Nihon Kohden CO2 Monitor

{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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary # Nihon Kohden CO2 Monitor, Model OLG-3800A | Submitter:<br>Address:<br>Phone number: | Nihon Kohden Corporation<br>1-31-4 Nishiochiai, 1-Chome, Shinjuku-<br>Ku Tokyo, Japan 161-8560<br>81-3-59968020 | |--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------| | Contact person:<br>Office number:<br>Mobile number:<br>Fax number: | Thomas Bento<br>(949) 580-1555 x3324<br>(949) 680-9048<br>(913) 273-0732 | | Date prepared: | June 12, 2017 | | Device name:<br>Common name:<br>Device classification: | Nihon Kohden CO2 Monitor, Model OLG-3800A<br>Carbon Dioxide (CO2) Gas Analyzer<br>Class II | | Primary Product code:<br>Secondary Product code (for<br>Cap-ONE Biteblock, YG-227T): | CCK<br>MNK | | Regulation: | 21 CFR 868.1400 | | CO2 Monitor, OLG-3800A<br>Predicate:<br>Reference: | Nihon Kohden CO2 Monitor, OLG-2800A (K062115)<br>Nihon Kohden Bedside Monitor, BSM-6000 series (K080342) | | Biteblock, YG-227T<br>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: - 1. The OLG-3800A is substantially equivalent to the OLG-2800A other than the additional function of blood oxygen saturation (SpO2) measurement. - 2. 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<br>Predicate<br>(K062115) | BSM-6000 Series<br>Reference Device<br>(K080342) | OLG-3800A<br>New Device | |---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Specification | Indications for Use | | | | | The OLG-2800A is a<br>portable monitor that<br>measures respiration<br>status of patients at a<br>medical facility setting.<br>The device is used with<br>commercially available<br>sensors for intubated and<br>non-intubated patients.<br>The device displays<br>waveforms and numeric<br>data of monitored<br>parameters, such as CO2,<br>EtCO2, respiratory rate<br>and trendgraphs. The<br>device may generate an<br>audible and/or visible<br>alarm when a measured<br>parameter falls outside<br>preset limits.<br><br>The device LED display<br>showsEtCO2 value and<br>respiration rate and the<br>LCD display shows CO2<br>waveforms, and alarms<br>settings. The device is AC<br>and/or battery operated.<br>The device will be<br>available for use by<br>medical personnel on all<br>patient populations<br>depending on the CO2<br>sensor kit. | The device is intended to<br>monitor, display and<br>record physiological data<br>to provide cardiac and<br>vital signs monitoring<br>within a medical facility.<br>The device is intended to<br>produce a visual record of<br>the electrical signals<br>produced by heart and<br>monitor the<br>electrocardiogram to<br>generate audible and/or<br>visible alarms when an<br>arrhythmia exists. The<br>device is also intended to<br>monitor heart rate, pulse<br>rate, blood oxygen<br>saturation (SpO2),<br>noninvasive blood<br>pressure (NIBP), invasive<br>blood pressure (IBP),<br>body temperature, BIS,<br>cardiac output (CO),<br>oxygen concentration<br>(FiO2), carbon dioxide<br>concentration (CO2),<br>EtCO2, respiratory rate,<br>and inspired and expired<br>anesthetic agents and<br>anesthetic gases<br>including N2O, Halothane,<br>Isoflurane, Enflurane,<br>Sevoflurane and<br>Desflurane. The device<br>may generate an audible<br>and/or visual alarm when<br>a measured rate falls<br>outside preset limits. The<br>device may also be used<br>to condition and transmit<br>physiological signals via<br>radio frequency.<br>The device will be<br>available for use by<br>medical personnel on<br>patients within a medical<br>facility on all patient<br>populations. | The OLG-3800A CO2<br>monitor is intended to<br>monitor respiratory rate,<br>CO2 partial pressure<br>and EtCO2. The device<br>is also intended to<br>monitor pulse rate and<br>SpO2.<br><br>The device may<br>generate an audible<br>and/or visible alarm<br>when a measured<br>physiological rate falls<br>outside preset limits, or<br>when a technical error is<br>detected.