(263 days)
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 NR0-200NX should not be used as the sole basis for diagnosis or therapy.
The NIRO-200NX is a reusable 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. The 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 provided document describes the Hamamatsu NIRO-200NX device, a near-infrared oximeter, and its clearance process. Here's a breakdown of the acceptance criteria and the studies that support it:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally framed as the device performing "equivalently" to predicate devices, rather than specific quantitative thresholds.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Regional Hemoglobin Oxygen Saturation (rSO2) | Substantially equivalent performance to INVOS 5100C in both phantom study and clinical setting. |
| Relative Levels of Oxygenated Hemoglobin and Deoxygenated Hemoglobin (ΔO2Hb, ΔHHb) | Substantially equivalent performance to Hitachi ETG-100 and ETG-4000 in phantom study. |
| Electrical Safety | Passed applicable safety testing per IEC 60601-1. |
| Electromagnetic Compatibility (EMC) | Passed applicable safety testing per IEC 60601-1-2. |
| Light Emitting LED Product Safety | Class 1 LED product per IEC 60825-1. |
| Software Verification and Validation | Verified and validated software with moderate level of concern, conforming to FDA guidance. |
| Clinical Safety Record | No reported adverse events over 4+ years of clinical use in Japan and Europe. |
2. Sample Size Used for the Test Set and Data Provenance
Phantom Study:
- Sample Size: Not explicitly stated as a number of "samples" but implied to be a comparative study using multiple phantom configurations.
- Data Provenance: Retrospective, conducted internally by Hamamatsu (manufacturer of NIRO-200NX).
Published Clinical Literature (Bickler et al.):
- Sample Size: 23 individuals for the comparison between NIRO-200NX and INVOS.
- 181 individual measurements for INVOS.
- 179 individual measurements for NIRO-200NX.
- Data Provenance: Prospective clinical study. The country of origin for the study is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number or qualifications of experts used to establish ground truth for the phantom study.
For the clinical study (Bickler et al.), the ground truth for regional hemoglobin oxygen saturation was established through blood draw results, which is a direct, objective measurement, not based on expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. The ground truth for the clinical study was based on direct blood draw measurements, which does not require adjudication. For the phantom study, the ground truth was based on the controlled properties of the phantom, also not requiring adjudication.
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. This device is an oximeter, which provides quantitative measurements, not images requiring human interpretation or AI assistance in reading. There are no "human readers" involved in interpreting the device's direct output in the context of an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the NIRO-200NX is a standalone device that provides measurements directly. Its performance as an algorithm-only device was evaluated both through the phantom study and the comparison to blood draws in the clinical study.
7. The Type of Ground Truth Used
- Phantom Study: Controlled and known properties of tissue phantoms (simulated models).
- Clinical Study (Bickler et al.): Direct blood draw results (for regional hemoglobin oxygen saturation).
8. The Sample Size for the Training Set
The document does not specify a training set sample size. This is typical for devices using established biophysical principles and comparative equivalence to predicates, rather than machine learning models that require explicit training datasets. The device's underlying principles are based on known light absorption characteristics of oxyhemoglobin and deoxyhemoglobin.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no explicit machine learning training set is mentioned or implied. The device's operation is based on established optical spectroscopy principles rather than data-driven machine learning training.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an emblem consisting of three stylized human profiles facing to the right, with a design above them that resembles a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Hamamatsu Photonics K.K. % Mr. Jeffrey K. Shapiro Hyman, Phelps and McNamara 700 Thirteenth Street, North West, Suite 1200 Washington, District of Columbia 20005
Re: K143219
Trade/Device Name: NIRO-200NX Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD, DQA Dated: July 6, 2015 Received: July 6, 2015
Dear Mr. Shapiro:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
July 31, 2015
{1}------------------------------------------------
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.
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" (21CFR 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.
For
Sincerely yours.
