Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a direct measurement and calculation method based on light absorption characteristics, with no mention of AI/ML algorithms or training/test data.

Therapeutic

No
Explanation: The device is described as an "adjunct trend monitor" that provides measurements of regional hemoglobin oxygen saturation and relative levels of oxygenated and deoxygenated hemoglobin. Its intended use explicitly states it "should not be used as the sole basis for diagnosis or therapy," indicating it is a diagnostic or monitoring tool, not a therapeutic one.

Diagnostic

No

The "Intended Use / Indications for Use" states, "The NR0-200NX should not be used as the sole basis for diagnosis or therapy." This indicates it's an adjunct monitor, not a primary diagnostic tool.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "reusable piece of equipment" with "patient probes" that have a "light source and 2 photodiodes," indicating it includes hardware components for data acquisition.

IVD (In Vitro Diagnostic)

Based on the provided information, the NIRO-200NX is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states that the device is 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 non-invasive measurement of physiological parameters directly from the patient's body.
Device Description: The description details the use of near-infrared light applied to the skin and detected by photodiodes to analyze light transmitted through the patient's tissue. This is a non-invasive, in vivo measurement technique.
Lack of mention of biological samples: IVD devices typically involve the analysis of biological samples (blood, urine, tissue, etc.) outside of the body. The description of the NIRO-200NX does not mention the collection or analysis of any such samples.

In summary, the NIRO-200NX operates by directly measuring physiological parameters within the patient's body using non-invasive methods, which is characteristic of a medical device for in vivo monitoring, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

MUD, DQA

Device Description

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.

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

Not Found

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)

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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K082327, K011320, K042501

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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

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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)

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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.

1. Electrical per IEC 60601-1
1. Electromagnetic Compatibility per IEC 60601-1-2
1. 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.

1. 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 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

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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.

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Table 1

| | NIRO-200NX
Hamamatsu Photonics K.K.
(New Device) | ETG-100 and ETG-4000
Hitachi Medical Systems America, Inc
(ETG-100 for K011320)
(ETG-4000 for K042501) | INVOS 5100C
Somanetics Corporation
(K082327) |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED
USE | Oximeter (MUD, DQA) | Oximeter (DQA) | Oximeter (MUD) |
| INDICATIONS
FOR 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. | A) K011320
The intended use of the ETG-100 is
the measurement of relative levels of
cerebral deoxy-hemoglobin and
oxyhemoglobin.

B) K042501
The intended use of the ETG-4000
is the measurement of relative levels
of cerebral deoxy-hemoglobin and
oxyhemoglobin. | The noninvasive INVOS 5100C is
intended for use as an adjunct
monitor or regional hemoglobin
oxygen saturation of blood in the
brain or in other tissue beneath the
sensor. It is intended for use in
individuals greater than 2.5kg at risk
for reduced-flow or no-flow ischemic
states.

It is also intended for use as an
adjunct trend monitor of regional
hemoglobin oxygen saturation of
blood in the brain or in other tissue
beneath the sensor in any individual.
The clinical value of trend data has
not been demonstrated in disease
states. The INVOS System should
not be used as the sole basis for
diagnosis or therapy. |

7

| NIRO-200NX
Hamamatsu Photonics K.K.
(New Device) | ETG-100 and ETG-4000
Hitachi Medical Systems America, Inc
(ETG-100 for K011320)
(ETG-4000 for K042501) | INVOS 5100C
Somanetics Corporation
(K082327) | |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PRINCIPLE
OF
OPERATION | The patient probe consists of a light
source (2 wavelengths) and 1
detector, and it is applied to the skin
over the tissue of interest.
Relative levels of oxy-hemoglobin,
deoxy-hemoglobin and total
hemoglobin are calculated from the
changes in the amount of the
detected lights by one detector. | The patient probe consists of a light
source (2 wavelengths) and 2
detectors, and it is applied to the skin
over the tissue of interest.
Hemoglobin oxygen saturation
(rSO2) is calculated from the
difference of the amount of detected
lights by the 2 detectors. | The patient probe consists of a light
source (3 wavelengths) and 2
detectors, and it is applied to the skin
over the tissue of interest.
Hemoglobin oxygen saturation (TOI)
is calculated from the differences of
the amount of detected lights by the 2
detectors. Relative value of the total
hemoglobin (nTHI) is calculated by
the same methods as that of TOI.
Relative levels of oxygenated,
deoxygenated and total
hemoglobines (△O2Hb, △HHb and
△cHb) are calculated from the
changes in the amount of the
detected lights by one detector. |

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TECHNOLOGICAL CHARACTERISTICS

| | NIRO-200NX
Hamamatsu Photonics K.K.
(New Device) | ETG-100 and ETG-4000
Hitachi Medical Systems America, Inc
(ETG-100 for K011320)
(ETG-4000 for K042501) | INVOS 5100C
Somanetics Corporation
(K082327) |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Light Source
Device
Wavelength
Safety Class | LED (Light Emitting Diode)
3 wavelengths
Class I | LD (Laser Diode)
2 wavelengths
Class I | LED
2 wavelengths
Class I |
| Light Detector | Photodiode | Photomultiplier Tube | 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 | Not applicable. Not measured by
this device.

1 Point Detection Method for
Relative Levels of Hemoglobins | 2 Point Detection Method for
Hemoglobin Oxygen Saturation
(rSO2)