(114 days)
The EarlySense (EverOn) System is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner, at home, hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EarlySense has been studied in children (weight ≥ 10 Kg) and adults (weight
The EarlySense (EverOn) System consists of the following main components:
- A piezoelectric Sensing Unit placed under the mattress or mattress pad.
- Bedside Unit with Proprietary recording and data analysis software
- OEM Oximetry Module (optional)
The EarlySense (EverOn) System is designed for continuous and contact-less monitoring of respiration rate, heart rate and movement. The under mattress Sensing Unit includes a piezoelectric sensor, which converts mechanical movements into an electric signal. The principles and the mode of operation for the capability of contactless monitoring of the EarlySense (EverOn) is identical to the cleared EverOn 1.0 (K092062). The EarlySense interfaces with a pulse oximeter OEM module (optional feature) and can therefore also monitor oxygen saturation. The oximetry module is connected externally via UART (RS232/TTL) to the Bedside unit. A compatible oximetry sensor is then attached to the patient's finger and the monitor begins to continuously display oximetry data (e.g. SpO2).
The Bedside Unit, processes inputted signals, displays the patient's parameters, and generates alerts (respiration rate, heart rate, movement, and SpO2) as per set thresholds when needed. The continuously accumulated data from the monitored period are displayed on the bedside unit and communicated, via wired or via wireless LAN communication to a dedicated may options of SerilySense Central Display Station (CDS) - cleared under K100376 and K110521). Analysis of the results may be performed either on-line during the monitoring session, or later, off-line. Data for each patient is recorded and can therefore also be retrieved and presented.
Here's a breakdown of the acceptance criteria and study information for the EarlySense (EverOn™) System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary focuses primarily on showing substantial equivalence to predicate devices and adherence to general safety and performance standards. It does not explicitly state specific quantitative acceptance criteria for respiration rate, heart rate, movement, or SpO2, nor does it provide detailed performance values for these metrics. Instead, the summary emphasizes that a "set of software and bench testing was performed to demonstrate the performance and accuracy" and that the device "performs according to its specifications described in the Software Requirements Specifications (SRS)."
However, given the context of a 510(k) for an oximetry module addition and an existing cleared device, we can infer the type of performance that would be required for the added oximetry function based on typical regulatory expectations for pulse oximeters. For the existing functions (respiration rate, heart rate, movement), the claim is that its operation is "identical to the cleared EverOn 1.0 (K092062)."
| Acceptance Criteria (Inferred from Regulatory Standards and Device Type) | Reported Device Performance (as stated or implied) |
|---|---|
| Respiration Rate, Heart Rate, Movement: Performance equivalent to predicate device EverOn 1.0 (K092062). | "The principles and the mode of operation for the capability of contactless monitoring of the EarlySense (EverOn) is identical to the cleared EverOn 1.0 (K092062)." |
| SpO2 Accuracy: (Typically, within ±2-3% of reference standard for 70-100% SpO2) | "Bench testing including demonstrating the accuracy of the oximetry data display and SpO2 alerting feature." (Specific quantitative accuracy values are not provided in this summary.) |
| Electrical Safety: Compliance with IEC 60601-1. | "Electrical safety and electromagnetic compatibility testing according to IEC 60601-1 (and amendments)." |
| Electromagnetic Compatibility: Compliance with EN/IEC 60601-1-2. | "Electrical safety and electromagnetic compatibility testing according to [...] IEC 60601-1-2 (and amendment) standards." |
| Software Validation: Performance according to Software Requirements Specifications (SRS). | "Software verification and validation testing was conducted to evaluate the performance of the EarlySense System and to verify that it performs according to its specifications described in the Software Requirements Specifications (SRS)." |
| Absence of New Safety/Effectiveness Issues: | "Testing was performed in order to demonstrate ... that as a result of combining the EarlySense technology and a standard OEM, no new safety and effectiveness issues, in comparison to its predicate devices, are raised." |
2. Sample Size Used for the Test Set and Data Provenance
The summary does not provide specific sample sizes for particular performance tests. It mentions "bench testing" and "software verification and validation testing." No information about human subject test sets (sample size, country of origin, retrospective/prospective) is provided beyond the existing claim of equivalence to the predicate device for respiration rate, heart rate, and movement. The indication for use states, "The operation of the EarlySense has been studied in children (weight ≥ 10 Kg) and adults (weight
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).