YG-125T AND YG-135T NASAL ADAPTER

K072843 · Nihon Kohden America, Inc. · CCK · Nov 29, 2007 · Anesthesiology

Device Facts

• Record ID: K072843
• Device Name: YG-125T AND YG-135T NASAL ADAPTER
• Applicant: Nihon Kohden America, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Nov 29, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: Pediatric

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 Story

The TG-920P CO2 Sensor Kit measures expired carbon dioxide concentration and respiratory airflow. It utilizes a cannula tube for patient interface and a pressure tube for breath detection. The device is used to aid clinicians in determining a patient's ventilatory status by monitoring CO2 levels during expiration. It is intended for use in pediatric patients weighing over 7kg. The output is used by healthcare providers alongside other diagnostic methods to assess patient condition. The device is non-sterile and designed for nasal-oral breathing monitoring.

Clinical Evidence

Bench testing only. Testing included safety, environmental, vibration, and impact testing (Report No. 1891). Results confirmed the device performed within specifications.

Technological Characteristics

Carbon dioxide gas analyzer; cannula-based sensing; pressure tube for breath detection; non-sterile; complies with IEC-60601-1 and 21 CFR 868.1400.

Indications for Use

Indicated for children weighing more than approximately 7kg to measure expired CO2 concentration and respiratory airflow via cannula tube to aid in determining ventilatory status.

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

• Nihon Kohden TG-920P CO2 Sensor Kit (K040875)

Submission Summary (Full Text)

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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 [phone] ex. 3325 Fax: [phone] jack [e-mail]

- 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

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## 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.

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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.

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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 (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 [phone]. 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 [phone] or [phone] 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

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# 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

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