K Number
K072843
Device Name
YG-125T AND YG-135T NASAL ADAPTER
Date Cleared
2007-11-29

(56 days)

Product Code
Regulation Number
868.1400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Nihon Kohden TG-920P 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 new TG-920P CO2 Sensor Kit has an airflow cannula where the device can be use for Children patients weighing more than approximately 7kg, where the predicate device TG-920P CO2 Sensor Kit is for weighing more than 10 kg. The new TG-920P CO2 Sensor Kit has a pressure tube for breath detection, where the predicate does and the new device is not sterilized where the predicate device can be sterilized once with ethylene oxide gas before use. The new device is similar to Nihon Kohden predicate device in use with the TG-920P CO2 sensor kit to measure the partial pressure of the expired CO> of the patient for nasal-oral breathing, use frequency, shelf-life, patient contact, storage environment, chemical resistance and safety.
More Information

Not Found

No
The summary describes a CO2 sensor kit and its modifications compared to a predicate device. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.

No.
The device is intended to measure the concentration of carbon dioxide to aid in determining the patient's ventilatory status, which is a diagnostic function, not a therapeutic one.

Yes
The "Intended Use / Indications for Use" section states that the device is "to aid in determining the patient's ventilatory status" and "is intended as an indicator of patient carbon dioxide concentration during expiration," which are diagnostic purposes. It also explicitly mentions aiding in "medical diagnosis" when used with other methods.

No

The device description explicitly mentions physical components like an "airflow cannula" and a "pressure tube," indicating it is a hardware device with a sensor.

Based on the provided information, the Nihon Kohden TG-920P CO2 Sensor Kit is not an In Vitro Diagnostic (IVD).

Here's why:

  • Intended Use: The intended use is to "measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status." This is a measurement of a physiological parameter (CO2 in expired breath) directly from the patient, not from a sample taken from the patient (like blood, urine, or tissue).
  • Device Description: The device description focuses on the physical components and how it interacts with the patient's breath (airflow cannula, pressure tube). It doesn't mention any reagents, test strips, or analysis of biological samples.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analysis of biological samples (blood, urine, etc.)
    • Use of reagents or test kits
    • Diagnosis based on the analysis of a sample

The device is designed to monitor a physiological process (respiration) by measuring the CO2 content of expired air. This falls under the category of physiological monitoring devices, not IVDs.

N/A

Intended Use / Indications for Use

The Nihon Kohden new TG-920P CO2 Sensor Kit has the same intended use as the predicate Nihon Kohden TG-920P CO2 Sensor Kit. Both are intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilator status. These device are intended to measure the partial pressure of the expired CO2 of the patient and the respiratory airflow with a cannula tube.

The Nihon Kohden TG-920P 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.

Product codes

CCK

Device Description

The new TG-920P CO2 Sensor Kit has an airflow cannula where the device can be use for Children patients weighing more than approximately 7kg, where the predicate device TG-920P CO2 Sensor Kit is for weighing more than 10 kg. The new TG-920P CO2 Sensor Kit has a pressure tube for breath detection, where the predicate does not and the new device is not sterilized where the predicate device can be sterilized once with ethylene oxide gas before use. The new device is similar to Nihon Kohden predicate device in use with the TG-920P CO2 sensor kit to measure the partial pressure of the expired CO> of the patient for nasal-oral breathing, use frequency, shelf-life, patient contact, storage environment, chemical resistance and safety.

The device is not sterile.
The devices comply with the IEC-60601-1 standard and sub-clause 56.3 (c) implemented by 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables.
The devices were subjected to tests including safety, environment, vibration and impact.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Children patients weighing more than approximately 7kg

Intended User / Care Setting

Prescription Use

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

Safety test was conducted only for display test using the new TG-920P CO2 Sensor Kit device as a prototype. The test results confirmed that the device performed within specifications.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The devices were subjected to tests including safety, environment, vibration and impact. Refer to the test report for TG-920P CO2 Sensor Kit (Report No. 1891). Refer to the post qualification test report for TG-920P CO2 Sensor Kit test report 1891. Safety test was conducted only for display test using the new TG-920P CO2 Sensor Kit device as a prototype. The test results confirmed that the device performed within specifications.

