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The Lap.Ox™ Laparoscopic Tissue Oximeter is intended to estimate the percent oxygen saturation (StO2) in a volume of tissue, including bowel tissue, during laparoscopy. The Lap.Ox™ Laparoscopic Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion assessment during laparoscopy. The Lap.Ox™ Laparoscopic Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment. The Lap.Ox™ Laparoscopic Tissue Oximeter should only be used on adult patients.

The proposed Lap.Ox™ Laparoscopic Tissue Oximeter ("Lap.Ox" or "Device") is a cordless, battery-powered device that estimates the percent oxygen saturation (StO2) in a volume of tissue, including bowel tissue. The device includes two components: - a Reusable Main Unit that shows a digital readout of percent oxygen saturation (StO2) when the system is in contact with tissue (also denoted as "main unit" or "durable"); and - a Disposable Kit that contains two AA batteries and a sterile single-use disposable consisting of sources, detectors, a laparoscopic tube, and a sheath that is placed around the Reusable Main Unit (denoted as "Disposable"). The Device uses spatially-resolved optical measurements at three wavelengths. The Device displays the StO2 estimate on the built-in screen. The Device is constructed from biocompatible materials that can tolerate bodily fluids. The basic principle of operation of the Lap.Ox Laparoscopic Tissue Oximeter is spectrophotometric oximetry which entails utilizing red and near-infrared light to measure the color of blood and determine an oxygen saturation value.

The Intra. Ox™ 2.0 Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue, including bowel tissue. The Intra. Ox™ 2.0 Handheld Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations. The Intra. Ox™ 2.0 Handheld Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment. The Intra.Ox™ 2.0 Handheld Tissue Oximeter should only be used on adult patients.

The ViOptix Intra.Ox" 2.0 Handheld Tissue Oximeter (device) is a sterile, cordless, battery-powered device that non-invasively estimates the percent oxygen saturation (StO2) in a volume of tissue. The device includes three components and an accessory: · Main Unit: a re-usable module consists of light sources, detectors, and processing electronics to convert measurements of reflected light into an estimate of StO2; • Sheath: a single-use, sterile Sheath placed around the Main Unit during device use (provide in the Disposable Kit); and · Battery Pack: a single-use battery (provided in the Disposable Kit) that is paired with the Main Unit to provide power. The device uses spatially resolved optical measurements. The device performs measurements on the patient by direct physical contact to the patient's tissue and displays the StO2 estimate on the Intra.Ox 2.0 Handheld Tissue Oximeter is a single-use disposable constructed from biocompatible materials that and other liquids such as disinfectants and marking materials. The device shares the same technological characteristics as the predicate device (K221010), including principle of operation, StO2 measured parameters, accuracy and range, energy delivered and power source.

The Intra. Ox™ 2.0 Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue. The Intra. Ox™ 2.0 Handheld Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations. The Intra. Ox™ 2.0 Handheld Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment. The Intra. Ox™ 2.0 Handheld Tissue Oximeter should only be used on adult patients.

The ViOptix Intra.Ox 2.0 Handheld Tissue Oximeter is a sterile, cordless, battery-powered device that non-invasively estimates the percent oxygen saturation (StO2) in a volume of tissue. The device includes three components and an accessory: - Main Unit: a re-usable module consists of light sources, detectors, and processing ● electronics to convert measurements of reflected light into an estimate of StO>: - Sheath: a single-use, sterile Sheath placed around the Main Unit during device use . (provide in the Disposable Kit); and - Battery Pack: a single-use battery (provided in the Disposable Kit) that is paired with the . Main Unit to provide power. The device uses spatially resolved optical measurements at five wavelengths. The device performs measurements on the patient by direct physical contact to the patient's tissue and displays the StO2 estimate on the built-in screen. The Intra.Ox 2.0 Handheld Tissue Oximeter is a single-use disposable constructed from biocompatible materials that can tolerate bodily fluids and other liquids such as disinfectants and marking materials. The device shares the same indication for use and the same technological characteristics as the predicate device (K191676), including principle of operation, StO2 measured parameters, accuracy and range, energy delivered and power source.

