The Fukuda Denshi model HC-500 End Tidal CO2 Module is intended to be used to noninvasively monitor inspired and end tidal CO2 and respiration rate by trained medical professionals by or on the order of a physician. The Fukuda Denshi model HC-500 End Tidal CO2 Module will function with all Novametrix reusable and disposable main stream sensors.

The Fukuda Denshi model HC-500 End Tidal CO2 Module is intended to be used in an adult, infant and/or neonate patient population who are under the care of a physician, within the confines of a health care facility. The intended environment is critical care monitoring situations, including ventilator support and anesthesia where the Fukuda Denshi model DS-5300 Patient Monitor is being utilized.

The Fukuda Denshi model HC-500 End Tidal CO2 Module is not intended for home use.

The Fukuda Denshi model HC-500 End Tidal CO2 Module is intended to be used as part of the Fukuda Denshi DynaScope™ DS-5000 series of bedside patient monitoring systems. The HC-500 will not function as a stand alone device.

The Fukuda Denshi model HC-500 End Tidal CO2 Module is indicated in those situation where it is desirable to perform real-time end tidal or inspired carbon dioxide concentration and/or respiration rate monitoring of intubated adult, infant and/or neonate patients who are under the care of a physician, within the confines of a health care facility.

Device Description

The Fukuda Denshi model HC-500 End Tidal CO2 Module is a computer controlled medical device. It is designed to non-invasively provide respiration, inspired and expired CO2 values when used as part of the DS-5300 Patient Monitoring System (K964187). The HC-500 is a module, not a stand alone device. As a module, it will only operate when installed into a DS-5300 bedside patient monitor. The Fukuda Denshi model HC-500 ETCO2 module will function with all NOVAMETRIX main stream sensors.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Fukuda Denshi model HC-500 End Tidal CO2 Module:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics in a tabular format as might be found in a more recent submission. Instead, it relies on demonstrating substantial equivalence to a predicate device and adherence to recognized standards.

Here's a summary of the implied "acceptance criteria" and the reported performance based on the text:

Acceptance Criterion (Implied)	Reported Device Performance
Safety:
Electrical safety	Meets UL 2601, CSA 22.2, and AAMI standards for electrical safety. Designed to prevent excessive electrical leakage current.
Effectiveness/Performance:
Accurate CO2 measurement	ETCO2 sensing and calculation algorithms are similar to the predicate HC-300 and the same as those employed by Novametrix Medical Systems Inc.
Accurate respiration rate monitoring	Implied by similarity of algorithms and overall intended use.
Compliance with design specifications	Laboratory testing validated and verified that the device met all design specifications.
Environmental robustnes	Environmental testing conducted according to FDA DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document.
Overall operation validation	Testing performed to validate the system's overall operation.
Substantial Equivalence to Predicate Device	Concluded to be as safe, as effective, and performs as well as or better than the Fukuda Denshi model HC-300 (K950044).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a test set in terms of patient data or clinical cases. The testing described is primarily laboratory-based to verify design specifications and compliance with standards.

Sample Size: Not specified.
Data Provenance: Not applicable in the context of clinical patient data, as the testing described is laboratory-based and involves general compliance and verification.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided in the document. The submission focuses on technical specifications, verification, and substantial equivalence to a predicate device, rather than a study involving expert-established ground truth for patient data.

4. Adjudication Method for the Test Set

This information is not provided in the document as it did not involve a study with a test set requiring adjudication of findings (clinical patient data).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done.
Effect Size: Not applicable.

This type of study is relevant for AI-powered diagnostic devices. The HC-500 is an End Tidal CO2 Module, which is a physiological monitoring device, not an AI-assisted diagnostic tool in the sense of image interpretation or complex clinical decision support.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document implies that the "ETCO2 sensing and calculation algorithms" were tested as part of the overall device validation. However, it does not specifically describe a standalone algorithm-only performance study separate from the integrated device. The device itself is not a standalone algorithm; it's a hardware module that relies on these algorithms.
The text states: "All ETCO2 sensing and calculation algorithms are similar to those used in the HC-300 (K950044) and are the same as those employed by Novametrix Medical Systems Inc." This suggests reliance on previously validated algorithms within the predicate device and the sensor manufacturer's technology.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims appears to be:

Predicate Device Performance: The Fukuda Denshi model HC-300 (K950044) served as the primary reference for performance and safety.
Novametrix Medical Systems Inc. Testing Protocols: End Tidal CO2 validation and verification testing was "conducted according to Novametrix Medical Systems Inc. testing protocol," implying that Novametrix's established and validated methods for CO2 measurement were used as a reference.
Industry Standards: Compliance with electrical safety standards (UL 2601, CSA 22.2, AAMI) and environmental testing guidance (FDA DCRND) also forms a basis for "ground truth" regarding safety and basic functionality.

