	Equivalent	Equivalent
Mesh Density	Equivalent	Equivalent
Tensile Strength	Equivalent	Equivalent
Mesh Stiffness	Equivalent	Equivalent
Flexural Rigidity	Equivalent	Equivalent
Tear Resistance	Equivalent	Equivalent
Burst Strength	Equivalent	Equivalent
Suture Pullout	Equivalent	Equivalent
Pyrogen Levels	Equivalent	Equivalent
Sleeve Removal Force	Met predefined acceptance criteria	Substantially equivalent
Suture Detachment Force	Met predefined acceptance criteria	Substantially equivalent

2. Sample Size for Test Set and Data Provenance:

The document does not specify exact sample sizes for the "test set" in terms of number of devices or data points for each characteristic. The testing was described as "mechanical bench and validation testing," implying laboratory-based data, not patient data. The provenance is internal to Caldera Medical, Inc.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. The "ground truth" for these engineering and material characteristic tests would be the measured values themselves, compared against the predicate device's established values or industry standards. There were no human experts establishing a subjective ground truth for diagnostic accuracy.

4. Adjudication Method:

Not applicable. This type of testing does not involve adjudication of expert opinions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This document describes a traditional 510(k) submission for a physical medical device, not an AI or imaging-based diagnostic tool. Therefore, a MRMC study comparing human readers with and without AI assistance was not performed.

6. Standalone (Algorithm Only) Performance:

No. This is not an AI algorithm. The performance evaluation is for a physical medical device.

7. Type of Ground Truth Used:

The ground truth used for the performance evaluation of the Desara® Blue OV and Desara® Blue SS devices was based on measured material and mechanical properties compared against those of the legally marketed predicate device, Desara® Blue (#K132069), and reference devices (Ascend® Blue, #K101462, and Desara® Mesh, #K112609). This falls under direct physical measurement and comparison to established product specifications.

8. Sample Size for the Training Set:

Not applicable. As this is not an AI device, there is no "training set."

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

Not applicable. There is no training set for an AI model.

Summary

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CERA MEDICAL

JUL 0 1 2014

K140843 Pg. 1 of 2

510(k) Summary

Date of Summary:

March 28, 2014

Applicant:

Caldera Medical, Inc. 5171 Clareton Drive Agoura Hills, CA 91301 P (818) 879-6555 F (818) 879-6556

Contact:

Vicki Gail QA/RA and Operations Manager P (818) 483-7602 F (818) 736-9083 E vaail@calderamedical.com

Desara® Blue OV

Desara® Blue SS

Class II

OTN

Trade Name:

Device Class: Product Code: C.F.R Section: Common Name: Product Code Name:

Classification Panel:

Predicate Device:

21 CFR 878.3300 Surgical Mesh Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator Obstetrics/Gynecology Panel

Desara® and Desara® Blue, K132069

Description of Device:

Intended Use of Device:

Desara Blue OV and Desara Blue SS 510{k} #K140843/S002 Question 003_510(k) Summary Caldera Medical Inc.

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Image /page/1/Picture/1 description: The image shows the logo for Caldera Medical. The logo consists of a stylized image of a caldera, which is a large volcanic crater, on the left. To the right of the image is the text "CALDERA MEDICAL" in all capital letters. The text is in a simple, sans-serif font.

Summary of Technological Characteristics

ﮯ

Desara® Blue OV and Desara® Blue SS devices submitted herein contain changes in the lengths of limited contact materials to additional device design options to the Desara® product family. Desara® Blue OV incorporates an overlapping (longer) sleeve design and Desara® Blue SS incorporates a shorter suture length design.

Desara® Blue QV and Desara® Blue SS are the same shape, overall size, comprised from the same raw materials and utilize the same mesh knit pattern and the same fundamental scientific technology as that of the predicate device. Desara® Blue (#K132069).

Performance Summary

Desara® Blue OV and Desara® Blue SS submitted herein are comprised of the same mesh resin as that of the bredicate device. Desara® Blue (K132069) and the reference device, Ascend® Blue, (#K101462), also products of Caldera Medical. In accordance with the FDA's Guidance for the Preparation of a Premarket Notification for Surgical Mesh, the following mesh characteristics were assessed: mesh thickness, mesh knit characteristics, pore size, mesh density, tensile strength, mesh stiffness, flexural rigidity, tear resistance, burst strength, suture pullout and pyrogen levels. Results of both mechanical bench and validation testing demonstrate equivalent device function based upon its intended use to the predicate device, Desara® Blue, (#K132069). The change in sleeve length with an overlapping feature in Desara Blue OV and the shortened suture length in Desara Blue SS are minor dimensional changes to limited contact materials of the device. Bench testing was completed to assess sleeve removal and suture detachment when compared to the predicate device, Desara® Blue, (#K132069). The testing data met the predefined acceptance criteria and demonstrated the sleeve removal and suture detachment forces to be substantially equivalent to the predicate device, Desara® Blue, (#K132069).

Desara® Mesh (#K112609) and Ascend® Blue, (#K101462) were used as a reference for Desara® Blue OV and Desara® Blue SS devices for biocompatibility since they are comprised of the same materials. Desara Mesh (#K112609) and Ascend Blue, (#K101462) have passed all biocompatibility testing as indicated per the FDA guidance documents, FDA Device Advice, Guidance Documents (Medical Device and Radiation Emitting Product), 3. Biocompatibility and FDA Draft Guidance Entitled "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing", dated April 23, 2013.

Testing documentation from Desara® Blue (#K132069) and Ascend® Blue, (#K101462) was used to
support the shelf life and transportation of Desara® Blue OV and Desara® Blue SS a performed in accordance with the FDA Device Advice, Guidance Documents (Medical Device and Radiation Emitting Product), 4. Labeling and FDA Consensus standard, ASTM F-1980-07, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices as the devices are comprised of the same materials and utilize the same packaging, manufacturing and sterilization processes as that of Desara® Blue (#K132069).

Desara® Blue OV and Desara® Blue SS devices submitted herein were validated for EtO sterilization in accordance with FDA Guidance, Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA and AAMI TIR 28:2009, Product Adoption and Process Equivalence.

Summary of Substantial Equivalence

The conclusions drawn from the non-clinical testing demonstrate that Desara® Blue OV and Desara® Blue SS submitted herein are substantially equivalent to the predicate device, Desara® Blue (#K132069).

Desara Blue OV and Desara Blue SS 510(k) #K140843/S002 Question 003_510(k) Summary Caldera Medical Inc.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is black and the background is white.

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Public Health Service

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

July 1, 2014

Caldera Medical, Inc. Vicki Gail QA/RA and Operations Manager 5171 Clareton Drive Agoura Hills, CA 91301

Re: K140843

Trade/Device Name: Desara® Blue OV and Desara® Blue SS Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: May 30, 2014 Received: June 2, 2014

Dear Vicki Gail,

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 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

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Page 2 - Vicki Gail

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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 Industry and Consumer Education 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,

Benia

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):_K140843

Device Name: Desara® Blue OV Desara® Blue SS

Indications for Use:

Desara® Blue OV and Desara® Blue SS are 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.

× Prescription Use (21 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 IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin R. Fisher -S
2014.06.30 17:26:37 -04'00'

Page 1 of 1

Caldera Medical, Inc. Desara Blue OV and Desara Blue SS Page 11

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.