(140 days)
The ESP7 Venous Imager is a non-invasive electronic visual aid device for the purpose of viewing of the human superficial venous vasculature. Indications for use: 1) viewing the superficial venous vasculature as a visual aid in taking blood or inserting an I.V.
The "ESP7 Venous Image" is designed for the same purpose, to locate veins which are otherwise not visible to the naked eye. It uses a similar technology in that it uses a standard Video Camera and television monitor mounted on a roll around height and angle adjustable metal stand. The ESP7 Venous Image, however, uses an Infrared filter placed between the camera lens and the CCD to eliminate visible light from entering the camera but allowing infrared and ultra violet light to pass through to the monitor. An on board light source broadcasts a low intensity light beam on the subject. The light source is a common household incandescent 50 watt light bulb that illuminates from a wave length of 350 to 900 nanometers. The ultra violet in the below 450 range is absorbed by the melanin in the epidermis forming a translucent window for the infra red to pass through the skin and differentiate the blue or carbon dioxide carrying venous vessels from the other objects in view.
I am sorry, but the provided text from K982612 contains a 510(k) summary and an FDA clearance letter for a device called the "ESP7 Venous Imager." However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) summary describes the device's technology and compares it to a predicate device ("E-Z-Jector"). The FDA letter details the clearance of the device based on substantial equivalence. Neither document includes:
- A table of acceptance criteria and reported device performance.
- Information on a test set (sample size, data provenance, ground truth experts, adjudication method).
- Details on MRMC comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used in any study.
- Training set sample size or how its ground truth was established.
Therefore, I cannot fulfill your request with the provided input.
§ 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.