Search Results

The C50 and C80 patient monitors are intended to be used for monitoring, displaying, reviewing, alarming and storing of multiple physiological parameters as following: ECG (3-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), temperature (Temp), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), cardiac output (C.O.) for single patient. The C80 can also monitor the ICG (impedance cardiography) and BIS (bispectral index).

All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:

· The ICG monitoring is applicable to the adult patients of 122229cm in height and 30159Kg (67~341 pounds) in weight only;

· NIBP measurement continual mode is not applicable to neonates;

· Anesthetic depth (BIS) of the multi-parameter patient monitor is not intended for neonatal patients;

The monitors are to be used in general healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. The monitors are not intended for home use.

The C50 and C80 patient monitors are intended to be used for monitoring, displaying, reviewing, alarming and storing of multiple physiological parameters as following: ECG (3-lead, 5-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), temperature (Temp), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), cardiac output (C.O.) for single patient. The C80 can also monitor the ICG (impedance cardiography) and BIS (bispectral index).

All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:
• The ICG monitoring is applicable to the adult patients of 122229cm in height and 30159Kg (67~341 pounds) in weight only;
• NIBP measurement continual mode is not applicable to neonates;
• Anesthetic depth (BIS) of the multi-parameter patient monitor is not intended for neonatal patients;
Those monitors provide patient monitoring capabilities by using corresponding accessories.
The multi-parameter Patient monitor, model: C50 and C80 have same design principle and technical characteristics:
But the software in the host and modules and components are different.
The differences between C50 and C80 are ICG, BIS and size of monitor.

The provided document describes the acceptance criteria and a study proving the C50 and C80 Multi-parameter Patient Monitor meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established through adherence to recognized international standards and clinical performance metrics. The document details a comparison with a predicate device (K170876, Passport Series Patient Monitors). While explicit "acceptance criteria" for each parameter are not always separately listed with a single performance value from the new device, the "Comparison" column in the table below infers if the new device meets or exceeds the predicate's performance or if sufficient justification is provided for differences.

Study that Proves the Device Meets Acceptance Criteria

The essential studies to prove the device meets acceptance criteria are divided into Non-Clinical Performance Data and Clinical Studies.

Non-Clinical Performance Data:

• Software Verification and Validation Testing: Conducted in accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Risk analysis was performed, and the software was deemed a "major" level of concern.
• Electrical safety and Electromagnetic Compatibility (EMC): Testing conducted according to:
  • ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012 (IEC 60601-1:2005, MOD)
  • IEC 60601-1-2 Edition 4: 2014-02
• Bench Testing: Functional and system-level tests were performed, showing the devices meet specifications and perform equivalently to the predicate.
• Biocompatibility Testing: Performed for patient-contacting components (ECG cable, SpO2 probes, temperature probes) that were not previously cleared. Cytotoxicity, sensitization, and irritation testing were conducted based on ISO 10993-1 and FDA's 2016 biocompatibility guidance.
• Conformance with Applicable Standards: The device demonstrated compliance with numerous recognized consensus standards, in addition to those listed above for specific modules (e.g., ISO 80601-2-55 for Respiratory Gas Monitors, ISO 80601-2-56 for Thermometers, ISO 80601-2-61 for Pulse Oximeter Equipment, ANSI AAMI EC57:2012 for Cardiac Rhythm and ST-Segment measurement algorithms).

Clinical Studies:

1. NIBP Clinical Study - for adults and children

• Device Parameter: Non-invasive Blood Pressure (NIBP)
• Acceptance Criteria/Standard: Complies with ISO 81060-2 Second Edition 2013-05-01 "Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type."
• Sample Size: 25 patients (19 adults, 6 children).
  • Demographics: 10 men, 15 women. 6 patients aged 3-12, 2 aged 12-40, 10 aged 40-60, 7 above 60.
• Data Provenance: Retrospective or Prospective not explicitly stated, but implies prospective data collection from "The Second Affiliated Hospital of Guangzhou Medical University and The First Affiliated Hospital of Guangzhou Traditional Chinese Medical University" from 2012 to 2013 (China).
• Ground Truth: Implicitly referent method (e.g., auscultation by trained observers) as required by ISO 81060-2.
• Adjudication Method: Not specified, but standard practice for NIBP clinical validation involves multiple observers for reference measurements.
• Results: "The results are accurate and reliable, and the repeated measurement consistency is in good condition, within the measurement range. Moreover, No adverse events and side effects were found in clinical trials."

2. NIBP Clinical Study - for neonate and infants

• Device Parameter: Non-invasive Blood Pressure (NIBP)
• Acceptance Criteria/Standard: Complies with ISO 81060-2 Second Edition 2013-05-01 "Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type."
• Sample Size: 20 subjects.
  • Demographics: 10 males, 10 females. 13 subjects

Ask a specific question about this device

The Datex-Ohmeda S/5™ BIS Module, E-BIS and accessories are intended to be used with Datex-Ohmeda modular multiparameter monitors for monitoring neurophysiological status of hospitalized patients.

