(101 days)
Not Found
No
The summary describes a device that measures CO2 concentration using infrared absorption and does not mention any AI or ML components.
No
The device measures CO2 concentration to aid in determining ventilatory status, it does not provide any treatment or therapy.
Yes
The device is described as aiding in medical diagnosis ("Along with other methods indicated by the physician for medical diagnosis").
No
The device description explicitly mentions a "CO2 Sensor Kit" and describes a measuring technique through "absorption of infrared radiation," indicating the presence of hardware components beyond just software.
Based on the provided information, this device 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 Nihon Kohden TG-970P Series 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 parameter outside of a sample taken from the body.
- Intended Use: The intended use is to aid in determining the patient's ventilatory status by measuring CO2 in expired breath. This is a direct measurement of a bodily function, not an analysis of a biological sample.
Therefore, while it's a medical device used for diagnosis, it 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 TG-970P Series 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 Nihon Kohden CO2 Sensor Kit, model number TG-970P Series, 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. The device measuring technique is through absorption of infrared radiation. The airway adapter is a Single -Patient Use disposable product.
The device is intended as an indicator of patient carbon dioxide concentration during expiration for intubated patients. The device is intended for use with patients weighing 7kg or more. The device is not recommended for patients with low tidal volume such as patients weighing less than 7kg or patients with a respiration rate greater than 150 breaths per minute.
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
Not Found
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 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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
NIHON KOHDEN AMERICA, INC.
SPECIAL 510(k) NOTIFICATION TG-970P Series CO2 Sensor Kit
08345
SECTION 2 - 510(K) SUMMARY
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
Trade/Device Name:
Nihon Kohden TG-970P Series CO2 Sensor Kit
MAR - 2 2009
Common or Usual Name:
Capnometer, Carbon Dioxide (CO2) Analyzer, Carbon Dioxide (CO2) Indicator
Classification Name:
The device has been classified as Class II by the Division of Anesthesiology Devices and Anesthesiology Classification Panel under 21 CFR Part 868.1400 "Analyzer. Gas. Carbon dioxide, Gaseous-phase" as per part 73 CCK.
Legally Marketed Predicate Device:
Nihon Kohden TG-920P CO2 Sensor Kit as per 510(k) K040875 commercial distribution certification dated October 15, 2004.
Intended Use:
The Nihon Kohden TG-970P Series 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.
A summary of the technological characteristics of the device:
The Nihon Kohden CO2 Sensor Kit, model number TG-970P Series, 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. The device measuring technique is through absorption of infrared radiation. The airway adapter is a Single -Patient Use disposable product.
The device is intended as an indicator of patient carbon dioxide concentration during expiration for intubated patients. The device is intended for use with patients weighing 7kg or more. The device is not recommended for patients with low tidal volume such as patients weighing less than 7kg or patients with a respiration rate greater than 150 breaths per minute.
1
510(k) Summary:
- The device is not sterile. ●
- . 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.
Therefore, Nihon Kohden believes that the TG-970P Series CO2 Sensor Kit device is substantially equivalent to Nihon Kohden's predicate device TG-920P CO2 Sensor Kit.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 2 2009
Mr. Jack Coggan Director of Regulatory Affairs/Quality Assurance Nihon Kohden America, Incorporated 90 Icon Street Foothill Ranch, California 92610-1601
Re: K083456
Trade/Device Name: TG-970P Series CO2 Sensor Kit Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: January 29, 2009 Received: February 2, 2009
Dear Mr. Coggan:
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.
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 (OS) 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 vour 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suite y. Michlene Dns.
Ginette Y. Michaud, M.D. Acting 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 AMERICA, INC.
SPECIAL 510(k) NOTIFICATION TG-970P Series CO2 Sensor Kit
G. Indications for Use Statement:
510(k) Number (if known):
Device Name: TG-970P Series CO2 Sensor Kit
ﺷﻴﺐ
Indications of Use:
The Nihon Kohden TG-970P Series 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.
Over The Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Souge L. Mocheil m.d.
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K083456