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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.

Cerebral Autoregulation Index (CAI) Algorithm is an informational index intended to represent a surrogate measurement of whether cerebral autoregulation is likely intact or is likely impaired as expressed by the level of coherence or lack thereof between Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO2) in patient's cerebral tissue. MAP is acquired by the HemoSphere pressure cable and StO2 is acquired by the ForeSight oximeter cable. CAI is intended for use in patients over 18 years of age receiving advanced hemodynamic monitoring. CAI is not indicated to be used for treatment of any disease or condition and no therapeutic decisions should be made based solely on the Cerebral Autoregulation Index (CAI) Algorithm.

The Cerebral Adaptive Index (CAI) Algorithm is being renamed to Cerebral Autoregulation Index (CAI) Algorithm. The originally cleared Cerebral Adaptive Index is in effect an index of cerebral autoregulation, and the renaming results in a labeling change. The evidence to support the proposed labeling change for the Cerebral Autoregulation Index algorithm demonstrates the capability of CAI to represent a surrogate measurement of whether cerebral autoregulation is likely intact or is likely impaired, as expressed by the level of coherence or lack thereof between MAP (as a surrogate of cerebral perfusion pressure) and cerebral StO2 (as a surrogate of cerebral blood flow) of the patient. The Cerebral Autoregulation Index (CAI) Algorithm is a derived parameter that quantifies the dynamic relationship between two existing hemodynamic parameters, Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO2) in the cerebral tissue. CAI is intended to represent a surrogate measurement of whether cerebral autoregulation is likely intact or is likely impaired as expressed by the level of coherence between MAP and cerebral StO2. The output will be represented as an index value in a trend plot. MAP is acquired from the HemoSphere Pressure Cable (initially cleared in K180881 on November 16, 2018). StO2 used for computing CAI is acquired from the ForeSight Oximeter Cable (cleared in K201446 on October 1, 2020). CAI will be continuously displayed at 20-second rate. The parameter will not have any alarm ranges and will be represented as a number with a range between 0 to 100. A high CAI value (CAI ≥45) means that MAP and StO2 have a greater coherence and informs the clinician that alterations in MAP may result in concomitant changes in cerebral oxygen saturation because cerebral autoregulation is likely impaired. Whereas a low CAI value (CAI < 45) means there is lesser coherence between the two parameters, and therefore alterations in MAP may not result in concomitant changes in cerebral oxygen saturation because cerebral autoregulation is likely intact.

The noninvasive ODI-Tech, when used with the DRS handpiece, is intended for use as an adjunct monitor of local hemoglobin oxygen saturation of blood in the skin beneath the sensor on the hand. It is intended as an adjunct for assessing local perfusion in individuals at risk of reduced-flow or no-flow ischemic states. The device is indicated for use on intact skin only. The clinical value of trend data has not been demonstrated in disease states. The ODI-Tech device should not be used as the sole basis for diagnosis or therapy. In patients with darkly pigmented skin, measurements should be interpreted with can interfere with the reflected light signal and reduce the quality of measurements.

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SnapshotNIR (KD205) is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of: - oxygen saturation (St02), - relative oxyhemogoblin level (Hb02), and - relative deoxyhemoglobin (Hb) level in superficial tissue. SnapshotNIR (KD205) displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports multispectral tissue oxygenation measurements for selected tissue regions. SnapshotNIR (KD205) is indicated for use to determine oxygenation levels in superficial tissues.

SnapshotNIR (KD205) is a medical device that operates like a camera. The SnapshotNIR device is completely non-contact, capturing images from 12 inches away from the patient or other imaging field-ofviews. The device uses six near-infrared wavelengths of light and white light emitting diodes (LEDs) to produce a resultant tissue oxygenation image and a colour-based "RGB" or clinical image, respectfully, that can be viewed on the touchscreen display. SnapshotNIR is based on multispectral imaging technology and performs spectral analysis at each pixel to determine the approximate values of tissue oxygen saturation (StO2), oxyhemoglobin levels (HbO2), and deoxyhemoglobin levels (Hb) in superficial tissues and displays a two-dimensional, color-coded image of the tissue oxygen saturation (StO2). SnapshotNIR consists of: - · SnapshotNIR - · Recharger - · User Guide - · Quick Start Guide - · Sterile Drape (Optional) The intended use and user interaction remained the same in the new model (KD205). The user will notice that the modified device no longer requires the user to take a calibration image prior to image capture. SnapshotNIR now uses an embedded computer module and a touchscreen LCD. Additional minor form factor changes were made on the new model (KD205) to accommodate the hardware change. With respect to the software used by SnapshotNIR, the predicate and new model (KD205) operate similarly.

