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The Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor provides a simple and reliable method to display and document the continuous hemodynamic. cardiovascular observations that are typically required of critically ill patients. The target populations of the system are adult, pediatric, and neonatal patients, who may be located in a hospitals ICU, CCU, OR, ER, recovery or other critical care area, with the exception of the ST segment, arrhythmia analysis, and SpHb for which the target populations are adult and pediatric only excluding neonates. The DS-8000 Series monitor can also be used to follow patients whose treatment requires close observation of specific physiological parameters. These patients mav be in a clinic or other healthcare environment under the care of a physician.

The availability of DS-LAN connection, through either a built in Ethernet LAN or external telemetry transmitter, allows remote monitoring when combined with Fukuda Denshi Central Station Monitors.

Parameters such as ECG, heart rate, respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and total hemoglobin concentration (SpHb), plethysmograph, temperature, invasive blood pressure (IBP), cardiac output, carbon dioxide concentration (CO2), nitrous oxide concentration (N>O), oxygen concentration (0>), anesthetic agent concentration (AG), and Spirometry may be monitored individually or in any grouping required by the clinician.

The Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor is not recommended for home use, when it has not been ordered by a physician.

The Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor is meant to acquire and monitor physiological signals from patients. The system is design to be used in ICU, CCU, OR, ER, or Recovery areas of the hospital or clinic. Patient ages from neonates to adults can all be monitored. Waveforms, numeric and trend data from these patients are available to the clinician on the systems display or may be printed on the system's recorder.

The model DS-8500 is a modular monitor. The system consists of the main control unit (model: DSC-8510/DSC-8530), the display unit (model: LC-8019T/LC-8019TC/LC-8015T/LC-8015TC), the Super Unit (model: HS-8312N/HS-8312M), the HS Adapter (model: HSA-80) for the Super Unit attachment, the Input Box (model: IB-8004), the Expansion Modules (model: HM-800/HG-810/HG-820/HP-800) that plug into the input box, the Expansion Units (model:MGU-801P/MGU-802/ MGU-803/MGU-811P/MGU-812/MGU-813/HR-800), CO2 Gas Unit (model: HCP-800), and Gas Unit I/F (model: HPD-800). The main body of the system in designed so it can be remotely located from the display unit, the Super Unit, the Recorder Unit, and the Input Box.

There are two (2) types of the main units depending on the built-in display board configuration as follows.

• External Monitor Output (1ch) DSC-8510:
• External Monitor Output (1ch), Extended Display Monitor Output (2ch), DSC-8530: LAN (TCP/IP) IF (1ch)

There are four (4) types of the display units depending on the display size and filter as follows.

LC-8019T: 19 inches LC-8019TC: 19 inches with Circular Polarizing Filter LC-8015T: 15 inches LC-8015TC: 15 inches with Circular Polarizing Filter

The display unit contains a 15/19 inches diagonal, active matrix TFT color display and a clear touch screen. The 15/19"display is capable of presenting up to 20/28 waveforms.

The user interfaces, the touch screen panel, is located on the front of the display unit. The transparent area covering the display has a variable number of keys that are activated by software and depend on the display/function that the user selects. And there are five (5) fixed keys (Alarm Silence, NIBP Start/Stop, Home, Menu, and Prev. Disp.) and Jog Dial on the right side of the front of the display unit. The infrared remote-control command is also available (optional). The right side of the display unit contains two (2) Mouse/Keyboard Connection Connectors (PS/2 port).

The model DS-8200 is a modular monitor. The system consists of the Display Unit (model: LC-8210), the HS Adapter (model: HSB-80), the Base Unit (model: BS-8210), the Super Unit (model: HS-8312N/HS-8312M), CO2 Gas Unit (model: HCP-800), Gas Unit I/F (model: HPD-800), and the Recorder Unit (model: HR-800).