Joshua C. Nipper -S
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K143219
Device Name Hamamatsu NIR0-200NX
Indications for Use (Describe)
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 NR0-200NX 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
K143219
Page 1 of 6
510(k) Summary NIRO-200NX
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: July 24, 2015
Device Trade Name: NIRO-200NX
Device Common Name: Oximeter
Product Code: MUD
Subsequent Product Code: DQA
Classification: Class II per 21 C.F.R. § 870.2700
Predicate Device:
Somanetics INVOS 5100C (K082327), Hitachi ETG-100 (K011320) and ETG-4000 (K042501)
The NIRO-200NX is a reusable piece of equipment that uses near Device Description: 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. The 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
{4}------------------------------------------------
photodiodes, the relative levels of oxygenated hemoglobin and deoxygenated hemoglobin are calculated.
Intended Use: 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.
Performance data: The following electrical, performance, and clinical literature has been conducted with and reported using the NIRO-200NX and is described in the 510(k) submission. All tests and literature demonstrate that the device functions as intended and performs equivalently to the predicate devices.
-
- Electrical per IEC 60601-1
-
- Electromagnetic Compatibility per IEC 60601-1-2
-
- Light Emitting LED Product per IEC 60825-1 (Class1 LED product)
- Bench data demonstrating that NIRO-200NX performs equivalently in tissue phantoms compared to the predicate devices.
-
- The NIRO-200NX has been sold and used clinically for more than 4 years in Japan and Europe without any reported adverse events. A review of the published literature concludes that the device worked as intended by safely being used as an adjunct 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. Specifically, clinical literature demonstrated that NIRO-200NX and the predicate INVOS performed equivalently in a clinical setting. In addition, clinical literature was provided to show that NIRO-200NX has been used successfully in infants.
Substantial Equivalence:
- The NIRO-200NX has been sold and used clinically for more than 4 years in Japan and Europe without any reported adverse events. A review of the published literature concludes that the device worked as intended by safely being used as an adjunct 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. Specifically, clinical literature demonstrated that NIRO-200NX and the predicate INVOS performed equivalently in a clinical setting. In addition, clinical literature was provided to show that NIRO-200NX has been used successfully in infants.
The predicate devices are ETG-100 (K011320), ETG-4000 (K042501), and INVOS 5100C (K082327).
The proposed NIRO-200NX and the predicate devices all have the same intended use: as Oximeters. The proposed and predicate devices also have similar indications for use. The proposed and predicate devices all have the same principles of operation: they all measure levels of oxygen based on light measurements taken from the surface of intact tissue on the outside of a patient's body. The NIRO-200NX and the predicate
{5}------------------------------------------------
devices have similar technological characteristics, and any minor differences do 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 safey testing in accordance with IEC 60601-1-2 (2008), IEC 60601-1 (2005), and IEC 60825-1 (1993 + A1 (1997) + A2 (2001). respectively. 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 is at least as safe and effective as the predicate devices as demonstrated by the results of bench and clinical data reported in literature, including the phantom study and the published clinical literature described below.
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 is substantially equivalent to the performance of INVOS at measuring regional hemoglobin oxygen saturation; and ETG at measuring relative levels of oxygenated hemoglobin and deoxygenated hemoglobin.
Published Clinical Literature
Bickler et al reported on a clinical study that directly compared the performance of NIRO-200NX and INVOS to each other (along with several other cleared devices) and to results of a blood draw in a clinical setting. The evaluation was performed in 23 individuals with 181 individual measurements taken for INVOS and 179 individual measurements taken for NIRO-200NX. The study subjects included those with light, intermediate and dark skin. The study results showed substantially equivalent performance between NIRO-200NX and INVOS in a clinical setting at measuring regional hemoglobin oxygen saturation.
The above information leads to the conclusion that the NIRO-200NX is substantially equivalent to the predicate devices. The Substantial Equivalence comparison chart is found below in Table 1.
