(119 days)
No
The summary describes a standard physiological monitor with alarm functions based on preset limits. There is no mention of AI/ML in the device description, intended use, or performance studies.
No
The device is described as a monitor intended to measure and display physiological parameters (respiratory rate, CO2, pulse rate, SpO2) and generate alarms. It does not actively treat or intervene in a patient's condition.
Yes
The device monitors physiological parameters (respiratory rate, CO2 partial pressure, EtCO2, pulse rate, SpO2) and generates alarms when measurements fall outside preset limits, which are characteristics of diagnostic devices used to assess a patient's medical condition.
No
The device description clearly states it is a "compact CO2 monitor with a 7-inch display" and is "AC and/or battery operated," indicating it is a physical hardware device, not software only.
Based on the provided text, the Nihon Kohden OLG-3800A CO2 monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality.
- OLG-3800A Function: The OLG-3800A monitors physiological parameters directly from the patient (respiratory rate, CO2 partial pressure, EtCO2, pulse rate, and SpO2). It does not analyze specimens taken from the body.
The device is a patient monitoring device, specifically focusing on respiratory and oxygenation status.
N/A
Intended Use / Indications for Use
The OLG-3800A CO2 monitor is intended to monitor respiratory rate, CO2 partial pressure and EtCO2. The device is also intended to monitor pulse rate and SpO2.
The device may generate an audible and/or visible alarm when a measured physiological rate falls outside preset limits, or when a technical error is detected.
The devices are intended to be used by qualified medical facility, such as hospital or clinic, on all patient populations including adult, neonate, infant, child, and adolescent subgroups.
Product codes (comma separated list FDA assigned to the subject device)
CCK, MNK
Device Description
The Nihon Kohden OLG-3800A is a compact CO2 monitor with a 7-inch display and is designed so the operator can directly touch the screen from the operator position. The CO2 monitor displays the patient's vital signs (CO2, RR, SpO2, PR) on the screen and generates an alarm according to the setting. Alarms are indicated with a screen message, sound, blinking or lighting of the alarm indicator. The device is used with commercially available sensors for intubated and non-intubated patients. The CO2 monitor is intended to be used in an ER, OR, ICU, CCU or general ward on all patient populations, depending on the accessories used with the device. The OLG-3800A is AC and/or battery operated.
When the operation mode is set to Network mode, the CO2 monitor can connect to a Nihon Kohden monitoring system network and communicate with the central monitor and bedside monitor on the network.
A new optional accessory, single-use adult cap-ONE Biteblock YG-227T can be used together with OLG-3800. YG-227T is inserted between the patient's teeth to prevent closure of the patient's jaws. It connects to a specified Nihon Kohden CO2 sensor kit to measure the partial pressure of the expired CO2 of a patient. Also, it allows oxygen (including an oxygen-air mixture) to be provided to the patient during endoscopy.
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
all patient populations including adult, neonate, infant, child, and adolescent subgroups.
Intended User / Care Setting
qualified medical facility, such as hospital or clinic
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)
Performance testing for the Nihon Kohden CO2 Monitor OLG-3800A includes software verification and validation test, software unit test, integration test, and testing to compliance standards for electrical and electromagnetic safety. Traceability has been documented between all system specifications to validation test results.
Performance testing for the Cap-ONE Biteblock. YG-227T includes compliance to the following standards:
IEC 60601-1:2005 + A1:2012: Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
IEC 60601-1-6:2010+A1:2013: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ISO 80601-2-55:2011 Medical Electrical Equipment - Part 2-55: Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas Monitors
ISO 10993-1:2009 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing
IEC 62366:2007 + Amendment 1:2014 - Medical devices -- Application of usability engineering to medical devices
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Nihon Kohden CO2 Monitor, OLG-2800A (K062115), Oridion/Covidien/Medtronic Smart CapnoLine Guardian (K093388)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Nihon Kohden Bedside Monitor, BSM-6000 series (K080342)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left, and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
October 19, 2018
Nihon Kohden Corporation % Thomas Bento St. Vice President, Ouality and Regulatory Affairs Nihon Kohden America, Inc. 15353 Barranca Parkway Irvine, California 92618
Re: K171765
Trade/Device Name: Nihon Kohden CO2 Monitor Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon dioxide gas analyzer Regulatory Class: Class II Product Code: CCK, MNK Dated: September 5, 2017 Received: September 8, 2017
Dear Thomas Bento:
This letter corrects our substantially equivalent letter of October 11, 2017.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Nihon Kohden CO2 Monitor OLG-3800A
Indications for Use (Describe)
The OLG-3800A CO2 monitor is intended to monitor respiratory rate, CO2 partial pressure and EtCO2. The device is also intended to monitor pulse rate and SpO2.
The device may generate an audible and/or visible alarm when a measured physiological rate falls outside preset limits, or when a technical error is detected.