The Intra. Oxim 2.0 Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (SKO2) in a volume of tissue. The Intra. OxTM 2.0 Handheld Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations. The Intra. Oxim 2.0 Handheld Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment. The Intra. OxTM 2.0 Handheld Tissue Oximeter should only be used on adult patients.

The ViOptix Intra.Ox 2.0 Handheld Tissue Oximeter is a sterile, cordless, battery-powered device that non-invasively estimates the percent oxygen saturation (StO2) in a volume of tissue. The device includes three components and an accessory: - . Main Unit: a re-usable module consists of light sources, detectors, and processing electronics to convert measurements of reflected light into an estimate of StO2; - . Sheath: a single-use, sterile Sheath placed around the Main Unit during device use (provided in the Disposable Kit); - Battery Pack: a single-use battery (provided in the Disposable Kit) that is paired with the . Main Unit to provide power; and - . Quality Control (QC) Target: a single-use accessory (provided in the Disposable Kit) that provides an optical check once the Sheath is placed around the Main Unit. The device uses spatially resolved optical measurements at five wavelengths. The device performs measurements on the patient by direct physical contact to the patient's tissue and displays the StO2 estimate on the built-in screen.

The Intra. Ox™ Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue. The Intra. Ox™ Handheld Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations. The Intra. Ox™ Handheld Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment. The Intra.Ox™ Handheld Tissue Oximeter should only be used on adult patients.

The ViOptix Intra.Ox" Handheld Tissue Oximeter is a sterile, cordless, battery-powered device that non-invasively estimates the percent oxygen saturation (StO2) in a volume of tissue. The device uses spatially resolved optical measurements at five wavelengths. The device performs measurements on the patient by direct physical contact to the patient's tissue and displays the StO2 estimate on the built-in screen. The Intra.Ox Handheld Tissue Oximeter is a single-use disposable constructed from biocompatible materials that can tolerate bodily fluids and other liquids such as disinfectants and marking materials. ViOptix has made modifications to the cleared Intra.Ox Handheld Tissue Oximeter (K133983) to optimize the design and improve manufacturability. The modified device shares the same indication for use and the same technological characteristics as the cleared device, including principle of operation, StO2 measured parameters, accuracy and range, energy delivered and power source.

The ViOptix ODISsey Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue. This is performed in medical environments including physician offices, hospitals, ambulatory care and Emergency Medical Services. The ODISsey Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.

The ODISsey Tissue Oximeter is an optically based device that noninvasively estimates the percent oxygen saturation (StO2) in a volume of tissue underneath the sensor. The T.Ox™ Tissue Oximeter is a lightweight and portable, AC poweroperated, unit with a lithium-ion battery backup that non-invasively estimates the percent oxygen saturation (StO2%) in a volume of tissue underneath the sensor. The console has a color LCD display monitor, a standard one sampling channel (with a two-channel option), and up to two fiber optic sensors. It has adjustable audible and visual alarms for: · StO2 low and high alarm limits · Low battery The T.Ox™ Tissue Oximeter has visual alarms. The T.Ox™ Tissue Oximeter consists of three parts: · Small computer console display module · AC power cord · Fiber optic sensor(s) If the console is using two channels, both channels can be used at the same time. Each channel samples and displays data independently of the other channel. Each channel can accommodate one sensor.

The VesseLink is to be used in the anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. Excluded is the use for coronary artery anastomosis.

The VesseLink Microvascular Anastomotic Coupler (VesseLink) is a mechanical method for anastomosis, or connection, of small vessels ranging in size from 0.8 mm to 4.3 mm in outer diameter. The VesseLink is intended for use in the end-to-end and end to side vessel anastomosis as well as arterial/venous vein grafts. It is to be used in veins and arteries that are normally encountered in microsurgical and vascular reconstructive procedures. Excluded is the use for coronary artery anastomosis.

The ViOptix ODISsey Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue. This is performed in medical environments including physician offices, hospitals, ambulatory care and Emergency Medical Services. The ODISsey Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.

The ODISsey Tissue Oximeter is an optically based device that noninvasively estimates the percent oxygen saturation (StO2) in a volume of tissue underneath the sensor.