{6}------------------------------------------------
Table 1
| NIRO-200NXHamamatsu Photonics K.K.(New Device) | ETG-100 and ETG-4000Hitachi Medical Systems America, Inc(ETG-100 for K011320)(ETG-4000 for K042501) | INVOS 5100CSomanetics Corporation(K082327) | |
|---|---|---|---|
| INTENDEDUSE | Oximeter (MUD, DQA) | Oximeter (DQA) | Oximeter (MUD) |
| INDICATIONSFOR USE | The NIRO-200NX is intended foruse as an adjunct trend monitor ofregional hemoglobin oxygensaturation and relative level ofoxygenated hemoglobin anddeoxygenated hemoglobin of bloodin brain or in other tissue beneath theprobes in any individual. The clinicalvalue of trend data has not beendemonstrated in disease states. TheNIRO-200NX should not be used asthe sole basis for diagnosis ortherapy. | A) K011320The intended use of the ETG-100 isthe measurement of relative levels ofcerebral deoxy-hemoglobin andoxyhemoglobin.B) K042501The intended use of the ETG-4000is the measurement of relative levelsof cerebral deoxy-hemoglobin andoxyhemoglobin. | The noninvasive INVOS 5100C isintended for use as an adjunctmonitor or regional hemoglobinoxygen saturation of blood in thebrain or in other tissue beneath thesensor. It is intended for use inindividuals greater than 2.5kg at riskfor reduced-flow or no-flow ischemicstates.It is also intended for use as anadjunct trend monitor of regionalhemoglobin oxygen saturation ofblood in the brain or in other tissuebeneath the sensor in any individual.The clinical value of trend data hasnot been demonstrated in diseasestates. The INVOS System shouldnot be used as the sole basis fordiagnosis or therapy. |
{7}------------------------------------------------
| NIRO-200NXHamamatsu Photonics K.K.(New Device) | ETG-100 and ETG-4000Hitachi Medical Systems America, Inc(ETG-100 for K011320)(ETG-4000 for K042501) | INVOS 5100CSomanetics Corporation(K082327) | |
|---|---|---|---|
| PRINCIPLEOFOPERATION | The patient probe consists of a lightsource (2 wavelengths) and 1detector, and it is applied to the skinover the tissue of interest.Relative levels of oxy-hemoglobin,deoxy-hemoglobin and totalhemoglobin are calculated from thechanges in the amount of thedetected lights by one detector. | The patient probe consists of a lightsource (2 wavelengths) and 2detectors, and it is applied to the skinover the tissue of interest.Hemoglobin oxygen saturation(rSO2) is calculated from thedifference of the amount of detectedlights by the 2 detectors. | The patient probe consists of a lightsource (3 wavelengths) and 2detectors, and it is applied to the skinover the tissue of interest.Hemoglobin oxygen saturation (TOI)is calculated from the differences ofthe amount of detected lights by the 2detectors. Relative value of the totalhemoglobin (nTHI) is calculated bythe same methods as that of TOI.Relative levels of oxygenated,deoxygenated and totalhemoglobines (△O2Hb, △HHb and△cHb) are calculated from thechanges in the amount of thedetected lights by one detector. |
{8}------------------------------------------------
TECHNOLOGICAL CHARACTERISTICS
| NIRO-200NXHamamatsu Photonics K.K.(New Device) | ETG-100 and ETG-4000Hitachi Medical Systems America, Inc(ETG-100 for K011320)(ETG-4000 for K042501) | INVOS 5100CSomanetics Corporation(K082327) | |
|---|---|---|---|
| Light SourceDeviceWavelengthSafety Class | LED (Light Emitting Diode)3 wavelengthsClass I | LD (Laser Diode)2 wavelengthsClass I | LED2 wavelengthsClass I |
| Light Detector | Photodiode | Photomultiplier Tube | Photodiode |
| MeasurementMethod | 2 Point Detection Method forHemoglobin Oxygen Saturation(TOI) and Relative value of the totalhemoglobin (nTHI)1 Point Detection Method forRelative Levels of Hemoglobins | Not applicable. Not measured bythis device.1 Point Detection Method forRelative Levels of Hemoglobins | 2 Point Detection Method forHemoglobin Oxygen Saturation(rSO2)Not applicable. Not measured bythis device. |
| PatientContact | Non-Invasive | Non-Invasive | Non-Invasive |
| EMC andElectricalSafety | Passed applicable safety testing | Passed applicable safety testing | Passed applicable safety testing |
§ 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).