(97 days)
Oxi-W system is intended for use:
To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate.
To analyze the pulse waveform (Photoplethysmography or PTG) provided by the oximeter. It only provides mathematical analysis of the input of the PTG using the first and second derivatives of the PTG values related to the microvascular condition.
To analyze the basic rhythms of the NN or RR intert rate from the PTG, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the heart rate to the autonomic nervous system function.
The system only provides mathematical analysis of input PTG values. It is practitioner to make proper judgement based on these values. The software provides a visual alarm for the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission.
The data are stored in PC in the Backup system of the device is intended use only for adult subjects (> 20 years old) This Oximeter is intended to be used in spot-checking (5 minutes).
The device is intended for use in licensed practitioner's office
This device is no intended to be used at home, in hospital or out-of-hospital transport
The device is not intended for use in support life and not for continuously monitoring
The system will be used by practitioner.
The Oxi-W System is a programmable electro medical system (PEMS) including:
- Pulse oximeter with data transmission via Bluetooth. -
- -Software installed on a computer
Hardware :
- collects SpO2%, pulse rate value and vertical bar graph pulse amplitude -
(photoplethysmography) and sends the encrypted numbers to the Software.
Software:
- Display SP02%, and photoplethysmography. -
- Mathematical analysis of the pulse waveform (Photoplethysmography) using the first and second derivative of the wave to provide values related to the microvascular condition.
- Mathematical analysis of the pulse waveform (Photoplethysmography) to detect the heart rate and provides values of the heart rate variability related to the autonomic nervous system function.
The Oxi-W System, a programmable electromedical system consisting of a pulse oximeter with Bluetooth data transmission and computer software, was evaluated for performance and effectiveness.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate device K160956) | Reported Device Performance (Oxi-W System) |
|---|---|
| Intended Use | To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoplethysmography or PPG) provided by the oximeter. It only provides mathematical analysis of the input of the PTG using the first and second derivatives of the PTG values related to the microvascular condition. To analyze the basic rhythms of the NN or RR intervals in heart rate from the PTG, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the heart rate variability values related to the autonomic nervous system function. The system only provides mathematical analysis of input PTG values. It is the practitioner's responsibility to make proper judgement based on these values. The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission. The data are stored in PC in the Backup system of the Oxi-W software. The device is intended for use only for adult subjects (> 20 years old). This Oximeter is intended to be used in spot-checking (5 minutes). The device is intended for use in licensed practitioner's office. This device is not intended to be used at home, in hospital or out-of-hospital transport. The device is not intended for use in support life and not for continuously monitoring. The system will be used by practitioner. |
| SpO2 Accuracy | 70% |
| Pulse Rate (PR) Range | 30~235 bpm |
| PR Accuracy | ±3 |
| IR light Wavelength | 890 nm ± 10 (Predicate: 880nm ± 10) |
| RED light Wavelength | 663 nm ± 10 (Predicate: 660nm ± 10) |
| Data Transmission Speed | 19200 Bauds |
| Software Measurements and Results | SpO2%, Pulse rate, Photoplethysmography, Heart rate variability analysis at rest and using Ewing tests, Photoplethysmography Second derivative analysis. |
| Data Transmitted by Hardware | SpO2%, Pulse rate, Photoplethysmography, |
| Standards Met | 60601-1 3rd Ed, 60601-1-2 3rd Ed, ISO 80601-2-61 |
| Mode of Data Reception | Hardware Bluetooth microcontroller to PC |
| Power Supply | Lithium battery 3.7 V rechargeable by USB port |
| Data Transmission | Bluetooth |
| Module Oximeter Circuit Board and Components | OEM (K120502), Bluetooth microcontroller (Soc), Circuit board integrated to the probe |
Study Proving Acceptance Criteria Met:
The Oxi-W system addresses differences from its predicate device (LD-Oxi system K160956) through a series of performance tests and analyses, rather than a clinical trial. The justification for not requiring clinical tests is that the Oxi-W algorithms and hardware share the same intended use and results as the predicate device, which itself did not require clinical tests.
Specifically, the following tests were conducted:
- Laboratory tests: These included compliance with international standards such as IEC 60601-1, IEC 60601-1-2, and ISO 80601-2-61, addressing general safety, electromagnetic compatibility, and particular requirements for pulse oximeter equipment.
- CRC (Cyclic redundancy check) Coding: This was performed to demonstrate the software's ability to accurately capture, store, and analyze data measured by the hardware.
- Calibration tests: These were conducted using a simulator oximeter.
- Software verification and validation (SRS/SDS/STD/STR): This comprehensive process confirmed the software's functionality and reliability, particularly for the new protocol communication required by the Bluetooth data transmission.
- Bluetooth testing and cybersecurity risk analysis: These were conducted in accordance with FDA Wireless Guidance (2014), Cybersecurity Guidance (2013), and relevant Bluetooth white papers and FDA safety communications. This addressed the increased risk associated with Bluetooth data transmission and a different microcontroller.
Absence of Specific Information:
The provided text does not include the following information:
- Sample size used for the test set and data provenance: No specific sample sizes for testing are mentioned beyond references to "laboratory tests" and "calibration tests." The origin of any test data (e.g., country of origin, retrospective/prospective) is also not provided.
- Number of experts used to establish the ground truth for the test set and their qualifications: No information is given about experts or their qualifications for establishing ground truth.
- Adjudication method for the test set: No adjudication method is described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: There is no indication that an MRMC study was performed. The document focuses on demonstrating substantial equivalence to a predicate device, not on comparing human reader performance with and without AI assistance.
- Standalone (i.e., algorithm only without human-in-the-loop performance) study: While the device provides mathematical analysis, the evaluation is not explicitly described as a standalone study of the algorithm's performance without human interaction. The device is intended to provide values for practitioner judgment.
- Type of ground truth used: The type of ground truth (e.g., expert consensus, pathology, outcomes data) used for the tests is not specified. Given the nature of the device (pulse oximetry and physiological signal analysis), it can be inferred that the ground truth for calibration and accuracy would likely come from established measurement standards and potentially comparison against clinical reference devices, but this is not explicitly stated.
- Sample size for the training set: There is no mention of a training set or its sample size, as the document focuses on regulatory submission and performance testing rather than algorithm development specifics.
- How the ground truth for the training set was established: As no training set is mentioned, this information is not provided.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).