(196 days)
Not Found
No
The description focuses on infrared absorption for CO2 measurement and does not mention AI or ML.
No
The device measures a physiological parameter (CO2 concentration) to aid in diagnosis, but it does not directly treat or alleviate a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "As interpreted by the physician for medical diagnosis".
No
The device description explicitly mentions a "CO2 Sensor Kit" and a "mouth/nose piece airway adapter," which are physical hardware components used to measure carbon dioxide. The description of performance studies also mentions "electromagnetic, environmental, safety and performance testing procedures," which are typical for hardware devices.
Based on the provided text, the Nihon Kohden TG-920P CO2 Sensor Kit is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The TG-920P CO2 Sensor Kit measures the concentration of carbon dioxide in a gas mixture (specifically, the patient's expired breath). This is a measurement of a physiological process happening in vivo (within the living body), not a test performed on a sample in vitro (outside the living body).
- 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 (end tidal CO>) status." This directly relates to monitoring a physiological function of the patient.
Therefore, the device falls under the category of a physiological monitoring device rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
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. When interpreted 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 TG-920P CO2 Sensor Kit measures the concentration of carbon dioxide in a gas mixture. The device measuring technique is through absorption of infrared radiation. The mouth/nose piece airway adapter is single-patient-use and disposable. The device is not sterile.
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
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.
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
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.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the logo. The logo is black and white.
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.
2
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 (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 Inter 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/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
3
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: