(91 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a surgical mesh, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used for the repair of uterine or vaginal vault prolapse, which is a therapeutic intervention aimed at correcting a medical condition.
No
The device is described as an implantable surgical mesh used for the repair of uterine or vaginal vault prolapse, not for diagnosing medical conditions.
No
The device description clearly states that Vertessa® Lite is comprised of macroporous monofilament polypropylene warp knit blue mesh, which is a physical material intended for implantation. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the repair of uterine or vaginal vault prolapse, requiring support material. This is a surgical intervention, not a diagnostic test performed in vitro (outside the body).
- Device Description: The device is a surgical mesh designed to be implanted or affixed within the body. This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze samples (blood, tissue, etc.), or provide information about a patient's health status through in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
Vertessa® Lite may be used for the repair of uterine or vaginal vault prolapse that require support material. It may be used in open or laparoscopic abdominal procedures.
Product codes (comma separated list FDA assigned to the subject device)
OTO
Device Description
Vertessa® Lite 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 devices are provided sterile and are comprised of macroporous monofilament polypropylene warp knit blue mesh. Vertessa "Lite will be available in a rectangular flat sheet mesh and rectangular strip mesh designs.
The flat sheet mesh designs are available in the following sizes: 8 x 16 cm, 8 x 18 cm, 8 x 20 cm, 8 x 22 cm, 8 x 24 cm, 8 x 26 cm, 10 x 16 cm, 10 x 18 cm, 10 x 20 cm, 10 x 22 cm, 10 x 24 cm, 10 x 26 cm, and 11 x 30 cm.
The strip mesh designs are available in the following sizes: 4 x 16 cm, 4 x 18 cm, 4 x 20 cm, 4 x 22 cm, 4 x 24 cm, 4 x 26 cm, 5 x 18 cm, 5 x 20 cm, 5 x 20 cm, 5 x 22 cm, 5 x 24 cm, 5 x 26 cm, and 6 x 30 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterine or 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, mesh stiffness (tensile and bending), tear resistance, and suture pullout strength. The results demonstrate that the Vertessa® Lite has comparative mechanical performance to the predicate device. Vertessa® Lite (K123337).
Vertessa® Lite has demonstrated biocompatibility as indicated per the FDA guidance 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 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.
Vertessa®Lite (K123337)
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.
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: K150016
Trade/Device Name: Vertessa® Lite Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: December 29, 2014 Received: January 6, 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.
for
Sincerely yours,
Herbert P. Lerner -S
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 on the left side, with a pattern of curved lines inside. To the right of the circle, the words "CALDERA MEDICAL" are written in a sans-serif font, with "CALDERA" in green and "MEDICAL" in gray.
Statement of Indications For Use
Indications For Use
510 (k) Number (if known): K150016
Device Name: Vertessa® Lite
Indications for Use:
Vertessa® Lite may be used for the repair of uterine or vaginal vault prolapse that require support material. It may be used in open or laparoscopic abdominal procedures.
Prescription Use -- X --(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)
3
Image /page/3/Picture/0 description: The image shows the logo for Caldera Medical. The logo consists of a circular graphic 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.
510(k) Summary K150016
Date of Summary: April 6, 2015
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 Trade Name:
| Classification: | Class II
OTO (mesh, surgical, gynecologic, for apical vaginal
prolapse, transabdominally placed)
21 CFR 878.3300 (surgical mesh) |
| ----------------- | ------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Vertessa®Lite (K123337), Caldera Medical, Inc. Predicates:
Description of Device:
Vertessa® Lite 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 devices are provided sterile and are comprised of macroporous monofilament polypropylene warp knit blue mesh. Vertessa "Lite will be available in a rectangular flat sheet mesh and rectangular strip mesh designs.
The flat sheet mesh designs are available in the following sizes: 8 x 16 cm, 8 x 18 cm, 8 x 20 cm, 8 x 22 cm, 8 x 24 cm, 8 x 26 cm, 10 x 16 cm, 10 x 18 cm, 10 x 20 cm, 10 x 22 cm, 10 x 24 cm, 10 x 26 cm, and 11 x 30 cm.
The strip mesh designs are available in the following sizes: 4 x 16 cm, 4 x 18 cm, 4 x 20 cm, 4 x 22 cm, 4 x 24 cm, 4 x 26 cm, 5 x 18 cm, 5 x 20 cm, 5 x 20 cm, 5 x 22 cm, 5 x 24 cm, 5 x 26 cm, and 6 x 30 cm.
Intended Use of Device:
Vertessa® Lite devices may be used for the repair of uterine or vaginal vault prolapse that requires support material. It may be used in open or laparoscopic abdominal procedures.
4
Image /page/4/Picture/0 description: The image shows the logo for Caldera Medical. The logo consists of a circular graphic on the left and the text "CALDERA MEDICAL" on the right. The word "CALDERA" is in green, while the word "MEDICAL" is in gray.
Technological Characteristics:
Vertessa® Lite devices submitted herein are a modification of the predicate mesh device, Vertessa® Lite (K123337). The modifications include available sizes, configuration (pre-cut strips), and a larger pore size. Vertessa® Lite devices submitted herein are comprised of the same blue mesh and the same mesh knit pattern as the predicate device. Vertessa® Lite submitted herein has the same intended use and same technological characteristics as that of its predicate device, Vertessa® Lite (K123337).
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, mesh stiffness (tensile and bending), tear resistance, and suture pullout strength. The results demonstrate that the Vertessa® Lite has comparative mechanical performance to the predicate device. Vertessa® Lite (K123337).
Vertessa® Lite has demonstrated biocompatibility as indicated per the FDA guidance 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 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 devices submitted herein are substantially equivalent to the predicate device, Vertessa" Lite (K123337) also a product of Caldera Medical, Inc.