(209 days)
Not Found
No
The 510(k) summary describes a surgical mesh device and does not mention any AI or ML components or functionalities.
No.
The device is a surgical mesh primarily used for structural support in treating vaginal vault prolapse, rather than actively treating an underlying disease or condition. While it aids in correcting a physical issue, its primary function is mechanical reinforcement rather than therapeutic intervention on a biological process.
No
Explanation: The device, Vertessa™ Lite Y-Mesh, is described as a bridging material used for surgical treatment of vaginal vault prolapse. Its function is to be implanted or affixed during surgery, not to diagnose a condition. The sections "Intended Use / Indications for Use" and "Device Description" clearly outline its role as a surgical mesh for repair, not for diagnostic purposes.
No
The device description clearly states it is a physical mesh comprised of polypropylene, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that Vertessa Lite Y-Mesh is a surgical mesh designed to be implanted or affixed within the body to treat vaginal vault prolapse. It is a physical implant, not a test performed on a sample outside the body.
- Intended Use: The intended use is for surgical treatment of vaginal vault prolapse, which involves a surgical procedure and the placement of a physical device.
The information provided describes a surgical implant, which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
Vertessa Lite Y-Mesh may be used as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy; laparoscopic, or robotically-assisted approach) where surgical treatment for vaginal vault prolapse is warranted.
Product codes
OTO
Device Description
Vertessa Lite Y-Mesh is designed to be used in women suffering from uterine or vaginal vault prolapse and is implanted or affixed using suture of the surgeon's choice. Vertessa Lite Y-Mesh is provided sterile and is comprised of non-absorbable macroporous monofilament polypropylene warp knit blue mesh in a y-shape design.
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 Industry and FDA Staff "Format for Traditional and Abbreviated 510/k/s the results of non-clinical bench, simulated use, surgeon feedback and validation testing has shown the Vertessa Lite Y-Mesh device to be substantially equivalent to that of the predicate device in its intended use, function, technological characteristics and performance.
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.
Vertessa Lite Y-Mesh has 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 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, Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry, FDA, 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, Vertessa Lite Y-Mesh has passed all testing requirements in terms of aging, shelf life, transportation and sterilization.
Bench and failure mode testing demonstrates that the performance of Vertessa Lite Y-Mesh is substantially equivalent to that of the predicate devices, Alyte Y-Mesh Graft (K101722) by C.R. Bard and Restorelle Y-Mesh (K112322) by Coloplast A/S.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
APR 2 5 2013
Date of Summary:
April 24, 2013
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 Fascimile: (818) 879-6556
Device Information:
Trade Name: Vertessa Lite Y-Mesh Classification: Class II, Product Code: OTO, Surgical Mesh, Gynecologic, 21 CFR 878.3300, General and Plastic Surgery Alyte Y-Mesh Graft (K101722), C.R. Bard, Inc. Predicates: Restorelle Y-Mesh (K112322), Coloplast A/S
Description of Device:
Vertessa Lite Y-Mesh is designed to be used in women suffering from uterine or vaginal vault prolapse and is implanted or affixed using suture of the surgeon's choice. Vertessa Lite Y-Mesh is provided sterile and is comprised of non-absorbable macroporous monofilament polypropylene warp knit blue mesh in a y-shape design.
Intended Use of Device:
Vertessa Lite Y-Mesh may be used as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy; laparoscopic, or robotically-assisted approach) where surgical treatment for vaginal vault prolapse is warranted.
Technological Characteristics
Vertessa Lite Y-Mesh a modification of the predicate mesh devices, Alyte Y-Mesh Graft (K101722) by C.R. Bard, Inc. and Restorelle Y-Mesh (K112322) by Coloplast A/S. The device design is a Y-shape configuration, which is similar to that of the predicate mesh devices, has a similar intended use as that of the predicate devices and does not change the fundamental scientific technology of the predicate devices.
Performance Summary
In accordance with the FDA's Guidance for Industry and FDA Staff "Format for Traditional and Abbreviated 510/k/s the results of non-clinical bench, simulated use, surgeon feedback and validation testing has shown the Vertessa Lite Y-Mesh device to be substantially equivalent to that of the predicate device in its intended use, function, technological characteristics and performance.
1
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.
Vertessa Lite Y-Mesh has 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 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, Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry, FDA, 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, Vertessa Lite Y-Mesh has passed all testing requirements in terms of aging, shelf life, transportation and sterilization.
Bench and failure mode testing demonstrates that the performance of Vertessa Lite Y-Mesh is substantially equivalent to that of the predicate devices, Alyte Y-Mesh Graft (K101722) by C.R. Bard and Restorelle Y-Mesh (K112322) by Coloplast A/S.
Summary of Substantial Equivalence
Vertessa Lite Y-Mesh has demonstrated that it is substantially equivalent to that of the predicate devices, Alyte Y-Mesh Graft, (K101722), a product of Bard Medical and Restorelle Y-Mesh (K112322) a product of Coloplast A/S.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 25, 2013
Caldera Medical, Inc. % Ms. Vicki Gail OA/RA Manager 5171 Clareton Drive AGOURA HILLS CA 91301
Re: K123028
Trade/Device Name: Vertessa™ Lite Y-Mesh Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: April 16, 2013 Received: April 18, 2013
Dear Ms. 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. 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 or any Federal statutes and regulations administered by other Federal agencies.
3
Page 2 - Ms. Vicki Gail
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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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Image /page/4/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 all capital letters. The font appears to be sans-serif.
Statement of Indications For Use
Indications For Use
510 (k) Number (if known): #K123028
Device Name: Vertessa™ Lite Y-Mesh
Indications for Use:
Vertessa™ Lite Y-Mesh may be used as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy; laparoscopic, or robotically-assisted approach) where surgical treatment for vaginal vault prolapse is warranted.
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)
Herbert ஜூட்ஜோer -S
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K123028 510(k) Number