(119 days)
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.
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.
This document describes the Nihon Kohden CO2 Monitor, Model OLG-3800A, and its substantial equivalence to predicate devices. However, it does not contain a typical study design with the elements requested (acceptance criteria, device performance, sample size, ground truth, expert involvement, etc.) for an AI/ML-based medical device. Instead, it details the device's technical specifications, indications for use, and compliance with various international standards for medical electrical equipment and a brief section on performance testing.
Therefore, many of the requested fields cannot be directly extracted from the provided text because they are not applicable to the type of regulatory submission (a 510(k) for a hardware medical device with standard electrical and performance testing against a predicate device, not an AI/ML algorithm requiring a clinical validation study with human readers or standalone performance metrics).
However, I can extract information related to the device's stated performance and compliance with relevant standards, which serve as its "acceptance criteria" in this context.
Here's the information that can be extracted or inferred based on the provided document:
1. A table of acceptance criteria (from standards) and the reported device performance:
| Acceptance Criteria (from Standards) | Reported Device Performance (from text) |
|---|---|
| CO2 Measurement Accuracy (with specific sensors): | Nihon Kohden CO2 Monitor, Model OLG-3800A (New Device) |
| TG-900P: ±3 mmHg (0 ≤ CO2 ≤ 10 mmHg) | TG-900P: ±3 mmHg (0 ≤ CO2 ≤ 10 mmHg) |
| ±4 mmHg (10 ≤ CO2 ≤ 40 mmHg) | ±4 mmHg (10 ≤ CO2 ≤ 40 mmHg) |
| ±10 % reading (40 ≤ CO2 ≤ 100 mmHg) | ±10 % reading (40 ≤ CO2 ≤ 100 mmHg) |
| TG-920P: ±3 mmHg (0 ≤ CO2 ≤ 10 mmHg) | TG-920P: ±3 mmHg (0 ≤ CO2 ≤ 10 mmHg) |
| ±4 mmHg (10 ≤ CO2 ≤ 40 mmHg) | ±4 mmHg (10 ≤ CO2 ≤ 40 mmHg) |
| ±10 % reading (40 ≤ CO2 ≤ 100 mmHg) | ±10 % reading (40 ≤ CO2 ≤ 100 mmHg) |
| TG-970P, TG-980P: ±2 mmHg (0 ≤ CO2 ≤ 40 mmHg) | TG-970P, TG-980P: ±2 mmHg (0 ≤ CO2 ≤ 40 mmHg) |
| ±5 % reading (40 < CO2 ≤ 70 mmHg) | ±5 % reading (40 < CO2 ≤ 70 mmHg) |
| ±7 % reading (70 < CO2 ≤ 100 mmHg) | ±7 % reading (70 < CO2 ≤ 100 mmHg) |
| ±10 % reading (100 < CO2 ≤ 150 mmHg) | ±10 % reading (100 < CO2 ≤ 150 mmHg) |
| Respiration Rate Display Range: | 0 to 150 bpm |
| 0 to 150 bpm | |
| SpO2 Displayed Range (NK type): | 0 to 100%SpO2 |
| 0 to 100% | |
| SpO2 Accuracy (NK type) and Range (with sensor): | 70 to 100%SpO2 |
| 70 to 100% (with sensor) | 80 to 100%SpO2 ±2% SpO2 |
| 80 to 100% ±2% SpO2 | 70 to 80%SpO2 ±3% SpO2 |
| 70 to 80% ±3% SpO2 | |
| Safety and Performance Standards Compliance: | The document states compliance with all listed standards, implying the device meets their requirements. |
| AAMI/ANSI ES60601-1:2005 /(R)2012 And A1: 2012. C1:2009/(R)2012 And A2:2010/(R)2012 (IEC 60601-1:2005 + A1:2012) | |
| IEC 60601-1-2:2007 Medical Electrical Equipment - Part 1-2 | |
| IEC 60601-1-8:2006 & A1:2012 Medical electrical equipment - Part 1-8 | |
| ISO 80601-2-55:2011 Medical Electrical Equipment - Part 2-55 | |
| ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61 (for SpO2) | |
| ISO 10993-1:2009 Biological Evaluation of Medical Devices – Part 1 | |
| ISO 14971:2007 Medical Devices – Application of Risk Management | |
| IEC 62304:2006 Medical Device Software - Software Life-cycle Processes | |
| IEC 62366:2007 + Amendment 1:2014 - Medical devices -- Application of usability engineering |
2. Sample size used for the test set and the data provenance:
- The document mentions "performance testing" and "software verification and validation test, software unit test, integration test." It also states, "It has been verified using standard ISO 80601-2-61:2011" for SpO2.
- However, specific sample sizes for these tests or data provenance (e.g., country of origin, retrospective/prospective) are not provided as this is not a clinical study on patient data for AI/ML. The testing likely refers to bench testing, functional testing, and electrical/software validation according to the listed standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and therefore not provided. The device's performance is validated against established physical/electrical/optical standards and measurement accuracy, not against expert interpretation of medical images or data.
4. Adjudication method for the test set:
- This information is not applicable and therefore not provided. It is not an expert-based review but a technical validation against specifications and standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This information is not applicable. The device is a monitor, not an AI-assisted diagnostic tool that would be used by human "readers" (like radiologists interpreting images). It provides direct physiological measurements.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The device itself is standalone in terms of its measurement function. It operates as an algorithm-only device (its internal processing) for measuring physiological parameters. Its performance is evaluated against the accuracy specifications derived from the standards mentioned (e.g., ISO 80601-2-55 for CO2, ISO 80601-2-61 for SpO2). The provided performance ranges (e.g., CO2 accuracy range, SpO2 accuracy range) represent its standalone performance.
7. The type of ground truth used:
- The "ground truth" for this monitoring device is based on reference measurement standards and calibrated equipment used in engineering and electrical safety testing, as well as the specific accuracy limits defined in the referenced ISO and IEC standards for CO2 and SpO2 monitoring. For example, SpO2 measurement "has been verified using standard ISO 80601-2-61:2011," which outlines methods and criteria for evaluating oximeter accuracy.
8. The sample size for the training set:
- This information is not applicable and therefore not provided. This is not an AI/ML device that undergoes "training" on a dataset in the conventional sense. Its internal algorithms are developed and calibrated based on engineering principles and physiological models, not machine learning from a large training dataset.
9. How the ground truth for the training set was established:
- This information is not applicable for the same reasons as #8.
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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
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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
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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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510(k) Summary
Nihon Kohden CO2 Monitor, Model OLG-3800A
| Submitter:Address:Phone number: | Nihon Kohden Corporation1-31-4 Nishiochiai, 1-Chome, Shinjuku-Ku Tokyo, Japan 161-856081-3-59968020 |
|---|---|
| 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-3800ACarbon Dioxide (CO2) Gas AnalyzerClass II |
| Primary Product code:Secondary Product code (forCap-ONE Biteblock, YG-227T): | CCKMNK |
| Regulation: | 21 CFR 868.1400 |
| CO2 Monitor, OLG-3800APredicate:Reference: | Nihon Kohden CO2 Monitor, OLG-2800A (K062115)Nihon Kohden Bedside Monitor, BSM-6000 series (K080342) |
| Biteblock, YG-227TPredicate: | 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.
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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.
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| OLG-2800APredicate(K062115) | BSM-6000 SeriesReference Device(K080342) | OLG-3800ANew Device | |
|---|---|---|---|
| Specification | Indications for Use | ||
