SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 & SC 9000XL & SIEMENS INFINITY EXPLORER

• K Number: K022889
• Device Name: SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 & SC 9000XL & SIEMENS INFINITY EXPLORER
• Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Date Cleared: 2002-09-25 ( 26 days)
• Product Code: MHX
• Regulation Number: 870.1025
• Type: Special
• Panel: CV
• Reference & Predicate Devices: K013515 , K012770 , K955059 , K983632 , K990563 , K003243 , K982730 , K980882

Intended Use

The INFINITY Modular Monitors are intended for multi-parameter patient monitoring. The devices will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. These devices will connect to a Siemens R50 Bedside recorder, either directly or via the INFINITY Network.

The INFINITY Modular monitors are capable of monitoring:

• Heart rate
• Respiration rate
• Invasive pressure
• Non-invasive pressure
• Arrhythmia
• Temperature
• Cardiac output
• Arterial oxygen saturation
• Pulse rate
• Apnca
• ST Segment Analysis
• 12-Lead ST Segment Analysis
• tcp02/tcpC02
• EEG signals
• FiO2

With the MultiGas and MultiGas+ modules the monitors are capable of measuring respiration rate, Inspired and expired Carbon Dioxide (CO2), inspired and expired Oxygen (MultiGas+ only), average inspired Oxygen (MultiGas only), inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane, Sevoflurane, and Nitrous Oxide.

With etCO2 the monitors can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored.

The monitors can interface with specific third party devices via an MIB protocol converter.

Device Description

The modifications implemented with the release of software version VF2 have not altered the basic fundamental technology of the INFINITY Modular Monitors. Testing with VF2 software indicates no new issues relative to safety and efficacy. The release of software version VF2 includes the following primary modifications:

• 1. Wireless capability
• Non-invasive blood pressure with step deflation 2.
• 3. MICRO2+(K012770) interface
• Support for Masimo sensors 4.

The INFINITY Modular Monitors (SC 7000 / SC 9000XL) with Wireless Option (a password protected option) allows the monitor to operate in a wireless network configuration. A wireless ethernet adapter installed in the PCMCIA port communicates with the INFINITY Network (K955059) through installed access points hardwired to the network. All patient related and network data is transmitted to the pre-installed access points allowing the transmitted data from the monitor to be viewed at an assigned MultiView WorkStation (K955059). This configuration provides the network with the same functionality as a hardwired system.

The Infinity Monitoring System utilizes the oscillometric method to measure noninvasive blood pressure (NIBP). With the SC7000/8000/9000XL VF2 release, the NIBP algorithm has changed from a linear to stepped deflation system.

The INFINITY Modular Monitor (SC 7000 / SC 8000 / SC 9000XL) VF2 release supports two simultaneous SpO2 measurements. Using a serial port already available on the monitors, the MicrO2+ pulse oximeter (K012770) can communicate with the monitors using a RS232 serial communication and power supply cable connected to the serial port on the monitor. The stand-alone MicrO2+ pulse oximeter transmits SpO2 and Pulse values to the monitor.

The monitor supports the use of Masimo SpO2 sensors via a password protected option and a specific adapter cable.

AI/ML Overview

The provided text describes modifications to the Siemens INFINITY Modular Monitors and makes references to equivalence assessments and clinical accuracy studies. However, it does not contain the detailed information necessary to fully answer your request regarding acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment.

The document states:

• "Assessment of non-clinical performance data for equivalence: See Section J"
• "Assessment of clinical performance data for equivalence: See Section J"
• "Clinical accuracy studies referenced to cooximetry (see Section J) were conducted by Masimo using the following sensors in conjunction with the INFINITY Modular monitors"

Since "Section J" is not provided in the input, the specific details of the acceptance criteria and the studies proving the device meets them are unavailable.

Based on the available text, here's what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

• Acceptance Criteria: Not provided in the given text.
• Reported Device Performance: Not provided in the given text, beyond the general statement that "Testing with VF2 software indicates no new issues relative to safety and efficacy."

2. Sample size used for the test set and the data provenance:

• Sample Size: Not provided.
• Data Provenance: Not provided (e.g., country of origin, retrospective/prospective). The text only states "clinical accuracy studies referenced to cooximetry... were conducted by Masimo."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not provided. The text mentions "clinical accuracy studies referenced to cooximetry," implying cooximetry serves as a reference, but it doesn't specify if human experts were involved in establishing ground truth or their qualifications.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• 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:

• Not applicable. The described device is a physiological monitor, not an AI-assisted diagnostic tool that human readers would use in a comparative effectiveness study. The text focuses on the device's ability to measure physiological parameters and its new features (wireless, NIBP, SpO2 interface, Masimo sensor support).

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• The text implies standalone testing of the device's physiological measurement capabilities through "clinical accuracy studies referenced to cooximetry." However, details of these studies are not provided.

7. The type of ground truth used:

• For SpO2 measurements, the text explicitly states "clinical accuracy studies referenced to cooximetry." Cooximetry is a gold standard for measuring oxygen saturation in blood. For other parameters (Heart rate, Respiration rate, NIBP, etc.), the type of ground truth is not specified in this document.

8. The sample size for the training set:

• Not provided. The document describes modifications to an existing device and refers to "accuracy studies" but does not detail a training set for an AI/algorithm.

9. How the ground truth for the training set was established:

• Not provided, as details of a training set are not mentioned.

In summary, for a complete answer to your questions, "Section J" of the original 510(k) submission would be required. The provided excerpt only gives a high-level overview of the device modifications and mentions that performance data exists, but not the specifics of that data or the studies.

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.