The Datex-Ohmeda S/5TM BIS Module, E-BIS and accessories are indicated for monitoring the state of the brain by data acquisition of electroencephalograph (EEG) signals of all hospitalized patients. The Bispectral index (BIS), a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents. The device is indicated for use by qualified medical personnel only.

The Datex-Ohmeda S/5™ BIS Module, E-BIS and accessories is a single-width plug-in parameter module for a Datex-Ohmeda modular monitoring system. The S/5 E-BIS module, M-BIS can be used with the following Datex-Ohmeda modular monitors: S/5 Anesthesia Monitor (AM), S/5 Compact Anesthesia Monitor (CAM), S/5 Critical Care Monitor (CCM) and S/5 Compact Critical Care Monitor (CCCM) with main software L-(C)ANE02(A)..00 or L-(C)ICU02(A)..00 or newer version. The Datex-Ohmeda S/5™ BIS Module, E-BIS and accessories is a parameter module for monitoring the state of the brain by data acquisition of EEG signals of all hospitalized patients. The BIS, a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents. The Datex-Ohmeda S/5TM BIS Module, E-BIS and its predicate M-BIS (K013389) are used in conjunction with Aspect Medical Systems, Digital Signal Converter-Expanded Performance, DSC-XP (K011534), Patient Interface Cable; PIC (K011534), and BIS Sensor Plus (K994330), BIS Sensor XP (K002734) or BIS Sensor Pediatric (K001980). The raw EEG signal can be displayed from one of the two monitored channels. The waveform size, color and sweep speed can be adjusted.

Calculated parameters are:

• Bispectral Index,BIS(Range=0-100),continuous processed EEG parameter correlating to the patient's level of hypnosis, where 100=awake and 0=comatose.
• Suppression Ratio,SR,(Range=0-100%), the percentage of epochs in the past 63 seconds in which the EEG signal is considered suppressed.
• . Electromyograph, EMG, the absolute power (in decibels) in the frequency range 70-110 Hz
• Signal Quality Index, SQI (Range:0-100%), the percentage of good epochs in the last 60sec. that could be used to calculate the Bispectral Index and spectral variables.

All the calculated parameters can be selected on the display, and trended.

Alarms for E-BIS are taken care of by the host monitor and follow the user interface for alarms in Datex-Ohmeda $/5 patient monitors. There are auditory and visual alarms and user adjustable limits for E-BIS. The default is OFF, because it doesn't provide information to be used for treatment or therapy. The BIS Engine at BIS module dictates error messages displayed at Datex-Ohmeda's host monitor's message fields and service page. These error messages are related to the BIS measurement, but follow Datex-Ohmeda user interface rules,

The provided text describes a Premarket Notification 510(k) Summary for the Datex-Ohmeda S/5™ BIS Module, E-BIS and accessories. However, it does not contain specific acceptance criteria or performance study details (e.g., accuracy, sensitivity, specificity, or results from clinical trials) in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device.

Here's an analysis based on the provided text:

• No detailed acceptance criteria or numerical performance metrics are explicitly stated in the document for the new device itself. The filing aims to demonstrate substantial equivalence to a predicate device (Datex-Ohmeda M-BIS Module (K013389)) based on similar technology, intended use, indications for use, and safety/effectiveness profiles.

• The document implies that the device meets existing standards by referencing various IEC, EN, CAN/CSA, UL, and AAMI standards, along with FDA guidance documents. These standards likely contain performance requirements, but the specific acceptance criteria and the device's reported performance against them are not enumerated in this summary.

Therefore, I cannot populate the table or answer all of your specific questions as the information is not present in the provided text.

Here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance
The document does not mention a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective status) for a performance study. Nonclinical testing is mentioned in terms of validation and verification against standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. No specific ground truth establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This type of study is not mentioned. The device is an EEG measurement module with a BIS index, and the context doesn't suggest an AI-driven interpretive system that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document doesn't explicitly describe a standalone performance study with specific metrics. It states the device calculates parameters like BIS, SR, EMG, and SQI. The performance is implied to be equivalent to the predicate, which also operates in a "standalone" or "algorithm only" fashion in terms of producing these processed EEG variables.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" in the context of this device (an EEG measurement module with a BIS index) would typically relate to the accuracy of its physiological measurements against a reference standard or validated algorithms. However, this level of detail regarding specific ground truth for performance evaluation is not present in the summary. The "ground truth" used for training (if applicable) is also not specified.

8. The sample size for the training set
The document does not mention any training set or its sample size. This device appears to be based on established signal processing algorithms for EEG, rather than a machine learning model that would typically require a "training set" in the modern sense. The "BIS Engine" is mentioned as being the same as the predicate, suggesting a stable and established algorithm.

9. How the ground truth for the training set was established
This information is not provided, as no training set is mentioned.

Ask a specific question about this device

The Datex-Ohmeda BIS module, M-BIS and accessories are indicated for monitoring the state of the brain by data acquisition of electroencephalograph (EEG) signals of all hospitalized patients. The Bispectral index (BIS), a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents. The device is indicated for use by qualified medical personnel only.