The OxiplexTS200 tissue oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue. It is indicated for monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. The device can be used for monitoring in Medical Clinics, laboratories and outpatient facilities. The OxiplexTS200 should not be used as the sole basis for diagnosis or therapy. The value of these measurements in disease states has not been demonstrated.

The ISS Medical non-invasive tissue oximeter. OxiplexTS200. is intended for use as an adjunct monitor of regional oxy- and deoxy-hemoglobin concentration, and of hemoglobin oxygen saturation of blood in tissues during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. The OxiplexTS200 is a device for use in spot-checking as well as continuous monitoring of patients in healthcare facilities. It is not intended for home use or to be used for "out of hospital" transport. The OxiplexTS200 is an instrument system and includes the following components: - OxiplexTS200 Unit with two sensors and phantom block ● - Power cable ● - Accessories (straps for sensors; strap for phantom block; dark cloth) ● - ISS flash memory - Operation Manual - Analoq Input module with USB cable (optional) - . Analog Output module with USB cable (optional) The OxiplexTS200 uses near-Infrared Spectroscopy (NIRS), a noninvasive diagnostic tool, to offer features for the assessment and monitoring of oxygenation in tissues such as brain and muscle. Near-infrared light (in the wavelength range 700-900 nm) can penetrate several centimeters into numerous body tissues. NIRS enables continuous real time measurements of changes in the hemoglobin oxygenation state, thus providing information on tissue oxygenation and hemodynamics.

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 Edwards Algorithm for Measurement of Blood Hemoglobin is indicated for continuously monitoring changes to hemoglobin concentration in the circulating blood of adults ≥ 40 kg receiving advanced hemodynamic monitoring using HemoSphere ForeSight Oximeter Cable and non-invasive ForeSight sensors (large) in cerebral locations. The Edwards Algorithm for Measurement of Blood Hemoglobin is intended for use as an adjunct monitor of relative and total hemoglobin concentration of blood in individuals at risk for reduced-flow or no-flow ischemic states in surgical and ICU settings.

The Edwards Algorithm for Measurement of Blood Hemoglobin is intended for continuously and non-invasively monitoring the relative and total hemoglobin values in the blood of patients requiring advanced hemodynamic monitoring in a critical care environment. The outputs of the algorithm include the relative changes in total hemoglobin in blood ( $\Delta$ tHb) and total hemoglobin in blood (tHb) parameters and are derived from the relative change in concentration of total tissue hemoglobin ( $\Delta$ ctHb parameter) measured by the ForeSight Oximeter Cable on the HemoSphere Advanced Monitoring Platform (K213682, cleared June 22, 2022). The subject algorithm provides relative blood hemoglobin ( $\Delta$ tHb; measured in g/dL of blood) values continuously as a change over time from 0 g/dL. It can also be calibrated using an optional input of reference blood hemoglobin measurements such as ones obtained in vitro from a blood gas analyzer. When calibrated, it provides the value of total blood hemoglobin (tHb). Additionally, the algorithm also provides three secondary output flags: o DoNotCalibrate Flag: This flag is intended to indicate when a calibration should not be performed. o Recalibrate Flag: This flag is intended to indicate when a new calibration is recommended. o Unstable Flag: This flag is intended to indicate when the input signal ( $\Delta$ ctHb) is unstable.

Cerebral Adaptive Index (CAI) Algorithm is an informational index to help assess the level of coherence or lack thereof between Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation (StO2) in patient's cerebral tissue. MAP is acquired by the HemoSphere Pressure Cable and StO2 is acquired by the ForeSight Oximeter Cable. CAI is intended for use in patients over 18 years of age receiving advanced hemodynamic monitoring. CAI is not indicated to be used for treatment of any disease or condition and no therapeutic decisions should be made based solely on the Cerebral Adaptive Index (CAI) Algorithm.

