(13 days)
The RTX3320 device is for use by patients at home. It is intended to be used in combination with a variety of patient monitors upon the prescription of a licensed physician or other authorized healthcare provider. RTX3320 serves as the remote communication link between compatible patient monitors, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management center, or with the healthcare/wellness provider or other out-of-hospital caregivers.
The purpose is to transmit selected medical information (such as weight, blood pressure, blood glucose) over a normal residential telephone line.
RTX3320 is a "black box" device – it is not connected to the patient and not operated by the patient. The installation must be performed by or under supervision of an authorized professional healthcare company.
This device does not measure, interpret or make any decisions on the vital data that it conveys.
The RTX3320 telemedicine device perform transmission of physiological patient information to and from wireless patient monitors, and a remote data server healthcare facility using standard digital communication technologies and protocols.
The RTX3320, with its build-in modem, transmits data using the public switched telephone network. It is designed not to interfere with the normal use of phones on the same telephone line.
The RTX3320 device is not operated by, or used directly on a patient, and poses no significant risk to the patient or other people within the patient's home.
The RTX3320 device is a "black box" telemedicine device designed to transmit physiological patient information from wireless patient monitors to a remote healthcare facility using standard digital communication technologies and protocols. It uses a built-in modem to transmit data over the public switched telephone network. The device is not operated by or used directly on a patient and is not intended for emergency calls or time-critical data.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety Standards: | |
| IEC 60601-1 (Medical Electrical Equipment - General Requirements for Safety) | The device has been tested to meet the requirements of IEC 60601-1. This standard ensures the fundamental safety and essential performance of medical electrical equipment. |
| IEC 60601-1-2 (Medical Electrical Equipment - Electromagnetic Compatibility - Requirements and Tests) | The device has been tested to meet the requirements of IEC 60601-1-2. This standard ensures that the device is electromagnetically compatible, meaning it does not interfere with other electronic devices and is not unduly affected by them. |
| Communication Standards: | |
| FCC Part 15 (Radio Frequency Devices) | The device has been tested to meet the requirements of FCC Part 15. This standard governs unintentional and intentional radiators of radio frequency energy, ensuring that the device's wireless communication (Bluetooth) does not cause harmful interference. |
| FCC Part 68 (Connection of Terminal Equipment to the Telephone Network) | The device has been tested to meet the requirements of FCC Part 68. This standard ensures that the device, with its built-in modem, can be safely connected to and used with the public switched telephone network without causing harm to the network. |
| Risk Management: | |
| ISO 14971:2000 (Medical Devices - Application of Risk Management to Medical Devices) | Risk management is performed according to ISO 14971:2000. This standard provides a process for a manufacturer to identify the hazards associated with medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The document states that the performance comparison of the predicate and submission device showed minor differences causing no harm, and that because of this and the similar intended use, they focused on verification and internal validation. |
| Functional Equivalence | The device is deemed substantially equivalent to the predicate device (Philips Telemonitoring System with TeleStation K023749) based on similar intended use/indications, users, site of use, prescription requirements, and general system functionality. Differences, such as the submission device being a "black box" without user interaction and using Bluetooth for wireless connectivity, are evaluated not to add additional risks, especially given its role as a communication hub and the need for compatible, validated patient monitors and servers. Verification and validation testing activities were conducted to establish performance and reliability characteristics, implicitly demonstrating functional and safety adherence to its intended purpose as a communication link. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a distinct "test set" sample size or data provenance in terms of patient data or clinical cases for the RTX3320 device. The focus of the substantiation is on:
- Conformance to standards: This involves testing the device against specific technical and safety standards (IEC, FCC). These tests typically involve laboratory setups and simulated environments, not patient data sets.
- Comparison to a predicate device (K023749): The assessment largely relies on demonstrating substantial equivalence by comparing the technical characteristics, intended use, and safety profiles with an already cleared device.
- Verification and internal validation: The document states that "Verification and validation testing activities [were] conducted to establish performance and reliability characteristics of the device." This implies internal testing of the device's hardware, software, and communication capabilities, likely through engineering tests and non-clinical scenarios rather than a clinical "test set" with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that the substantiation is primarily based on standards conformance, risk management, and comparison to a predicate device, and not on the evaluation of medical images or diagnostic outputs from a clinical test set, there is no mention of experts establishing a "ground truth" for a test set in the traditional sense of clinical studies.
The "ground truth" in this context is established by:
- Regulatory bodies and standards organizations: The standards (IEC, FCC, ISO) themselves represent a form of "ground truth" for device safety and performance.
- Engineering and quality assurance personnel: Internal experts at RTX Healthcare would have conducted the verification and validation tests against these standards.
- The predicate device's established safety and effectiveness: The predicate device (Philips M3810A) serves as a benchmark for equivalence.
4. Adjudication Method for the Test Set
As there is no specific clinical "test set" involving human interpretation of medical data, there is no mention of an adjudication method (like 2+1 or 3+1). The "adjudication" is implicitly handled by the adherence to established engineering standards and regulatory requirements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed and is not applicable to this device. The RTX3320 is a communication gateway, not a diagnostic or interpretive device. It explicitly states: "This device does not measure, interpret or make any decisions on the vital data that it conveys." Therefore, there is no human-in-the-loop performance to improve with or without AI assistance, and no effect size regarding human reader improvement is relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study in the context of an algorithm's diagnostic accuracy was not performed and is not applicable. The device's primary function is data transmission, not data analysis or diagnosis. Its "performance" is assessed by its ability to reliably transmit data according to communication standards and safety requirements.
7. Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on:
- Compliance with recognized international and national standards (IEC, FCC): These standards define acceptable levels of safety, electromagnetic compatibility, and communication performance.
- Risk management principles (ISO 14971:2000): Ensures that identified risks are mitigated to acceptable levels.
- Substantial equivalence to a legally marketed predicate device: The functional and safety characteristics of the predicate device (Philips M3810A) serve as a benchmark for the RTX3320.
- Verification and internal validation testing: This involves engineering tests to confirm the device meets its design specifications and performs reliably in its intended environment.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. The RTX3320 is a hardware device designed for data transmission, not for machine learning or AI models that require training data.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set, this question is not applicable.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).