NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES

K990063 · Nihon Kohden America, Inc. · CCK · Jun 9, 1999 · Anesthesiology

Device Facts

• Record ID: K990063
• Device Name: NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES
• Applicant: Nihon Kohden America, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Jun 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Nihon Kohden TG-901T CO2 Sensor 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. The device is intended as an indicator of patient carbon dioxide concentration during expiration and is not intended as the sole basis for medical diagnosis. This device is intended for use with patients three (3) years of age and older. This device is not recommended for patients with low tidal volume such as patients younger than three (3) years of age or weighing less 22 pounds or patients with a respiration rate greater than or equal to 60 breaths per minute.

Device Story

The TG-901T CO2 Sensor Kit measures carbon dioxide concentration in gas mixtures during expiration. It functions as a CO2 indicator to assist clinicians in evaluating patient ventilatory status. The device is not intended for use as the sole basis for medical diagnosis. It is designed for patients aged 3 years and older, excluding those with low tidal volume or high respiratory rates (≥60 bpm). The device provides CO2 concentration data to healthcare providers to inform clinical decision-making regarding patient ventilation. It is intended for use in clinical settings.

Clinical Evidence

Bench testing only. The device underwent electromagnetic, environmental, safety, and performance testing procedures to verify operation.

Technological Characteristics

Gas analyzer for carbon dioxide (21 CFR 868.1400). Non-sterile. Operates as a CO2 indicator for expiratory gas monitoring.

Indications for Use

Indicated for patients 3 years and older to measure expiratory CO2 concentration to aid in assessing ventilatory status. Contraindicated for patients <3 years old, <22 lbs, or with respiration rates ≥60 breaths per minute.

Regulatory Classification

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.

Predicate Devices

• OLG-1100A PocketCap CO2 Monitor (K964305)

Submission Summary (Full Text)

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NIHON KOHDEN January 7, 1999

510(k) NOTIFICATION TG-901T CO2 Sensor Kit

SECTION 2 - 510(K) SUMMARY

Name and Address of Applicant Nihon Kohden America, Inc. Attn: Regulatory Affairs 2601 Campus Drive Irvine, California 92612-1601

Nihon Kohden Corporation 31-4 Nishiochiai, 1-Chome Shinjuku-ku, Tokyo, 161 Japan

The TG-901T CQ2 Sensor Kit is classified as Class II by the Division of Anesthesiology Devices and the Anesthesiology Device Classification Panel under 21 CFR Part 868.1400 "Analyzer, Gas, Carbon dioxide, Gaseous-phase" as per part 73 CCK.

Common names for the TG-901T CO2 Sensor Kit include CO2 Analyzer and CO2 Indicator.

The predicate device is the OLG-1100A PocketCap CO2 Monitor per 510(k) # K964305, commercial distribution certification dated February 19, 1997.

The Nihon Kohden CO2 Sensor Kit, model number TG-901T, 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. The device is intended as an indicator of patient carbon dioxide concentration during expiration and is not intended as the sole basis for medical diagnosis. This device is intended for use with patients of ages three (3) years and older. This device is not recommended for patients with low tidal volume such as patients younger than three (3) years of age or weighing less 22 pounds or patients with a respiration rate greater than or equal to 60 breaths per minute.

To date, no performance standards or special controls are known or established for this device as required by Section 514 of the Food, Drug and Cosmetic Act and implemented by 21 CFR Part 861.

The TG-901T is not intended to be sterile.

The TG-901T was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device.

Therefore, based on the above, Nihon Kohden believes that the TG-901T CO2 Sensor Kit is substantially equivalent to the OLG-1100A Pocket CO2 Monitor.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN d 1999

Mr. Gary Reasoner Director of Program Operations Nihon Kohden 2601 Campus Drive Irvine, CA 92612

K990063/S1 Re: Nihon Kohden TG-901T CO, Sensor Kit With Accessories Requlatory Class: II (two) Product Code: CCK Dated: April 19, 1999 Received: April 20, 1999

Dear Mr. Reasoner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and

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Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Atl. A. Ciarkowski

. Thomas J. Callahan, Ph.D. Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## ATTACHMENT J: Indications for Use Statement

510(k) Number (if known): K990063

Device Name: TG-901T CO2 Sensor

Indications for Use:

The Nihon Kohden TG-901T CO2 Sensor is intended for medical purposes to measure the concentration of The Nulon Kondon't C 7011 of aid in determining the patient's ventilatory status. The device is intended as an indicator of patient carbon dioxide concentration during expiration and is not intended as the sole basis for medical diagnosis.

This device is intended for use with patients three (3) years of age and older. This device is not recommended for patients with low tidal volume such as patients younger than three (3) years of age or weighing less 22 pounds or patients with a respiration rate greater than or equal to 60 breaths per minute.

H. A. Cirlawski.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)