8. The Sample Size for the Training Set

Not applicable. The device described is not an AI/ML device that requires a "training set" in the modern sense. Its algorithms are based on established physiological principles and have been carried over from a predicate device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Summary

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JUN 12 1998

K980979

510(k) Summary Fukuda Denshi model HC-500 End Tidal CO2 Module

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR part 807.92.

The assigned 510(k) number is :

Submitter:

FUKUDA DENSHI AMERICA CORP. 17725 NE 65th St., Bldg C Redmond WA 98052 425/881-7737 Tel: 425/869-2018 Fax:

Contact Person:

David J. Geraghty Regulatory Affairs Manager FUKUDA DENSHI AMERICA CORP. 17725 NE 65th St., Bldg C Redmond WA 98052 425/881-7737 Tel: 425/869-2018 Fax:

Date Prepared:

March 9, 1998

Device Name:

Proprietary Name:

model HC-500 End Tidal CO2 Module

Common Name:

ETCO, Gas Module

Classification Name:

Carbon Dioxide Gas Analyzer (§869.1400)

Legally Marketed Device:

FUKUDA DENSHI model HC-300 End Tidal CO2 Module 510(k) number K950044. (The HC-500 is an addition to the to the DS-5300, 510(k), K964187.)

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Description:

The safety and efficacy of the HC-500 module has been established through various techniques. Review of the Fukuda Denshi model HC-300 predecessor product's history does not reveal any complaints related to safety and/or effectiveness. There are no reports of adverse effects or reportable incidents for the currently marketed HC-300 ETCO, product.

Statement of Intended Use:

The Fukuda Denshi model HC-500 End Tidal CO2 Module is intended to be used to non-invasively monitor inspired and expired CO, and respiration rate by trained medical professionals by or on the order of a physician. The Fukuda Denshi model HC-500 End Tidal CO2 Module will function with all NOVAMETRIX reusable and disposable main stream sensors.

The Fukuda Denshi model HC-500 End Tidal CO2 Module is intended to be used in all patient populations who are under the care of a physician, within the confines of a health care facility. The intended environment is critical monitoring situations, including ventilator support and anesthesia, where the Fukuda Denshi DS-5300 bedside patient monitor is being utilized with an IB-5006 Input Box.

The Fukuda Denshi model HC-500 End Tidal CO2 Module is NOT INTENDED FOR HOME USE.

The Fukuda Denshi model HC-500 End Tidal CO, Module is intended to be used as part of the Fukuda Denshi DS-5000 series of bedside patient monitoring systems. The HC-500 will not function as a stand alone device.

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Comparison to Predicate Device

In summary, the HC-500 module is an updated version of the HC-300 ETCO2 module designed for use in the DS-5000 series of patient monitors. Changes to the system include a reduction in size and weight to meet the requirements of the DS-5000 series modules. Control circuits have been incorporated into a Fukuda Denshi designed CPU. The front end design, as specified by Novametrix Medical Systems, Inc. has been relayed out to DS-5000 series module size specifications. The majority of the changes can be summarized as re-layout of circuits and a reduction in size.

Technological Characteristics

The Fukuda Denshi model HC-500 End Tidal CO2 Module uses small, light weight main stream sensors, Capnostat IITM or Capnostat III™, manufactured by Novametrix Medical Systems Inc. The sensors employ Novametrix solid state infrared technology. All ETCO, sensing and calculation algorithms are similar to those used in the HC-300 (K950044) and are the same as those employed by Novametrix Medical Systems Inc.

Control circuits have been incorporated into a Fukuda Denshi designed CPU. The front end design, as specified by Novametrix Medical Systems, Inc. has been relayed out to DS-5000 series module size specifications. The majority of the changes can be summarized as re-layout of circuits and a reduction in size.

