(98 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a surgical mesh, with no mention of AI or ML capabilities.
Yes.
The device is intended for the repair of uterine or vaginal vault prolapse, which addresses a health condition and involves supporting and repairing anatomical structures.
No
The device, Vertessa™, is a surgical mesh intended for the repair of uterine or vaginal vault prolapse. It is an implanted support material, not a device used to identify or determine the nature of a disease or condition.
No
The device description clearly states that Vertessa™ is a physical mesh comprised of macroporous monofilament polypropylene warp knit clear mesh, designed to be implanted or affixed using suture. This indicates it is a hardware medical 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 using a support material (mesh). This is a surgical procedure performed on the patient's body.
- Device Description: The device is a surgical mesh designed to be implanted or affixed within the body.
- 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.
This device is a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
Vertessa™ 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.
Product codes (comma separated list FDA assigned to the subject device)
OTO
Device Description
Vertessa™ is designed to be used in the inpatient or outpatient surgery setting in women suffering from uterine or vaginal vault prolapse and is implanted or affixed using suture of the surgeon's choice. Vertessa™ mesh will be provided sterile and is comprised of macroporous monofilament polypropylene warp knit clear mesh.
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
Inpatient or outpatient surgery setting
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 bench, simulated use, surgeon feedback and validation testing has shown Vertessa ™ to be substantially equivalent to the predicate devices in its intended use, technological characteristics and performance.
Vertessa M is comprised of the same mesh as the predicate device. Ascend® Blue, FDA 510(k) #K101462, also a product 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. Vertessa™ mesh demonstrates substantial equivalence to the predicate device, Ascend® Blue.
Vertessa™ 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". Vertessa™ demonstrates substantial equivalence to the predicate device, Ascend® Blue.
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™ has passed all testing requirements in terms of aging, shelf life: transportation and sterilization and has demonstrated substantial equivalence to the predicate device, Ascend® Blue.
Results of mechanical bench and validation testing demonstrate equivalent device function based upon its intended use to the predicate devices, POPMesh™ and Ascend® Blue.
The performance of Vertessa'" demonstrates that the device is as safe, and as effective, and performs at least as safely and effectively as the predicate devices, Ascend® Blue and POPMesh™.
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.
Ascend® Blue (K101462), POPMesh™ (K053424)
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
MAY 1 0 2012
510(k) Summary
Date of Summary:
Mav 4, 2012
Submitted by:
- Submitter: Address: Contact: Phone:
Caldera Medical, Inc. 5171 Clareton Drive Agoura Hills, CA 91301 Vicki Gail. Manager QA/RA (818) 879-6555 x 102
Device Name:
| Device | Surgical Mesh (878.3300) |
|---|---|
| Trade Name: | Vertessa™ |
| Common Name: | Surgical Mesh |
| Classification: | Class II, Product Code: OTO - Surgical Mesh, Gynecolgic, 21 |
| CFR 878.3300, General And Plastic Surgery | |
| Predicate Device: | Ascend® Blue (K101462), Caldera Medical Inc. |
| POPMesh™ (K053424), Caldera Medical, Inc. |
Description of Device:
Vertessa™ is designed to be used in the inpatient or outpatient surgery setting in women suffering from uterine or vaginal vault prolapse and is implanted or affixed using suture of the surgeon's choice. Vertessa™ mesh will be provided sterile and is comprised of macroporous monofilament polypropylene warp knit clear mesh.
Intended Use of Device:
Vertessa™ 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.
Technological Characteristics
Vertessa™ is a modification of the predicate mesh device, Ascend® Blue, which is comprised of the same knit pattern. Vertessand has a specific intended use from the predicate device, POPMesh™, 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 bench, simulated use, surgeon feedback and validation testing has shown Vertessa ™ to be substantially equivalent to the predicate devices in its intended use, technological characteristics and performance.
Vertessa M is comprised of the same mesh as the predicate device. Ascend® Blue, FDA 510(k) #K101462, also a product 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
1
characteristics, pore size, mesh density, tensile strength, mesh stiffness, flexural rigidity, tear resistance, burst strength, suture pullout and pyrogen levels. Vertessa™ mesh demonstrates substantial equivalence to the predicate device, Ascend® Blue.
Vertessa™ 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". Vertessa™ demonstrates substantial equivalence to the predicate device, Ascend® Blue.
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™ has passed all testing requirements in terms of aging, shelf life: transportation and sterilization and has demonstrated substantial equivalence to the predicate device, Ascend® Blue.
Results of mechanical bench and validation testing demonstrate equivalent device function based upon its intended use to the predicate devices, POPMesh™ and Ascend® Blue.
The performance of Vertessa'" demonstrates that the device is as safe, and as effective, and performs at least as safely and effectively as the predicate devices, Ascend® Blue and POPMesh™.
Summary of Substantial Equivalence
Vertessa™ is safe and effective for its intended use and is substantially equivalent to the predicate devices, Ascend® Blue and POPmesh™, also products of Caldera Medical.
Confidential
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird symbol, with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Vicki Gail Manager, QA/RA Caldera Medical, Inc. 5171 Clareton Drive AGOURA HILLS CA 91301
MAY 1 0 2012
Re: K120327
Trade/Device Name: VertessaTM Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: March 15, 2012 Received: March 15, 2012
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, 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
3
Page 2 -
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 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/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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin K. Evanko
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
4
Statement of Indications For Use
Indications For Use
510 (k) Number (if known): K120327
Device Name: Vertessa™
Indications for Use:
Vertessa™ 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.
Prescription Use -- X-
AND/OR
Over the Counter Use_ (Part 21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Graine Bupt for Bergfisher
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K120327
Vertessa (formerly CentraSoft) #K120328 Caldera Medical, Inc.
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