The optional AG-920RA module will measure carbon dioxide (CO2), nitrous oxide (N₂O), oxygen (O₂), and any of five anesthetic agents (Halothane, Isoflurane, Enflurane, Sevoflurane, and Desflurane) of a patient undergoing anesthesia and display the results on a bedside monitor.

Device Description

The device currently marketed per K001693 is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring including arrhythmia detection and alarms within a medical facility. With the new AG-920PA option, the device will measure and display Carbon dioxide (CO2), nitrous oxide (N2O), oxygen (O2), and any of five anesthetic agents (Halothane, Isofilurane, Enflurane, Sevoflurane, and Desflurane).

AI/ML Overview

The provided documentation for the NIHON KOHDEN AMERICA, INC. BSM-4100A Series with AG-920RA Option does not contain the detailed information necessary to complete all sections of the request.

Specifically, the document focuses on regulatory equivalence and general performance testing, not on a specific study designed to prove the device meets acceptance criteria related to accuracy, specificity, or sensitivity of gas measurement.

Here's an attempt to answer based on the available information, with many sections marked as "Not provided in the document."

Acceptance Criteria and Device Performance Study for BSM-4100A Series with AG-920RA Option

Based on the provided 510(k) notification summary (K020046), the acceptance criteria and study details are largely about general performance and safety rather than specific measurement accuracy criteria for the gas analyzer function.

The document states that "The device was subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the device software. The results confirmed that the device performed within specifications." However, it does not specify what those "specifications" or "acceptance criteria" are for the gas measurement accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
General Performance	Device operates within specifications (implied)	"The results confirmed that the device performed within specifications."
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 (1993-05) and CISPR11 Group 1, Class A	Device tested and verified operation; designed to comply with standards.
Environmental Safety	Performance under various environmental conditions (implied)	Device tested and verified operation.
Electrical Safety	Compliance with IEC 60601-1 (1988-12), Amendment 1 (1991-11), Amendment 2 (1995-03)	Device tested and verified operation; designed to comply with standards.
Software Validation	Software operates as intended (implied)	"Software validation tested the operation of the device software."
Electrode Lead Wires & Patient Cables	Compliance with IEC 601-1 subclause 56.3(c) implemented by 21 CFR Part 898 (if applicable to BSM-4100A base unit)	The BSM-4100A base unit complies with this standard. (Specific to AG-920RA, this is not a direct requirement as it does not contact patients).
Gas Measurement Accuracy, Range, etc.	Not provided in the document.	Not provided in the document.

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 provided for the gas analysis function. The document refers to "testing procedures" without specifying sample sizes for specific performance metrics of the AG-920RA module.
Data Provenance: Not provided. The company is based in Foothill Ranch, California, USA, but actual test location/origin is not specified.
Retrospective or Prospective: Not provided. The testing described appears to be pre-market validation testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. The testing described focuses on engineering validation and compliance with standards, not on clinical interpretation or expert-derived ground truth for gas analysis.

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

Not applicable/Not provided. This type of adjudication pertains to human interpretation/review, which is not relevant to the described engineering and performance testing.

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

Not applicable. This device is a measurement instrument, not an AI-assisted diagnostic tool requiring human reader studies.

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

The AG-920RA module, as a measurement device, inherently operates in a "standalone" fashion to measure gas concentrations. The "performance testing procedures" and "software validation" would constitute its standalone evaluation for its specified functions. However, specific results for accuracy, precision, etc., for each gas are not detailed.

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

For a gas analyzer, the "ground truth" would typically be established by reference instruments or known gas concentrations, calibrated against traceable standards. The document does not specify the exact methods or reference standards used to establish ground truth for the gas measurements. It implies that "performance testing" was conducted which would involve such methods.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would require a "training set."

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

Not applicable. (See #8)

Summary

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NIHON KOHDEN AMERICA, INC. January 3, 2002

K 020046

510(k) NOTIFICATION BSM-4100A Series with AG-920RA Option

JUL 2 5 2002

SECTION 2 - 510(K) SUMMARY

Name and Address of Applicant Nihon Kohden America, Inc. Attn: Regulatory Affairs 90 Icon Street Foothill Ranch, California 92610

Phone: (949) 580-1555 Fax: (949) 580-1550

Common names for the device include Bedside Monitor, Patient Monitor, Cardiac Monitor and Vital Signs Monitor. The functions of the device added by the AG-920RA option are classified as Class II per the Anesthesiology Device Classification Panel per 21 CFR 868.1500, "Analyzer, Gas, Enflurane, Gaseous-Phase", CBQ; 21 CFR 868.1620, "Analyzer, Gas, Halothane, Gaseous-Phase", CBS; and 21 CFR 868.1700, "Analyzer, Gas, Nitrous-Oxide, Gaseous-Phase", CBR.

The AG-920PA module is equivalent to the 90518 Multi-gas Analyzer per K954962 and the SC9000/SC9015 Multi-gas Module per K965062.

The device complies with IEC 601-1 subclause 56.3(c) implemented by 21 CFR Part 898 Performance Standard for Electrode Lead Wires and Patient Cables. To date, no other special controls or performance standards are known or established for this device.

The device is not sterile.

The device does not directly contact patients, therefore, good laboratory practice studies were not required per 21 CFR part 58.

The device was subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the device software. The results confirmed that the device performed within specifications.

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 (1993-05) and CISPR11 Group 1, Class A

Therefore, Nihon Kohden believes that the device is substantially equivalent to the predicate.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines, suggesting a person in profile.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 25 2002

Ms. Serrah Namini Regulatory Affairs Manager Nihon Kohden America, Incorporated 90 Icon Street Foothill Ranch, California 92610

Re: K020046

Trade/Device Name: Multigas Unit, Model AG-920RA Regulation Number: 868.1400; 868.1720; 868.1700; 868.1500; 868.1620 Regulation Name: Carbon dioxide gas analyzer: Oxygen gas analyzer: Nitrous oxide gas analyzer; Enflurane gas analyzer; Halothane gas analyzer Regulatory Class: II Product Code: CCK; CCL; CBR; CBQ; NHO, NHP, NHQ; CBS Dated: May 2, 2002 Received: May 2, 2002

Dear Ms. 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.

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.

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Page 2 - Ms. Namini

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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

:Sincerely yours,

Timothy A. Ulatowski

Timothy A. I 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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NIHON KOHDEN AMERICA, INC. January 3, 2002

510(k) NOTIFICATION BSM-4100A Series with AG-920RA Option

G. Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: BSM-4100A Bedside Monitor with AG-920RA Option

Prescription Use

R.W. Wisham

Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number -

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).