<br><br>The devices are<br>intended to be used by<br>qualified medical<br>personnel within a<br>medical facility, such as<br>hospital or clinic, on all<br>patient populations<br>including adult, neonate,<br>infant, child, and<br>adolescent subgroups. | | | OLG-2800A | BSM-6000 Series | OLG-3800A | | Specification | Predicate<br>(K062115) | Reference Device<br>(K080342) | New Device | | Display | | | | | Type | FSTN monochrome<br>LCD,<br>7 segment LED, 3 digits<br>display EtCO2 | TFT Color LCD,<br>10.4" (BSM-6301A)<br>12.1" (BSM-6501A)<br>15.0" (BSM-6701A) | 7-inch, color TFT type<br>LCD | | Resolution | 200 x 108 | 800x600 (BSM-<br>6301A/6501A);<br>1024x768 (BSM-<br>6701A) | 800 (H) × 480 (V) | | Waveform<br>Display | CO2 | ECG (12 leads),<br>respiration, pulse, CO2,<br>cardiac output, external<br>input,<br>O2, EEG (BISx) ,<br>IBP(7) | CO2, SpO2 | | Numeric Data<br>Display | EtCO2, respiration rate | Heart Rate, Pulse Rate,<br>VPC rate, ST level (12<br>leads),<br>Respiration Rate,<br>NIBP (SYS/DIA/MAP)<br>Temperature (4), SpO2,<br>EtCO2, FiCO2,FiO2,<br>cardiac output, O2, BIS,<br>IBP(7) (sys/dia/mean) | ETCO2, FiCO2, INST<br>CO2, RR, SpO2, PR, PI | | Alarm | | | | | Vital Signs<br>Alarm<br>Parameters | ETCO2, FiCO2<br>RR, No breath | HR, PR, VPC, ST, RR,<br>Apnea, SpO2, NIBP,<br>PRESS, TEMP, CO2(E),<br>CO2(I), O2(E), O2(I),<br>N2O(E), N2O(I), HAL(E),<br>HAL(I), ISO(E), ISO(I),<br>ENF(E), ENF(I), DES(E),<br>DES(I), SEV(E), SEV(I),<br>MV, PEEP, Ppeak, SEF,<br>TP, CCO, CCI | CO2(E), CO2(I),INST<br>CO2,RR,NO<br>BREATH,SpO2,PR | | Respiration | | | | | Method | CO2 | Impedance, thermistor,<br>CO2 | CO2 | | Respiration<br>Rate Display | 0 to 150 bpm | 0 to 150 bpm | 0 to 150 bpm | | Alarm Limits:<br>Upper<br>Lower | 2 to 150 bpm, off<br>0 to 148 bpm, off | 2 to 150 bpm, OFF<br>0 to 148 bpm, OFF | Upper limit: 2 to 150<br>bpm, OFF<br>Lower limit: OFF, 0 to<br>148 bpm | | No Breath<br>Detection Time<br>Limit | 5 to 40 seconds, off | 5 to 40 seconds, OFF | 5 to 40 seconds, off | | No breath<br>Detection<br>CO2 | Yes | Yes (Displayed as<br>"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<br>(K062115) | Reference Device<br>(K080342) | New Device | | Declared range<br>and accuracy<br>with sensor | TG-900P:<br>$±3$ mmHg (0 ≤ CO2 ≤ 10 mmHg)<br>$±4$ mmHg (10 ≤ CO2 ≤ 40 mmHg)<br>$±10$ % reading (40 ≤ CO2 ≤ 100 mmHg)<br>(At 1 atmospheric pressure, air inspiration, no condensation)<br>TG-920P:<br>$±3$ mmHg (0 ≤ CO2 ≤ 10 mmHg)<br>$±4$ mmHg (10 ≤ CO2 ≤ 40 mmHg)<br>$±10$ % reading (40 ≤ CO2 ≤ 100 mmHg)<br>(At 1 atmospheric pressure, air inspiration, no condensation,<br>7 minutes passed after stabilization of the sensor temperature)<br>TG-970P, TG-980P:<br>$±2$ mmHg (0 ≤ CO2 ≤ 40 mmHg)<br>$±5$ % reading (40 < CO2 ≤ 70 mmHg)<br>$±7$ % reading (70 < CO2 ≤ 100 mmHg)<br>$±10$ % reading (100 < CO2 ≤ 150 mmHg)<br>(When no condensation) | TG-900P:<br>$±3$ mmHg (0 ≤ CO2 ≤ 10 mmHg)<br>$±4$ mmHg (10 ≤ CO2 ≤ 40 mmHg)<br>$±10$ % reading (40 ≤ CO2 ≤ 100 mmHg)<br>(At 1 atmospheric pressure, air inspiration, no condensation)<br>TG-920P:<br>$±3$ mmHg (0 ≤ CO2 ≤ 10 mmHg)<br>$±4$ mmHg (10 ≤ CO2 ≤ 40 mmHg)<br>$±10$ % reading (40 ≤ CO2 ≤ 100 mmHg)<br>(At 1 atmospheric pressure, air inspiration, no condensation,<br>7 minutes passed after stabilization of the sensor temperature)<br>TG-970P, TG-980P:<br>$±2$ mmHg (0 ≤ CO2 ≤ 40 mmHg)<br>$±5$ % reading (40 < CO2 ≤ 70 mmHg)<br>$±7$ % reading (70 < CO2 ≤ 100 mmHg)<br>$±10$ % reading (100 < CO2 ≤ 150 mmHg)<br>(When no condensation) | TG-900P:<br>$±3$ mmHg (0 ≤ CO2 ≤ 10 mmHg)<br>$±4$ mmHg (10 ≤ CO2 ≤ 40 mmHg)<br>$±10$ % reading (40 ≤ CO2 ≤ 100 mmHg)<br>(At 1 atmospheric pressure, air inspiration, no condensation)<br>TG-920P:<br>$±3$ mmHg (0 ≤ CO2 ≤ 10 mmHg)<br>$±4$ mmHg (10 ≤ CO2 ≤ 40 mmHg)<br>$±10$ % reading (40 ≤ CO2 ≤ 100 mmHg)<br>(At 1 atmospheric pressure, air inspiration, no condensation,<br>7 minutes passed after stabilization of the sensor temperature)<br>TG-970P, TG-980P:<br>$±2$ mmHg (0 ≤ CO2 ≤ 40 mmHg)<br>$±5$ % reading (40 < CO2 ≤ 70 mmHg)<br>$±7$ % reading (70 < CO2 ≤ 100 mmHg)<br>$±10$ % reading (100 < CO2 ≤ 150 mmHg)<br>(When no condensation) | | Alarm Limits,<br>CO2: Upper<br>Lower | 2 to 99 mmHg, off<br>1 to 98 mmHg, off | 2 to 99mmHg, OFF<br>1 to 98 mmHg, OFF | Upper limit: 2 to 99 mmHg, OFF<br>Lower limit: 1 to 98 mmHg, OFF | | Respiration<br>Detection From<br>CO2 | Yes | Yes | Yes…