Vertessa® Lite Y-Mesh may be used a bridging material for as sacrocolposuspension/sacrocolpopexy (laparotomy; laparoscopic, or robotically-assisted approach) where surgical treatment for vaginal vault prolapse is warranted.

Device Description

Vertessa® Lite Y-Mesh devices are designed to be used in women suffering from uterine or vaginal vault prolapse and are implanted or affixed using suture of the surgeon's choice. Vertessa® Lite Y-Mesh devices are provided sterile and are comprised of macroporous monofilament polypropylene warp knit clear mesh. Vertessa® Lite Y-Mesh will be available in a y-shape design of five different sizes (22 x 4 x 3 cm, 22 x 4 x 4 cm, 22 x 5 x 4 cm, 26 x 4 x 3 cm, 26 x 5 x 4 cm).

AI/ML Overview

I am sorry, but the provided text is a 510(k) summary for a medical device (surgical mesh). It does not describe a study involving an AI or an algorithm, nor does it present acceptance criteria or performance data in the context of an AI device.

Therefore, I cannot extract the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Summary

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

April 6, 2015

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

Re: K150023

Trade/Device Name: Vertessa® Lite Y-Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: December 29, 2014 Received: January 7, 2015

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

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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Statement of Indications For Use

Indications For Use

510 (k) Number (if known): K150023

Device Name: Vertessa® Lite Y-Mesh

Indications for Use:

Prescription Use --Х--(Part 21 CFR 801 Subpart D) AND/OR

Over the Counter Use_ (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image shows the logo for Caldera Medical. The logo consists of a circular graphic on the left and the words "CALDERA MEDICAL" on the right. The word "CALDERA" is in green, while the word "MEDICAL" is in gray.

510(k) Summary K150023

Date of Summary:

Submitted by:

Submitter:	Caldera Medical, Inc.
Address:	5171 Clareton DriveAgoura Hills, CA 91301
Contact:	Vicki Gail, Manager QA/RA
Phone:	(818) 879-6555 x 102

Device Information:

Vertessa® Lite Y-Mesh Trade Name:

Classification: Class II OTO (mesh, surgical, gynecologic, for apical vaginal prolapse, transabdominally placed) 21 CFR 878.3300 (surgical mesh)

Predicates: Vertessa® Lite Y-Mesh (K123028), Caldera Medical, Inc.

Description of Device:

Intended Use of Device:

Vertessa® -Y-Mesh may be used bridging Lite as a material for sacrocolposuspension/sacrocolpopexy (laparotomy; laparoscopic, or roboticallyassisted approach) where surgical treatment for vaginal vault prolapse is warranted.

Technological Characteristics

Vertessa® Lite Y-Mesh devices submitted herein are a modification of the predicate mesh device, Vertessa® Lite Y-Mesh (K123028). The modifications include available sizes, a larger pore size, and removal of the mid-line marker. Vertessa" Lite Y-Mesh devices are comprised of the same blue mesh as the predicate device. Vertessa Lite Y-Mesh submitted herein has the same intended use and same technological characteristics as that of its predicate device, Vertessa® Lite Y-Mesh (K123028).

Vertessa® Lite Y-Mesh Caldera Medical, Inc.

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Image /page/4/Picture/0 description: The image shows the logo for Caldera Medical. The logo consists of a gray globe-like icon on the left, followed by the text "CALDERA MEDICAL" in green and gray. The word "CALDERA" is in green, while the word "MEDICAL" is in gray.

Performance Summary

In accordance with the FDA's Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh, the following mesh characteristics were assessed: mesh thickness, mesh knit characteristics, pore size, mesh density, tensile strength, tensile strength across stitching, mesh stiffness (tensile and bending), tear resistance, and suture pullout strength. Vertessa® Lite Y-Mesh has comparative mechanical performance to the predicate device. Vertessa® Lite Y-Mesh. (K123028),

Vertessa® Lite Y-Mesh has demonstrated biocompatibility as indicated per the FDA quidance document, FDA Blue Book Memorandum #G95-1 Entitled "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing."

In accordance with the FDA guidance document, Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry, FDA, and the FDA Consensus standard, ASTM F-1980-07, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, Vertessa® Lite Y-Mesh has demonstrated appropriate sterilization validation and information to support a three-year shelf life.

Summary of Substantial Equivalence

The performance data demonstrate that the Vertessa® Lite Y-Mesh devices submitted herein are substantially equivalent to that of the predicate device, Vertessa® Lite Y-Mesh (K123028), also a product of Caldera Medical, Inc.

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.