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Hutchinson Technology Incorporated's InSpectra™ StO2 Spot Check is intended for use as a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in thenar skeletal muscle tissue (StO2). The InSpectra™ StO2 Spot Check is indicated for use in monitoring patients during circulatory or perfusion examinations or when there is a suspicion of compromised circulation of thenar skeletal muscle.

The InSpectra™ StO2 Spot Check System and its predicate device are designed to estimate the percent oxygen saturation of hemoglobin in a volume of tissue (StO2). The InSpectra"M StO2 Spot Check System is composed of the following components: The InSpectra™ StO2 Spot Check Monitor (model 300) contains an LCD screen, light source/detection circuitry, microcontrollers, internal software, one set of optical fibers to transmit light to the Cable, a second set of optical fibers that receive light from the Cable and return it to a photosensitive detector and internal software. The InSpectra™ StO2 Cable (model 3003) is a replaceable component of the InSpectra™ StO2 Spot Check System that transmits light between the Spot Check and the clip. The InSpectra™ StO2 Thenar Clip (model 1315) has a shield to protect the measurement from ambient light interference and a clip to facilitate the attachment to the patient's thenar for integre the first in a clip to laciniale the attaching thenar eminones (the flock thenar eminence (the fleshy mass on the palmar surface the hand at the base of the thumb) and connects to the InSpectra™ StO2 Cable, model 3003. - The Charging Station contains circuitry to simultaneously charge the InSpectra™ StO2 Spot Check Monitor and a spare battery. LED indicators display the status of the charging batteries. The Spot Check System also includes a replaceable/rechargeable lithium ion battery and a wall/IV pole mounting system

Hutchinson Technology Incorporated's InSpectra™ StO2 Tissue Oxygenation Monitor is intended for use as a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2). The InSpectra™ StO2 Tissue Oxygenation Monitor 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 InSpectra" StO2 Tissue Oxygenation Monitor ("Model 650"), is a lightweight and transportable system that is designed to estimate the percent oxygen saturation of hemoglobin in a volume of tissue (StO2). The Model 650 is composed of the following components: InSpectra™ StO2 Tissue Oxygenation Monitor. The InSpectra™ StO2 Monitor contains an LCD screen, a microcontroller, cooling fan, back-up battery, and internal software. The monitor has an internal lithium ion battery and two external data ports. It is equipped with an adjustable C-clamp for attachment to an IV pole. InSpectra™ StO2 Cable, which can be removed from the monitor and replaced, contains light detection circuitry, a microcontroller, one set of optical fibers to transmit light to the tissue, and a second set of optical fibers that receive light from the tissue and return it to a photosensitive detector and internal software. The InSpectraTM StO2 Sensor. The single-use InSpectra™ StO2 Sensor, when connected to the InSpectra™ StO2 Cable, conducts the optical signal to the patient and back to the monitor. The sensor has a shield to protect the measurement from ambient light interference, a reinforced cable to protect the optical fibers, and an adhesive surface to facilitate attachment of the sensor to the patient for continuous monitoring.

Hutchinson Technology Incorporated's InSpectra St02 Tissue Oxygenation Monitor is intended for use as a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2). The InSpectra St02 Tissue Oxygenation Monitor 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 InSpectra StO2 Tissue Oxygenation Monitor is designed to estimate the percent oxygen saturation of hemoglobin in a volume of tissue (StO2). The InSpectra StO2 is composed of the following components: Monitor and Optical Cable and The InSpectra StO2 Sensor.

Hutchinson Technology Incorporated's InSpectra™ Tissue Spectrometer System, Model 325, is intended for use as a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2). The InSpectra™ Tissue Spectrometer 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 InSpectra™ is designed to estimate the percent oxygen saturation of hemoglobin in a volume of tissue (StO2). This value is a reflection of localized perfusion of that tissue. The InSpectra™ is composed of the following components: Monitor, Patient Cable, Patient Interface, Printer, Optical Converter, Set-up Accessories, and Inspectra System Software.

Hutchinson Technology Incorporated's InSpectra™ Tissue Spectrometer System, Model 325, is a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2) The InSpectra™ Tissue Spectrometer 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 InSpectra™ Tissue Spectrometer System is intended to noninvasively and continuously measure hemoglobin oxygen saturation: in the upper extremity, shoulder, or lower extremity.

The InSpectra™ is designed to estimate the percent oxygen saturation of hemoglobin in a volume of tissue (StO2). This value is a reflection of localized perfusion of that tissue. The InSpectra™ is the same version of the previously cleared Hutchinson Technology Inc. (HTI) InSpectra™ Tissue Spectrometer System, Model 325, and represents changes to the indications for use statement. The InSpectra™ is composed of the following components: InSpectra™ Tissue Spectrometer: A spectrometer that contains light detection circuitry, a microprocessor, and a display screen. InSpectra™ Optical Cable: A fiber optic light integration cable that contains one set of optical fibers to integrate wavelengths of light and transmit to the tissue, and a second set of optical fibers that receives light from the tissue and returns it to a photosensitive detector. Light emitting diodes in the optical cable connector are the light source. Optical cable distal tips are available in 12, 15, 20, 25, and 35mm spacing, and are differentiated by color. The 12-25mm cable tips are gray; the 35mm cable tip is blue. The optical cable is supplied with a storage case. InSpectra™ Calibrator: A disposable module used to normalize the tissue spectrometer and calibrate during startup of the InSpectra tissue spectrometer system. The calibrator is available in two sizes: 12-25mm (labeled in black) and 35mm (labeled in blue). InSpectra™ Shield: A disposable interface that attaches to the distal tip of the optical cable. The shield protects the measurement from ambient light interference, protects the optical fibers, and has an adhesive surface to attach to the patient for continuous monitoring and a liner to use for intermittent measurements. The shields are available in two sizes to fit the optical cables and are differentiated by color: 12-25mm (gray) and 35mm (blue). The shield is packaged in the calibrator. To ensure accurate Sto2 measurements, use a new InSpectra shield for each patient. Do not reuse. InSpectra™ System Check: A method to check system measurements. InSpectra™ OptoLink™ RS232 Optical Converter: A device used to export StO2, date, and time data from the spectrometer. InSpectra™ Software: Software, which displays data from the tissue spectrometer on a computer during a live session or from an encrypted data file

