NIHON KOHDEN OLG-100A POCKETCAP POCKET CO2 MONITOR WITH ACCESSORIES
K964305 · Nihon Kohden America, Inc. · CCK · Feb 19, 1997 · Anesthesiology
Device Facts
Record ID
K964305
Device Name
NIHON KOHDEN OLG-100A POCKETCAP POCKET CO2 MONITOR WITH ACCESSORIES
Applicant
Nihon Kohden America, Inc.
Product Code
CCK · Anesthesiology
Decision Date
Feb 19, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 868.1400
Device Class
Class 2
Attributes
Pediatric
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. 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.
Device Story
Pocket-sized CO2 monitor; measures expired gas CO2 concentration; aids assessment of patient ventilatory status. Used by medical personnel in hospitals, remote sites, or during transport. Input: gas mixture samples; Output: CO2 concentration display. Not intended as sole diagnostic basis. Provides real-time monitoring to assist clinical decision-making regarding ventilation. Benefits: portable, immediate feedback on patient respiratory status.
Clinical Evidence
No clinical data. Bench testing only: electromagnetic, environmental, safety, and performance testing conducted. Software validation performed for acquisition, processing, and display functions. Results confirmed device performance within specifications.
Technological Characteristics
Gas analyzer (CO2); portable form factor. Software-based acquisition, processing, and display. Non-sterile. Electromagnetic and environmental testing performed to verify operation.
Indications for Use
Indicated for monitoring CO2 concentration during expiration to assess ventilatory status in clinical settings. Contraindicated for patients <3 years old, <22 lbs, or with respiratory rates ≥60 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.
{0}
K964305
NIHON KOHDEN
October 28, 1996
510(k) NOTIFICATION
OLG-1100A Pocket CO₂ MONITOR
SECTION 2 -510(k) SUMMARY
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.
Page 6
