(16 days)
Siemens INFINITY MIB II Duo Protocol Converter is indicated for use in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that third party devices that do not provide data per the IEEE 1073 Medical Information Protocol Standard should be connected to a Siemens INFINITY Modular Monitor (SC 9000 / SC 8000 / SC 9000XL) for the display of data. MIB connectivity to third party medical devices such as:
Siemens SV 300 ventilator Baxter Vigilance blood gas/continuous cardiac output monitor Siemens SV900 ventilator Draeger Evita II ventilator Draeger Evita IV ventilator Draeger Babylog ventilator Puritan Bennett 7200 ventilator Draeger Narkomed II Anesthesia System Draeger Narkomed IV Anesthesia System Draeger Julian Anesthesia Machine Ohmeda 7900 Anesthesia Machine Abbott Oximetrix 3 Blood Gas Analyzer A VL Medical Instruments: Opti Critical Care Analyzer, Portable Blood Gas Analyzer Optical Sensors Inc .: OSI - Optical CAM VIA Medical: VIA V-ABG1 Blood Gas Chemistry Monitor * Aspect A-2000 BIS Monitor
- The SC 9000 does not support communication with the Aspect BIS Monitor
The new INFINITY MIB II Duo Protocol Converter employs the same fundamental scientific technology and has the same intended use as that of the predicate device. The INFINITY MIB II Duo Protocol and no all band internets and device specific cables as that of the predicate device, 510(k) Converter Supperts original MIB Protocol Converter (K970368, K973222, K991661, K003248) uses SDL style connectors. The MIB II (K010640) uses RJ45 connectors. Modifications have been implemented to enable use of both connector types. The INFINITY MIB II Duo Protocol Converter supports IEEE Standards 1073.3.1 (Medical Device Communications-Transport Profile-Connection Mode) and 1073.3.2-2000 (Medical Communications - Transport Profile - IrDA Based - Cable Connected).
The only difference between the INFINITY MIB II and INFINITY MIB II Duo Protocol Converter is that the "Duo" has an additional interface and is compatible with the IEEE Standard 1073.3.1. No other modifications were required to implement this change. Testing has been performed to validate the overall performance of the modified MIB II Duo Protocol Converter and to verify proper communication with the INFINITY modular bedside monitors and the MIB supported devices.
The provided 510(k) summary for the Siemens INFINITY MIB II Duo Protocol Converter describes modifications to an existing device and focuses on establishing substantial equivalence. It does not contain information about a study proving the device meets specific acceptance criteria in the traditional sense of a clinical or performance study with defined metrics for accuracy, sensitivity, or specificity.
Instead, the submission emphasizes verification and validation activities to ensure the modified device functions as intended and is equivalent to the predicate device. The acceptance criteria are implicitly related to proper communication and performance, rather than specific quantitative metrics.
Here's an breakdown based on the provided text, highlighting the absence of certain information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Proper communication with INFINITY modular bedside monitors and MIB-supported devices | Testing has been performed to validate the overall performance... and to verify proper communication. (No specific metrics or quantitative results provided) |
| Compliance with IEEE Standards 1073.3.1 and 1073.3.2-2000 | The INFINITY MIB II Duo Protocol Converter supports these standards. (Implicitly met through design and testing) |
| Electromagnetic compatibility | Electromagnetic compatibility testing has been performed by Chomerics Test Services in accordance with EN 60601-1-2. (Implicitly met through testing) |
| Same fundamental scientific technology and intended use as predicate device | The new INFINITY MIB II Duo Protocol Converter employs the same fundamental scientific technology and has the same intended use as that of the predicate device. (Stated as a design principle) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in terms of patient data or a specific number of instances. The testing described appears to be engineering validation and verification. No data provenance (e.g., country of origin, retrospective/prospective) is provided as there isn't a patient data-based study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The device is a protocol converter, not a diagnostic or prognostic tool that requires expert-established ground truth for its performance assessment in a clinical context.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of adjudication as the testing does not involve subjective assessment of clinical outcomes or images.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC study is not relevant for this device, which is a protocol converter facilitating data communication, not an AI-powered diagnostic or assistive tool for human readers.
6. Standalone (Algorithm Only) Performance Study
Yes, in a conceptual sense. The "testing performed to validate the overall performance... and to verify proper communication" effectively represents a standalone evaluation of the device's function as a protocol converter. However, this is engineering verification rather than a clinical performance study with metrics such as sensitivity or specificity. The device's "performance" is measured by its ability to correctly translate and transmit data.
7. Type of Ground Truth Used
The ground truth for this device would be the correct and expected data transmission and protocol adherence according to the IEEE standards and the specifications of the connected medical devices and monitors. This is established by comparing the device's output to the known, correct communication protocols and data streams.
8. Sample Size for the Training Set
Not applicable. This device is a protocol converter, a hardware/software interface; it is not based on machine learning or AI that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no 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.