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

Not Found

Predicate Device(s)

Nihon Kohden TG-920P CO2 Sensor Kit per 510(k) #040875

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

K072843

SECTION 2- 510(K) SUMMARY

Date: October 2, 2007

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 jack coggan@nkusa.com

  • Trade/Device Name: TG-920P CO2 Sensor Kit .
  • Common or usual Name: Carbon Dioxide Gas Analyzer .
  • Classification Name: The devices have been classified as Class II by the . Division of Anesthesiology Devices and the Anesthesiology Classification Panel under 21 CFR Part 868.1400 Analyzer, gas, carbon dioxide, gaseous-phase as per product code 73 CCK.
  • Legally Marketed Predicate: Nihon Kohden TG-920P CO2 Sensor Kit per . 510(k) #040875, commercial distribution certification dated October 15, 2004.

Intended Use:

The Nihon Kohden new TG-920P CO2 Sensor Kit has the same intended use as the predicate Nihon Kohden TG-920P CO2 Sensor Kit. Both are intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilator status. These device are intended to measure the partial pressure of the expired CO2 of the patient and the respiratory airflow with a cannula tube.

A summary of the technological characteristics of the device compared to the predicate device: The new TG-920P CO2 Sensor Kit has an airflow cannula where the device can be use for Children patients weighing more than approximately 7kg, where the predicate device TG-920P CO2 Sensor Kit is for weighing more than 10 kg. The new TG-920P CO2 Sensor Kit has a pressure tube for breath detection, where the predicate does not and the new device is not sterilized where the predicate device can be sterilized once with ethylene oxide gas before use. The new device is similar to Nihon Kohden predicate device in use with the TG-920P CO2 sensor kit to measure the partial pressure of the expired CO> of the patient for nasal-oral breathing, use frequency, shelf-life, patient contact, storage environment, chemical resistance and safety. See attachment # 5 for comparison of the TG-920P CO2 Sensor Kit to the predicate device ..

NOV 2 3 2007

1

510(k) Summary

  • The device is not sterile. .
  • The devices comply with the IEC-60601-1 standard and sub-clause 56.3 (c) . implemented by 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables.
  • The devices were subjected to tests including safety, environment, vibration and . impact. Refer to the test report for TG-920P CO2 Sensor Kit (Report No. 1891). Refer to the post qualification test report for TG-920P CO2 Sensor Kit test report 1891. Safety test was conducted only for display test using the new TG-920P CO2 Sensor Kit device as a prototype. The test results confirmed that the device performed within specifications.
  • Therefore, based on the above, Nihon Kohden believes that the new TG-920P . CO2 Sensor Kit is substantially equivalent to the TG-920P CO2 Sensor Kit predicate device.

2

Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally oriented. The words are stacked on a single line and are left-aligned.

Image /page/2/Picture/2 description: The image shows the seal for the Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the edge. In the center of the seal is an image of an eagle.

NOV 2 9 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K072843

Trade/Device Name: TG -920P CO2 Sensor Kit Regulation Number: 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: November 8, 2007 Received: November 9, 2007

Dear Mr. Coggan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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.

3

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 (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.

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 your 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

510(k) PREMARKET NOTIFICATION TG-920P CO2 SENSOR KIT

G. Indications for Use Statement:

510(K) Number (if known):

Device Name: TG-920P CO2 Sensor Kit

Indications for Use:

The Nihon Kohden TG-920P 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.

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

Over The Counter Use (21 CFR 807 Subpart C)

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

VALUATION (SDE),

Mil Thulal

II of Anesthesiciony. Ger

K072843

Page 8 of 19