(98 days)
The M1205A OmniCare Component Monitoring System is intended for monitoring, recording, and alarming of multiple physiological parameters for adult, neonatal and pediatric patients in the hospital environment. There was no change to the intended use statement.
HP M1205A OmniCare Component Monitoring System Rev. E (Rev. D is not used for this product) is a modification of OmniCare Model 24 Rev. C. Modification of the device was limited to three of 29 functional blocks of software that comprise the OmniCare Model 24 Product (originally cleared under K950821). Changes to the OmniCare Model 24 device software were confined to the ECG/ Respiration, CO2 and SpO2/PLETH functional blocks. Modification was accomplished by reusing and leveraging software originally developed for CMS Rev. D (K941811). No new software was designed for this device. For that reason, the modification and this notification are nearly identical to that of the previously modified CMS device.
Analysis of K960934 for Acceptance Criteria and Study Details
Based on the provided text for K960934, the information regarding acceptance criteria and detailed study methodology is very limited. This 510(k) summary primarily focuses on describing the nature of the modification to an existing device rather than presenting a new, comprehensive validation study with explicit performance metrics.
Here's an attempt to extract and infer information based on the provided text, along with a clear indication of what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device performs as intended for monitoring, recording, and alarming of multiple physiological parameters (ECG/Respiration, CO2, SpO2/PLETH) in adult, neonatal, and pediatric patients. | "Modification of the device was limited to three of 29 functional blocks of software... Changes... were confined to the ECG/ Respiration, CO2 and SpO2/PLETH functional blocks." |
| "Modification was accomplished by reusing and leveraging software originally developed for CMS Rev. D (K941811)." | |
| "The comparison of intended use and technological features... together with the validation results and other information in this submission indicate that this device is substantially equivalent to legally marketed predicate devices in safety, effectiveness and intended use." | |
| Safety: Device is as safe as the predicate. | "substantially equivalent to legally marketed predicate devices in safety, effectiveness and intended use." |
| Effectiveness: Device is as effective as the predicate. | "substantially equivalent to legally marketed predicate devices in safety, effectiveness and intended use." |
| Validation: Thoroughly validated in R&D and SQE department. | "OmniCare Model 24 was thoroughly validated in R&D and in the SQE department." |
Critique: The summary does not explicitly state quantitative acceptance criteria for specific performance metrics (e.g., accuracy, precision, sensitivity, specificity for alarm detection or parameter measurement). Instead, it relies on the concept of "substantial equivalence" and the reuse of previously validated software. The "reported device performance" is a general statement of equivalence and the fact that validation was performed, not specific data points.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions "device validation" and "validation results," but no details on the number of patients, data points, or scenarios used in the testing.
- Data Provenance: Not specified. It's unclear if the validation involved clinical data, simulated data, or a combination. The country of origin and whether the data was retrospective or prospective are also not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable/Not specified. Given the nature of a multi-parameter physiological monitor, ground truth would typically be established by calibrated reference devices and expert clinical assessment during the validation process (e.g., confirming the accuracy of displayed parameters against a gold standard). However, the number of experts, their qualifications, and their role in establishing "ground truth" for a test set are not detailed in this summary.
4. Adjudication Method for the Test Set
- Not applicable/Not specified. Since there's no mention of specific human-reviewed "ground truth" or a test set requiring adjudication in the context of diagnostic interpretation, an adjudication method is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. This type of study is typically conducted for diagnostic imaging devices or algorithms where human readers interpret medical images. For a physiological monitoring system, an MRMC study is generally not relevant or performed. The focus is on the accuracy of the measurements and alarms.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
- Implied, but not explicitly detailed. The validation mentioned ("OmniCare Model 24 was thoroughly validated in R&D and in the SQE department") would inherently involve testing the device's algorithms and sensors "standalone" to ensure they accurately measure and display physiological parameters and trigger alarms. However, the summary does not provide specifics of such a study or its results.
7. The Type of Ground Truth Used
- Inferred: Reference device measurements and clinical assessment. For physiological monitoring, ground truth is usually established by comparing the device's readings (ECG, SpO2, CO2 values) against highly accurate, calibrated reference instrumentation or direct clinical observations made by qualified personnel. The summary does not explicitly state the type of ground truth used.
8. The Sample Size for the Training Set
- Not applicable/Not specified. This device is described as a "modification" by reusing and leveraging software from a previous 510(k) cleared device (K941811). This suggests that the core algorithms were already developed and validated. If machine learning was involved (which is not indicated for this type of device at that time), a training set would be relevant, but it's not mentioned here as a new development.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not specified. As there's no mention of a new training set, the method of establishing its ground truth is not discussed.
Conclusion regarding K960934:
The provided 510(k) summary for K960934 is a class 2 device (predicate device modification) clearance, not a de novo clearance requiring extensive new clinical trial data. It primarily emphasizes that the changes to the software are minor (three out of 29 functional blocks) and that this modified software was already leveraged from another cleared device (K941811). Therefore, the validation relies heavily on the premise of substantial equivalence to the original OmniCare Model 24 (cleared under K950821) and the previous validation of the reused software.
This type of summary is typical for minor modifications where new, extensive validation studies with explicit acceptance criteria tables and detailed performance metrics are often not required, as the performance is assumed to be substantially equivalent to the already cleared predicate. The "study" referenced is the "validation results" that supported the claim of substantial equivalence, but the specifics of that validation are not provided 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.