The devices are intended to be used by qualified medical facility, such as hospital or clinic, on all patient populations including adult, neonate, infant, child, and adolescent subgroups.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Nihon Kohden CO2 Monitor, Model OLG-3800A
| Submitter:
Address:
Phone number: | Nihon Kohden Corporation
1-31-4 Nishiochiai, 1-Chome, Shinjuku-
Ku Tokyo, Japan 161-8560
81-3-59968020 |
|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact person:
Office number:
Mobile number:
Fax number: | Thomas Bento
(949) 580-1555 x3324
(949) 680-9048
(913) 273-0732 |
| Date prepared: | June 12, 2017 |
| Device name:
Common name:
Device classification: | Nihon Kohden CO2 Monitor, Model OLG-3800A
Carbon Dioxide (CO2) Gas Analyzer
Class II |
| Primary Product code:
Secondary Product code (for
Cap-ONE Biteblock, YG-227T): | CCK
MNK |
| Regulation: | 21 CFR 868.1400 |
| CO2 Monitor, OLG-3800A
Predicate:
Reference: | Nihon Kohden CO2 Monitor, OLG-2800A (K062115)
Nihon Kohden Bedside Monitor, BSM-6000 series (K080342) |
| Biteblock, YG-227T
Predicate: | Oridion/Covidien/Medtronic Smart CapnoLine Guardian (K093388) |
Description:
The Nihon Kohden OLG-3800A is a compact CO2 monitor with a 7-inch display and is designed so the operator can directly touch the screen from the operator position. The CO2 monitor displays the patient's vital signs (CO2, RR, SpO2, PR) on the screen and generates an alarm according to the setting. Alarms are indicated with a screen message, sound, blinking or lighting of the alarm indicator. The device is used with commercially available sensors for intubated and non-intubated patients. The CO2 monitor is intended to be used in an ER, OR, ICU, CCU or general ward on all patient populations, depending on the accessories used with the device. The OLG-3800A is AC and/or battery operated.
When the operation mode is set to Network mode, the CO2 monitor can connect to a Nihon Kohden monitoring system network and communicate with the central monitor and bedside monitor on the network.
4
A new optional accessory, single-use adult cap-ONE Biteblock YG-227T can be used together with OLG-3800. YG-227T is inserted between the patient's teeth to prevent closure of the patient's jaws. It connects to a specified Nihon Kohden CO2 sensor kit to measure the partial pressure of the expired CO2 of a patient. Also, it allows oxygen (including an oxygen-air mixture) to be provided to the patient during endoscopy.
Indications for Use:
The OLG-3800A CO2 monitor is intended to monitor respiratory rate, CO2 partial pressure and EtCO2. The device is also intended to monitor pulse rate and SpO2.
The device may generate an audible and/or visible alarm when a measured physiological rate falls outside preset limits. or when a technical error is detected.
The devices are intended to be used by qualified medical personnel within a medical facility, such as hospital or clinic, on all patient populations including adult, neonate, infant, child, and adolescent subgroups.
Technological Characteristics - Substantial Equivalence Discussion:
The Nihon Kohden CO2 Monitor OLG-3800A is substantially equivalent to the predicate device. Nihon Kohden CO2 Monitor Model OLG-2800A (K062115). The Nihon Kohden BSM 6000 Series Bedside Monitor is shown as a reference device for comparison. Differences between the devices are minor and do not raise questions regarding safety or efficacy.
These differences include:
-
- The OLG-3800A is substantially equivalent to the OLG-2800A other than the additional function of blood oxygen saturation (SpO2) measurement.
-
- The OLG-3800A has a new added feature to measure SpO2. The SpO2 measurement method is the same as that of the reference device, BSM-6000 series bedside monitor. It has been verified using standard ISO 80601-2-61:2011.
The following table shows a comparison of the subject device, and the predicate and reference devices.
5
| | OLG-2800A
Predicate
(K062115) | BSM-6000 Series
Reference Device
(K080342) | OLG-3800A
New Device |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Specification | Indications for Use | | |
| | The OLG-2800A is a
portable monitor that
measures respiration
status of patients at a
medical facility setting.
The device is used with
commercially available
sensors for intubated and
non-intubated patients.
The device displays
waveforms and numeric
data of monitored
parameters, such as CO2,
EtCO2, respiratory rate
and trendgraphs. The
device may generate an
audible and/or visible
alarm when a measured
parameter falls outside
preset limits.
The device LED display
showsEtCO2 value and
respiration rate and the
LCD display shows CO2
waveforms, and alarms
settings. The device is AC
and/or battery operated.
The device will be
available for use by
medical personnel on all
patient populations
depending on the CO2
sensor kit. | The device is intended to
monitor, display and
record physiological data
to provide cardiac and
vital signs monitoring
within a medical facility.