The Display Unit (LC-8210) contains a 10.2 inches diagonal, active matrix TFT color display and a clear touch screen. The 10.2"display is capable of presenting up to 14 waveforms. It also contains the Standby Switch, the Power Supply Indicator, and the Battery Charge LED on the bottom left of the front side, an alarm indicator, which alerts to alarm conditions, on the top, Telemeter Module (HLX) Insertion Slot (with the cover), one (1) CF Card Slot, one (1) CF Card Access Indicator, one (1) SD Card Slot, and one (1) SD Card Access Indicator on the right side, one (1) Display Unit Extension Cable Connector on the left side, and interface connector to the HS Adapter (HSB-80) on the rear side.

The HS Adapter (HSB-80) contains one (1) Display Unit Connector, the Display Unit Extension Cable Connector, the Operation Mode Change Switch (reserved), and the Battery Charge LED on the front side, one (1) module-LAN Connector on the right side, and the Super Unit Connector and the Battery Insertion Slot (with the cover) on the left side.

The Base Unit (BS-8210) contains the Power Supply Indicator, the Battery Charge LED, the Battery Insertion Slot (with the cover), and one (1) Serial Connector (COM1) on the front side, the AC Mains Input Connector, one (1) Serial Connector (COM2), one (1) External Monitor Connector, two (2) Status Input/Output Connectors, and one (1) DS-LAN Connector on the rear side, one (1) U-LINK Connector on the left side, and the HS Adapter Connector on the top.

The user interfaces, the touch screen panel, is located on the front of the display unit. The transparent area covering the display has a variable number of keys that are activated by software and depend on the display/function that the user selects. The infrared remote-control command is also available (optional). An option battery, which is built in to the Base Unit (BS-8210) and/or HS Adapter (HSB-80), operation allows a patient to continue to be monitored during intra-hospital transport.

The HS-8312N/HS-8312M Super Unit provides monitoring of ECG (Up to 12lead), heart rate, respiration (RESP), non-invasive blood pressure (NIBP), pulse rate (PR), arterial oxygen saturation (SpO>), plethysmograph, and up to six (6) channels of parameters in any combination of invasive blood pressure (IBP), temperature (TEMP), and cardiac output (CO) using three (3) multiparameter connectors. In addition, the HS-8312M provides monitoring of carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and total hemoglobin concentration (SpHb). The NIBP measurement for the HS-8312N/M utilizes the NIBP module that is the exact same technology and algorithm as approved in the Fukuda Denshi Model DS-7000 Series Patient Monitor and provides the 510(k) #K083697. And the 12-Lead ECG monitoring provides the 12-Lead ECG analysis function using the 12-Lead ECG analysis software module that is the same as that used in the Fukuda Denshi CardioMax model FX-4010 Multi Channel Electrocardiograph, 510(k) #K981066. The HS-8312N for SpO2 measurement utilizes a technology of an OxiMax N-560 Pulse Oximeter manufactured by Nellcor and previously cleared under 510(k) #K021090. The HS-8312M for SpO2, SpCO. SpMet, and SpHb measurement utilizes a technology of a Masimo Rainbow SET® RADICAL 7R CO-Oximeter manufactured by Masimo and previously cleared under 510(k) # K100428. The NIBP Start /Stop Key with indicator, which lights during NIBP measuring, BP Zero Balance Key with indicator, which lights during BP zero balancing, Alarm Silence Key with indicator, which lights during the alarm silence condition, and Power Supply Indicator are located on the top of the front panel. And all parameter connectors are on the front panel and are labeled. The left side of the unit contains the Analog Output Connector that outputs the ECG and BP waveforms, including the QRS SYNC output signal. To connect the Super Unit to the Main Unit, the HSA-80 HS Adapter (for DS-8500)/HSB-80 HS Adapter (for DS-8200) is required.

The HCP-800 CO2 Gas Unit or HPD-800 Gas Unit I/F provides monitoring of carbon dioxide concentration (CO2) by connecting to the AUX Connector on the front of the Super Unit. The CO2 Gas Unit (HCP-800) that utilizes Oridion Medical 1987 Ltd. technology "Microstream" and previously cleared under 510(k) #K094012. The Gas Unit I/F (HPD-800) allows to connect the Capnostat 5 Mainstream CO2 Sensor, 510(k) #K042601, manufactured by Respironics Novametrix, LLC. to the Super Unit with serial communication protocol for CO2 monitoring.

