(97 days)
The Nvision VLETM Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, crosssectional, real-time depth visualization.
The NinePoint Medical Nvision VLE™ Imaging System is a general imaging system The Niler offit Wediod Nivision VLE TM Console, NVISion VLE™ Catheter and the Nvision VLE™ Inflation Accessory Kit.
The submission describes a labeling change for the Nvision VLE™ Imaging System, specifically an increase in the maximum recommended inflation pressure for the catheter balloon from 5 psi to 30 psi. The study conducted to support this change is a burst pressure test of the balloons.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Minimum burst pressure for catheter balloons | Approximately 64.8 psi |
| Device must withstand increased inflation pressure (30 psi) | Device's minimum burst pressure (64.8 psi) is greater than 2x the new maximum inflation pressure (30 psi). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Samples from two balloon manufacturing lots were characterized. The exact number of individual balloons tested is not specified beyond "samples from two lots."
- Data Provenance: The data is prospective, as the burst pressure testing was performed specifically to support this labeling change. The country of origin of the data is not explicitly stated, but given the submission is to the FDA in the US, it is likely that the testing was conducted either in the US or in a manner compliant with US regulatory standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This study does not involve human experts establishing ground truth for image interpretation or clinical outcomes. It is an engineering performance test assessing the physical integrity of a component.
4. Adjudication Method for the Test Set:
Not applicable. This is a direct measurement of physical properties (burst pressure) and does not involve adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No. This is not an MRMC comparative effectiveness study. It is a performance test of a device component's physical characteristic.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is an imaging system, but the study described is a component-level performance test, not an evaluation of the imaging algorithm's standalone performance. The submission refers to a "labeling change only," implying the imaging algorithm itself was cleared in the predicate device (K112770).
7. The Type of Ground Truth Used:
The ground truth used is the measured burst pressure of the catheter balloons. This is a direct physical measurement.
8. The Sample Size for the Training Set:
Not applicable. There is no machine learning "training set" for this type of engineering performance test.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth established in this context. The "ground truth" for the burst pressure test is the physical measurement itself.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.