The Nihon Kohden TG-970P and 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 and is available for use on any patient weighing 2kg or more.

Device Description

The TG-970P Series CO2 Sensor Kit 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. The CO2 Sensor incorporates an infrared light source, of specified wavelength, and an infrared detector. The photo detector and light emitter end of the CO2 sensor is connected to an airway adapter. The airway adapter is connected between the patient airway and the respirator. As the patient completes an expiratory breath the sensor measures the CO2 levels in the expiratory breath and sends that data to the CO2 adapter. The adapter then reads the data and converts the data so it can be displayed on the patient monitor.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Nihon Kohden TG-970P Sensor Kit with the new Airway Adaptor, based on the provided document:

Acceptance Criteria and Device Performance

The core of this submission is about demonstrating that the new YG-213T airway adapter for the existing TG-970P CO2 Sensor Kit is substantially equivalent to the predicate device, specifically extending its use to smaller patients (2kg to 7kg). The acceptance criteria are implicitly tied to maintaining the accuracy and safety established by the predicate device (TG-970P with YG-211T) for this new patient population.

Table of Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria (Predicate YG-211T Performance/Expectation for YG-213T)	Reported Device Performance (YG-213T)	Comments
Intended Use	To measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status.	Same (with extended patient population)	The new airway adapter (YG-213T) expands the patient population from >7kg to 2kg or more, while maintaining the same fundamental intended use.
Use Frequency	Single Patient Use	Same	No change.
Shelf Life	36 months	Same	No change.
Patient Population	For patients more than approx. 7kg.	For patients 2kg to 7kg.	This is the primary change and where the new adapter needs to demonstrate equivalence. The document states: "Validation/verification testing confirms that the accuracy of the measured gas is substantially equivalent to the predicate device. No new questions of safety or effectiveness were raised." This implies the acceptance criteria for accuracy (e.g., within a certain deviation from a reference measurement) were met for this new population. However, the specific quantifiable accuracy criteria are not explicitly detailed in the provided text.
Dead Space	4mL (with YG-211T)	1mL (with YG-213T)	The dead space changed due to the smaller airway adapter. The document states: "Validation/verification testing confirms that the smaller dead space does not affect the accuracy of the measured gas and is substantially equivalent to the predicate device. No new questions of safety or effectiveness were raised." This implies that despite the change, the impact on measurement accuracy remained within acceptable limits.
Function	Airway adapter with windows through which infrared light of the CO2 sensor kit can pass, connected to respiratory circuit.	Same	No change to the fundamental principle.
Transmissivity	More than approx 45% (at 4.27um±0.02um)	Same	The optical properties of the window material are maintained.
Optical Length	6mm±0.2mm	Same	The physical dimension crucial for CO2 measurement is maintained.
Antifogging Performance (Ratio of fog)	Less than 5% (at 15°C to 35°C, 20% to 80RH, 10 minutes later)	Same	Critical for maintaining optical clarity and accurate readings in challenging environments.
Antifogging Performance (Ratio of Wet)	Less than ±8% (at 15°C to 35°C, 20% to 80RH, 10 minutes later)	Same	Critical for maintaining optical clarity and accurate readings when moisture is present.
Continuous Use Time	24 hours (for predicate YG-211T)	72 hours (for YG-213T)	This is an improvement in performance. The document states: "Validation/verification testing confirms that the accuracy of the measured gas is not changed with longer continuous use time. No new questions of safety or effectiveness were raised." This indicates that the device met its accuracy criteria even over the extended 72-hour period.
Safety Standards	Compliance with relevant IEC and ISO standards	IEC 60601-1, IEC 60601-1 Amendment 1 & 2, ISO 10993-1, ISO 14971	The new adapter maintains compliance with these regulatory standards, indicating safety and risk management are addressed.

