The Nihon Kohden TG-970P Series 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.

Device Description

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. The airway adapter is a Single -Patient Use disposable product.

The device is intended as an indicator of patient carbon dioxide concentration during expiration for intubated patients. The device is intended for use with patients weighing 7kg or more. The device is not recommended for patients with low tidal volume such as patients weighing less than 7kg or patients with a respiration rate greater than 150 breaths per minute.

AI/ML Overview

This document is a 510(k) Summary for a medical device (CO2 Sensor Kit) and does not contain detailed information about a specific study with acceptance criteria and reported device performance. It primarily focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information from the given text. The document states:

"The device performance and specifications are consistent with all requirements for this device type."
"To date, no performance standards or special controls are known or established for this type of device."
"The device was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the safety and efficacy of the device under intended operation for this device."

However, it does not provide the specific acceptance criteria, reported device performance data, sample sizes, ground truth establishment, or details of efficacy studies (such as MRMC or standalone performance) that typically accompany such claims in a detailed study report. The intent of this 510(k) summary is to assert equivalence rather than present original performance study data against specific criteria.

Summary

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NIHON KOHDEN AMERICA, INC.

SPECIAL 510(k) NOTIFICATION TG-970P Series CO2 Sensor Kit

08345

SECTION 2 - 510(K) SUMMARY

Name and Address of Applicant

Nihon Kohden America, Inc. 90 Icon Street Foothill Ranch, CA 92610

Contact: Jack Coggan 、 Director, Regulatory Affairs (949) 580-1555 ex. 3325 Fax: (949) 580-1550

Trade/Device Name:

Nihon Kohden TG-970P Series CO2 Sensor Kit

MAR - 2 2009

Common or Usual Name:

Capnometer, Carbon Dioxide (CO2) Analyzer, Carbon Dioxide (CO2) Indicator

Classification Name:

The device has been classified as Class II by the Division of Anesthesiology Devices and Anesthesiology Classification Panel under 21 CFR Part 868.1400 "Analyzer. Gas. Carbon dioxide, Gaseous-phase" as per part 73 CCK.

Legally Marketed Predicate Device:

Nihon Kohden TG-920P CO2 Sensor Kit as per 510(k) K040875 commercial distribution certification dated October 15, 2004.

Intended Use:

A summary of the technological characteristics of the device:

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510(k) Summary:

The device is not sterile. ●
. The device performance and specifications are consistent with all requirements for this device type. To date, no performance standards or special controls are known or established for this type of device. The device was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the safety and efficacy of the device under intended operation for this device.

Therefore, Nihon Kohden believes that the TG-970P Series CO2 Sensor Kit device is substantially equivalent to Nihon Kohden's predicate device TG-920P CO2 Sensor Kit.

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Image /page/2/Picture/1 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 an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 2 2009

Mr. Jack Coggan Director of Regulatory Affairs/Quality Assurance Nihon Kohden America, Incorporated 90 Icon Street Foothill Ranch, California 92610-1601

Re: K083456

Trade/Device Name: TG-970P Series CO2 Sensor Kit Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: January 29, 2009 Received: February 2, 2009

Dear Mr. Coggan:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Coggan

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); good manufacturing practice requirements as set forth in 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Suite y. Michlene Dns.

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NIHON KOHDEN AMERICA, INC.

SPECIAL 510(k) NOTIFICATION TG-970P Series CO2 Sensor Kit

G. Indications for Use Statement:

510(k) Number (if known):

Device Name: TG-970P Series CO2 Sensor Kit

ﺷﻴﺐ

Indications of Use:

Over The Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Souge L. Mocheil m.d.
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K083456

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).