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The Sentec Digital Monitoring System (SDMS) - consisting of monitors, sensors, cables, accessories and disposables for sensor application/maintenance and PC-based software - is indicated for non-invasive patient monitoring of oxygenation and ventilation. The Sentec Digital Monitoring System is for prescription use only. Devices are non-sterile and non-invasive. The monitor is not in direct contact with the patient during monitoring. The V-Sign™ Sensor 2, the OxiVenT™ Sensor. the Ear Clip, the Multi-Site Attachment Rings, the Non-Adhesive Wrap, the Staysite™ Adhesive and the Contact Gel are in contact with the intact skin of the patient during monitoring.

Sentec's Digital Monitoring System is intended for the continuous and noninvasive monitoring of cutaneous carbon dioxide partial pressure (PCO2), cutaneous oxygen partial pressure (PC2), oxygen saturation (SpO2) and pulse rate (PR) in adult and pediatric patients as well as for PCO2 and PO2 monitoring in neonatal patients. The tCOM+ (REF 103164) is a portable, lightweight, stand-alone monitor with a convenient carrying handle and with an integrated calibration and storage facility for the V-Sign™ Sensor 2 or OxiVenT™ Sensor, respectively. It provides continuous and noninvasive PCO2, SpO2 and PR monitoring if used with a V-Sign™ Sensor 2 or PCO2, PO2, SpO2 and PR monitoring if used with a OxiVenT™ Sensor.

The SenTec Digital Monitoring System – consisting of the SenTec Digital Monitor (SDM), Sensors and Accessories - is indicated for continuous, noninvasive patient monitoring. The SenTec Digital Monitoring System is indicated for use in clinical and non-clinical settings such as hospital-type facilities, intra-hospital transport environments, clinics, physician offices, ambulatory surgery centers and - if under clinical supervision-home environments. The SenTec Digital Monitoring System is for prescription use only. The V-Sign Sensor 2, model VS-A/P/N, is indicated for use with the SenTec Digital Monitor when continuous, noninvasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients. In neonatal patients the use of V-Sign Sensor 2 is indicated for carbon dioxide tension monitoring only. The OxiVenT Sensor, model OV-A/P/N, is indicated for use with the SenTec Digital Monitor when continuous, noninvasive monitoring of carbon dioxide tension as well as oxygen saturation and pulse rate are required for adult and pediatric patients. In neonatal patients the use of OxiVenT Sensor is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia. SenTec's Ear Clip, model EC-MI, is intended for use with the V-Sign Sensor 2 when continuous, noninvasive carbon dioxide tension, oxygen saturation and pulse rate monitoring and with the OxiVenT Sensor when continuous, noninvasive carbon dioxide and oxygen tension monitoring as well as oxygen saturation and pulse rate monitoring are required. The Ear Clip is for single-patient use and is indicated to attach the V-Sign Sensor 2 or OxiVenT Sensor to the earlobe of the patient. The use of the Ear Clip is contraindicated for patients whose earlobes are too small to ensure adequate sensor application. SenTec's Multi-Site Attachment Rings, model MAR-SF and model MAR-MI, are intended to attach V-Sign Sensor 2 to conventional measurement sites for carbon dioxide tension monitoring when continuous, noninvasive carbon dioxide tension monitoring is required for adult, pediatic, and neonatal patients. The Multi-Site Attachment Rings, model MAR-SF and model MAR-MI, are intended to attach the OxiVenT Sensor to conventional measurement sites for carbon dioxide and/or oxygen tension monitoring when continuous, noninyasive carbon doxide and/or oxygen tension monitoring is required for adult, pediatric, and neonatal patients. If oxygen saturation and pulse rate monitoring are (additionally) required in adult and pediatric patients the Multi-Site Attachment Rings, model MAR-MI, are intended to attach the V-Sign Sensor 2 or the OxiVenT Sensor to the forehead, cheek, upper arm as well as on the back above the shoulder blade. The Multi-Site Attachment Rings, model MAR-MI, are for single use. SenTec's Staysite Adhesive pad for MAR, model SA-MAR, is an optional, single-use adhesive pad which is indicated for use with Multi-Site Attachment Rings, models MAR-MI and MAR-SF, if more secure attachment is required. The Staysite Adhesive pad for MAR, model SA-MAR, is for single use. V-STATS is an optional PC-based software which is indicated for use with the SenTec Digital Monitor (SDM) when remote monitoring and/ or trend reporting and statistical analysis of data measured by the SDM is required. V-STATS is not intended to provide diagnosis; it is intended to supplement and not to replace any part of the SDM monitoring procedures.

