The Fukuda Denshi model DS-5300 Patient Monitor provides a simple and reliable method to display and document the continuos hemodynamic, cardiovascular observations that are typically required of critically ill patients. These patients: neonate, pediatric, and adult; mav be located in a hospital ICU, CCU, OR, ER, recovery, or other critical care unit. The DS-5300 can also be used to follow patients whose treatment requires close observation of specific physiological parameters. These patients may be in a clinic or other healthcare environment under the care of a physician. Parameters such as ECG, respiration, noninvasive or invasive blood pressures, temperature, pulse oximetry, and cardiac output may be monitored individually or in any grouping required by the clinician. This device is not intended for home use.

Device Description

The DS-5300 Patient Monitor System is meant to acquire and monitor physiological signals from patients located within a healthcare facility. The system is designed to be used in an ICU, CCU. OR, ER, or Recovery areas of a hospital or clinic. Patient ages from neonates to adults can all be monitored. Waveforms, numeric, and trend data from these patients are available to the clinician on the system's display or it may be printed on the system's recorder. The basic system consists of the main control unit, the display unit and the input box connected to the main unit via fiber optic cable to reduce electrical artifact and noise. The main body of the system can be remotely located from the display unit and input box for increased flexibility. Small, lightweight, but powerful in its application of technology, the DS-5300 patient monitoring system is flexible and easy to use. Incorporation of high speed RISC (reduced instruction set computing) microprocessors, a 9.4 inch TFT color LCD display and a high quality, analog touch screen has made the DS-5300 a unique and versatile patient monitor. The die cast aluminum body eliminates the need for a cooling fan and provides a light, strong body. Use of low power, high speed, flash memory allows for easy upgradeability through a standard PCMCIA compatible IC card. Physiological parameters are monitored through the use of flexible parameter modules that are easily inserted or removed from the input box.

AI/ML Overview

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Fukuda Denshi model DS-3300 Patient Monitor) rather than providing extensive details about specific acceptance criteria and detailed study results for each function. Therefore, some of the requested information cannot be fully extracted.

Here's what can be inferred and stated:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of acceptance criteria with corresponding performance metrics for all functions. Instead, it states that the device was tested to meet various design specifications and standards. For certain modules (NIBP, Pulse Oximetry, Arrhythmia/ST Level), it mentions that the results are presented in tabular and graphic format in an unprovided appendix.

Function/Parameter	Acceptance Criteria (Inferred from Standards)	Reported Device Performance
Overall System Safety	Compliance with UL 601, CSA 22.2, AAMI standards for electrical safety for medical equipment (to prevent excessive electrical leakage current).	"The device is designed to meet UL 601, CSA 22.2 and AAMI standards for electrical safety for medical equipment..."
Environmental Testing	Identified in the FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document.	"Laboratory testing was conducted to validate and verify that the Fukuda Denshi model DS-5300 Patient Monitor met all design specifications..."
ECG Performance	Compliance with ANSI/AAMI EC11-1991, "Diagnostic electrocardiographic devices."	"Additional testing was performed to demonstrate compliance with the ANSI/AAMI standards... EC11-1991..."
Cardiac Monitor/HR Alarm Performance	Compliance with ANSI/AAMI EC13-1992, "Cardiac monitors, heart rate meters, and alarms."	"Additional testing was performed to demonstrate compliance with the ANSI/AAMI standards... EC13-1992..."
Non-Invasive Blood Pressure (NIBP)	Requirements outlined in ANSI/AAMI SP10-1992, "Electronic or automated sphygmomanometers."	"The results of this testing is presented in tabular and graphic format in the appendix." (Specific performance values not in provided text)
Pulse Oximetry	Nellcor Puritan Bennett's testing protocol.	"The results of this testing is presented in tabular and graphic format in the appendix." (Specific performance values not in provided text)
Arrhythmia and ST Level Detection	AAMI Recommended Practice ECAR-1987, "Recommended Practice for Testing and Reporting Performance Results of Ventricular Arrhythmia Detection Algorithms."	"The results of this testing is presented in tabular format in the appendix." (Specific performance values not in provided text)
Software Validation	Addressed in the systems hazard analysis and in the system validation.	"Any safety issues that may be raised by a software controlled medical device are the same issues already addressed by the predicate device and are addressed in the systems hazard analysis and in the system validation."
Overall Operation	Validated through hazard analysis and specific testing.	"...testing was conducted to validate the systems overall operation."

