The Nihon Kohden TG-970P CO2 sensor kit is intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status. Along with other methods indicated by the physician for medical diagnosis, this device is intended as an indicator of patient carbon dioxide concentration during expiration.

The device is intended for use by qualified medical personnel within a hospital or clinical environment.

Device Description

The TG-970P CO2 Sensor Kit measures the partial pressure of the expired CO2 of the patient by measuring the amount of absorbed CO2 infrared light, using a CO2 feature which absorbs infrared light. It is comprised of three main components; a CO2 Sensor (photo detector and light emitter) with cable and connector, a CO2 adapter and an airway adapter (YG-211T, YG-213T and YG-214T) or mask (YG-232T and YG-242T).

The CO2 Sensor incorporates an infrared light source, of specified wavelength, and an infrared detector. It detects the infrared light from the light emitter which passes through the expired air in the airway adapter and calculates the partial pressure of the expired CO2. The photo detector and light emitter end of the CO2 Sensor is connected to the airway adapter or mask. The airway adapter is then connected between the patient airway and the respirator. The CO2 adapter processes the electrical signal of the detected infrared light into digital data which is sent to the instrument.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Nihon Kohden TG-970P CO2 Sensor Kit. The submission focuses on demonstrating substantial equivalence to a predicate device (K122214) rather than presenting a detailed acceptance criteria table and a comprehensive study for a novel device. Therefore, much of the requested information cannot be directly extracted as it pertains to AI/algorithm-based devices or detailed clinical performance studies, which are not the primary focus of this submission.

However, I can extract information related to the changes made and the testing performed to demonstrate substantial equivalence for the modified device.

Here's the breakdown of the information that can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance:

The document primarily focuses on demonstrating substantial equivalence through design verification/validation testing of the modifications made to the device, particularly the new airway adapter and durability improvements. It doesn't present a table of specific acceptance criteria with corresponding performance metrics in a quantitative manner typical of a new device's performance study. Instead, it states that modifications "do not impact the intended use of the device" or are "equivalent in safety and effectiveness."

Acceptance Criteria (Inferred from changes)	Reported Device Performance (as stated)
YG-214T/TW (new airway adapter) equivalence to YG-213T/TW:	"The new airway adapter YG-214T/TW is being added and is considered substantially equivalent to YG-213T/TW." "An additional accessory, airway adapter YG-214T/TW, has been shown to be equivalent to the predicate, YG-213T/TW."
YG-214T/TW (new airway adapter) impact on intended use:	"It was assessed through design verification/validation testing that this modification does not impact the intended use of the device."
Updated dead space calculation for YG-213T/TW:	"Bench testing was conducted to confirm the calculation." "This change does not impact the intended use of the device."
Device durability improvement:	"Bench testing was conducted to evaluate this change and this modification does not impact the intended use of the device."
Maintenance of CO2 waveform with YG-213T:	"Confirmation of CO2 waveform with YG-213T on the bench test."
CO2 waveform with YG-214T:	"YG-214T bench test for CO2 waveform."
Minimal dead space for neonate/infant use:	"It has been shown that the minimal dead space in the YG-213T/TW and YG-214T/TW airway adapters allows monitoring at low tidal volumes,"
Biocompatibility:	"YG-211T/YG-213T/YG-214T Biocompatibility evaluation" (implies successful evaluation)

2. Sample size used for the test set and the data provenance:

The document mentions "bench testing," "design verification/validation testing," and "clinical evaluation for prototype of a new neonatal airway adapter." However, specific sample sizes (e.g., number of test specimens, number of patients) for these tests are not provided. The provenance of the data is generally from the manufacturer, Nihon Kohden Corporation (Japan and USA). The nature of the studies ("clinical evaluation for prototype") suggests prospective testing, but without detailed protocols, it's hard to confirm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The testing described appears to be primarily benchtop and engineering design verification, which might not involve external experts in the same way clinical ground truth establishment for AI models would.

4. Adjudication method for the test set:

This information is not applicable/provided. The studies described are not focused on interpreting results where adjudication by multiple experts would be needed.

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:

This is not applicable. The device is a CO2 sensor kit, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

While the device (CO2 sensor) operates in a "standalone" fashion to measure CO2, the concept of "standalone performance" as it applies to AI algorithms is not applicable here. The sensor provides raw data (CO2 concentration) to aid medical personnel.

7. The type of ground truth used:

For the performance testing, the "ground truth" would implicitly be established through engineering measurement standards and validated measurement techniques (e.g., highly accurate CO2 gas analyzers or calibrated flow and gas systems for bench testing). For the "clinical evaluation," the ground truth for physiological parameters (like CO2 in expired air) would be the actual physical/chemical concentration measured by a reference method. The document states, "The TG-970P CO2 Sensor Kit... is capable of accurately measuring CO2 in the patient's airway during expiration," implying a comparison against an accurate reference.

8. The sample size for the training set:

This is not applicable. The device is not an AI/machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:

This is not applicable. The device is not an AI/machine learning algorithm that requires a training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 24, 2017

Nihon Kohden Corporation Thomas Bento Sr. Vice President, Quality and Regulatory Affairs Nihon Kohden America, Inc. 15353 Barranca Parkway Irvine, California 92618

Re: K161860

Trade/Device Name: TG-970P CO2 Sensor Kit Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: January 23, 2017 Received: January 24, 2017

Dear Thomas Bento:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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" (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,

Susan Runne, DDS, MA

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name Nihon Kohden TG-970P CO2 Sensor Kit

Indications for Use (Describe)

The device is intended for use by qualified medical personnel within a hospital or clinical environment.