| The OLG-2800A is aportable monitor thatmeasures respirationstatus of patients at amedical facility setting.The device is used withcommercially availablesensors for intubated andnon-intubated patients.The device displayswaveforms and numericdata of monitoredparameters, such as CO2,EtCO2, respiratory rateand trendgraphs. Thedevice may generate anaudible and/or visiblealarm when a measuredparameter falls outsidepreset limits.The device LED displayshowsEtCO2 value andrespiration rate and theLCD display shows CO2waveforms, and alarmssettings. The device is ACand/or battery operated.The device will beavailable for use bymedical personnel on allpatient populationsdepending on the CO2sensor kit. | The device is intended tomonitor, display andrecord physiological datato provide cardiac andvital signs monitoringwithin a medical facility.The device is intended toproduce a visual record ofthe electrical signalsproduced by heart andmonitor theelectrocardiogram togenerate audible and/orvisible alarms when anarrhythmia exists. Thedevice is also intended tomonitor heart rate, pulserate, blood oxygensaturation (SpO2),noninvasive bloodpressure (NIBP), invasiveblood pressure (IBP),body temperature, BIS,cardiac output (CO),oxygen concentration(FiO2), carbon dioxideconcentration (CO2),EtCO2, respiratory rate,and inspired and expiredanesthetic agents andanesthetic gasesincluding N2O, Halothane,Isoflurane, Enflurane,Sevoflurane andDesflurane. The devicemay generate an audibleand/or visual alarm whena measured rate fallsoutside preset limits. Thedevice may also be usedto condition and transmitphysiological signals viaradio frequency.The device will beavailable for use bymedical personnel onpatients within a medicalfacility on all patientpopulations. | The OLG-3800A CO2monitor is intended tomonitor respiratory rate,CO2 partial pressureand EtCO2. The deviceis also intended tomonitor pulse rate andSpO2.The device maygenerate an audibleand/or visible alarmwhen a measuredphysiological rate fallsoutside preset limits, orwhen a technical error isdetected.The devices areintended to be used byqualified medicalpersonnel within amedical facility, such ashospital or clinic, on allpatient populationsincluding adult, neonate,infant, child, andadolescent subgroups. | |
| OLG-2800A | BSM-6000 Series | OLG-3800A | |
| Specification | Predicate(K062115) | Reference Device(K080342) | New Device |
| Display | |||
| Type | FSTN monochromeLCD,7 segment LED, 3 digitsdisplay EtCO2 | TFT Color LCD,10.4" (BSM-6301A)12.1" (BSM-6501A)15.0" (BSM-6701A) | 7-inch, color TFT typeLCD |
| Resolution | 200 x 108 | 800x600 (BSM-6301A/6501A);1024x768 (BSM-6701A) | 800 (H) × 480 (V) |
| WaveformDisplay | CO2 | ECG (12 leads),respiration, pulse, CO2,cardiac output, externalinput,O2, EEG (BISx) ,IBP(7) | CO2, SpO2 |
| Numeric DataDisplay | EtCO2, respiration rate | Heart Rate, Pulse Rate,VPC rate, ST level (12leads),Respiration Rate,NIBP (SYS/DIA/MAP)Temperature (4), SpO2,EtCO2, FiCO2,FiO2,cardiac output, O2, BIS,IBP(7) (sys/dia/mean) | ETCO2, FiCO2, INSTCO2, RR, SpO2, PR, PI |
| Alarm | |||
| Vital SignsAlarmParameters | ETCO2, FiCO2RR, 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),INSTCO2,RR,NOBREATH,SpO2,PR |
| Respiration | |||
| Method | CO2 | Impedance, thermistor,CO2 | CO2 |
| RespirationRate Display | 0 to 150 bpm | 0 to 150 bpm | 0 to 150 bpm |
| Alarm Limits:UpperLower | 2 to 150 bpm, off0 to 148 bpm, off | 2 to 150 bpm, OFF0 to 148 bpm, OFF | Upper limit: 2 to 150bpm, OFFLower limit: OFF, 0 to148 bpm |
| No BreathDetection TimeLimit | 5 to 40 seconds, off | 5 to 40 seconds, OFF | 5 to 40 seconds, off |
| No breathDetectionCO2 | 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 rangeand accuracywith 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 < CO2 ≤ 70 mmHg)$±7$ % reading (70 < CO2 ≤ 100 mmHg)$±10$ % reading (100 < CO2 ≤ 150 mmHg)(When no condensation) | 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 < CO2 ≤ 70 mmHg)$±7$ % reading (70 < CO2 ≤ 100 mmHg)$±10$ % reading (100 < CO2 ≤ 150 mmHg)(When no condensation) | 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 < CO2 ≤ 70 mmHg)$±7$ % reading (70 < CO2 ≤ 100 mmHg)$±10$ % reading (100 < CO2 ≤ 150 mmHg)(When no condensation) |
| Alarm Limits,CO2: UpperLower | 2 to 99 mmHg, off1 to 98 mmHg, off | 2 to 99mmHg, OFF1 to 98 mmHg, OFF | Upper limit: 2 to 99 mmHg, OFFLower limit: 1 to 98 mmHg, OFF |
| RespirationDetection FromCO2 | Yes | Yes | Yes |
| EtCO2 NumericDisplay | Yes | Yes | Yes |
| Respiratorysynchronizationsound(ETCO2) | Fixed | No | Fixed, 5 levels |
| SpO2 | |||
| Probe type | N/A | Nihon Kohden (NK),Nellcor (NL) or Masimo(MS) | Nihon Kohden (NK) |
| DisplayedRange (NKtype) | N/A | 0 to 100% | 0 to 100%SpO2 |
| Specification | OLG-2800APredicate(K062115) | BSM-6000 SeriesReference Device(K080342) | OLG-3800ANew Device |
| DeclaredRange (NKtype) andAccuracy withSensor | N/A | 70 to 100% (withsensor)80 to 100% ±2% SpO270 to 80% ±3% SpO2 | 70 to 100%SpO280 to 100%SpO2 ±2%SpO270 to 80%SpO2 ±3%SpO2 |