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

Sample Size:
- For NIBP, Pulse Oximetry, and Arrhythmia/ST Level sections, the document states "The results of this testing is presented in tabular and graphic format in the appendix" or "in tabular format in the appendix," but the specific sample sizes (number of patients, number of measurements, etc.) are not provided in the excerpt.
- No information on test set sample sizes for other tests like electrical safety or environmental testing.
Data Provenance: Not specified in the provided text. It's unclear if the data was retrospective or prospective, or the country of origin.

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

Not specified. The document mentions testing against standards and protocols (e.g., AAMI, Nellcor protocols), but it does not describe the involvement of human experts in establishing a ground truth for testing the device's diagnostic performance.

4. Adjudication Method for the Test Set:

Not specified. Given the lack of information on expert-established ground truth, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The provided text does not describe an MRMC study comparing human readers with and without AI assistance. The testing described is primarily for device performance against established standards and safety requirements. The device is a "Patient Monitor," and its algorithms are based on "Fukuda Denshi algorithms that have been in use and are part of the standard Fukuda Denshi software library," suggesting existing, validated algorithms rather than a novel AI system requiring human-AI comparative studies for this submission.

6. Standalone Performance Study:

Yes, implicitly. The various performance tests (NIBP, Pulse Oximetry, Arrhythmia/ST Level) conducted according to recognized standards (ANSI/AAMI, Nellcor protocols) are evaluating the algorithm's performance in a standalone capacity (i.e., the algorithm's output is being compared to the output dictated by the standard or protocol, not against a human's interpretation of data from the device). The device is a patient monitor, designed to "display and document" physiological observations, so its primary function is standalone measurement and display.

7. Type of Ground Truth Used:

Expert Consensus/Standard Reference: For NIBP, Pulse Oximetry, and Arrhythmia/ST Level, the ground truth is implicitly defined by the referenced industry standards and testing protocols (e.g., ANSI/AAMI SP10 for NIBP, Nellcor's protocol for pulse oximetry, AAMI ECAR-1987 for arrhythmia). These standards typically define methods for generating known, accurate physiological signals or for comparing device measurements against highly accurate reference devices (which could be considered a form of "expert consensus" in their development and validation).
Design Specifications & Safety Standards: Many of the other tests (environmental, electrical safety) use compliance with established safety and performance standards as their ground truth.

8. Sample Size for the Training Set:

Not provided. The document states that the algorithms are "based on Fukuda Denshi algorithms that have been in use and are part of the standard Fukuda Denshi software library." This suggests the algorithms were developed and potentially trained (if applicable to the algorithm type) prior to this specific device, but no details about any training sets are given. Given the 1996 date, "AI" as we understand it now was not prevalent, and "algorithms" likely refer to more traditional signal processing and detection methods.

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

Not provided. As the training set details are absent, the method for establishing its ground truth is also not mentioned.

Summary

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510(k) Summary Fukuda Denshi model DS-5300 Patient Monitor

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: K964187.

MAY - 1 1997

Submitter:

FUKUDA DENSHI AMERICA CORP. 17725 NE 65th St., Bldg C Redmond WA 98052 206/881-7737 Tel: 206/869-2018 Fax:

Contact Person:

David J. Geraghty Regulatory Affairs Manager FUKUDA DENSHI AMERICA CORP. 17725 NE 65th St., Bldg C Redmond WA 98052 206/881-7737 Tel: 206/869-2018 Fax:

Date Prepared:

September 20, 1996

Device Name:

Proprietary Name:
	model DS-5300 Patient Monitor

Common Name:

Patient Monitor

and the contraction and consistences and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the c

Classification Name:

Arrhythmia detector and alarm

Legally Marketed Device:

FUKUDA DENSHI model DS-3300 Patient Monitor, 510(k) number K894628. (Also references FUKUDA DENSHI model HB-310, 510(k) number K901889, and FUKUDA DENSHI model HG-302, 510(k) number K945464. These models added additional features to the DS-3300)

as and the result of the comments of the program and comments of the

DS-5300 510(k) Submittal SECTION2.doc

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Description:

System

The basic system consists of the main control unit, the display unit and the input box connected to the main unit via fiber optic cable to reduce electrical artifact and noise.