The SenTec Digital Monitoring System (SDMS) as listed under K101690 is a device consisting of a standalone monitor [SenTec Digital Monitor (SDM)], the digital sensors V-Sign™ Sensor (model VS-A/P) and its successor V-Sign™ Sensor 2 (model VS-A/P/N), connecting cables, and accessories for sensor application and maintenance. The SDMS is designed for the continuous and non-invasive monitoring of carbon dioxide partial pressure (PCO2), functional oxygen saturation (SpO2), and pulse rate (PR) using the ear lobe, forehead or cheek as monitoring site in adult and pediatric patients. It is furthermore designed for PCO2-only monitoring in adult, pediatric and neonatal patients using conventional PCO2 measurement sites. V-STATS™ is an optional PC software application for remote monitoring and/or trend reporting and statistical analysis of the data measured with the SDMS. The additions and expanded indications of the SenTec Digital Monitoring System (SDMS) introduced by this new 510(k) submission are summarized below: - This new 510(k) submission expands the intended use of the SDMS by introducing non- invasive, transcutaneous oxygen (tcPO2) by measuring the oxygen partial pressure (PO2) as new monitoring parameter to the SDMS. Introducing the tcPO2 parameter includes updated firmware versions of the existing SenTec Digital Monitor (SDM) and the introduction of a new digital sensor (OxiVenT™ Sensor, see below). - This new 510(k) submission introduces SenTec's OxiVenT™ Sensor, model OV-A/P/N. The - OxiVenT™ Sensor is a combined sensor for the continuous measurement of transcutaneous oxygen (tcPO2), as well as the previously cleared measurement of transcutaneous carbon dioxide (tcPCO2), oxygen saturation (SpO2) and pulse rate (PR). - V-Sign™ Sensor 2 (model VS-A/P/N) has been cleared under K101690. This new 510(k) submission expands the intended use by introducing new SpO2/PR measurement sites in adult and pediatric patients: Next to the already existing measurement sites on the forehead and cheek, new the upper arm and area on the back above the shoulder blade are added. - This new 510(k) submission expands the intended use of the Multi-Site Attachment Rings, models MAR-MI and MAR-SF, approved under K101690 and K071672. to attach the new OxiVenT™ Sensor to conventional measurement sites for carbon dioxide and/or oxygen tension monitoring when continuous, noninyasive carbon dioxide and/or oxygen tension monitoring is required for adult. pediatric, and neonatal patients. If oxygen saturation and pulse rate monitoring are (additionally) required in adult and pediatric patients the Multi-Site Attachment Rings, model MAR-SF and model MAR-MI, are intended to attach the V-Sign™ Sensor 2 or the new OxiVenT™ Sensor to the forehead, cheek, as well as the new pulse oximetry (SpO2/PR) measurement sites upper arm as well as on the shoulder blade. - This new 510(k) submission introduces the Staysite™ Adhesive pad (REF SA-MAR), an additional adhesive pad that can be used optionally if more secure attachment is required – the pad is attached on top off the Multi-Site Attachment Rings (MAR-SF/MI). - The V-STATS™ PC software for trend data reporting and remote monitoring (cleared in K101690) has been updated to version 4.00 in order to incorporate download and display of the new PO2 parameter. In total, the modifications, additions, and enhancements described above represent the step-wise evolution of the SenTec Digital Monitoring System (SDMS) to provide improved monitoring as well as expanded measurement and reporting capabilities. A traditional 510(k) has been selected instead of a special 510(k) because some of the changes affect the indications for use.

PeriFlux 6000 equipped with PF 6040 is intended for continuous non-invasive transcutaneous monitoring of the partial pressures of oxygen and/or carbon dioxide. It is intended for use on neonates, pediatrics, and adults not under gas anesthesia.

PeriFlux 6000 is a transcutaneous oxygen/carbon dioxide (tcpO2/CO2) monitor, and consists of a main unit, PF 6001, that can be equipped with 1 to 8 PF 6040 function units. An electrode E5250 or E5280 is connected to each function unit and is applied to a patient's skin. Electrode E5250 consists of a Clark sensor and is used for O2 measurement. Electrode E5280 is a combined Clark sensor and Stow-Severinghaus-type sensor, and is used for both O2 and CO2 measurement. Upon measurement, the electrode is heated to make the skin permeable to gas diffusion, which allows O2 and CO2 to diffuse through the skin into the sensor. The instrument is operated from its touch screen interface and allows the users to record, analyze and report top(22 and tcpCO2 values.

