(104 days)
The Wireless Monitoring System is intended for use by health care professionals for routine surveillance of patient physiological parameters to include, pulse rate, respiratory rate and axillary temperature, in a hospital setting. Data is transmitted wirelessly to a central location. Notifications can be prospectively set to notify healthcare professionals to excursions outside of selected parameters.
The device is not intended to be used on critical care patients and is intended to supplement vital signs monitoring by healthcare professionals, not to replace current standards of care. The device is intended for use on general care patients and on patients who are 18 years of age or older.
The proposed device consists of a patient patch with integrated temperature sensor, an electronic bridge and server software. The patch is attached to the patient and connected to existing monitoring leads to capture heart rate, respiration and body temperature. This data is wirelessly transmitted to a bridge. Multiple bridges can be installed in a hospital setting to capture signals in case the patient is moved or becomes ambulatory. Data from the patch is transmitted through a hard-wire connection to the nurses' station for surveillance. The healthcare practitioner can set limits on the patient data which in turn may trigger an alert.
Here's a breakdown of the requested information based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary primarily focuses on non-clinical performance and equivalence to predicate devices, rather than explicit acceptance criteria with specific thresholds for accuracy or sensitivity/specificity typical of clinical performance studies for diagnostic devices. However, the comparative information table provides implicit acceptance criteria by stating "Same or similar" to the predicate devices for key physiological parameters.
| Characteristic | Acceptance Criteria (based on predicate equivalence) | Reported Device Performance (New Device) |
|---|---|---|
| FCC Approval | Letter of approval | Yes |
| Frequency Range | 911.38-918.59 (Mhz). FCC Part 15 | Same or similar |
| Type of Device | Near-patient data collection | Disposable |
| Heart Rate | 30 to 200 bpm | Same or similar |
| Axillary Temp | 89.6° F – 111.2°F | Same or similar |
| Respiratory Rate | 5 - 60 resp/min | Same or similar |
| HL7 Protocol | Communicate with HIS using HL7 | Yes |
| Interval reporting | Range: 2-30 minute increments in 2 minute increments | Range: 2-30 minute increments in 2 minute increments |
| Battery power | Low power battery for near patient device | 3.0 volts |
| Power for bridges | Bridges use AC Main for power | Yes |
| Notifications | System has programmable notifications | Yes |
| Telemetry | Transmissions between bridge and patch shall use ISM bands | Yes |
| Vital signs data | Provides: (1) heart rate, (2) Respiration rate, (3) Axillary temperature | Yes |
| Operating Paradigm | Uses: (1) Patient data collection device, (2) bridges, (3) Hospital servers | Yes |
| Biocompatibility | Pass ASTM 2475-05 | Passes applicable tests and standards |
| Basic safety | Pass IEC 60601-1 | Passes applicable tests and standards |
| EMC Compatibility | Pass IEC60601-1-2 | Passes applicable tests and standards |
| Collateral Safety | Pass IEC 60601-1-1 | Passes applicable tests and standards |
| Electrocardiographic equipment | Pass IEC 60601-2-27 | Passes applicable tests and standards |
| Patient Monitoring | Pass IEC 60601-2-49 | Passes applicable tests and standards |
| Degrees of Protection | Pass IEC 60529 IP 64 | Passes applicable tests and standards |
| Human exposure to electromagnetic fields | Pass IEC 62311 | Passes applicable tests and standards |
| IT Equipment | Pass IEC 60950-1 | Passes applicable tests and standards |
| Animal welfare | Pass ISO 10993-2 | Passes applicable tests and standards |
| Interactions with Blood | Pass ISO 10993-4 | Passes applicable tests and standards |
| In Vitro Cytotoxicity | Pass ISO 10993-5 | Passes applicable tests and standards |
| Irritation and Skin Sensitization | Pass ISO 10993-10 | Passes applicable tests and standards |
| Systemic Toxicity | Pass ISO 10993-11 | Passes applicable tests and standards |
| Sample Preparation | Pass ISO 10993-12 | Passes applicable tests and standards |
| Leachable Substances | Pass ISO 10993-17 | Passes applicable tests and standards |
| Chemical Characterization of Materials | Pass ISO 10993-18 | Passes applicable tests and standards |
| Risk Management | Pass ISO 14971 | Passes applicable tests and standards |
| Usability | Good usability (subjective user feedback) | "Good usability"; user interest |
| Wireless Functionality | Operate as designed and intended (no interference) | "Operated as designed and as intended"; no interference with hospital equipment |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Usability Testing: The summary does not specify the exact number of participants for the usability testing. It mentions "participants" in the context of user opinions.
- Wireless Testing: The summary does not provide a specific sample size (e.g., number of patients, devices, or test points) for the wireless testing.
- Data Provenance:
- Usability Testing: Conducted at "The University of Texas at Arlington."
- Wireless Testing: Conducted at "Palomar Pomerado Hospital."
- The studies appear to be prospective as they are described as "testing" of the new device's operation and usability.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Usability Testing: "Staff opinions were positive with participants showing an interest in using the proposed device." No specific number of experts or their qualifications for establishing a "ground truth" on usability are provided, as usability is often assessed through user feedback rather than expert ground truth.
- Wireless Testing: "Testing for EMI and other parameters were monitored and recorded." No specific number of experts or their qualifications for interpreting these technical results are provided. The "ground truth" here is the measurement data itself against predefined technical standards.
4. Adjudication Method for the Test Set
- No formal adjudication method (e.g., 2+1, 3+1) is mentioned for either the usability or wireless performance testing. The reported results are summaries of observations and measurements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
- No MRMC study was done. This device is a physiological monitoring system, not an AI-assisted diagnostic imaging device that typically uses human readers. The clinical studies focused on usability and wireless functionality, not on improving human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This device is not an algorithm-only device. It is a hardware system that collects and transmits physiological data for healthcare professionals to monitor. The "standalone" performance in this context would refer to its technical accuracy and reliable data transmission, which were broadly addressed by technical testing and wireless performance checks, not an AI algorithm.
7. The Type of Ground Truth Used
- Non-Clinical (Technical/Performance) Tests: The ground truth for these tests would be the established performance standards (e.g., IEC, ISO, FCC) against which the device's technical specifications and measurements were compared.
- Usability Testing: The "ground truth" was subjective user feedback and observation of the system's operation as intended.
- Wireless Testing: The "ground truth" was direct measurement of wireless transmission parameters and observation of interference, compared against expected operational norms.
- No pathology or outcomes data was used as ground truth because this device is for surveillance of physiological parameters, not for diagnosis based on pathology or for evaluating clinical outcomes directly tied to a specific diagnostic accuracy.
8. The Sample Size for the Training Set
- Not applicable. The device described is a hardware and software system for physiological monitoring, not a machine learning or AI model that requires a "training set" in the conventional sense. The development likely involved engineering design, testing, and refinement, but not machine learning training on a dataset.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no mention of a "training set" for machine learning algorithms in this 510(k) summary.
§ 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).