(35 days)
The Vision Telepak™ Telemetry Transmitter is portable monitor intended to be used for monitoring vital signs on critically ill adult and pediatric patients in the hospital environment.
The Vision Telepak Telemetry Transmitter unit is a portable, wireless, patient monitor intended to be used for monitoring the ECG and SpO2 vital signs of critically ill and pediatric patients. The Telepak unit is used in all areas of the hospital which utilize telemetry transmitters for ECG and/or SpO2 monitoring. The Telepak transmits vital sign information to an ESCORT Vision Central Station or an ESCORT Series bedside monitor. Both the central station and beside monitors were cleared under K970763.
Here's an analysis of the provided text regarding the Vision Telepak™ Telemetry Transmitter, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided general information, the acceptance criteria and specific performance metrics are not explicitly detailed in a quantitative table. However, we can infer the general acceptance criteria and the claimed performance:
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Environmental Safety | The device passed all tests performed per UL-2601-1 and EN 60601-1-2, as well as other applicable standards and procedures. This indicates compliance with electrical safety, electromagnetic compatibility, and other environmental requirements. |
| Non-Clinical Safety | The device passed all tests performed per UL-2601-1 and EN 60601-1-2, as well as other applicable standards and procedures. This implies compliance with relevant non-clinical (e.g., mechanical, materials) safety standards. |
| Performance (Accuracy & Precision) | The study "met the performance requirements for accuracy and precision relative to the reference laboratory system." While specific numeric values for accuracy and precision are not given, the claim is that it meets the required standards. |
| Equivalency to Predicate Device | The study demonstrated "equivalent performance in meeting user requirements" compared to the predicate device (MTS Option for the Escort II Monitor). The overall conclusion is that the Vision Telepak™ Telemetry Transmitter is "substantially equivalent" to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The provided documentation does not explicitly state the sample size used for the performance testing or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "The study conducted to compare equivalency..."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the submitted documents. The device is for physiological monitoring (ECG and SpO2), which typically relies on established medical standards and potentially reference instruments, rather than expert interpretation of images or complex data needing multiple clinical experts.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the device (physiological monitoring), traditional adjudication methods (like 2+1 or 3+1 for imaging) are unlikely to apply. Performance would likely be assessed against reference instruments or established clinical guidelines.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. This type of study is typically relevant for interpretative devices (like AI for image analysis) where human readers' performance is being evaluated with and without AI assistance. The Vision Telepak™ is a monitoring device, not an interpretative AI system in the context of this submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
A standalone performance study of the device itself was implicitly done as part of the "Performance Testing." The statement "met the performance requirements for accuracy and precision relative to the reference laboratory system" suggests an evaluation of the device's output against a known standard, independent of user interpretation for its core measurements (ECG and SpO2). However, this is not an "algorithm only" study in the sense it would be for an AI diagnostic tool, but rather the performance of the physical monitoring device.
7. The Type of Ground Truth Used
The ground truth used for the performance testing was a "reference laboratory system." This implies that the device's ECG and SpO2 measurements were compared against highly accurate and precise reference instruments or methodologies in a controlled laboratory setting.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The Vision Telepak™ Telemetry Transmitter, as described in this 510(k) summary, is a traditional medical device for vital sign monitoring, not a machine learning or AI-based device that would typically have a "training set." Its functionality is based on established engineering and physiological principles.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reasons as point 8.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).