Study Information

The document describes a "verification and validation testing" process to demonstrate substantial equivalence, rather than a formal human clinical trial in the traditional sense.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the sample size for the test set used in the verification/validation testing.
- Data Provenance: The document does not explicitly state the country of origin for the data. Given the company (Nihon Kohden Corporation) and Nihon Kohden America, Inc. being the sponsor, it's likely the testing was conducted by or in collaboration with the manufacturer, potentially in Japan or the US, but this is not confirmed. The study appears to be retrospective in the sense that the testing was performed to validate a design change rather than a new device from scratch with prospective patient enrollment. However, the exact nature of the testing (e.g., simulated breath patterns, animal models, limited human subjects) is not detailed.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not mention the use of experts to establish ground truth for a test set. This type of device relies on objective physical measurements of CO2 concentration rather than subjective interpretation like medical images. Ground truth would typically be established by a highly accurate reference gas analyzer or a calibrated gas mixture.
Adjudication Method for the Test Set:
- Not applicable. As the "ground truth" for a CO2 sensor is a quantitative physical measurement (e.g., from a reference gas analyzer or known gas concentration), an adjudication method by human experts is not relevant.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and comparing human performance with and without AI assistance. The Nihon Kohden TG-970P is a CO2 sensor, which provides objective physiological measurements, not an AI-assisted diagnostic tool for human interpretation.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, implicitly. The "verification and validation testing" performed by Nihon Kohden to confirm the accuracy of the measured gas and the substantial equivalence to the predicate device would be a standalone performance assessment of the device, independent of human operators, beyond the normal operation. The device essentially is the algorithm/measurement system for CO2 concentration. However, it's important to clarify that this isn't an "AI algorithm" in the conventional sense (e.g., for image recognition or predictive analytics), but rather the performance of a physical sensor and its associated signal processing.
Type of Ground Truth Used:
- The ground truth would have been established using reference gas mixtures with known CO2 concentrations or a highly accurate and calibrated reference CO2 analyzer. The document refers to "accuracy of the measured gas," implying comparison against a standard. It does not mention pathology or outcomes data.
Sample Size for the Training Set:
- Not applicable in the typical AI/ML sense. The Nihon Kohden TG-970P is a hardware device based on infrared absorption principles, not a machine learning algorithm that undergoes a "training" phase with a dataset. The design and calibration would have been based on physical principles and engineering specifications, not statistical learning from a training set.
How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 7.

Summary

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KIZZZIY

Nihon Kohden America, Inc. Revised May 3, 2013

510(k) Notification TG-970P Sensor Kit w/new Airway Adaptor

510(k) Summary

MAY 2 1 2013

Company Name:	Nihon Kohden Corporation 90 Icon Street Foothill Ranch, CA 92610
Device Name:	Nihon Kohden TG-970P CO2 Sensor Kit w/new Airway Adaptor
510(k) Sponsor, Contact:	Nihon Kohden America, Inc. 90 Icon Street Foothill Ranch, CA 92610 Steve Geerdes Director Quality Assurance and Regulatory Affairs Phone: (949) 580-1555 Ext. 3325 Fax: (949) 580-1550
Summary Date:	Revised 05/03/2013
Common Name:	Carbon Dioxide (CO2) Analyzer
Classification Names:	Anesthesiology Device868.1400CCK	Anesthesiology Device	868.1400	CCK
Anesthesiology Device	868.1400	CCK
Predicate Device(s):

Predicate Device(s):

TG-970P CO2 Sensor Kit

1.0 Description of Device

K083456

Depending on which airway adapter is used, the TG-970 can be used with patients weighing 2kg or more. The device is not recommended for patients weighing less than 2kg or patients with a respiration rate greater than 150 breaths per minute.

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Nihon Kohden America, Inc. Revised May 3, 2013

510(k) Notification TG-970P Sensor Kit w/new Airway Adaptor

Image /page/1/Figure/2 description: This image shows the parts of a CO2 adapter. The parts include a photo detector and light emitter, a CO2 adapter connector, a JG-970P CO2 adapter, and a TG-221T CO2 sensor. The image also shows an airway adapter, a transparent film, and the connection points to the mask or tracheal tube and to the resuscitation bag or respirator.

2.0 -Intended Use of Device

The device is intended for use by qualified medical personnel within a hospital or clinical environment and is available for use on any patient weighing 2kg or more.

3.0 Technical Characteristics

The Nihon Kohden CO2 Sensor Kit, model number TG-970P Series, 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.

