(88 days)
Not Found
No
The device description details a straightforward calculation based on light absorption characteristics and detected light levels. There is no mention of AI, ML, or any learning algorithms. The purpose of the 510(k) is specifically for the clearance of disposable probes and compatible connectors, not a change in the core analytical method.
No
The device is described as an "adjunct trend monitor" and is explicitly stated "should not be used as the sole basis for diagnosis or therapy," indicating it provides information for diagnosis rather than directly treating a condition.
No
The "Intended Use / Indications for Use" explicitly states that the device "should not be used as the sole basis for diagnosis or therapy," indicating it is an adjunct monitor rather than a primary diagnostic tool.
No
The device description explicitly states it is a "piece of equipment" that uses near infrared light, patient probes with a light source and photodiodes, and a display unit. This indicates significant hardware components are involved in the device's function.
Based on the provided information, the NIRO-200NX DP is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's a "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." This describes a device that measures physiological parameters in vivo (within the living body).
- Device Description: The description details how the device uses near infrared light and probes applied to the skin to measure these parameters non-invasively. This further confirms it's an in vivo measurement.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices that are used to examine specimens, such as blood, urine, or tissue, that have been taken from the human body to provide information for diagnosis, monitoring, or screening. The NIRO-200NX DP does not examine specimens taken from the body; it measures parameters directly within the body.
Therefore, the NIRO-200NX DP falls under the category of in vivo diagnostic or monitoring devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MUD, DOA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain or in other tissue beneath the probes
Indicated Patient Age Range
any individual
Intended User / Care Setting
The NIRO-200NX DP is intended for use in a hospital setting by healthcare professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- 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)
- 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).
- 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.
- Report on the Tissue Phantom Measurements with NIRO-200NX Reusable and Disposable Probes. Hamamatsu 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.
Key Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Hamamatsu NIRO-200NX (K143219)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.
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.
1
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 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. | |
| 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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5
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.
6
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 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 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 should not be | ||
| used as the sole basis for | ||
| diagnosis or therapy. | ||
| Subject Device: | Predicate Device: | |
| NIRO-200NX DP | NIRO-200NX (K143219) | |
| Principle of | ||
| Operation | The NIRO-200NX DP is | |
| intended for use in a hospital | ||
| setting by healthcare | ||
| professionals. To use the | ||
| NIRO-200NX DP, the probes | ||
| are placed on any healthy tissue | ||
| of the patient. The probes can | ||
| remain on the patient for up to | ||
| 12 hours, and measurement data | ||
| can be continuously collected (at | ||
| a maximum sampling rate of | ||
| 20Hz (0.05s)) over that time | ||
| period. The data recorded from | ||
| the probe is calculated as | ||
| discussed below and reported on | ||
| the LCD on the DU for | ||
| monitoring by the physician. | The NIRO-200NX is intended | |
| for use in a hospital setting by | ||
| healthcare professionals. To use | ||
| the NIRO-200NX, the probes | ||
| are placed on any healthy tissue | ||
| of the patient. The probes can | ||
| remain on the patient for up to | ||
| 12 hours, and measurement data | ||
| can be continuously collected (at | ||
| a maximum sampling rate of | ||
| 20Hz (0.05s)) over that time | ||
| period. The data recorded from | ||
| the probe is calculated as | ||
| discussed below and reported on | ||
| the LCD on the DU for | ||
| monitoring 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 Source | ||
| Device | LED (Light Emitting Diode) | LED (Light Emitting Diode) |
| Wavelength Safety | ||
| Class | 3 wavelengths | |
| Class I | 3 wavelengths | |
| Class I | ||
| Light Detector | Photodiode | Photodiode |
| Measurement | ||
| Method | 2 Point Detection Method for | |
| Hemoglobin Oxygen Saturation | ||
| (TOI) and Relative value of the | ||
| total hemoglobin (nTHI) |
1 Point Detection Method for
Relative Levels of Hemoglobins | 2 Point Detection Method for
Hemoglobin Oxygen Saturation
(TOI) and Relative value of the
total hemoglobin (nTHI)
1 Point Detection Method for
Relative Levels of Hemoglobins |
| Patient Contact | Non-Invasive | Non-Invasive |
| EMC and
Electrical 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).