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 nonintubated 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 visual alarm when a measured parameter falls outside preset limits.

The device LED display shows ETCO2 value and respiration rate and the LCD display shows CO2 waveforms, and alarm settings. The device is AC and/or battery operated. This device will be available for use by medical personnel on all patient populations depending on the CO2 sensor kit.

Device Description

The OLG-2800A is a portable monitor that monitors 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 is a monitor, which displays waveforms and numeric data, such as: , EtCO2, and respiratory rate, as well as trendgraphs. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. Alarms are indicated by sound, blinking LED (numeric display) and messages on the LCD.

The device LED displays EtCO2 value and respiration rate and the LCD indicates CO2 waveforms, and alarm settings and trendgraphs. The device is AC and/or battery operated.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Nihon Kohden OLG-2800A, a breathing frequency monitor and carbon dioxide gas analyzer. However, the document does not contain specific acceptance criteria or an explicit study proving that the device meets those criteria, as one would expect for a detailed performance study.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Nihon Kohden BMS-5130A Series Bedside Monitor). The "Performance Testing" section states: "To date, no special controls or performance standards are known or established for this device." This indicates that the regulatory pathway for this device did not require the applicant to conduct and report a study with explicit performance targets and outcomes in the same way that a novel high-risk device or a device with established performance standards would.

Here's an breakdown of the information that is available based on your request, and where the requested information is not present in the provided text:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The submission focuses on substantial equivalence to a predicate device rather than meeting specific quantifiable performance criteria for accuracy, sensitivity, or specificity.	The device was subject to: Environmental testing (temperature/humidity stress)Electromagnetic interference / electromagnetic compatibility testingSafety standards testingPerformance testing procedures "Test criteria were established before testing based on product specifications and applicable standards. The completed testing showed that the device met its product specifications and verified conformance to safety, reliability, and recognized standards as applicable."
Compliance with voluntary industrial standards	Complies with: IEC 60601-1 (1988-12), Amendment 1 (1991-11), Amendment 2 (1995-03)IEC 60601-1-2 (2001)IEC 60601-1-1 (2000)
Software verification and validation	"Software verification and validation verified and confirmed the operation of the software and hardware functions of the device."

Explanation: The document does not provide specific numerical acceptance criteria (e.g., target accuracy, precision) for parameters like EtCO2 or respiratory rate, nor does it present the direct numerical results from performance tests against such criteria. The "performance testing" described is general and confirms the device met its own product specifications and recognized standards, rather than a pre-defined set of regulatory acceptance criteria for clinical performance that would typically be described in detail in a study report.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified.
Data Provenance: Not specified. The performance testing appears to be primarily engineering and standards-based (environmental, EMC, safety) rather than clinical performance data from patient populations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable/Not specified.
Qualifications of Experts: Not applicable/Not specified. The testing described is against engineering specifications and industry standards, not against "ground truth" established by clinical experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable/Not specified. There is no mention of clinical adjudication for performance evaluation.

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

MRMC Study: No. This device is a monitor displaying physiological data (EtCO2, respiratory rate); it is not an AI-assisted diagnostic imaging device requiring a "reader" study. The concept of "human readers improve with AI" is not relevant to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: The described "performance testing" (environmental, EMC, safety, and software verification) is essentially standalone testing of the device's adherence to its specifications and applicable standards. However, it's not "standalone" in the context of an AI algorithm's diagnostic performance without human intervention. This device provides raw data and alarms, which humans then interpret and act upon.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: Not applicable in the traditional sense for clinical diagnostic performance. The "ground truth" for the device's described performance testing would be the engineering specifications for the device itself and the requirements of the voluntary industrial standards (IEC 60601 series). For example, a CO2 sensor's accuracy might be verified against a calibrated gas mixture, but the details of such verification are not in this summary.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device is a physiological monitor, not an AI/machine learning system that requires a "training set" in the context of developing its core functionality.

