CAP-ONE, MODEL TG-920P

K040875 · Nihon Kohden America, Inc. · CCK · Oct 15, 2004 · Anesthesiology

Device Facts

• Record ID: K040875
• Device Name: CAP-ONE, MODEL TG-920P
• Applicant: Nihon Kohden America, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Oct 15, 2004
• Decision: SESE
• Submission Type: Traditional
• 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 (end tidal CO2) status. As 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 carbon dioxide concentration in gas mixtures to assess patient ventilatory status. It utilizes infrared radiation absorption technology to detect CO2 levels during expiration. The system includes a single-patient-use, disposable mouth/nose airway adapter. It is intended for use in non-intubated patients. Healthcare providers use the output as an indicator for medical diagnosis and monitoring. The device aids in clinical decision-making regarding patient ventilation.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and efficacy were verified through electromagnetic, environmental, and performance testing procedures.

Technological Characteristics

Infrared radiation absorption sensing principle. Disposable mouth/nose airway adapter. Non-sterile. Class II device (21 CFR 868.1400).

Indications for Use

Indicated for non-intubated patients aged 3 years and older. Contraindicated for patients with low tidal volume, patients younger than 3 years, patients weighing less than 22 pounds, or patients with a respiration rate >= 150 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

• Nihon Kohden TG-901T CO2 Sensor Kit (K990063)

Submission Summary (Full Text)

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## SECTION 2 - 510(K) SUMMARY

OCT 1-5 2004

Name and Address of Applicant: Nihon Kohden America, Inc. 90 Icon St. Foothill Ranch, California 92610 Attn: Regulatory Affairs, Ms. Serrah Namini

Name and address of Manufacturer: Nihon Kohden Corporation 1-31-4 Nishiochiai, Shinjuku-ku, Tokyo, 161-8560 Japan

The TG-920P CO2 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-920P CO2 Sensor Kit include CO2 Analyzer and CO2 Indicator.

The predicate marketed device is the Nihon Kohden TG-901T CO2 Sensor Kit as per 510(k): K990063, commercial distribution certification dated June 1999.

The Nihon Kohden CO2 Sensor Kit, model number TG-920P, 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 CO>) status. The device measuring technique is through absorption of infrared radiation. The mouth/nose piece airway adapter, is a Single-Patient-Use and hence, disposable.

The device is intended as an indicator of patient carbon dioxide concentration during expiration, for non-intubated patients. 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 than 22 pounds or patients with a respiration rate greater than or equal to 150 breaths per minute.

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. The device is not sterile.

Therefore, based on the above, Nihon Kohden believes that the TG-920P CO2 Sensor Kit is substantially equivalent to Nihon Kohden's TG-901T CO2 Sensor Kit.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 15 2004

Ms. Serrah Namini Regulatory Affairs, Associate Director Nihon Kohden America, Incorporated 90 Icon Street Foothill Ranch, California 92610

Re: K040875

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: October 7, 2004 Received: October 8, 2004

Dear Ms. Namini:

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 - Ms. Namini

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 DT of issuaires on that your device complies with other requirements Incall that I DA mas made a aversand regulations administered by other Federal agencies. of the Act of any I oderal baters and surface and such and limited to: registration 1 ou must comply with an are habeling (21 CFR Part 801); good manufacturing practice allu listing (21 er revers) (QS) regulation (QS) regulation (21 CFR Part 820); and if requirements as sections are quality ajon 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) I mis letter will and in J o The FDA finding of substantial equivalence of your device to a premarket notification - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you desire specific a a 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 Inter Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runner
for Shirin Liu, 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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## NIHON KOHDEN

Indications for Use Statement G.____________________________________________________________________________________________________________________________________________________________________________

040895 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 The Ninon Xondon 1 0 720 in a gas mixture to aid in determining the patient's ventilatory concentiation of earbon dromation in a gia ted by the physician for medical diagnosis, this device is intended as an indicator of patient carbon dioxide concentration during expiration.

Prescription Use X (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)

Ques Sefiver

(Division Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Dental De 510(k) Number: