(113 days)
No
The summary describes a standard CO2 monitor and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is intended to measure carbon dioxide concentration to aid in determining ventilatory status, which is a diagnostic or monitoring function, not a therapeutic one.
Yes
The device aids in determining a patient's ventilatory status by measuring carbon dioxide concentration, which contributes to medical diagnosis, even if it's not the sole basis.
No
The device description explicitly refers to the "OLG-1100A PocketCap Pocket CO2 Monitor" and mentions electromagnetic, environmental, and safety testing procedures, which are typically associated with hardware components. While software validation is mentioned, it's in the context of testing the software functions of the device, implying the existence of hardware.
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 PocketCap Pocket CO2 Monitor measures the concentration of carbon dioxide in a gas mixture (specifically, the patient's expired breath). This is a measurement of a gas, not a sample taken from the body.
- Intended Use: The intended use describes measuring CO2 in a gas mixture to aid in determining ventilatory status. This is a respiratory measurement, not a diagnostic test performed on a biological sample.
Therefore, the device falls under the category of a respiratory monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Nihon Kohden PocketCap Pocket CO2 Monitor, model number OLG-1100A, 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. The device is intended as an indicator of patient carbon dioxide concentration during expiration and is not intended as the sole basis for medical diagnosis.
Product codes
CCK
Device Description
Common names for the OLG-1100A PocketCap Pocket CO2 Monitor include CO2 Analyzer, CO2 Monitor and CO2 Indicator. The OLG-1100A PocketCap is not intended to be 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
The device is not recommended for patients with low tidal volume such as patients younger than three (3) years of age or weighing less 22 pounds or patients with a respiration rate greater than or equal to 60 breaths per minute.
Intended User / Care Setting
The device will be available for use only by medical personnel within a hospital or other medical facility, at a remote site, or during transport from a remote site to a hospital or other medical facility.
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
The OLG-1100A PocketCap was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the software functions of acquiring, processing and displaying all functions of the device. The results confirmed that the device performed within specifications.
Key Metrics
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
1997
NIHON KOHDEN October 28, 1996 510(k) NOTIFICATION OLG-1100A Pocket CO2 MONITOR
SECTION 2 -510(k) SUMMARY
FEB 1 9 1997
Name and Address of Applicant Nihon Kohden Corporation 31-4 Nishiochiai, 1-Chome Shinjuku-ku, Tokyo, 161 Japan
Contact Person and Telephone Mr. Gary Reasoner Director of Product Operations Nihon Kohden America, Inc. 2601 Campus Drive Irvine, California 92612-1601 (714) 250-3959 ext. 3387
The OLG-1100A PocketCap Pocket CO2 Monitor 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 OLG-1100A PocketCap Pocket CO2 Monitor include CO2 Analyzer, CO2 Monitor and CO2 Indicator.
The predicate device is the Nellcor N-60 Stat-Cap Airway CO2 Indicator per 510(k) #K915494, commercial distribution certification dated August 6, 1993.
The Nihon Kohden PocketCap Pocket CO2 Monitor, model number OLG-1100A, 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. The device is intended as an indicator of patient carbon dioxide concentration during expiration and is not intended as the sole basis for medical diagnosis. The device will be available for use only by medical personnel within a hospital or other medical facility, at a remote site, or during transport from a remote site to a hospital or other medical facility. This device is not recommended for patients with low tidal volume such as patients younger than three (3) years of age or weighing less 22 pounds or patients with a respiration rate greater than or equal to 60 breaths per minute.
To date, no performance standards or special controls are known or established for this device as required by Section 514 of the Food, Drug and Cosmetic Act and implemented by 21 CFR Part 861.
The OLG-1100A PocketCap is not intended to be sterile.
The OLG-1100A PocketCap was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the software functions of acquiring, processing and displaying all functions of the device. The results confirmed that the device performed within specifications.
Therefore based on the above, Nihon Kohden believes that the OLG-1100A PocketCap Pocket CO2 Monitor is substantially equivalent to the Nellcor N-60 Stat-Cap Airway CO2 Indicator.