Hutchinson Technology Incorporated's InSpectra™ Tissue Spectrometer System, Model 325, is a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2). The InSpectra™ Tissue Spectrometer with 12 to 25 mm probes 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 InSpectra™ Tissue Spectrometer System is intended to noninvasively and continuously measure hemoglobin oxygen saturation: in the upper extremity, shoulder, or lower extremity with 12 mm to 25 mm probes. The value of these measurements in disease states has not been demonstrated.

The InSpectra™ is designed to estimate the percent oxygen saturation of hemoglobin in a volume of tissue (StO2). This value is a reflection of localized perfusion of that tissue. The InSpectra™ is composed of the following components. - Monitor: The "InSpectra Tissue Spectrometer" houses the user interface, and associated electronics. It serves as the analytical and display instrument. - Patient Cable: The "Optical Integrator" transmits light to and from the Tissue Spectrometer and the patient; - Patient Interface: The "OptoShield™" interface is a disposable pad that mechanically attaches to the distal end of the Optical Integrator. Its bottom has an adhesive backing for attachment to the patients skin for continuous monitoring. Until ready for use, the adhesive is covered with a liner to allow intermittent measurements. - Printer: A "Thermal Printer" may be used to print out the StO2 results for time trending and recording purposes. - Optical Converter: An "Optolink™" RS232 Optical Converter - Model 300 is a device that converts the optical output of the Spectrometer to an electrical signal. - Set-up Accessories: A "System Check™" module with both "High" and "Low" "Single Point References" are provided to verify proper system operation. - Inspectra System Software: Software provided on a compact disk for use on a personal computer that displays data from the tissue spectrometer on a computer during a live session or from an encrypted data file.

Hutchinson Technology Incorporated's InSpectra™ Tissue Spectrometer System, Model 325, is a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2). The InSpectra™ Tissue Spectrometer with 12 to 25 mm probes 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 InSpectra™ Tissue Spectrometer System is intended to noninvasively and continuously measure hemoglobin oxygen saturation: in the upper extremity, shoulder, or lower extremity with 12 mm to 25 mm probes. The value of these measurements in disease states has not been demonstrated.

The InSpectra™ is designed to estimate the percent oxygen saturation of hemoglobin in a volume of tissue (StO₂). This value is a reflection of localized perfusion of that tissue. The InSpectra™ is a modified version of the previously cleared Hutchinson Technology Inc. (HTI) Biospectrometer NB Oximeter, Model 1111, and represents upgrades in hardware and software, while relying on the same principles of operation. The InSpectra™ is composed of the following components. - Monitor: The "InSpectra Tissue Spectrometer" houses the user interface, associated electronics. It serves as the analytical and display instrument. - Patient Cable: The "Optical Integrator" transmits light to and from the Tissue Spectrometer and the patient; - Patient Interface: The "OptoShield™" interface is a disposable pad that mechanically attaches to the distal end of the Optical Integrator. Its bottom has an adhesive backing for attachment to the patients skin for continuous monitoring. Until ready for use, the adhesive is covered with a liner to allow intermittent measurements. - Printer: A "Thermal Printer" may be used to print out the StO2 results for time trending and recording purposes. - Optical Converter: An "Optolink™" RS232 Optical Converter Model 300 is a device that converts the optical output of the Spectrometer to an electrical signal. - Set-up Accessories: An "OptoCheck™" module as well as both "High" and "Low" "Single Point References" are provided to verify proper system operation.

The Biospectrometer - NB 1111 is intended to noninvasively and continuously measure hemoglobin oxygen saturation: - in the ear lobe with the 3mm probe - in the arm, leg, or shoulder with the 15mm probe. The value of these measurements in disease states has not been demonstrated.

The Biospectrometer - NB Oximeter Model 1111 is a spectrophotometric monitoring system which measures an approximated value of percent hemoglobin oxygen saturation in tissue (S,O2). More specifically, the Biospectrometer - NB Oximeter measures the percent hemoglobin oxygen saturation of blood contained within the volume of tissue illuminated by the noninvasive probe. The S.O2 value is a function of the relative contribution of arterial, venous, and capillary blood. The system consists of a patient probe (either 3mm or 15mm) containing optical fibers for transmitting light to tissue and receiving reflected light which is returned to a photo-sensitive detector. The nonsterile probe is designed to be placed on intact skin. The second system component is a monitor containing a spectrometer, light assembly, microprocessor, power supply, display monitor and kevboard. The third type of system component includes two (reference) canisters for use in calibration of the system. The Biospectrometer - NB Oximeter Model 1111 is AC operated. The Biospectrometer - NB Oximeter Model 1111 measures an approximated value of the percent oxygen saturation of hemoglobin based on spectrophotometric measurement principles. Spectrophotometric measurements of hemoglobin have been well described by numerous authors. Today, spectrophotometric oximeters are commonly used clinically. By measuring absorbencies at suitable wavelengths, the ratio of oxygenated hemoglobin to total hemoglobin can be determined. The depth of tissue measured by the Biospectrometer - NB Oximeter Model 1111 probe is determined by the probe design. The HTI Biospectrometer - NB 15mm probe measures to a maximum depth of 20mm. The 3mm probe measures to a maximum depth of 4mm.