(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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 25, 2016
Hamamatsu Photonics K.K. % Ms. Allyson Mullen Hyman, Phelps & Mcnamara 700 Thirteenth Street, Northwest, Suite 1200 Washington, District of Columbia 20005
Re: K162117
Trade/Device Name: Niro-200NX DP Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD, DOA Dated: July 29, 2016 Received: July 29, 2016
Dear Ms. Mullen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162117
Device Name NIRO-200NX DP
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------- |
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510(k) Summary K162117 – NIRO-200NX DP
| Submitter Name: | Hamamatsu Photonics K.K. |
|---|---|
| Submitter Address: | 812 Joko-cho, Higashi-ku, Hamamatsu City, 431-3196,JAPAN |
| Contact Person: | Susumu Suzuki |
| Phone Number: | 81-53-431-0124 |
| Fax Number: | 81-53-431-0148 |
| Date Prepared: | October 24, 2016 |
| Device Trade Name: | NIRO-200NX DP |
| Device Common Name: | Oximeter |
| Product Code: | MUD |
| Subsequent Product Code: | DQA |
| Classification: | Class II per 21 C.F.R. § 870.2700 |
| Predicate Device: | Hamamatsu NIRO-200NX (K143219) |
| Device Description: | The NIRO-200NX is a piece of equipment that uses near infraredlight for non-invasive measurement of hemoglobin oxygensaturation and relative levels of oxygenated hemoglobin anddeoxygenated hemoglobin of blood in brain or in other tissuebeneath the probes. Patient probes are applied to the skin over thetissue of interest. The probes have a light source and 2photodiodes, one closer to the light source and one further awayfrom the light source. The 2 photodiodes detect the lighttransmitted through the patient's tissue. The detected light isanalyzed with the known light absorption characteristics ofoxyhemoglobin and deoxyhemoglobin. The amount of lightdetected by the photodiode closer to the light source is subtractedfrom 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. | |
| Intended Use: | 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. |
| Performance Data: | The following electrical and performance data have been generated using the NIRO-200NX DP and are described in this 510(k) submission. All tests demonstrate that the device functions as intended. |
| 1. | 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) |
| 2. | 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). |
| 3. | 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. |
| 4. | Report on the Tissue Phantom Measurements with NIRO-200NX Reusable and Disposable Probes. Hamamatsu |
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performed a phantom study to compare performance of the proposed and predicate device side by side in a simulated model. The results of the study demonstrate that performance of the NIRO-200NX DP is substantially equivalent to the performance of the NIRO-200NX (K143219).
-
- The NIRO-200NX DP has been sold and used clinically for more than two years in Japan and Europe without any reported adverse events.
-
- Hamamatsu followed the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices May 11, 2005, ' to classify the NIRO-200NX software as a "moderate level of concern." The software was verified and validated, and the software verification and validation documents were prepared and presented in accordance with FDA's guidance document.
Substantial Equivalence:
The predicate device is the Hamamatsu NIRO-200NX (K143219).
The NIRO-200NX DP has the same intended use, indications for use, principle of operation, and measurement method as the predicate device. The NIRO-200NX DP and the predicate device have similar technological characteristics. The only difference is the inclusion of a disposable probe option, which includes a compatible adapter and AMPs for connection of the disposable probes to the NIRO-200NX display unit. This minor difference does not raise different questions of safety or efficacy, as confirmed by Hamamatsu's testing and validation activities described in this submission, including EMC, electrical safety, and laser safety testing in accordance with IEC 60601-1-2 (2008), IEC 60601-1 (2005), and IEC 60825-1 Ed. 2.0 (2007). Hamamatsu followed the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices May 11, 2005," to classify the NIRO-200NX software as a "moderate level of concern." The software was verified and validated, and the software verification and validation documents were prepared and presented in accordance with FDA's guidance document.
Further. NIRO-200NX DP is at least as safe and effective as the predicate devices as demonstrated by the results of a phantom study. 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.
