(72 days)
The IR Viewer is a non-invasive, electronic medical device that provides visualization of patient vasculature to supplement normal, line-of-sight viewing of vascular structures. The IR Viewer is indicated for use in procedures for inserting a needle or catheter in superficial, peripheral vessels.
The IR Viewer is a non-invasive, electronic medical device that provides visualization of patient vasculature to supplement normal, line-of-sight viewing of vascular structures.
The provided document does not contain acceptance criteria or a study that proves the device meets acceptance criteria.
The document is a 510(k) premarket notification summary for the IR Viewer, a device for visualizing patient vasculature. It outlines the device description, intended use, predicate devices, and the FDA's substantial equivalence determination.
Here's a breakdown of what is and isn't in the document regarding your request:
What is present:
- Device Description: The IR Viewer is a non-invasive, electronic medical device that provides visualization of patient vasculature to supplement normal, line-of-sight viewing for procedures involving needle or catheter insertion in superficial, peripheral vessels.
- Intended Use Statement: Clearly defined.
- Predicate Devices: ESP7 (Ironmaster) and Venoscope (Trinity Partners) are mentioned.
- FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence.
What is explicitly stated but lacks detail:
- "Performance Data: Performance data were submitted to characterize the device." This line is present, indicating that performance data exists and was submitted to the FDA, but the document does not elaborate on what that data entails, what the acceptance criteria were, or the results of any specific study.
Therefore, I cannot provide the requested information because it is not contained within the provided text. To answer your questions, details from the actual performance data submission would be required.
§ 880.6970 Liquid crystal vein locator.
(a)
Identification. A liquid crystal vein locator is a device used to indicate the location of a vein by revealing variations in the surface temperature of the skin by displaying the color changes of heat sensitive liquid crystals (cholesteric esters).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.