	Modified Device	Predicate Device	Comments
Product	TG-970P with YG-213Tairway adapter	TG-970P with YG-211Tairway adapter (K#083456)
Intended Use	To measure the	Same
	Modified Device	Predicate Device	Comments
Product	TG-970P with YG-213Tairway adapter	TG-970P with YG-211Tairway adapter (K#083456)
	concentration of carbondioxide in a gas mixture toaid in determining thepatient's ventilatory status
Use frequency	Single Patient Use	Same
Shelf life	36 months	Same
Population	YG-213T: For patients 2kg to7kg.	For patients more thanapprox. 7kg.	Technology & materialsare substantially equivalentto the predicate device.Validation/verificationtesting confirms that theaccuracy of the measuredgas is substantiallyequivalent to the predicatedevice. No new questionsof safety or effectivenesswere raised
Dead space	1mL	4mL	The change in dead spaceis due to smaller airwayadapter.Validation/verificationtesting confirms that thesmaller dead space doesnot affect the accuracy ofthe measured gas and issubstantially equivalent tothe predicate device. Nonew questions of safety oreffectiveness were raised
Function	Airway adapter with windowswhich infrared light of the CO2sensor kit can pass through isconnected to respiratorycircuit.	Same
Specifications
Transmissivity	More than approx 45%(at 4.27um±0.02um)	Same
	Modified Device	Predicate Device	Comments
Product	TG-970P with YG-213Tairway adapter	TG-970P with YG-211Tairway adapter (K#083456)
Optical length	6mm±0.2mm	Same
Ratio ofantifoggingperformance :fog	Ratio of fog: less than 5%(at15°Cto35°C 20% to 80RH 10minutes later)	Same
Ratio ofantifoggingperformance: Wet	Ratio of Wet: less than ±8%(at 15°C to 35°C, 20% to 80RH10 minutes later)	Same

Technical Comparison

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Nihon Kohden America, Inc. Revised May 3, 2013

510(k) Notification

TG-970P Sensor Kit w/new Airway Adaptor

Page 3 of 3

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Nihon Kohden America, Inc. Revised May 3, 2013

510(k) Notification

TG-970P Sensor Kit w/new Airway Adaptor

Environment
Facility	Hospitals, Clinics, Physician office	Same
		Same
		Same
Operating environment	10 to 40 degree C30 to 85%RH, non condensing	Same
Storage environment	-20 to 65 degree C10 to 95%RH	Same
Chemical resistance	This product cannot becleaned or disinfected.	Same
Sterilization	No	No
Continuation use time	72 hours	24 hours	Validation/verification testing confirms that the accuracy of the measured gas is not changed with longer continuous use time.No new questions of safety or effectiveness were raised

4.0 Data Summary

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Testing of the Nihon Kohden TG-970P with new YG-213T Neonatal/Infant Airway Adapter was performed in compliance with Nihon Kohden Corporation design control process. Testing included:

The device is in compliance with the following voluntary industrial standards:

Medical Electrical Equipment

IEC 60601-1	Part 1: General requirements for safety 1998-12
IEC 60601-1, Amendment 1	Part 1: General Requirements for safety, Amendment 1 1991-11
IEC 60601-1, Amendment 2	Part 1: General Requirements for safety, Amendment 2 1995-03
ISO 10993-1	Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing, 2003-08

Medical Devices - Application of Risk Management to Medical Devices, 2007

5.0 Conclusions

ISO 14971

TG-970P CO2 Sensor Kit was previously cleared in K083456 and the airway adaptor cleared with the TG-970P (YG-211T) is capable of accurately measuring CO2 in the patient's airway during expiration on patients 7kg or larger. A new airway adapter (YG-213T) is being added to the TG-970P. This will allow the TG-970P to accurately measure CO2 in the patient's airway during expiration on patients 2kg or larger.

The technology of the photo detector and light emitter of the TG-970P has not changed. The only change is the new YG-213T airway adapter which has under gone verification and validation testing.

Based on the comparison in the technical comparison chart above and confirmed by verification/validation testing in compliance with the Design Control requirements. The intended use, technology and materials of the YG-213T Airway Adapter was shown to be equivalent in safety and effectiveness to the predicate devices YG-211T and YG-211TW which are accessories of the TG-970P CO2 Sensor Kit K083456 (TG-970P). No new questions of safety or effectiveness are raised.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing a bird, representing the department's mission to protect and promote the health and well-being of Americans.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

May 21, 2013

Mr. Steve Geerdes Director of Regulatory Affairs and Quality Assurance Nihon Kohden Corporation 90 Icon Street FOOTHILL RANCH CA 92610

Re: K122214

Trade/Device Name: Nihon Kohden TG-970P Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: May 8, 2013 Received: May 9, 2013

Dear Mr. Geerdes:

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.

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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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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 yours,

Kwame O. Ulmer -S for

Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use Form

510(k) Number (if known): K122214

Nihon Kohden TG-970P Device Name:

Indications for Use:

The device is intended for use by qualified medical personnel within a hospital or clinical environment and is available for use on any patient weighing 2kg or more.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off Office of In Device Evaluation 510(k)

Lester W. Schultheis Jr
2013.05.21[13:40:16-04'00']

510(k) Number:

Page 1 of

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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).