(218 days)
The EarlySense 2.0 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 modified EarlySense System 2.0 is similar to cleared (EverOn™1.0S) System (K120465) except for the hardware and software changes that are described below.
The cleared (K120465) EarlySense (EverOn™1.0S) System is comprised of the following components:
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A Bed Sensing Unit based on piezoelectric sensing
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A Bedside Unit incorporating a medical grade power supply and the following modules:
A Signal Sampling Module consisting of amplifiers, filters and analog to a. digital converter as well as a microprocessor designated to transfer the sampled data to the Signal Processing Module, and
b. A Signal Processing and Display Module.
- An Optional Oximetry OEM module with communication interface and compatible marketed sensors.
The EarlySense System 2.0 is a modified version of the EarlySense (EverOn™1.0S) System (K120465). The changes include modifications to the Bed Sensing Unit (adding an accelerometer, piezoelectric polymer sensor, and base plate handles) and the Bedside Unit (dimensional changes, replacement of power supply, speaker's buzzer, communication card, fan, additional USB and sensor's connectors, and software update to version 1.0.3).
Acceptance Criteria and Device Performance:
The provided 510(k) summary does not explicitly list numerical acceptance criteria or detail the specific performance metrics achieved by the EarlySense System 2.0. Instead, it states that the device was subject to various verification and validation tests and that the modifications "did not affect its performance, effectiveness or safety." The submission aimed to demonstrate substantial equivalence to the predicate device (K120465).
The performance claims rely on the device maintaining the same functionality and performance as its predicate, which was already cleared. The performance criteria for the predicate device would be relevant here, but are not provided in this document.
Studies and Ground Truth Information:
The document focuses on demonstrating that the modifications did not negatively impact the performance of the device and thus, it remains substantially equivalent to the cleared predicate. It does not present new clinical studies with detailed acceptance criteria and performance results in the same way a de novo submission might.
Here's an analysis of the provided information concerning studies:
| # | Feature | Details Provided in K131379 |
|---|---|---|
| 1. | Acceptance Criteria & Reported Performance | Acceptance Criteria: Not explicitly stated as numerical targets for key performance metrics (e.g., accuracy, precision for HR/RR). The implicit acceptance criterion is that the modified device's performance is not worse than the predicate device. |
| Reported Performance: The document states that "The results of the tests showed, that the modifications to the system did not affect its performance, effectiveness or safety." It does not provide specific performance values for respiration rate, heart rate, or movement. | ||
| 2. | Sample Size & Data Provenance (Test Set) | Not specifically mentioned for a new clinical test set. The document refers to "Performance Bench Testing" (See Section 18 of the current submission), but details are not provided in this extract regarding sample size, country of origin, or retrospective/prospective nature. The intended use indicates studies were done with "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).