The Datex-Ohmeda BIS module, M-BIS is a single-width plug-in parameter module for a Datex-Ohmeda modular monitoring system. The Datex-Ohmeda BIS module, M-BIS can be used with the following Datex-Ohmeda modular monitors: S/5 Anesthesia Monitor (AM), S/5 Compact Anesthesia Monitor (CAM), S/5 Critical Care Monitor (CCM) and S/5 Compact Critical Care Monitor (CCCM) with main software L-ANE02(A)... 00 or L-ICU02(A)... 00 or newer version. The Datex-Ohmeda BIS module M-BIS, and accessories is a parameter module for monitoring the state of the brain by data acquisition of EEG signals of all hospitalized patients. The BIS, a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents. The accessories: The Datex-Ohmeda BIS module, M-BIS is used in conjunction with Aspect Medical Systems, Digital Signal Converter-Expanded Performance, DSC-XP (KOI 1534), Patient Interface Cable; PIC (KOI 1534), and BIS Sensor Plus (K994330), BIS Sensor XP (K002734) or BIS Sensor Pediatric (K001980). The raw EEG signal can be displayed from one of the two monitored channels. The waveform size, color and sweep speed can be adjusted. Calculated parameters are: Bispectral Index,BIS(Range=0-100),continuous processed EEG parameter correlating to the patient's level of hypnosis, where 100=awake and 0=comatose. Suppression Ratio.SR.(Range=0-100%), the percentage of evochs in the past 63 seconds in which the EEG signal is considered suppressed. Electromyograph, EMG, the absolute power (in decibels) in the frequency range 70-110 Hz Signal Quality Index, SQI (Range:0-100%), the percentage of good epochs in the last 60sec. that could be used to calculate the Bispectral Index and spectral variables. All the calculated parameters can be selected on the display, and trended. Alarms for BIS are taken care of by the host monitor and follow the user interface for alarms in Datex-Ohmeda S/5 patient monitors. There are auditory and visual alarms and user adjustable limits for BIS. The default is OFF, because it doesn't provide information to be used for treatment or therapy. The BIS Engine at BIS module dictates error messages displayed at Datex-Ohmeda's host monitor's message fields and service page. These error messages are related to the BIS measurement, but follow Datex-Ohmeda user interface rules.

The provided text describes a 510(k) premarket notification for the Datex-Ohmeda S/5 BIS Module, M-BIS, and accessories. This submission focuses on establishing substantial equivalence to a predicate device (Aspect Medical Systems Inc. BIS Engine K011534) rather than presenting a de novo study with specific acceptance criteria and performance data for a new, unique device.

Therefore, the document does not contain a table of acceptance criteria or a study proving the device meets those criteria in the way a clinical trial for a novel device would.

Instead, the submission demonstrates equivalence by stating:

• Identical fundamental technology: The BIS engine technology (hardware and software) is identical to the predicate.
• Same basic functions, operating principles, and signal processing: These are described as being the same as the predicate.
• Identical parameters: Raw EEG, processed EEG variables (BIS Index, Suppression Ratio, Electromyograph, Signal Quality Index), and electrode impedance information are supplied by the same BIS Engine as the predicate.
• Identical user features: Multiple BIS smoothing rates, update rates, and various filters are available and identical to the predicate.
• Identical accessories: Uses the same DSC-XP, PIC Plus, and BIS Sensors as the predicate.
• Compliance with safety standards: The device complies with numerous electrical safety, electromagnetic compatibility, mechanical, environmental, and software validation standards, as listed.

Based on the provided text, the following information is NOT available and would typically be found in a study proving acceptance criteria for a novel device:

1. A table of acceptance criteria and the reported device performance: This document doesn't define specific performance metrics with acceptance thresholds (e.g., accuracy, sensitivity, specificity, or correlation coefficients with specific targets) for the M-BIS module, nor does it report the results of a study against such criteria. Its entire premise is that the core technology is identical to a previously cleared device.
2. Sample size used for the test set and the data provenance: Not applicable as no new clinical performance study is described for the M-BIS module's core function. The core technology is considered identical to the predicate.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a measurement module for physiological signals, not an AI diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states the "BIS engine technology (Hardware and Software) are identical compared to the predicate," implying that the core algorithm performance is already established through the predicate. It doesn't describe new standalone testing for this specific submission's purpose.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of submission. The ground truth for the predicate device would have been established previously, likely through correlation with clinical observations of anesthetic depth.
8. The sample size for the training set: Not applicable, as no new algorithm development or training is described. The algorithm is stated to be identical to the predicate.
9. How the ground truth for the training set was established: Not applicable.

In summary:

This 510(k) submission focuses on demonstrating substantial equivalence to a predicate device by asserting that the underlying technology, functions, accessories, and core algorithms are identical. It relies on the pre-existing clearance and validation of the predicate device (Aspect Medical Systems Inc. BIS Engine K011534) for its safety and effectiveness claims. Therefore, the document does not detail a new study with explicit acceptance criteria and corresponding performance data for the M-BIS module itself, as would be expected for an entirely novel device or a de novo submission.

Ask a specific question about this device