(49 days)
The Carematix Wellness System is a physiological monitoring system. The system collects, accumulates and transmits patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner. It is intended for patient home use for the following and can record physiological information such as:
Non-invasive blood pressure measurement; Pulse rate measurement; Blood glucose level using a Glucometer; Blood hemoglobin oxygen saturation (%SpO2) and pulse rate using a digital Pulse Oximeter; Prothrombin Time (PT) and International Normalized Ratio (INR) measurement using an in-home coagulation measurement system; Body temperature measurement using a digital thermometry device or system; Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV) measurements using an electronic peak flow meter; Patient weight using a stand-on electronic scale. The results of these measurements are transmitted to a computer monitoring station in a clinical setting via common telephone lines from the patient's home setting.
The Carematix Wellness System (CWS) provides easy monitoring of the basic wellness parameters via a wireless connection between the monitoring device and a hub (receiving station) located in the home. The hub transmits the information to the Carematix Internet server where the data is added to the patient's chart. Using a web-browser, the caregiver can track the patient's data, graph the results, monitor trends, annotate variances, set alert criteria, and send reminders and receive alerts via e-mail or pager. The following monitoring devices are currently available from Carematix: Blood pressure unit (Arm cuff and Wrist cuff), Weight Scale, Blood Glucose Meter adaptors, Pulse Oximeter adaptors, Coagulation Measurement System adaptors, Digital Thermometer adaptors, Peak Flow Meter adaptors.
The Carematix Wellness System is a telemedicine system that collects, accumulates, and transmits patient vital signs and other physiological data from a patient at home to a healthcare practitioner. The device being cleared in K040966 is a modified version of the Carematix Wellness System (K031840). The modification is primarily related to the connectivity method between the hub and the sensor devices, changing from wired to wireless (RF protocol). The acceptance criteria and the study that proves the device meets these criteria are outlined below:
1. Acceptance Criteria and Reported Device Performance
The submission relies on a substantial equivalence comparison to predicate devices, rather than predefined quantitative performance acceptance criteria for the overall system. The implicit acceptance criteria are that the modified device remains "as safe and effective" as the predicate devices, despite the technological differences.
| Feature | Acceptance Criteria (Implicit) | Reported Device Performance and Compliance |
|---|---|---|
| Safety & Effectiveness | Be as safe and effective as predicate devices. | "The results of bench and user testing indicate that the new device is as safe and effective as the predicate devices." |
| "After analyzing bench, electrical safety, FCC, and user testing data, it is the conclusion of Carematix, Inc. that the Carematix Wellness System is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices." | ||
| Functional Specifications | Meet product requirements and functional specifications. | Non-clinical testing demonstrates conformity to product requirements and functional specifications. The specific details of these requirements are not provided, but the conclusion states they were met. |
| Physiologic Data Storage | Physiologic data received by patient monitors must be stored properly. | Non-clinical testing verified that "the physiologic data received by the patient monitors are stored properly." |
| Data Transmission Security & Integrity | Data must be transmitted to the healthcare practitioner in a manner that maintains security and integrity. | Non-clinical testing verified that "the data is transmitted to the healthcare practitioner in a manner that maintains the security and integrity of the data." |
| Indications for Use | Have identical indications for use as the predicate device (K031840 and other earlier predicates). | The "Indications for Use" for the modified system are identical to those of the predicate Carematix Wellness System (K031840) and align with other predicates: "The modified Carematix Wellness System [...] has no new indications for use." The system collects, accumulates, and transmits physiological data including non-invasive blood pressure, pulse rate, blood glucose, %SpO2, PT/INR, body temperature, PEFR, FEV, and patient weight. |
| Technological Equivalence | The modification to the system (specifically, wireless connectivity for sensors) should not alter the fundamental scientific technology of the sensor devices and should be comparable to predicate devices. | The substantial equivalence chart clearly outlines the "Carematix Modified System" and its features, showing that fundamental aspects like data collection software functionality, communication method of hub with central server, and sensor software remain "Same" as predicates. The key technological difference, "Communication method of hub with devices" changed from "Wired - over serial port" in some predicates to "Wireless RF protocol" (915MHz FCC assigned channel) in the modified system, which is also present in other predicates (e.g., Philips K023749 and previous Carematix K031840). The application states: "The modification to the Carematix Wellness System approved under K031840 submitted for approval in this application does not alter the fundamental scientific technology of the sensor devices." |
2. Sample Size for the Test Set and Data Provenance
The document describes "bench and user testing" as methods used to demonstrate safety and effectiveness. However, no specific sample size (number of participants or tests) for these "user testing" or "bench testing" activities is provided in the document.
The data provenance is not explicitly stated. Given the context of a 510(k) submission for a medical device aiming for the US market, it can be inferred that the testing would typically adhere to US regulatory standards. However, details like country of origin for user data or whether the studies were retrospective or prospective are not mentioned.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth for a test set in the traditional sense of clinical studies (e.g., radiologists interpreting images). The system relies on measurements from existing 510(k) cleared sensor devices. These sensor devices themselves would have undergone validation against established references or expert diagnoses during their own clearance processes.
For the Carematix Wellness System, the "ground truth" for the collected vital signs is implicitly assumed to be the accurate readings from the 510(k) cleared sensor devices. The system's role is to collect, store, and transmit these readings accurately, not to interpret or diagnose. Therefore, expert consensus or qualification of experts on the Carematix system's data collection and transmission wouldn't typically involve medical diagnostic experts but rather technical experts validating data integrity, security, and functionality.
4. Adjudication Method for the Test Set
No adjudication method is described, as the testing focuses on the accurate collection, storage, and transmission of data from existing cleared sensors, rather than diagnostic interpretation requiring expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The device is a data collection and transmission system, not an AI-assisted diagnostic tool that would typically involve human readers. Therefore, there is no discussion of human readers improving with or without AI assistance.
6. Standalone Performance Study
A standalone performance evaluation of the system's ability to collect, store, and transmit data was conducted through "bench and user testing." The key outcomes verified were:
- Meeting product requirements and functional specifications.
- Proper storage of physiologic data received.
- Secure and integral transmission of data.
These tests would represent the standalone (algorithm/system only, without human interpretation of the system's core function) performance of the Carematix Wellness System in its defined role.
7. Type of Ground Truth Used
The "ground truth" for the performance claims rests on the accurate readings provided by the integrated, pre-cleared sensor devices. The Carematix system's function is to relay these existing "truths" reliably. The testing verified the integrity of handling these known values rather than establishing new diagnostic ground truths. Specifically, the "ground truth" for the system's function is:
- The known output from the 510(k)-cleared biometric devices.
- The expected functional behavior as defined in product specifications.
- Normative standards for electrical safety and FCC compliance.
8. Sample Size for the Training Set
This submission does not discuss a training set. The device is a system for collecting and transmitting physiological data, not an AI/machine learning algorithm that requires a training set for model development. The focus is on the functional performance and equivalence to predicate devices, using established engineering and verification methods rather than algorithm training.
9. How the Ground Truth for the Training Set Was Established
As there is no training set mentioned for an AI/ML algorithm, 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).