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510(k) Data Aggregation
K Number
K152088Device Name
IV-eye
Manufacturer
Date Cleared
2016-02-24
(212 days)
Product Code
Regulation Number
880.6970Why did this record match?
Product Code :
KZA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IV-eye is a hand-held, non-invasive imaging device that assists medical personnel, trained in vascular access procedure, to identify and locate suitable peripheral veins for the purposes of cannulation and venipuncture.
The IV-eye should only be used in conjunction with standard techniques of visualization and palpation in assessing and locating veins.
The IV-eye is intended only for skin contact via a disposable single use cover.
Device Description
The IV-eye is a hand-held, battery powered electronic non-invasive imaging device that assists medical personnel, trained in vascular access procedure, to identify and locate suitable peripheral veins for the purposes of cannulation and venipuncture. The IV-eye transmits near infrared light into a patient's tissue at a wavelength of 850nm. As the light hits a vascular structure it is absorbed by the hemoglobin in the blood, whereas it passes through other tissue.
The camera in the device captures the light that has passed through the patient and, in identifying the blocked light and applying a number of algorithms, the IV-eye is able to produce an image on its LCD display of the patient's vascular structure directly underneath the device. This appears as a darker color to the contrasting tissue. The picture is updated in real-time and is close to actual size. Trained medical personnel can use the image of the patient's vascular structure to assist them in choosing a suitable vein for cannulation and venipuncture.
The IV-eye is intended to be used only by trained medical personnel to assist them in locating suitable veins for venipuncture and cannulation. It does not differentiate between arteries and veins and should therefore only be used in conjunction with standard techniques of locating veins. Other than regular cleaning and replacement of batteries, the IV-eye requires no routine or preventative maintenance.
The IV-eye includes a single-use cover which prevents the lower casing and wings of the device having direct contact with the patient, and is intended to reduce cross-contamination risk in using the device. The IV-eye is intended only for skin contact via this disposable single use cover.
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K Number
K101838Device Name
VTS1000
Manufacturer
Date Cleared
2011-02-18
(232 days)
Product Code
Regulation Number
880.6970Why did this record match?
Product Code :
KZA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The VTS1000 is a non-invasive electronic device to aid in the visualization of superficial vasculature. It is indicated for use during procedures requiring vascular or peripheral vessel access.
Device Description
The VueTek Scientific™ VTS1000 is a near-infrared (NIR) emitter, video acquisition, and head mounted display (HMD) device that affords viewing of superficial, and its nead invanced and, by differentiating it with higher contrast from surrounding tissue. Visualization of vascular structures is provided by a portable headset display system which supplements normal line of sight viewing during vascular access procedures. The VTS1000 device does not replace the accepted conventional vascular identification and confirmation methods used by qualified professionals.
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K Number
K042679Device Name
IR VIEWER
Manufacturer
Date Cleared
2004-12-10
(72 days)
Product Code
Regulation Number
880.6970Why did this record match?
Product Code :
KZA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
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 of vascular structures.
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K Number
K982612Device Name
ESP7 VENOUS IMAGE
Manufacturer
Date Cleared
1998-12-14
(140 days)
Product Code
Regulation Number
880.6970Why did this record match?
Product Code :
KZA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
Device Description
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.
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