The Fukuda Denshi model HG-500 Pulse Oximeter Module is indicated in those situations where it is desirable to perform continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin(SpO2) and pulse rate for adult, pediatric and neonatal patients who are under the care of a physician, within the confines of a health care facility. It is is not intended for home use

Device Description

The Fukuda Denshi model HG-500 Pulse Oximeter (SpO2) module is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate when used as part of the DS-5300 Patient Monitoring System (K964187). The HG-500 is a module not a stand-alone device. As a module it will only operate when installed into a DS-5300 Patient Monitoring System. The Fukuda Denshi model HG-500 Pulse Oximetry module will function with all Nellcor reusable and disposable oximeter sensors.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria in a table format. However, it does describe the general performance and safety goals for the device. The reported device performance is largely qualitative, asserting substantial equivalence to predicate devices and compliance with relevant standards.

Acceptance Criteria (Implied)	Reported Device Performance
Safety:
- Electrical Safety (Prevent excessive leakage current)	Designed to meet UL 2601, CSA 22.2, and AAMI standards for electrical safety for medical equipment.
- No adverse effects or reportable incidents	Review of predecessor product (HG-302) history revealed no complaints related to safety or effectiveness, and no reports of adverse effects or reportable incidents.
Effectiveness/Performance:
- Accurate measurement of SpO2 and Pulse Rate	The device's technological characteristics detail how it measures SpO2 and pulse rate by calculating light absorption. The algorithms are "similar of those used in the used the Fukuda Denshi HG-302 Pulse Oximeter module (K945464) and are identical to those used in the Nellcor N-395."
- Compliance to sensor accuracy specification	A non-invasive controlled hypoxia study was performed by Nellcor Inc. to validate the HG-500's compliance to sensor accuracy specification when used with all eighteen models of Nellcor oxygen transducers.
- Motion filtering capability	Possesses "identical motion filtering software that is resident in the Nellcor model N-395," which "reduces the adverse effect of patient/sensor motion, allowing the HG-500 to read through motion artifact" and provide valid measurements during many types of patient motion.
- Mitigation of misdiagnosis due to inadequate design of:
- Signal processing and measurement circuitry/programs	"The conclusions drawn from the testing of the Fukuda Denshi model HG-500 Pulse Oximeter Model demonstrates the device is safe, as effective and performs as well or better than the legally marketed predicate device, the Fukuda Denshi model HG-302 Pulse Oximeter Module (K945464)." This implies adequate signal processing and measurement.
- Device's software (for measurements)	(Same as above, implying software design leads to accurate data)
- Adequate alerts (audible and visual indicators)	Minor software changes were required to the DS-5300 Patient Monitoring system to accommodate the HG-500, including "adding additional message indicators and assigning system priority SpO2 function to the HG-200." This suggests that the system's ability to alert users was addressed.
- Meets all design specifications and is substantially equivalent	"Laboratory testing was conducted to validate and verify that the Fukuda Denshi model HG-500 Pulse Oximeter module meet all design specifications and was substantially equivalent to the Fukuda Denshi model HG-302 Pulse Oximeter (K945464) and the Nellcor model N-395 Pulse Oximeter (K991823 and K993637)." "The conclusions drawn from the testing... demonstrates the device is safe, as effective and performs as well or better than the legally marketed predicate device."

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: The document mentions a "non-invasive controlled hypoxia study was performed by Nellcor Inc., to validate the HG-500 compliance to sensor accuracy specification when used with all eighteen models of Nellcor oxygen transducers." It does not specify the number of human participants or data points in this study.
Data Provenance: The study was performed by "Nellcor Inc." No explicit country of origin is mentioned, but Nellcor is a US-based company. The study is described as a "controlled hypoxia study," which implies a prospective, interventional design where oxygen levels are intentionally varied.

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)

This information is not provided in the summary. For a hypoxia study, ground truth for arterial oxygen saturation is typically established using a co-oximeter (a device that directly measures different hemoglobin species from an arterial blood sample). However, the number and qualifications of individuals interpreting these results or validating the setup are not mentioned.

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

This information is not provided in the summary. Given the nature of a pulse oximeter accuracy study, adjudication of readings is less common than for, say, image interpretation. The comparison would likely be directly against a gold standard (e.g., co-oximetry).

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

No, an MRMC comparative effectiveness study was not done. This type of study typically applies to diagnostic devices where human interpretation is a key component, often with AI assistance. The HG-500 is a direct measurement device (pulse oximeter) that provides numerical output (SpO2, pulse rate).