The HM-800 Multi Module provides monitoring of up to four (4) channels of parameters in any combination of invasive blood pressure (IBP), temperature (TEMP), and cardiac output (CO) using two (2) multiparameter connectors, which are on the front panel and are labeled. The Power Supply Indicator and BP Zero Balance Key with indicator, which lights during BP zero balancing, are located on the top of the front panel.

The HG-810/MG-820 SpO2 Module provides monitoring of arterial oxygen saturation (SpO2), plethysmograph, and pulse rate (PR). The HG-810 also provides monitoring of carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and total hemoglobin concentration (SpHb). The MG-810 utilizes a technology of a Masimo Rainbow SET® RADICAL 7R CO-Oximeter manufactured by Masimo and previously cleared under 510(k) # K100428. The HG-820 utilizes a technology of an OxiMax N-560 Pulse Oximeter manufactured by Nellcor and previously cleared under 510(k) # K021090. And the SpO2 connector is on the front panel and is labeled and the Power Supply Indicator is located on the top of the front panel. In addition, in conjunction with the Super Unit. it provides monitoring of two (2) different sites of arterial oxygen saturation (SpO2). In case of HG-810 in conjunction with the HS-8312M, the monitoring of two (2) different sites of carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and total hemoglobin concentration (SpHb) is also available.

The HP-800 Multiport Module contains two (2) Status Input/Output Connectors for serial communications with the external device and one (1) Analog Input Connector, which 2 channels of inputs are available, to input analog signal from the external device. All connectors related to connection with the external devices are on the front panel and are labeled and the Power Supply Indicator is located on the top of the front panel.

The IB-8004 Input Box provides the expansion monitoring by plugging the Expansion Modules, such as HM-800, HG-810/MG-820, and HP-800, into. There are four (4) slots for Expansion Module plug-in. Within one (1) DS-8500 system, the connectable number of Input Box is up to two (2), so the plugging of up to eight (8) Expansion Modules is available.

The MGU-800 series (MGU-801P/MGU-802/MGU-803)/ 810 series (MGU-811P/MGU-812/MGU-813) Multigas Unit provides monitoring of carbon dioxide concentration (CO2), nitrous oxide concentration (N2O), oxygen concentration (O2), and anesthetic agent concentration (AG). It utilizes a technology of the sidestream multigas analyzer manufactured by ARTEMA Medical AB. and previously cleared under 510(k) # K053234 by Mindray. Depending on the following model type of the Multigas Unit, the measurable gas parameters are as follows.

MGU-801P/MGU-811P: CO2, N2O, O2, and AG
MGU-802/MGU-812: CO2, N2O, and AG
MGU-803/MGU-813: CO2, and N2O

In addition, the MGU-810 series (MGU-811P/MGU-812/MGU-813) provides monitoring of spirometry that utilizes the respiratory mechanics analyzer and flow sensor, manufactured by ARTEMA Medical AB, which is similar to a technology previously cleared under 510(k) # K062754 by Datascope. All connectors related to measurement are on the front panel and are labeled and the Power Supply Indicator is located on the top of the front panel.

The HR-800 Recorder Unit, a dot matrix thermal printer, provides hard copy recording s of all monitored parameters and can print up to three (3) waveforms simultaneously. On the top of the front panel, the Power Supply Indicator, Print Key with indicator, which lights during printing, and Paper Feed Key with indicator, which lights during paper feeding, are located. The Open/Close Lever to open/close the paper holder is located on the right upper part of the front of the unit.

Additional standard features include the DS-LAN connection, which is a proprietary network system based on an Ethernet LAN (K970585), through either a built in Ethernet LAN or external telemetry transmitter (the Fukuda Denshi DS-5000 series telemetry model HLX-501/561, K980728) connection for connection to the Fukuda Denshi Central Station Monitors.

