(67 days)
The Telstar™ Biplane Digital Imaging System provides the utility of fluoroscopic imaging of vascular systems for applications including vascular angiography and electrophysiology (EP) studies. This xray system may be used stand-alone, or in conjunction with an associated Stereotaxis Magnetic Navigation System.
The Telstar™ Biplane Digital Imaging System [TIS] is a digital fluoroscopic system providing bi-plane fluoroscopic clinical images of both patients and medical devices during conventional and magnetic procedures.
This document (K022565) describes a modification to an existing medical device, the Telstar™ Biplane Digital Imaging System, previously cleared under K013484. The submission focuses on demonstrating substantial equivalence of the modified device to the predicate device, rather than establishing acceptance criteria for a novel device. Therefore, a direct "acceptance criteria" table and a "study that proves the device meets the acceptance criteria" in the typical sense (e.g., performance metrics against a threshold for a new AI algorithm) are not present because the modification does not change the intended use or fundamental scientific technology.
Instead, the submission primarily relies on comparison to the predicate device and compliance with regulatory standards.
Here's a breakdown of the requested information based on the provided text, heavily emphasizing the absence of certain elements due to the nature of this 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
As this 510(k) is for a modification to an already cleared device (K013484) that does not alter its intended use or fundamental scientific technology, there are no specific numerical acceptance criteria for performance (e.g., sensitivity, specificity, or accuracy) established in this document for the modified device itself.
The "acceptance criteria" in this context are primarily:
- The modified device's characteristics remain substantially equivalent to the predicate device.
- The modified device complies with relevant regulatory standards.
The table below outlines the comparison of the modified device's characteristics to the predicate device:
| Characteristic | Acceptance Criteria (Predicate Device K013484) | Reported Device Performance (Modified TIS) |
|---|---|---|
| Imaging | Fluoroscopic | Fluoroscopic |
| Pulsed fluoro | 7.5, 15, 30 pulses/sec | 7.5, 15, 30 pulses/sec |
| Pulsed cardiac | 15, 30 pulses/sec | 15, 30 pulses/sec |
| X-ray tube assembly | Rotating anode | Rotating anode |
| Image intensifier | Yes | Yes |
| Monitor | Quad 15" | Quad 15" |
| Operating modes | Fast Scan Fluoro (2x2 binning) only | Fast Scan Fluoro and Low Noise, High Sensitivity Fluoro (2x4 binning) |
| Frame rate | Same (as predicate) | Same (as predicate) |
Study Proving Device Meets Acceptance Criteria:
The "study" proving the device meets the acceptance criteria is the demonstration of substantial equivalence through direct comparison of technical characteristics and the statement that "No new studies were required or necessary to support the modifications." This indicates that the safety and effectiveness established for the predicate device (K013484) are considered applicable to the modified device due to the nature of the changes.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: Not applicable. No new test set or clinical study was conducted as part of this 510(k) submission for the modified device. The submission states: "Preclinical animal performance data were provided in K013484. No new studies were required or necessary to support the modifications. Clinical performance data were provided in K013484. No new studies were required or necessary to support the modifications."
- Data Provenance: Not applicable, as no new data was presented. Any prior data would have originated from the K013484 submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No new test set or ground truth establishment was performed for this modification.
4. Adjudication Method for the Test Set
- Not applicable. No new test set and therefore no adjudication was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC comparative effectiveness study was not done. This submission is for a modification to a fluoroscopic imaging system, not an AI-assisted diagnostic device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
- No. This device is a fluoroscopic imaging system, not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
- Not applicable for this modification. For the original device (K013484) to which this is a modification, ground truth for imaging systems typically involves physical testing, phantom studies, and potentially expert assessment of image quality against known anatomical structures or pathologies. However, this specific submission does not detail how ground truth was established for the predicate, and asserts that no new studies were needed for the modification.
8. The Sample Size for the Training Set
- Not applicable. This device is a hardware imaging system, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As this is not an AI/machine learning algorithm, there is no training set or ground truth established in this context.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.