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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Traditional 510(k) Summary

Company Name:	Nihon Kohden Corporation1-31-4 Nishiochiai, 1-Chome, Shinjuku-KuTokyo, Japan 161-18560
Phone number:	81-2-59968020
510(k) Sponsor,Contact:	Nihon Kohden America, Inc.15353 Barranca ParkwayIrvine, CA 92618Thomas BentoSr. VP Quality Assurance and Regulatory AffairsOffice: (949) 580-1555 x3324Mobile: (949) 680-9048Fax: (913) 273-0732
Date Prepared:	February 22, 2017
Device Name:	Nihon Kohden TG-970P CO2 Sensor Kit
Common Name:	Carbon Dioxide (CO2) Gas Analyzer

Classification:

The device has been classified as Class II per the Division of Anesthesiology Devices.

Carbon Dioxide (CO2) Gas Analyzer	868.1400	CCK
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Predicate Device(s): Nihon Kohden TG-970P CO2 Sensor Kit (K122214)

1.0 Description of Device

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2.0 Indications For Use

The Nihon Kohden TG-970P CO2 sensor kit is intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status. Alonq with other methods indicated by the physician for medical diagnosis, this device is intended as an indicator of patient carbon dioxide concentration during expiration.

The device is intended for use by qualified medical personnel within a hospital or clinical environment.

3.0 Technical Characteristics

The Nihon Kohden CO2 Sensor Kit, model number TG-970P, is intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory (end tidal CO2) status. The device measuring technique is through absorption of infrared radiation.

4.0 Substantial Equivalence

The technology, performance and materials of the Nihon Kohden TG-970P CO2 Sensor Kit, with airway adapters YG-213T and YG-214T, is substantially equivalent to the predicate device, the Nihon Kohden TG-970P CO2 Sensor Kit with airway adapter YG-213T (K122214). Differences between the devices are minor and are described below.

4.1 The new airway adapter YG-214T/TW is being added and is considered substantially equivalent to YG-213T/TW. The difference between the YG-213T/TW and YG-214T/TW is that the YG-214T/TW does not have an inner connection tube, which allows it to be connected to other types of respirators that have an existing inner connection tube. There is no change to the materials. It was assessed through design verification/validation testing that this modification does not impact the intended use of the device.
4.2 The dead space calculation for airway adapter YG-213T/TW has been updated to better simulate the clinical setting. The connection between the adapter and the endotracheal tube overlap in the respiration circuit and the actual dead space volume is decreased by the connecting parts. Bench testing was conducted to confirm the calculation. This change does not impact the intended use of the device.
4.3 The device durability of the airway adapter was improved by changing the outer shape where the user holds the device for connecting and disconnecting. The thickness of this area has increased. Bench testing was conducted to evaluate this change and this modification does not impact the intended use of the device.
4.4 The intended use of the TG-970P has not changed as a result of the above described modifications. The neonate/infant airway adapters, YG-213T/TW and YG-214T/TW, may be used for intubated neonates and infants, using an endotracheal tube size of ≤ 4.0 mm. It has been shown that the minimal dead space in the YG-213T/TW and YG-214T/TW airway adapters allows monitoring at low tidal volumes

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which helps identify the intended patient population, as described in the literature review letter and bench testing. The proposed labeling for YG-213T/TW and YG-214T/TW would remove the current patient weight requirement of 2-7kg and recommend the intended population based on the endotracheal tube size and dead space volume of the airway adapters. The physician should determine the total dead space of the capnography setup with all other connected equipment to determine the appropriate airway adaptor based on the individual patients tidal volume and weight. Warnings and Caution statements are provided in the Operators Manual on p. 3.

5.0 Performance Testing

The following tests were identified and performed based on the modifications made to the device.

Clinical evaluation for prototype of a new neonatal airway adapter with no inner ● tube, applied to patient mouth
Confirmation of CO2 waveform with YG-213T on the bench test .
. Design change evaluation for YG-213T shape
. YG-214T bench test for CO2 waveform
Airway adapter for neonate and infant YG-214T, 214-TW dead space volume ●
Evaluation of reducing mechanical burden on the sensor part due to YG-214T ● shape change
YG-214T/214-TW device detailed design specification conformity evaluation
. YG-211T/YG-213T/YG-214T Biocompatibility evaluation

6.0 Conclusions

The TG-970P CO2 Sensor Kit was previously cleared in K122214 and the airway adapter (YG-213T/TW) cleared with the TG-970P is capable of accurately measuring CO2 in the patient's airway during expiration. The technology of the photo detector and light emitter of the TG-970P has not changed. An additional accessory, airway adapter YG-214T/TW, has been shown to be equivalent to the predicate, YG-213T/TW.

The intended population for the YG-213T and YG-214T airway adapters is for neonates and infants. Removal of the patient weight from the labeling is supported by literature and similar products. Furthermore, a recommended endotracheal tube size has been added to the labeling. Additionally, the dead space has been updated for YG-213T, which also further identifies the intended patient population. The device durability was also improved by changing the outer shape where the user holds the device for connecting and disconnecting. Based on a literature review and verification/validation testing in compliance with the Design Control requirements, these airway adapters are shown to be equivalent in safety and effectiveness to the predicate device.

Regulation Number and Section

§ 868.1400 Carbon dioxide gas analyzer.

(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).