(199 days)
The device is intended to provide ambulatory and nonambulatory monitoring of ECG and SpO2 parameters of adult, and pediatric patients in a professional health care facility. It is intended to be used by trained health care personnel. It is not intended for home use.
The Hewlett-Packard HP M2600A OmniCare Telemetry System consists of a pocket sized digital synthesized transmitter, synthesized receiver, and a mainframe that accommodates up to eight receiver channels. Patient physiological parameter information is displayed on HP M2350A/60A, a central station device. Patient physiological parameter displays, controls, recordings and alarms are controlled from an HP M2350A/60A Component Central Monitor. Recordings can also be initiated from the transmitter. System functions such as bedside overview, remote arthythmia monitoring, remote data management and remote clinical data access are available to the user at the central station. No changes were made to the ST or arrhythmia monitoring algorithms. The addition of SpO2 monitoring is a new feature compared to the HP telemetry predicate device and is the most significant change. Two changes were made to ECG monitoring. A third lead was added and pace pulse detection is now done in software as opposed to hardware with similar performance. The new system utilizes synthesized tuning as opposed crystal module replacement to select a new channel. An infra-red serial port was added to the transmitter for communication with an external service tool to facility tuning. The new system leverages heavily off of Hewlett-Packard devices previously cleared. The system is a digital UHF system that uses the same antenna devices, and much of the same transmitter and receiver design as the predicate device. The SpO2 capability is based on existing cleared devices. The HP M1020A SpO2 electronics were modified to work in the transmitter. New patient studies for SpO2 were done as part of the validation work for the new sy stem .
Here's an analysis of the provided 510(k) summary, focusing on acceptance criteria and study data for the HP M2600A OmniCare Telemetry System:
Note: This document is a 510(k) summary, which is typically a high-level overview. It often lacks the granular detail of a full study report or clinical trial documentation. Therefore, some information requested might not be explicitly stated or might need inference.
Acceptance Criteria and Device Performance
The 510(k) summary does not explicitly list quantitative acceptance criteria for performance. Instead, it relies on demonstrating substantial equivalence to predicate devices and describes the successful implementation of new features like SpO2 monitoring. The "reported device performance" is primarily described qualitatively in terms of functionality and similarity to existing, cleared devices.
| Acceptance Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|
| ECG Monitoring: | |
| - Accurate ECG waveform display | Leveraged off development work (ECG) done on previously cleared devices. Third lead added; pace pulse detection in software with similar performance to hardware. |
| - Arrhythmia monitoring accuracy | No changes were made to the ST or arrhythmia monitoring algorithms (implies continued performance as predicate). |
| - ST monitoring accuracy | No changes were made to the ST or arrhythmia monitoring algorithms (implies continued performance as predicate). |
| SpO2 Monitoring: | |
| - Accurate SpO2 measurement | Based on existing cleared devices (HP M1020A SpO2 electronics modified for transmitter). "New patient studies for SpO2 were done as part of the validation work for the new system." |
| Telemetry System Functionality: | |
| - Reliable wireless communication | Digital UHF system using same antenna devices and much of the same transmitter/receiver design as predicate. |
| - Synthesized tuning | New system utilizes synthesized tuning (replaces crystal modules). |
| - Overall Safety & Effectiveness | Comparison to predicate devices shows device to be substantially equivalent in safety, effectiveness, and intended use. |
Study Details
Given the nature of a 510(k) summary, particularly for a telemetry system where core algorithms might be unchanged or where new features leverage existing cleared technology, dedicated, fully-detailed clinical studies (especially comparative effectiveness studies) are often not presented in this summary. The focus is on demonstrating "substantial equivalence."
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Sample Size and Data Provenance (Test Set):
- SpO2: "New patient studies for SpO2 were done as part of the validation work for the new system."
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country, retrospective/prospective). While "patient studies" implies prospective clinical data, this isn't explicitly stated.
- ECG/Arrhythmia/ST: No new specific patient studies are mentioned for these functions, implying reliance on the predicate device's performance and validation. The change to software-based pace pulse detection "with similar performance" likely refers to internal testing, not necessarily a new clinical patient study.
- SpO2: "New patient studies for SpO2 were done as part of the validation work for the new system."
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Number of Experts & Qualifications (Ground Truth for Test Set):
- This information is not provided in the summary. For a telemetry system, ground truth for SpO2 studies would typically be established by co-oximetry, and for ECG/arrhythmia, it would be a physician (e.g., cardiologist, critical care physician) review of ECG tracings. The summary does not detail how ground truth was established for the "new patient studies for SpO2."
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Adjudication Method (Test Set):
- This information is not provided in the summary.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study is not mentioned or implied. The summary focuses on demonstrating the device's inherent performance and substantial equivalence, not on comparing human reader performance with and without AI assistance. This type of study is more common for diagnostic imaging AI systems.
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Standalone (Algorithm Only) Performance Study:
- Yes, implicitly for SpO2. The "new patient studies for SpO2" would assess the standalone performance of the SpO2 algorithm/hardware ensemble against a reference standard (ground truth).
- For ECG, arrhythmia, and ST monitoring, the summary states "No changes were made to the ST or arrhythmia monitoring algorithms," and ECG leverages "previously cleared devices," implying that their standalone performance was established previously and is maintained.
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Type of Ground Truth Used:
- SpO2: Likely co-oximetry as a reference standard for the "new patient studies." This is the standard for validating SpO2 devices.
- ECG/Arrhythmia/ST: For predicate devices, ground truth would typically involve expert consensus (e.g., cardiologist review) of ECG tracings or, in some cases, outcomes data or other physiological measurements. The summary doesn't detail this for the present device, as it inherits these algorithms.
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Sample Size for Training Set:
- This information is not provided. It's important to note that for a traditional medical device like this, especially one leveraging existing technology, there might not be a "training set" in the machine learning sense. The algorithms for ECG, arrhythmia, and SpO2 are likely based on established physiological principles and signal processing, not necessarily trained on large datasets in the way modern AI algorithms are. If any machine learning component were present (which isn't explicitly stated for this device), training set details would be crucial.
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How Ground Truth for Training Set Was Established:
- As with the training set size, this information is not provided and is likely not directly applicable in the modern "AI training" sense. The underlying physiological models and calibration for SpO2 and ECG would have been developed and validated through extensive research and testing over many years, with ground truth established via methods like co-oximetry and expert clinical interpretation.
Summary of Limitations in the K961165 Document Regarding Detailed Study Information:
The 510(k) summary intentionally provides a high-level overview. It emphasizes that:
- The device is "substantially equivalent" to predicate devices.
- New features (like SpO2) leverage existing cleared technology.
- "New patient studies for SpO2" were conducted, but specifics regarding sample size, methodology, ground truth, and specific performance metrics are omitted from this summary document.
- For existing features (ECG, arrhythmia), performance is assumed to be maintained as algorithms are unchanged or improvements (like software-based pace detection) are stated to have "similar performance."
For detailed quantitative acceptance criteria and comprehensive study results, one would typically need to review the full 510(k) submission and supporting validation documents, which are not included in this summary.
§ 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.