| Alarm Limits(SpO2): UpperLower | N/A | 51 - 100%, OFF50 - 99%, OFF | Upper limit: 51 to 100%SpO2, OFFLower limit: 50 to 99%SpO2, OFF |
| Alarm Limits(PR): UpperLower | N/A | Upper limit range: WhenSYNC SOURCE is set toECG:16 to 300 beats/min in 1beat/min steps, OFFWhen SYNC SOURCE isset to PRESS or SpO2:31 to 300 beats/min in 1beat/min steps, OFFLower limit range: WhenSYNC SOURCE is set toECG:OFF, 15 to 299 beats/minin 1 beat/min stepsWhen SYNC SOURCE isset to PRESS or SpO2:OFF, 30 to 299 beats/minin 1 beat/min steps | Upper limit: 31 to 300bpm, OFFLower limit: OFF, 30 to299 bpm |
| Pulse RateCount Range: | N/A | 0, 30-300 bpm(NK)0, 20-300 bpm(NL)0, 25-240 bpm(MS) | 30 to 300 bpm |
| Power Requirements | |||
| Line Voltage | 117 VAC | 117 VAC | AC 100 to 240 V ±10% |
| PowerConsumption | 50 VA | 90VA (BSM-6501A)100VA (BSM-6701A) | 45 VA |
| Safety Standard | |||
| Safety Standard | IEC 60601-1:1988IEC 60601-1 Amendment1: 1991IEC 60601-1 Amendment2: 1995IEC 60601-1-2: 2001 | IEC 60601-1:1988IEC 60601-1 Amendment1: 1991IEC 60601-1 Amendment2: 1995IEC 60601-1-2: 2001 | IEC 60601-1:2005+Amendment1:2012IEC 60601-1-2:2007 |
| Memory | |||
| Full DisclosureStorage | No | 24 hours, 5 waves,Standard | 120 hours, 2 wavesCO2,SpO2 |
| List Capacity | 24 hours | 24 hours,Standard | 120 hours |
| Dimension and Weight | |||
| Dimensions,mm (H x W xD) | 62 x 210 x 164 mm | 316 x 325 x 188 (BSM-6301A) mm342 x 353 x 183 (BSM-6501A) mm | 140 × 200 × 145 mm |
| Specification | OLG-2800APredicate(K062115) | BSM-6000 SeriesReference Device(K080342) | OLG-3800ANew Device |
| 415 x 392 x191 (BSM-6701A) | |||
| Weight (withoutaccessories) | 1.3 Kg (includingBattery) | 6.6 kg (BSM-6301A)8.3 kg (BSM-6501A)10.3 kg (BSM-6701A) | 1.7 kg (includingBattery) |
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The Nihon Kohden cap-ONE Biteblock, YG-227T is substantially equivalent to the predicate device, Oridion/Covidien/Medtronic Smart CapnoLine Guardian (K093388).
The following table shows a comparison of the subject device and the predicate.
| Smart CapnoLine Guardian(Oridion/Covidien/Medtronic, K093388) | Cap-ONE Biteblock, YG-227T(New device) | |
|---|---|---|
| IFU | The Smart CapnoLine Guadian isintended to sample CO2 and administersupplemental oxygen, for patients whocan wear 60 fr. Bite block, during upperendoscopy type procedures.The set is intended for single patient useonly. | The cap-ONE Biteblock is intended tosample CO2 and administersupplemental oxygen, for patients whocan wear a 20mm bite block, duringendoscopy type procedures.The device is intended for single patientuse only. |
| Patientpopulation | Patients who can wear 60 fr. Bite block | Patients who can wear a 20mm biteblock |
| Components | Image: Smart CapnoLine Guardian components | Image: Cap-ONE Biteblock components |
| Dimension | (W) 120 x (H) 45 x (D) 26mm* | (W) 43 × (H) 70.6 × (D) 39.7mm±10% |
| Weight | 18g+10% |
*Manual measurements from actual device
Test Summary:
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.
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Standards compliance testing includes:
AAMI/ANSI ES60601-1:2005 /(R)2012 And A1: 2012. C1:2009/(R)2012 And A2:2010/(R)2012 (IEC 60601-1:2005 + A1:2012): Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
IEC 60601-1-2:2007 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
IEC 60601-1-8:2006 & A1:2012 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - collateral standard: General requirements, tests and quidance for alarm systems in medical electrical equipment and medical electrical systems
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 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for the basic safety and essential performance of pulse oximeter equipment
ISO 10993-1:2009 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing
ISO 14971:2007 Medical Devices – Application of Risk Management to Medical Devices
IEC 62304:2006 Medical Device Software - Software Life-cycle Processes
IEC 62366:2007 + Amendment 1:2014 - Medical devices -- Application of usability engineering to medical devices
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
Conclusion:
The performance of the Nihon Kohden CO2 Monitor OLG-3800A is substantially equivalent to the predicate device, the Nihon Kohden CO2 Monitor Model OLG-2800A and does not raise different questions of safety or effectiveness.
§ 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).