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

Yes, in essence, standalone performance was assessed. The "non-invasive controlled hypoxia study" directly tested the HG-500's accuracy (an algorithm-driven device) against a gold standard in a simulated physiological environment. The module itself operates without direct human interpretive input into its primary SpO2 and pulse rate measurements. The submission focuses on the device's ability to measure accurately, not on how humans interpret those measurements.

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

The ground truth for the accuracy assessment (hypoxia study) would have been arterial blood gas analysis using a co-oximeter. This is the accepted gold standard for determining actual arterial oxygen saturation. The summary mentions "sensor accuracy specification," which implicitly refers to this type of comparison.

8. The sample size for the training set

This information is not provided and is generally not applicable in the way it is for AI/machine learning models that learn from vast datasets. The HG-500 utilizes algorithms licensed from Nellcor and identical to those in the Nellcor N-395, which are based on established physiological principles of light absorption by hemoglobin. While these algorithms were developed and refined using empirical data, the "training set" in the context of modern machine learning is not explicitly detailed here. It's more about validated engineering and physiological modeling.

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

As above, details about an explicit "training set" for the algorithms are not provided. The algorithms are described as licensed from Nellcor and identical to existing, validated devices. The development of such algorithms historically involved extensive physiological studies where arterial blood gas measurements (co-oximetry) served as the gold standard for correlating light absorption patterns with actual oxygen saturation. This would have been done during the original development of pulse oximetry technology and specific manufacturer algorithms, rather than being a specific "training set" for this particular 510(k) submission.

Summary

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510(k) Summary Fukuda Denshi model HG-500 Pulse Oximeter Module

12-20-01

This summary of 510(k) safety and effectiveness information is being submitted in accordance with I ins sullimary of STO(II) cannot 21 CFR part 807.92.

The assigned 510(k) number is: _ K013273 ___

Submitter:

Fukuda Denshi, USA Inc. 17725 NE 65th St., Bldg C Redmond, WA 98052 425/881-7737 Tel: 425/869-2018 Fax:

Contact Person:

Larry Walker Regulatory Affairs Manager Fukuda Denshi-Seattle Branch 17725 NE 65th St., Bldg C Redmond, WA 98052 425/881-7737 Tel: 425/869-2018 Fax:

September 19 , 2001 Date Prepared:

Device Name:

Proprietary Name:

Model HG-500 Pulse Oximeter Module

Common Name:

Pulse Oximeter

Classification Name:

Pulse Oximeter (§870.2700/74DQA)

Legally Marketed Device:

FUKUDA DENSHI model HG-302 Pulse Oximeter Module 510(k) FURODA DENSTH model TO 5-500 is an addition to the DS-5300, 501(k) K964187)

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

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Description:

The safety and efficacy of the HG-500 module has been established through various techniques. Review of the Fukuda Denshi model HG-302 predecessor product's history does not revel any complaints related to safety or effectiveness. There are no reports of adverse effects or reportable incidents for the HG-302 Pulse Oximeter product.

Statement of Intended Use:

The Fukuda Denshi model HG-500 Pulse Oximeter model is intended to be used for non-invasively continual monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by trained medical professionals by or on the order of a physician. The model HG-500 monitor will function with all Nellcor reusable or disposible oximeter sensors.

The Fukuda Denshi model HG-500 Pulse Oximeter 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 where the Fukuda Denshi DS-5300 bedside patient monitor is being utilized with an IB-5006 Input Box.

The Fukuda Denshi HG-500 Pulse Oximeter module is NOT INTENDED FOR HOME USE.

The Fukuda Denshi HG-500 Pulse Oximeter module is intended to be used as a part of the Fukuda Denshi Ds-5000 series of bedside patient monitoring systems. The HG-500 will not function as a stand alone device.

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

September 19, 2001 Page 2 of 6

134

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Comparison to Predicate Device:

In summary, the HG-500 module is an improved version of the HG-302 Pulse Oximeter module, utilizing the latest technology, for use in the DS-5300 patient monitor.. Changes to the system include a reduction in size and weight to meet the requirements of the DS-5000 series modules. The HG-500 utilizes the Nellcor OEM MP-404 which is an upgrade of the Nellcor MP-203 used in the predicate. Each device continues to require the exclusive use of Nellcor manufactured sensors. Additionally the HG-500 allows increased motion filtering capability as compared to the predicate. The majority of the changes can be summarized as OEM circuit re-layout and a reduction in size

Technological Characteristics

The HG-500 Pulse Oximeter module, when used with the Fukuda Denshi DS-5000 series of patient monitor, (DS-5300, K964187) is designed to non-invasively measure functional oxygen saturation by calculating the light absorption of tissue, bone and blood during the pulsatile cycle. Inferred and red LED's are utilized as the light source. A photodiode senses the signal strength of the two wavelength of light which vary with the amount of light received through the tissue. The oximetry algorithm within the HG-500 processes the electrical information received from the sensor to provide real time SpO2 , Pulse Rate and Pulse Amplitude measurements.

