(168 days)
The Siemens SC9000/SC9015 MULTIGas "" and MULTIGas+"" Modules are indicated for adult and pediatric patient populations in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that these devices are required to measure any one or more of the following parameters:
- . Respiration rate
- inspired and expired Carbon Dioxide (CO3) .
- inspired and expired Oxygen (MULTIGas+ only) 9
- average inspired Oxygen (MULTIGas only)
- inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane, . Sevoflurane, and Nitrous Oxide
There are two multi gas modules being submitted as part of this 510(K) Notification: the MULTIGas™ (MGM) and the MULTIGas+ "" (MGM+). Both modules are free standing units that perform sidestream measurements of respiratory gases (CQ2, N3O, and O2) and anesthetic gases. Both modules automatically identify and report measurement data to the SC9000/SC9015 Bedside Monitor for display.
The MULTIGas™ and MULTIGas+ ™ modules differ only in the way they measure O2. The basic MULTIGas Module measures O2 using a galvanic cell, and calculates average inspiratory values for O2 (labeled iO2). The MULTIGas+ incorporates a faster-responding paramagnetic sensor that provides both inspired and expired O2 measurements (iO2 and etO2).
The enhanced software (version VB1.1) is compatible with previously sold versions of the monitor. A retrofit will be offered to the owners of units with previous software versions.
The Siemens SC9000/SC9015 MULTIGas™ and MULTIGas+™ Modules are gas and anesthetic agent monitoring devices. The 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device, the Hewlett-Packard model M1026A Anesthesia Gas Module, rather than presenting a detailed study with specific acceptance criteria and detailed performance metrics of the new device itself.
Based on the provided document, the device itself is a measurement module that internally uses the Andros Inc Model 4700 MGM Multi Gas Module. The submission argues for equivalence based on the shared internal measurement component and similar principles of operation. Therefore, the "acceptance criteria" and "reported device performance" in this context refer to the demonstrated substantial equivalence to the predicate device, especially regarding its operational principles and intended use.
Here's an attempt to extract and present the information as requested, though it's important to note the limitations due to the nature of a 510(k) submission for substantial equivalence.
1. Table of acceptance criteria and the reported device performance
Since this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" for the performance of the Siemens device are not detailed as they might be for a novel device. Instead, the "acceptance criteria" are implied by the similarity to the predicate device. The "reported device performance" is essentially the statement of shared internal components and measuring methods.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Siemens MULTIGas™/MULTIGas+™) |
|---|---|
| Similar Core Measurement Technology: The predicate device uses an internal module for gas measurement. The Siemens device should utilize the same or an equivalent technology. | Meets Criteria: Both the Siemens MULTIGas™ Modules and the HP M1026A Anesthesia Gas module employ, internally, the Andros Inc Model 4700 MGM Multi Gas Module as the means for measuring the various gases. |
| Similar Principle of Operation: The gas measurement methods should be consistent with the predicate device. | Meets Criteria: The principle of operation for both the predicate and the Siemens device is "Non-dispersive Infra Red". The measuring method is "sidestream". |
| Similar Displayed Parameters: The types of gases and related parameters measured and displayed should be comparable. | Meets Criteria: Both devices display "CO2, N2O, Respiration Rate, Anesthetic Agents." The Siemens device further specifies: "Respiration rate, inspired and expired Carbon Dioxide (CO3), 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." While the predicate doesn't list all individual anesthetic agents, "Anesthetic Agents" implies a similar functionality. The MULTIGas+ adds expired O2, which is a stated difference but still within the scope of gas analysis. |
| Similar Intended Use: The target patient population and environments should be consistent. | Meets Criteria: The Siemens device is intended for "adult and pediatric patient populations in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that these devices are required to measure any one or more of the following parameters: Respiration rate, inspired and expired Carbon Dioxide (CO3), 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." The predicate's intended population was "Not stated in literature," but the 510(k) process accepts a well-defined intended use for the new device if it aligns with general clinical practice for similar devices. |
| Acceptable Performance (Non-clinical Data): Non-clinical data, such as bench testing or engineering specifications, should support the device's functionality. | Meets Criteria: Section "8. Assessment of non-clinical performance data for equivalence" states: "Both the Siemens MULTIGas™ Modules and the HP M1026A Anesthesia Gas module employ, internally, the Andros Inc Model 4700 MGM Multi Gas Module as the means for measuring the various gases." This is the primary non-clinical basis for equivalence. No other specific quantitative performance data (e.g., accuracy, precision tests) are provided in this summary. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "9. Assessment of clinical performance data for equivalence: Not applicable".
This indicates that no dedicated clinical test set data was used or presented for the Siemens MULTIGas™ and MULTIGas+™ modules to demonstrate their performance against pre-defined acceptance criteria, beyond the equivalence claimed by using the same internal measurement component as a previously cleared device. Therefore:
- Sample size for test set: Not applicable (no separate clinical test set data provided).
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no separate clinical test set data was presented. Ground truth determination would be relevant for a clinical study comparing device performance to a referent standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no separate clinical test set was used requiring adjudication.
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. This device is a measurement module for physiological gases, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The primary basis for this 510(k) is the assertion that the core measurement component (Andros Inc Model 4700 MGM Multi Gas Module) is the same as that used in a predicate device. This implies that the standalone performance of this internal module was considered adequate as part of the predicate device's clearance. However, no specific standalone performance metrics (e.g., accuracy, bias, limits of agreement) for the Siemens device itself are provided in this 510(k) summary. The submission relies on the "substantial equivalence" of the components rather than new standalone performance testing specific to the Siemens branding.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no new clinical performance data was presented. For gas analyzers, ground truth would typically be established by highly accurate laboratory-grade gas standards or alternative validated measurement techniques. The reliance on the shared internal component implies that such ground truth was used in the assessment of the Andros Inc Model 4700 MGM during its own development or the predicate device's clearance.
8. The sample size for the training set
Not applicable. This device is a hardware-based gas analyzer, not an algorithm that requires a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable, as it's not an algorithm requiring a training set.
§ 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.