(88 days)
The NIRO-200NX DP is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation and relative level of oxygenated hemoglobin and deoxygenated hemoglobin of blood in brain or in other tissue beneath the probes in any individual. The clinical value of trend data has not been demonstrated in disease states. The NIRO-200NX DP should not be used as the sole basis for diagnosis or therapy.
The NIRO-200NX is a piece of equipment that uses near infrared light for non-invasive measurement of hemoglobin oxygen saturation and relative levels of oxygenated hemoglobin and deoxygenated hemoglobin of blood in brain or in other tissue beneath the probes. Patient probes are applied to the skin over the tissue of interest. The probes have a light source and 2 photodiodes, one closer to the light source and one further away from the light source. The 2 photodiodes detect the light transmitted through the patient's tissue. The detected light is analyzed with the known light absorption characteristics of oxyhemoglobin and deoxyhemoglobin. The amount of light detected by the photodiode closer to the light source is subtracted from the light detected by the farther photodiode. The result is then used to calculate the hemoglobin oxygen saturation. Also, by measuring the changes in light detected from one of the photodiodes, the relative levels of oxygenated hemoglobin and deoxygenated hemoglobin are calculated.
The predicate NIRO-200NX (K143219) utilized reusable patient probes. The purpose of this premarket notification is to obtain clearance for use of disposable probes and compatible connectors with the cleared display unit. Use of the disposable probes and compatible connectors with the cleared display unit is referred to as the NIRO-200NX DP.
The provided text describes the 510(k) summary for the Hamamatsu NIRO-200NX DP device. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a predicate device already on the market.
Based on the provided document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not present explicit acceptance criteria for performance in a quantitative table with corresponding numerical performance results. Instead, the performance testing focuses on demonstrating substantial equivalence to an existing predicate device (Hamamatsu NIRO-200NX, K143219).
The key "acceptance criteria" can be inferred from the areas where substantial equivalence was demonstrated:
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (as stated in the document) |
|---|---|
| Maintain equivalent measurement performance for regional hemoglobin oxygen saturation (rSO2) and relative levels of oxygenated and deoxygenated hemoglobin. | "The results of the study demonstrate that performance of the NIRO-200NX DP is substantially equivalent to the performance of the NIRO-200NX (K143219)." |
| "Hamamatsu performed a phantom study to compare performance of the proposed and predicate devices side by side in a simulated model. The results of the study demonstrated that performance of the NIRO-200NX DP is substantially equivalent to the performance of NIRO-200NX at measuring regional hemoglobin oxygen saturation and relative levels of oxygenated hemoglobin and deoxygenated hemoglobin." | |
| Electrical Safety | "Electrical Safety was established by testing in accordance with IEC 60601-1 Edition 3.0, Medical Electrical Equipment - Part 1: General requirements for Safety (2005)." (Implied passing of this test). "Passed applicable safety testing" in Table 1. |
| Electromagnetic Compatibility (EMC) | "Electromagnetic Compatibility was established by testing in accordance with IEC 60601-1-2 3rd Edition, Medical Electrical Equipment - Part 1-2: Electromagnetic Compatibility – Requirements and Tests (2008)." (Implied passing of this test). "Passed applicable safety testing" in Table 1. |
| Laser Safety (for LED light source) | "Laser Safety was established by testing in accordance with IEC 60825-1 Ed. 2.0 (2007). The light source in the NIRO-200NX DP is a Class 1 Light Emitting Diode (LED) Product." (Implied passing of this test). |
| Software Verification and Validation | "The software was verified and validated, and the software verification and validation documents were prepared and presented in accordance with FDA's guidance document [Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices May 11, 2005]." |
| Lack of Adverse Events (Clinical History) | "The NIRO-200NX DP has been sold and used clinically for more than two years in Japan and Europe without any reported adverse events." |
2. Sample size used for the test set and the data provenance
The primary performance study mentioned is a phantom study.
- Sample Size: The document does not specify a quantitative sample size (e.g., number of phantom measurements, or number of different phantom conditions). It only states "a phantom study to compare performance."
- Data Provenance: The study was "performed a phantom study to compare performance of the proposed and predicate device side by side in a simulated model." This indicates a laboratory or in-vitro setting, not human data. The document also mentions the device has been sold and used clinically for more than two years in Japan and Europe without any reported adverse events, which is real-world observational data, but not a controlled clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The reported performance data comes from a phantom study comparing the new device against a predicate device in a simulated model, and from engineering tests (electrical safety, EMC, laser safety). There is no mention of human expert involvement for establishing ground truth in these types of tests, as these are objective physical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies to studies involving human interpretation or subjective assessments, often in imaging. The described studies are objective phantom measurements and engineering tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The NIRO-200NX DP is an oximeter, a measurement device, not an AI-assisted diagnostic imaging system that would involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The phantom study evaluates the device's measurement capability independently. The device itself performs the measurement of hemoglobin oxygen saturation and relative levels of oxygenated and deoxygenated hemoglobin based on light absorption, which is an algorithmic process. The study evaluates the device's performance in isolation from a human operator's interpretation of the raw signals, though the operator would monitor the calculated values.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the phantom study, the "ground truth" is implied to be the known or established properties of the simulated tissue phantom model and the performance of the predicate device which is already cleared and accepted. The goal was to prove substantial equivalence, meaning the new device performs measurements consistent with the predicate device in the same conditions. For the electrical, EMC, and laser safety tests, the "ground truth" is established by the standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1) themselves, which define acceptable parameters.
8. The sample size for the training set
Not explicitly stated. The device is not a "learning" algorithm in the sense of modern deep learning AI that requires a labeled training set. It's a measurement device based on established physical principles (near-infrared light absorption characteristics of oxyhemoglobin and deoxyhemoglobin). If there's any internal calibration or parameter tuning, the "training set" would likely be laboratory measurements or physical models used during design and development, but this is not detailed in the 510(k) summary.
9. How the ground truth for the training set was established
Not applicable or not detailed, as elucidated in point 8. The device operates on fixed physical principles rather than being a trained AI model.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).