IntelliVue MP40, MP50, MP60, MP70, MP80, MP90 and MX800 and IntelliBridge EC10 and EC5 IC Module: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. IntelliVue TcG10 Measurement Module: Indicated for use by health care professionals whenever there is a need to support the continuous and noninvasive monitoring of transcutaneous partial pressures of blood gas carbon dioxide and oxygen of patients not under gas anesthesia.

The modified Philips MP40, MP50, MP70, MP80, MP90, and MX800 IntelliVue Patient Monitors are a flexible and modular monitoring solution optimized for the surgical, cardiac, general medical and neonatal care environments. The monitors can be connected to the Philips Multi-Measurement Module (MMS) family with its extensions and to the IntelliVue family plug-in measurement modules. The monitors can also be connected to the IntelliVue anesthetic gas modules and to the new Intellivue TcG10 Measurement Module. The modified Philips IntelliBridge EC10 and EC5 ID modules build an external medical device solution to collect data from external devices at the bedside providing the data to patient monitors, and patient monitoring networks. The modified EC10 and EC5 ID modules support the interface of the IntelliVue patient monitors with the new IntellVue TcG10 Measurement Module. The new IntellVue TcG10 Measurement Module is a device for the continuous and noninvasive measurement of the transcutaneous partial pressures of blood gas carbon dioxide (pCO2) and oxygen (p02) of patients from all pediatric subgroups and of adult patients not under gas anesthesia in hospital environment. The transcutaneous measurement of pCO2 and pO2 makes use of the fact that carbon dioxide and oxygen gases are able to diffuse through body tissue and skin and can be detected by a sensor placed at the skin surface. By warming up this sensor, a local hyperemia is induced, which increases the supply of arterial blood to the dermal capillary bed below the sensor. The transcutaneous blood gas values (tcpCO2 and tcpO2) have to be interpreted primarily as the blood gas partial pressures prevailing at the level of the arterialized skin tissue. In general, this value correlates well with the corresponding arterial blood gas partial pressure.

The SenTec Digital Monitoring System - consisting of the SenTec Digital Monitor (SDM), Sensors and Accessories - is indicated for continuous, non-invasive patient monitoring. The SenTec Digital Monitoring System is indicated for use in hospital-type facilities, intra-hospital transport environments, and - if under clinical supervision - home environments. The SenTec Digital Monitoring System is for prescription use only. V-Sign™ Sensor, model VS-A/P, and V-Sign™ Sensor 2, model VS-A/P/N, are indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients. In neonatal patients the use of V-Sign™ Sensor and of V-Sign™ Sensor 2 is indicated for carbon dioxide tension monitoring only. SenTec's Ear Clip, model EC-MI, is intended for use with V-Sign™ Sensor or V-Sign™ Sensor 2 when continuous, non-invasive carbon, oxygen saturation and pulse rate monitoring are required. The Ear Clip is for single-patient use and is indicated to attach V-Sign™ Sensor or V-Sign™ Sensor 2 to the ear lobe of the patient. The use of the Ear Clip is contraindicated for patients whose earlobes are too small to ensure adequate sensor application. SenTec's Multi-Site Attachment Rings, model MAR-SF and model MAR-MI, are intended to attach V-Sign™ Sensor or V-Sign™ Sensor 2 to conventional measurement sites for carbon dioxide tension monitoring when continuous, non-invasive carbon dioxide tension monitoring is required for adult, pediatric, and neonatal patients. They are intended to attach the V-Sign™ Sensor 2 to the forehead or the cheek when continuous, non-invasive carbon dioxide tension, oxygen saturation, and pulse rate monitoring is required for adult and pediatric patients. The Multi-Site Attachment Rings, model MAR-MI, are for single use. SenTec's multi-compatible and reusable SpO2 Soft Sensors, models RSS-L, RSS-M and RSS-S, are indicated for use with the monitoring devices indicated in the respective sensor directions for use when continuous non-invasive monitoring of oxygen saturation, and pulse rate are required for patients weighing more than 20 kg. V-STATS™ is an optional PC-based software which is indicated for use with the SenTec Digital Monitor (SDM) when remote monitoring and/or trend reporting and statistical analysis of the data measured by the SDM is required. V-STATS™ is not intended to provide diagnosis, it is intended to supplement and not to replace any part of the SDM monitoring procedures. Caution: Federal law restricts this device to sale by or on the order of a physician.