The provided text is a 510(k) premarket notification for a patient monitor and does not contain the detailed clinical study information typically found for devices with specific performance claims related to diagnostic accuracy (like computer-aided detection/diagnosis systems).

The Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor is a physiological monitoring device that measures various parameters. The 510(k) submission primarily focuses on establishing substantial equivalence to predicate devices. This means that instead of conducting new clinical trials to prove efficacy, the manufacturer demonstrates that their device is as safe and effective as devices already on the market, usually by showing it has the same technological characteristics and meets established performance standards.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, expert ground truth, and comparative effectiveness studies are not explicitly present in this document because the device's approval hinges on demonstrating equivalence through testing to standards and internal verification rather than de novo clinical performance studies for AI algorithms.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of specific acceptance criteria or quantitative performance metrics in the way one might see for a diagnostic AI device (e.g., sensitivity, specificity, AUC). Instead, it states that the device was subjected to "extensive safety, environmental and performance testing" to ensure "all functional and performance specifications were met." This implies the acceptance criteria were compliance with a range of standards and internal functional specifications.

Reported Device Performance (Implicit): The device is considered to perform "as well as the legally marketed predicate devices" because it incorporates identical technology or modules from previously cleared devices and complies with relevant standards.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified. The testing mentioned refers to "final testing for the device" and "host tested at the previously noted OEM engineering test facility," which typically involve engineering verification and validation on a limited set of test inputs or simulated data, rather than a large patient-based test set for performance claims.
• Data Provenance: Not specified, but given the nature of the device (physiological monitor), testing would likely involve simulated physiological signals and possibly a small number of human subjects for usability and basic functionality, not large-scale retrospective or prospective patient data for algorithm performance validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This level of detail about expert-established ground truth is not applicable to this type of submission. The device is a physiological monitor, where parameters like ECG, heart rate, or blood pressure are measured directly using established sensor technologies, and their accuracy is typically validated against known reference standards or other calibrated devices, not through expert consensus on interpretations.

4. Adjudication Method for the Test Set:

Not applicable for the same reasons as #3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

An MRMC study is not applicable. This device is a monitor, not an AI-assisted diagnostic tool that interprets or provides clinical recommendations for human readers. It provides raw and processed physiological data. The document does not mention any AI components that would assist human readers in interpretation or diagnosis.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The device itself is a standalone physiological monitor. Its performance is evaluated on its ability to accurately measure and display physiological parameters. The "algorithms" mentioned (e.g., NIBP, 12-Lead ECG analysis software, SpO2) are components embedded in the device, and their performance is considered based on their prior clearance or established standards for those specific modules. No specific "algorithm-only" performance study distinct from the device's overall function is described.

7. The Type of Ground Truth Used:

For physiological measurements, the ground truth would typically be:

• Reference Standards: Calibrated instruments for known values (e.g., blood pressure cuffs calibrated against a mercury manometer, ECG simulators generating known waveforms).
• Predicate Device Comparison: Comparing measurements from the new device to those from a legally marketed predicate device.
• Pathology/Outcomes Data: Not typically used for a physiological monitor of this type.

The document states that the new device's NIBP measurement utilizes the "exact same technology and algorithm" as a previously approved monitor, and the 12-Lead ECG monitoring uses the "same" software module as a previous device. This implies that the ground truth for these components was established during the clearance of those predicate devices, likely through comparison to reference standards or established clinical methods.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physiological monitor built from established technologies and previously cleared modules. It does not describe a machine learning or AI model that requires a distinct "training set" in the context of contemporary AI/ML device development. The underlying algorithms for parameters like ECG analysis or pulse oximetry are fixed and well-understood.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no mention of a distinct training set for an AI/ML algorithm within the context of this 510(k) submission. The ground truth for the components of the device (e.g., 12-Lead ECG analysis) would have been established during the development and clearance of those original component technologies, likely through extensive testing against known physiological signals and clinical validation studies at that time.

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