9. How the ground truth for the training set was established

Ground Truth for Training Set Establishment: Not applicable, as there is no "training set" for this type of device.

Summary of Regulatory Approach:

The K062115 submission for the Nihon Kohden OLG-2800A relies on demonstrating substantial equivalence to an existing predicate device (Nihon Kohden BMS-5130A Series Bedside Monitor). The performance testing described is primarily focused on confirming the device's compliance with engineering specifications and recognized safety/EMC standards, and the proper functioning of its software/hardware. It explicitly states that no special controls or performance standards are known or established for this device, which means the FDA did not require a dedicated clinical performance study with specific acceptance criteria in this 510(k) submission.

Summary

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510(k) NOTIFICATION

K062115

SECTION 2 - 510(K) SUMMARY

Name and Address of Applicant Nihon Kohden America, Inc. 90 Icon Street Foothill Ranch, CA 92610

Pro 9 7 2006 Contact: Serrah Namini, Regulatory Affairs Assoc. Director (949) 580-1555 Ext. 4401 Fax: (949) 580-1550

Date: June 28, 2006

. Device Name: OLG-2800A series
. Trade or proprietary name: OLG-2800A
The common or usual name: Breathing Frequency Monitor, Carbon Dioxide Gas . Analyzer
. The classification name: Monitor, breathing frequency
Legally Marketed Predicate: Nihon Kohden BMS-5130A Series Bedside Monitor per . 510(k)# K030105.

Description and Intended Use: The OLG-2800A is a portable monitor that monitors 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 is a monitor, which displays waveforms and numeric data, such as: , EtCO2, and respiratory rate, as well as trendgraphs. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. Alarms are indicated by sound, blinking LED (numeric display) and messages on the LCD.

The device LED displays EtCO2 value and respiration rate and the LCD indicates CO2 waveforms, and alarm settings and trendgraphs. The device is AC and/or battery operated. This device will be available for use by medical personnel at medical facility setting, including ER, OR, ICU, CCU, clinic and doctor's office on all patient populations, depending on the accessories (CO2 sensors) used with the device. These accessories have been cleared and are available with other Nihon Kohden monitors.

A summary of the technological characteristics of the device compared to the predicate device:

Performance Testing

To date, no special controls or performance standards are known or established for this device. ■ The device is designed to comply with the following voluntary industrial standards: IEC 60601-1 (1988-12), Amendment 1 (1991-11), Amendment 2 (1995-03), IEC 60601-1-2 (2001), IEC 60601-1-1 (2000)
트 The device is not sterile.

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The device does not directly contact patients. Accessories that contact patients, such breathing 트 adapters, are the same accessories used with other legally marketed products.
The device was subject to environmental testing including temperature/humidity stress 트 testing, electromagnetic interference / electromagnetic compatibility testing and safety standards testing and performance testing procedures. Test criteria were established before testing based on product specifications and applicable standards. The completed testing showed that the device met its product specifications and verified conformance to safety, reliability, and recognized standards as applicable. Software verification and validation verified and confirmed the operation of the software and hardware functions of the device.

There are no significant changes in function, biocompatibility, performance or manufacturability compared to the predicate device that would affect the safety and effectiveness of the device as intended for use. Therefore, Nihon Kohden believes that the new OLG-2800A series, is substantially equivalent to the predicate BSM-5130A Series Bedside Monitor with having fewer indications for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three legs, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Serrah Namini Regulatory Affairs Associate Director Nihon Kohden America, Incorporated 90 Icon Street Foothill Ranch, California 92610-1601

DEC 2 7 2006

Re: K062115

Trade/Device Name: Carbon Dioxide Monitor, Model OLG-2800A Regulation Number: 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: November 27, 2006 Received: November 28, 2006

Dear Mr. Namini:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Namini

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 801); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Shaila A. Murphy, MD. Chan for PhD

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, 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: OLG-2800A

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Will C. May for A.A.6.

masthesiology, General Hospilal, ontrol. Dental Devices

Regulation Number and Section

§ 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).