The SenTec Digital Monitoring System (SDMS) as listed under K071672 is a device consisting of a standalone monitor [SenTec Digital Monitor (SDM)], a digital sensor [V-Sign™ Sensor (model VS-A/P)], connecting cables, and accessories for sensor application and maintenance. The SDMS is designed for the continuous and non-invasive monitoring of carbon dioxide partial pressure (PCO2), functional oxygen saturation (SpO2), and pulse rate (PR) using the ear lobe as monitoring site in adult and pediatric patients. It is furthermore designed for PCO2-only monitoring in adult, pediatric and neonatal patients using conventional PCO2 measurement sites. This new 510(k) introduces the following additional features/functions to the SDMS: - V-Sign™ Sensor 2 (model VS-A/P/N) [successor of V-Sign™ Sensor (model VS-A/P) with improved embedded hardware/software] for PCO2, SpO2, PR monitoring using the ear lobe, the forehead or the check as monitoring site in adult and pediatric patients as well as for PCO2-only monitoring in adult, pediatric and neonatal patients using conventional PCO2 measurement sites - SpO2 Soft Sensor (models RSS-L, RSS-M, RSS-S) with the SpO2 Adapter Cable (model SC-XX; where XX=150, 250, or 750) for continuous and non-invasive SpO2/PR monitoring in patients weighing more than 20 kg. These conventional oximetry sensors, which are applied to a patient's digit, must be connected to the SDM by using the new SpO2 Adapter Cable. - V-STATS™, an optional PC software application for remote monitoring and/or trend reporting and statistical analysis of the data measured with the SDMS. This new 510(k) furthermore introduces the following modifications/enhancements: - Modified intended use for the Multi-Site Attachment Rings: In K071672 the Multi-Site Attachment Rings (model MAR-MI, formerly designated MAR-A/P; and model MAR-SF, formerly designated MAR-A/P/N) were listed for continuous and non-invasive PCO2-only monitoring. This new 510(k) submission expands the intended use for both models to additionally include continuous and noninvasive SpO2 and PR monitoring if V-Sign™ Sensor 2 (model VS-A/P/N) is applied to the forehead or cheek of adult or pediatric patients. In K071672 the Multi-Site Attachment Ring (model MAR-MI) was listed for use in adult and pediatric patients. This new 510(k) submission expands the intended use for the Multi-Site Attachment Ring (model MAR-MI) to additionally include the neonatal population. Proposed labeling states that model MAR-MI can be used for patients with mature and intact skin, whereas for patients with sensitive/fragile skin model MAR-SF must be used. - Modified firmware for the SenTec Digital Monitor: the modified firmware of the SDM introduces an expanded sensor temperature / site time management two new monitoring parameters (Pulsation expanded benser comports the new sensors being introduced with introduced with this new 510(k).

The TCM CombiM Monitoring Systems is intended for continuous monitoring of transcutaneous Carbon Dioxide (tcpCO₂), oxygen (tcpO₂) partial pressure in neonates, pediatrics and adults not under gas anesthesia. The TCM TOSCA Monitoring Systems is intended for continuous monitoring of transcutaneous Carbon Dioxide (tcpCO2), oxygen saturation of arterial haemoglobin (SpO2) and pulse rate in pediatrics and adults.

The TCM TOSCA monitoring system and the TCM CombiM monitoring system are based on the TCM 4/40 Monitoring System (K043003) which consist of a basic unit that has touch screen and two modules. One module for the combined tcpO2/tcpCO2 monitoring and one for SpO2. Both new modules have an integrated callbration unit. Both Sensors can be used with either earclip- or a conventional fixation ring application system. In addition the CombiM also comes with a double adhesive ring. The software of the TCM 4/40 basic unit has been updated (to version 3.01) and two new modules have been developed to enable the use of the sensor technology from the TOSCA500 Monitoring System (K063434) and from the MicroGas 7650 rapid (K003943). Thereby the SpO2 and tcpCO2 can be measured using the new TCM TOSCA module and the combined SpO2/tcpCO2 sensor of the TOSCA500 system. The tcpO2 and tcpCO2 can be monitored using the new TCM CombiM module and the combined tcpOz/tcpCO2 sensor of the MicroGas 7650 rapid system. A new single tcpCO2 sensor can also be used with this module.

The Linde TOSCA 500 Monitoring System is designed for the simultaneous continuous monitoring of transcutaneous PCO₂, functional oxygen saturation SpO2 and Pulse Rate in adults and pediatrics.

The Linde TOSCA 500 Monitoring System is designed for the simultaneous continous monitoring of transcutaneous PCO2 functional oxygen saturation SpO2 and pulse rate, using a single sensor (Tosca Sensor) applied to the ear lobe. The system consists of a Tosca Monitor equipped with an integrated calibration unit which allows a fully automatic calibration of the PCO2 part of the sensor and also provides a storage facility for the sensor, and with the Masimo SET signal extraction technology for the calculation of the functional oxygen saturation and the pulse rate ; a Tosca Sensor comprising the elements of an electrochemical Stow-Severinghaus-type carbon dioxide sensor and of an optical pulse oximetry sensor; supplies for the sensor preparation; supplies for the sensor attachment at the ear lobe; and a gas mixture for the sensor calibration.