The Pulse Oximetry circuitry is licensed, manufactured and purchased from Nellcor Inc. and is the same as used in the Nellcor N-395 Pulse Oximeter Model (K991823 and K993637) All algorithms are similar of those used in the used the Fukuda Denshi HG-302 Pulse Oximeter module (K945464) and are identical to those used in the Nellcor N-395.

In addition, the HG-500 possesses the identical motion filtering software that is resident in the Nellcor model N-395. This software reduces the the adverse effect of patient/ sensor motion, allowing the HG-500 to read through motion artifact. This allows the HG-500 to provide valid pulse rate and SpO2 measurement during many types of patient motion situations.

Minor software changes were required to the DS-5300 Patient Monitoring system to accommodate the HG-500. Changes included adding additional

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

September 19, 2001 Page 3 of 6

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message indicators and assigning system priority SpO2 function to the HG-200

TESTING

Laboratory testing was conducted to validate and verify that the Fukuda Denshi model HG-500 Pulse Oximeter module meet all design specifications and was substantially equivalent to the Fukuda Denshi model HG-302 Pulse Oximeter (K945464) and the Nellcor model N-395 Pulse Oximeter (K991823 and K993637). Additionally a noninvasive controlled hypoxia study was performed by Nellcor Inc, to validate the HG-500 compliance to sensor accuracy specification when when used with all eighteen models of Nellcor oxygen transducers.

Product tested included all environmental testing identified in the FDA's DCRND November 1993 "Reviewers Guidance Document for Premarket notification Submissions" Draft Guidance Document. Additional testing was performed to demonstrate compliance with the ANSVAAMI standards ES1-1993, "Safe current limits for electro medical apparatus. Finally, testing was 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 disrupt 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 programs 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

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

September 19, 2001 Page 4 of 6

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managing the patient, the physician may prescribe a course 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 patients condition. If an inadequate response to the patient's condition should occur the patient may unnecessarily be placed at risk.
The design of the HG-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.

Conclusion:

The conclusions drawn from the testing of the Fukuda Denshi model HG-500 Pulse Oximeter Model demonstrates the device is safe, as effective and performs as well or better than the legally marketed predicate device, the Fukuda Denshi model HG-302 Pulse Oximeter Module (K945464)

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

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three wavy lines emanating from its head, representing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2001

Mr. Larry Walker Fukuda Denshi, USA Inc. 17725 NE 65th Street, Bldg. C Redmond, WA 98052

Re: K013273

Fukuda Denshi Model HG-500 Pulse Oximeter Module Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: Class II (two) Product Code: DQA Dated: September 24, 2001 Received: October 1, 2001

Dear Mr. Walker:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave a vowe 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 for are cance in 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. Larry Walker

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I toase oc acrised that I brinination that your device complies with other requirements of the Act that I Dr has intact and regulations administered by other Federal agencies. You must or any I catal statuted and registerents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fart 6077, idoling (21 (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) This letter with and w yours of substantial equivalence of your device to a legally premated predicated. "The elassification 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 11 you dosite apoently and 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of ICP are 646. Additionally, for questions on the promotion and advertising of Compliance at (301) 594 to 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 Other general 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,

Dakita Teller

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use Statement

510(k) Number (if known):	K013273
Device Name :	Fukuda Denshi Model HG-500Pulse Oximeter Module
Indications for use:	The Fukuda Denshi model HG-500 Pulse Oximeter Moduleis indicated in those situations where it is desirable to performcontinuous non-invasive monitoring of functional oxygensaturation of arterial hemoglobin(SpO2) and pulse rate foradult, pediatric and neonatal patients who are under the careof a physician, within the confines of a health care facility. It isis not intended for home use

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

Concurrence of CDHR, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number 2013273

Prescription Use
(Per 21 CFR 801.109

.. .

... ..........................................................................................................................................................................

Over the Counter Use__________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).