The device is intended to
produce a visual record of
the electrical signals
produced by heart and
monitor the
electrocardiogram to
generate audible and/or
visible alarms when an
arrhythmia exists. The
device is also intended to
monitor heart rate, pulse
rate, blood oxygen
saturation (SpO2),
noninvasive blood
pressure (NIBP), invasive
blood pressure (IBP),
body temperature, BIS,
cardiac output (CO),
oxygen concentration
(FiO2), carbon dioxide
concentration (CO2),
EtCO2, respiratory rate,
and inspired and expired
anesthetic agents and
anesthetic gases
including N2O, Halothane,
Isoflurane, Enflurane,
Sevoflurane and
Desflurane. The device
may generate an audible
and/or visual alarm when
a measured rate falls
outside preset limits. The
device may also be used
to condition and transmit
physiological signals via
radio frequency.
The device will be
available for use by
medical personnel on
patients within a medical
facility on all patient
populations. | The OLG-3800A CO2
monitor is intended to
monitor respiratory rate,
CO2 partial pressure
and EtCO2. The device
is also intended to
monitor pulse rate and
SpO2.
The device may
generate an audible
and/or visible alarm
when a measured
physiological rate falls
outside preset limits, or
when a technical error is
detected.
The devices are
intended to be used by
qualified medical
personnel within a
medical facility, such as
hospital or clinic, on all
patient populations
including adult, neonate,
infant, child, and
adolescent subgroups. |
| | OLG-2800A | BSM-6000 Series | OLG-3800A |
| Specification | Predicate
(K062115) | Reference Device
(K080342) | New Device |
| Display | | | |
| Type | FSTN monochrome
LCD,
7 segment LED, 3 digits
display EtCO2 | TFT Color LCD,
10.4" (BSM-6301A)
12.1" (BSM-6501A)
15.0" (BSM-6701A) | 7-inch, color TFT type
LCD |
| Resolution | 200 x 108 | 800x600 (BSM-
6301A/6501A);
1024x768 (BSM-
6701A) | 800 (H) × 480 (V) |
| Waveform
Display | CO2 | ECG (12 leads),
respiration, pulse, CO2,
cardiac output, external
input,
O2, EEG (BISx) ,
IBP(7) | CO2, SpO2 |
| Numeric Data
Display | EtCO2, respiration rate | Heart Rate, Pulse Rate,
VPC rate, ST level (12
leads),
Respiration Rate,
NIBP (SYS/DIA/MAP)
Temperature (4), SpO2,
EtCO2, FiCO2,FiO2,
cardiac output, O2, BIS,
IBP(7) (sys/dia/mean) | ETCO2, FiCO2, INST
CO2, RR, SpO2, PR, PI |
| Alarm | | | |
| Vital Signs
Alarm
Parameters | ETCO2, FiCO2
RR, No breath | HR, PR, VPC, ST, RR,
Apnea, SpO2, NIBP,
PRESS, TEMP, CO2(E),
CO2(I), O2(E), O2(I),
N2O(E), N2O(I), HAL(E),
HAL(I), ISO(E), ISO(I),
ENF(E), ENF(I), DES(E),
DES(I), SEV(E), SEV(I),
MV, PEEP, Ppeak, SEF,
TP, CCO, CCI | CO2(E), CO2(I),INST
CO2,RR,NO
BREATH,SpO2,PR |
| Respiration | | | |
| Method | CO2 | Impedance, thermistor,
CO2 | CO2 |
| Respiration
Rate Display | 0 to 150 bpm | 0 to 150 bpm | 0 to 150 bpm |
| Alarm Limits:
Upper
Lower | 2 to 150 bpm, off
0 to 148 bpm, off | 2 to 150 bpm, OFF
0 to 148 bpm, OFF | Upper limit: 2 to 150
bpm, OFF
Lower limit: OFF, 0 to
148 bpm |
| No Breath
Detection Time
Limit | 5 to 40 seconds, off | 5 to 40 seconds, OFF | 5 to 40 seconds, off |
| No breath
Detection
CO2 | Yes | Yes (Displayed as
"Apnea") | Yes |
| Display range | 0 to 150 mmHg | 0 to 150 mmHg | 0 to 150 mmHg |
| | OLG-2800A | BSM-6000 Series | OLG-3800A |
| Specification | Predicate
(K062115) | Reference Device
(K080342) | New Device |
| Declared range
and accuracy
with sensor | TG-900P:
$±3$ mmHg (0 ≤ CO2 ≤ 10 mmHg)
$±4$ mmHg (10 ≤ CO2 ≤ 40 mmHg)
$±10$ % reading (40 ≤ CO2 ≤ 100 mmHg)
(At 1 atmospheric pressure, air inspiration, no condensation)
TG-920P:
$±3$ mmHg (0 ≤ CO2 ≤ 10 mmHg)
$±4$ mmHg (10 ≤ CO2 ≤ 40 mmHg)
$±10$ % reading (40 ≤ CO2 ≤ 100 mmHg)
(At 1 atmospheric pressure, air inspiration, no condensation,
7 minutes passed after stabilization of the sensor temperature)
TG-970P, TG-980P:
$±2$ mmHg (0 ≤ CO2 ≤ 40 mmHg)
$±5$ % reading (40