The TCM4 Monitoring System is intended for continuous transcutaneous monitoring of oxygen and carbon dioxide partial pressures. It is indicated for use on neonates, pediatrics, and adults not under gas anesthesia. The TCM40 Monitoring System is intended for continuous transcutaneous monitoring of oxygen and carbon dioxide partial pressures as well as of oxygen saturation of arterial hemoglobin and pulse rate. It is indicated for use on neonates, pediatrics, and adults not under gas anesthesia.

The TCM4/40 Monitoring Systems essentially consist in a monitor unit, a combined oxygen/carbon dioxide interface module along with the combined electrodes assembly and (for the TCM40 only) an oxygen saturation/pulse module with a selection of three sensors.

The SenTec Digital Monitor System (comprising the SenTec Digital Monitor, V-Sign™ Sensor and Accessories) is indicated for continuous noninvasive monitoring. The SenTec Digital Monitor System is indicated for use in hospital type realities, includes intra-hospital transport environments, and clinical supervision, home environments. The SenTec Digital Monitor System is for prescription use only. The V-Sign™ Sensor, model VS-A/P, is indicated for use with the Sentec Digital Monitor when continuous noninvasive carbon dioxide tension, oxygen saturation and pulse rate monitoring are required for adult through pediatric patients. SenTec's Ear Clip, model EC-A/P, is intended for use with the V-Sign™ Sensor when continuous, non-invasive carbon dioxide tension, oxygen saturation and pulse rate monitoring are required. The Ear Clip is for single-patient use and is indicated for patients weighing 30 kg or more, using exclusively the ear lobe as the monitoring site. The use of the SenTec Ear Clip is contraindicated for patients whose ear-lobes are very small (resulting in inadequate sensor application). Caution: Federal law restricts this device to sale by or on the order of a physician.

The Sentec Digital Monitor System (SDMS) is a device consisting of a stand-alone monitor, a digital sensor, a connecting cable, and accessories for sensor application and maintenance. The SDMS is designed for the continuous noninvasive measurement of cutaneous carbon dioxide partial pressure (PCO2), functional oxygen saturation (SpO2) and pulse rate (PR), using a single, digital sensor (V-Sign™ Sensor). The V-Sign™ Sensor combines within one digital sensor the technology to measure cutaneous PCO2 with the optical elements (LED, photodetector) needed for pulse oximetry. The PCO2 measurement of the V-Sign™ Sensor is based on a Stow-Severinghaus type PCO2 sensor. The V-Sign™ Sensor slightly raises the temperature at the monitoring site to achieve the cutaneous PCO2 measurement. Safe temperature is achieved using two independent measurement and control systems. The sensor is applied to the patient's ear lobe using SenTec's single patient use Ear Clip and a thin layer of Sensor Gel. The Sentec Digital Monitor (SDM) is equipped with an integrated calibration unit, the Docking Station, allowing an automatic PCO2 sensor calibration that begins when the V-Sign™ Sensor is stored in the Docking Station. This ensures that the V-Sign™ Sensor is continuously ready to use. The V-Sign Disposable Set provides a straight-forward preparation of the V-Sign™ Sensor - with the ease of 4 "Push-and-Turn" procedures, all necessary steps to exchange the sensor's membrane are performed.

When installed in the Periflux System 5000, the Transcutaneous PO₂ and PCO₂ Monitor (PF5040) is intended to monitor the levels of oxygen and/or carbon dioxide from tissue transcutaneously. The unit provides continuous, non-invasive monitoring of cutaneous oxygen and carbon dioxide. The Periflux System 5000 with the pO₂/pCO₂ module is intended to be used in hospitals and facility offices. It is intended to monitor transcutaneous pCO₂ in adults and pO₂ in infants not under gas anesthesia. The system is not intended for use by patients without the supervision of a physician.

The Transcutaneous PO₂ and PCO₂ Monitor (PF5040) is a modular unit which can be installed in the Periflux System 5000 transcutaneous monitoring system. Patient monitoring is accomplished by the application of an electrode to specific sites on the patient after calibration of the unit. The Periflux System 5000 is a multi-channel, multi-function system capable of hosting several function units including: the Modular Laser Doppler system for blood perfusion and the Transcutaneous PO₂ and PCO₂ Monitor (PF5040) for monitoring oxygen and/or carbon dioxide levels. The Periflux system 5000 can accommodate up to four different function units enabling different types of simultaneous measurements.