Search Results
Found 1 results
510(k) Data Aggregation
(296 days)
The Navis Torquer is intended to facilitate guide wire manipulation during interventional procedures.
The Navis Torquer is a guide wire accessory intended to assist with the manipulation and placement of guide wires during interventional procedures. It accommodates guide wires with diameters from 0.010 to 0.038 inches and is composed of the following two components: 1) a polycarbonate cylindrical body and collet; and 2) an acetal rotatable cap.
The side-entry design of the device allows single-handed operation. To mount the device on a guide wire, the cylinder body is rotated into the cap until a tactile 'click' is felt and the longitudinal slots in both parts are aligned, the device is then mounted on the guide wire. Holding the guide wire stationary, the device is rotated onto the guide wire until the guide wire is aligned within the center of the device. The device is positioned optimally on the guide wire and then secured by rotation of the cap or cylinder body. As the cap is rotated on the body, the collet grips the guide wire.
This 510(k) summary for the Navis Torquer describes a device intended to facilitate guide wire manipulation during interventional procedures. The submission is based on substantial equivalence to predicate devices, rather than a clinical trial with specific acceptance criteria as would be seen for new technology. Therefore, the information provided below will reflect the data available in the 510(k) summary regarding performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Top Tests) | Reported Device Performance (Bench Top Tests) |
|---|---|
| Equivalent grip characteristics to predicate devices | Navis Torquer demonstrated equivalent grip characteristics to predicate devices. |
| Equivalent torque characteristics to predicate devices | Navis Torquer demonstrated equivalent torque characteristics to predicate devices. |
| Biocompatibility (cytotoxicity) | Navis Torquer passed biocompatibility testing for cytotoxicity. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" with a defined sample size in the context of human data or a statistically powered study. The performance testing mentioned refers to "bench top tests" comparing the Navis Torquer to predicate devices. The exact number of units tested, the material properties of those units, or the number of trials performed during these bench top tests are not specified in the provided text.
The data provenance is from bench top testing conducted by Navis Medical, Inc. The document does not indicate any human or animal data, nor does it mention a country of origin for such data, as it's not applicable to the type of testing described. It is retrospective in the sense that the testing was performed, and the results are being reported to support substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the ground truth was established through direct physical measurements during bench top testing, comparing the device to predicate devices. There was no 'ground truth' that required expert consensus in the context of clinical outcomes or imaging interpretation.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. Bench top tests involve direct measurement and comparison, not expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission relies on bench top testing and comparison to predicate devices, not on human readability or interpretation of medical images/data. The device is a mechanical accessory, not a diagnostic or therapeutic AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The Navis Torquer is a physical medical device, not an algorithm or software. Its function inherently involves human interaction for manipulating a guidewire.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing was established by direct measurement of physical characteristics (grip and torque) of the Navis Torquer and its predicate devices, as well as standard biocompatibility testing. This is a functional comparison based on engineering and material science principles, not clinical outcomes, pathology, or expert consensus on a disease state.
8. The Sample Size for the Training Set
This information is not applicable. The device is not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
Ask a specific question about this device
Page 1 of 1