No changes to the DS-5300 Patient Monitoring System (K964187) hardware or software were required to accommodate the HC-500.

Testing:

Laboratory testing was conducted to validate and verify that the Fukuda Denshi model HC-500 End Tidal CO2 Module met all design specifications and was substantially equivalent to the Fukuda Denshi model HC-300 (K950044). End Tidal CO2 validation and verification testing conducted according to Novametrix Medical Systems Inc. testing protocol

Product testing included of all environmental testing identified in the FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document. Additional testing was performed to demonstrate compliance with the ANSI/AAMI standards ES1-1993, "Safe current limits for electromedical apparatus." Finally, testing was

HC-500 510(k) Submission Section 2.doc

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performed to verify that the design addressed all hazards and to validate the systems overall operation.

Although the device is neither life supporting nor life sustaining, diagnostic information derived from the use of the device and alarms generated by the device may be critical to the proper management of the patient.

The primary areas of risk for this device are the same as the predicate device and other devices in this class, and are the following:

Electrical shock .
Excessive electrical chassis leakage current can disturb the normal electrophysiology of the heart, and possibly leading to the onset of cardiac arrhythmias.
Misdiagnosis
- Inadequate design of the signal processing and measurement circuitry or program can lead to generation of inaccurate diagnostic data. If inaccurate diagnostic data are used in managing the patient, the physician may prescribe a course of treatment that places the patient at risk unnecessarily.
- Inadequate design of the device's software, used to make various measurements, can lead to generation of inaccurate diagnostic data. If inaccurate diagnostic data are used in managing the patient, the physician may prescribe a course of treatment that places the patient at risk unnecessarily.
- Inadequate design of the systems ability to alert the users through audible and visual indicators, can lead to user mistrust and/or inadequate response to the patient's condition. If an inadequate response to the patient's condition should occur the patient may unnecessarily be placed at risk.

The design of the HC-500 has taken into account all the above. The device is designed to meet UL 2601, CSA 22.2 and AAMI standards for electrical safety for medical equipment to prevent the possibility of excessive electrical leakage current to the patient.

The conclusions drawn from clinical and laboratory testing of the Fukuda Denshi model HC-500 End Tidal CO, Module demonstrates that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the Fukuda Denshi model HC-300 End Tidal CO2 Module, K950044

Conclusion:

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COMPLIANCE CERTIFICATE

I certify that in my capacity as Regulatory Affairs Manager and official FDA correspondent of FUKUDA DENSHI AMERICA CORP. that I have conducted a reasonable search of all information known or otherwise available about the types and causes of safety or effectiveness problems that have been reported for cardiac monitors and arrhythmia detectors and alarms. I further certify that I am aware of the types of problems to which cardiac monitors and arrhythmia detectors and alarms are susceptible to and that to the best of my knowledge, the attached summary of the types of causes of safety or effectiveness problems about these devices is complete and accurate.

I hereby certify that the attached software development process and quality assurance procedures were adhered to and that all testing performed demonstrates that the functional requirements were met and that the system specifications were fulfilled.

Dara J. Durag, Rq
Signature

David J. Geraghty

Name

Regulatory Affairs Manager Fukuda Denshi America Corp.

Title

HC-500 510(k) Submission Section 2.doc

$\infty$

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Image /page/5/Picture/2 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 2 1998

Mr. David J. Geraghty Fukuda Denski USA, Inc. 17725 N.E. 65th Street, Building C Redmond, WA 98052

Re: K980979 Fukuda Denshi Model HC-500 End Tidal CO2 Module Requlatory Class: II (two) Product Code: 73 CCK Dated: March 13, 1998 Received: March 17, 1998

Dear Mr. Geraghty:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 You provisions of the Federal Food, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Mr. David J. Geraghty

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Collebon
Thomas J. Collebon, Ph.D.

Thomas J. Callahan, Ph. D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Intended Use:

The Fukuda Denshi model HC-500 End Tidal CO2 Module is not intended for home use.

Statement of Indications for Use

M. Pugh

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 1880979 510(k) Number .

prescriptions use
✓

HC-500 510(k) Submission Section 3.doc

March 16, 1998 Page 2 of 5

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).