(90 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a surgical mesh, with no mention of AI or ML technologies.
Yes.
The device is a surgical mesh used to treat vaginal vault prolapse, which is a therapeutic intervention.
No
The device is a surgical mesh intended for use as a bridging material in sacrocolposuspension/sacrocolpopexy for vaginal vault prolapse. It is an implantable device used for treatment, not diagnosis. The “Summary of Performance Studies” section also describes physical and biological assessments of the mesh material itself and makes no mention of diagnostic capabilities.
No
The device description clearly states it is a physical mesh device made of polypropylene, designed for surgical implantation. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical treatment of vaginal vault prolapse by acting as a bridging material. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical mesh implanted during surgery. It does not interact with biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of Diagnostic Function: The description focuses on the physical and mechanical properties of the mesh and its surgical application. There is no mention of analyzing biological samples or providing diagnostic results.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OTO
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal vault
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol representing the human form, composed of three abstract figures facing to the right.
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
1
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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Image /page/2/Picture/0 description: The image shows the logo for Caldera Medical. The logo consists of a gray circle with a white design inside, followed by the words "CALDERA MEDICAL" in green and gray. The word "CALDERA" is in green, and the word "MEDICAL" is in gray.
Statement of Indications For Use
Indications For Use
510 (k) Number (if known): K150023
Device Name: Vertessa® Lite Y-Mesh
Indications for Use:
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.
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 Drive |
| Agoura 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:
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).
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.