Cerebral Adaptive Index (CAI) Algorithm is a derived parameter that quantifies the dynamic relationship between two existing hemodynamic parameters, Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO2) in the cerebral tissue. CAI is intended to show the level of coherence between MAP and cerebral StO2. The output will be represented as an index value and a trended graph. MAP is acquired from the HemoSphere Pressure Cable (initially cleared in K180881 on November 16, 2018). StO2 used for computing CAI is acquired from the ForeSight Oximeter Cable (cleared in K201446 on October 1, 2020). The CAI parameter can enhance clinician's understanding of the underlying hemodynamic changes behind cerebral desaturation events. It helps the clinician recognize/ identify possible causes of, for example, decrease in StO2 and clinical events related to StO2 decrease (e.g., hypotension as opposed to inadequate oxygen content). CAI will be continuously displayed at 20-second rate. The parameter will not have any alarm ranges and will only be represented as a number with a range between 0 to 100. A high CAI value (CAI ≥45) means that MAP and StO2 have a greater coherence and informs the clinician that alterations in MAP may result in concomitant changes in cerebral oxygen saturation Whereas a low CAI value (CAI < 45) means there is lesser coherence between the two parameters, and therefore alterations in MAP may not result in concomitant changes in cerebral oxygen saturation.

The non-invasive Masimo O3® Regional Oximeter System and accessories are indicated for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood (rSO2) in the tissue under the sensors in patients in healthcare environments. The O3® Regional Oximeter is only to be used with Masimo O3 sensors. The use of any other sensor is not supported or recommended by Masimo and could give erroneous results. When used with the O3 Adult Sensor, the O3® Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) in adults ≥ 40kg. When used with the O3 Pediatric Sensor, the O3® Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) on cerebral sites and trending rSO2 on non-cerebral sites in pediatrics ≥ 5 kg and < 40 kg. When used with the O3 Neonatal Sensor, the O3® Regional Oximeter is indicated for measuring only trending regional hemoglobin oxygen saturation of blood (rSO2) on cerebral sites and trending rSO2 on non-cerebral sites in neonates < 10kg. The ΔcHb, ΔΟ2Hb, ΔΗΗb provided as part of the Masimo Ο3 are indicated for the monitoring of the relative hemoglobin changes of oxygenated hemoglobin (ΔΟ2Ηb), deoxygenated hemoglobin (ΔΗΗΒ), and total hemoglobin (ΔcHb) as measured from the Masimo O3 sensor when applied to the cerebral tissue in adults.

The Masimo O3 Regional Oximeter is a noninvasive regional oximeter designed to continuously measure and monitor regional hemoglobin oxygen saturation (rSO2) in the tissue under the sensor. The Masimo O3 Regional Oximeter consists of the following components: 03 Module, 03 Sensors (e.g. O3 Adult, O3 Pediatric, and O3 Infant/Neonatal Sensors), and a display monitor (e.g. Root). The O3 Regional Oximeter System provides the following key measurements and calculated features: - Regional Oxygenation (rSO2): Regional tissue oxygenation level in the deep tissue local to the sensor site. - Delta Baseline (Abase): Calculation of the relative difference in rSO2 with respect to baseline rSO2. - Area Under the Limit (AUL index): Index that quantifies the duration (amount of time) the patient stays below rSO2 low alarm limit and depth (refers to the gap between the patient's rSO2 level and the rSO2 low alarm limit) of patient's stay below the user defined rSO2 low alarm limit (LAL). - Delta SpO2 (4SpO2): Calculation of the difference between SpO2 and rSO2. The source of SpO2 is from peripheral SpO2 measurement (using pulse oximeter). - Delta HHb (1HHb): Index associated with the change in deoxygenated hemoglobin. - Delta O2Hb (ΔO2Hb): Index associated with the change in the oxygenated. - Delta cHb (AcHb): Calculation of the sum of the Delta HHb and Delta O2Hb, and is an index, associated with the change in the total (oxygenated and deoxygenated) hemoglobin.