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The data presented demonstrate that the NIRO-200NX DP is at least as safe and effective as the predicate NIRO-200NX. Therefore, the NIRO-200NX DP is substantially equivalent to the predicate device. The Substantial Equivalence comparison chart is found below in Table 1.
| Subject Device: | Predicate Device: | |
|---|---|---|
| NIRO-200NX DP | NIRO-200NX (K143219) | |
| Intended Use | Oximeter (MUD, DQA) | Oximeter (MUD, DQA) |
| Indications for Use | The NIRO-200NX DP isintended for use as an adjuncttrend monitor of regionalhemoglobin oxygen saturationand relative level of oxygenatedhemoglobin and deoxygenatedhemoglobin of blood in brain orin other tissue beneath theprobes in any individual. Theclinical value of trend data hasnot been demonstrated indisease states. The NIRO-200NX DP should not be usedas the sole basis for diagnosis ortherapy. | The NIRO-200NX is intendedfor use as an adjunct trendmonitor of regional hemoglobinoxygen saturation and relativelevel of oxygenated hemoglobinand deoxygenated hemoglobinof blood in brain or in othertissue beneath the probes in anyindividual. The clinical value oftrend data has not beendemonstrated in disease states.The NIRO-200NX should not beused as the sole basis fordiagnosis or therapy. |
| Subject Device: | Predicate Device: | |
| NIRO-200NX DP | NIRO-200NX (K143219) | |
| Principle ofOperation | The NIRO-200NX DP isintended for use in a hospitalsetting by healthcareprofessionals. To use theNIRO-200NX DP, the probesare placed on any healthy tissueof the patient. The probes canremain on the patient for up to12 hours, and measurement datacan be continuously collected (ata maximum sampling rate of20Hz (0.05s)) over that timeperiod. The data recorded fromthe probe is calculated asdiscussed below and reported onthe LCD on the DU formonitoring by the physician. | The NIRO-200NX is intendedfor use in a hospital setting byhealthcare professionals. To usethe NIRO-200NX, the probesare placed on any healthy tissueof the patient. The probes canremain on the patient for up to12 hours, and measurement datacan be continuously collected (ata maximum sampling rate of20Hz (0.05s)) over that timeperiod. The data recorded fromthe probe is calculated asdiscussed below and reported onthe LCD on the DU formonitoring by the physician. |
| Technological Characteristics | ||
| Display Unit (DU) | Liquid crystal display (LCD)and instrument control panel | Liquid crystal display (LCD)and instrument control panel |
| Probes | Disposable | Reusable |
| Adaptor | Disposable Probe Adaptor(DPA) | Pulse 2ch Adaptor (P2A) |
| AMP Unit | DPA AMP Unit | AMP Unit |
| Subject Device: | Predicate Device: | |
| NIRO-200NX DP | NIRO-200NX (K143219) | |
| Light SourceDevice | LED (Light Emitting Diode) | LED (Light Emitting Diode) |
| Wavelength SafetyClass | 3 wavelengthsClass I | 3 wavelengthsClass I |
| Light Detector | Photodiode | Photodiode |
| MeasurementMethod | 2 Point Detection Method forHemoglobin Oxygen Saturation(TOI) and Relative value of thetotal hemoglobin (nTHI)1 Point Detection Method forRelative Levels of Hemoglobins | 2 Point Detection Method forHemoglobin Oxygen Saturation(TOI) and Relative value of thetotal hemoglobin (nTHI)1 Point Detection Method forRelative Levels of Hemoglobins |
| Patient Contact | Non-Invasive | Non-Invasive |
| EMC andElectrical Safety | Passed applicable safety testing | Passed applicable safety testing |
Table 1: Comparison to Predicate
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Conclusion: Based on the indications for use, performance testing, and technological characteristics, the NIRO-200NX DP has been shown to be as safe and effective for its stated intended use as the NIRO-200NX (K143219).
§ 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).