The main body of the system can be remotely located from the display unit and input box for increased flexibility. Small, lightweight, but powerful in its application of technology, the DS-5300 patient monitoring system is flexible and easy to use. Incorporation of high speed RISC (reduced instruction set computing) microprocessors, a 9.4 inch TFT color LCD display and a high quality, analog touch screen has made the DS-5300 a unique and versatile patient monitor. The die cast aluminum body eliminates the need for a cooling fan and provides a light, strong body. Use of low power, high speed, flash memory allows for easy upgradeability through a standard PCMCIA compatible IC card.

Physiological parameters are monitored through the use of flexible parameter modules that are easily inserted or removed from the input box.

Features

High performance, module type bedside monitor with an LCD panel display.

Designed to allow the main Monitor block and the LCD panel block to be separated.

A high intensity, 9.4 inch, color TFT LCD panel display.

An analog system touch screen selected for superior transparency.

A RISC type CPU for high performance.

Operates on a standard Ethernet LAN network.

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A variety of physiological parameters may be added by simply plugging in additional modules.

A Super Module incorporating several typically monitored parameters in a single plug-in.

A 3 channel recorder modular.

A multiport module for accepting DATA from a peripheral device.

Patient DATA is easily moved via PCMCIA memory cards.

A high resolution patient DATA review function.

An on-line help display adds to the user friendly features.

Global version control function.

Built to comply with international standard (UL, CSA, TUV, IEC and others.)

Statement of Intended Use:

Comparison to Predicate Device

In summary, the DS-5300 system is an improved version of the DS-3300 utilizing the latest technology and incorporating a color display. Changes to the system include a single multi-parameter module that replaces several of the individual modules used in the DS-3300. A change is processor technology required software changes but all algorithms are based on Fukuda Denshi algorithms that have been in use and are part of the standard Fukuda Denshi software library. The majority of the changes can be

DS-5300 510(k) Submittal SECTION2.doc

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summarized as display oriented or minor changes to alarm limit adjustment ranges.

Technological Characteristics

The DS-5300 incorporates high speed RISC (reduced instruction set computing) microprocessors as compared to the CISC (complex instruction set computing) employed in the predicate device. The DS-5300 utilizes 9.4 inch TFT color LCD display with a high quality, analog touch screen as compared to the 12 inch monochrome CRT with a similar touch screen used in the predicate device. Physiological information is acquired through modular inouts in the same manner as the predicate device. A PCMCIA card interface provides a means to temporarily store data or to update the system's flash memory.

The pulse oximetry design is licensed from Nellcor Puritan Bennett and is similar to the Nellcor design used in the predicate device.

These technological differences do not affect the safety or efficacy of the device. Any safety issues that may be raised by a software controlled medical device are the same issues already addressed by the predicate device and are addressed in the systems hazard analysis and in the system validation.

Laboratory testing was conducted to validate and verify that the Fukuda Denshi model DS-5300 Patient Monitor met all design specifications and was substantially equivalent to the FUKUDA DENSHI model DS-3300. This testing consisted 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"; EC11-1991, "Diagnostic electrocardiographic devices"; and EC13-1992, "Cardiac monitors, heart rate meters, and alarms." Finally, a hazard analysis of the system and its software was performed and testing was conducted to validate the systems overall operation.

Testing of the non-invasive blood pressure portion of the system was conducted according to the requirements outlined in the ANSI/AAMI standards SP10-1992, "Electronic or automated sphygmomanometers." The results of this testing is presented in tabular and graphic format in the appendix.

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Testing:

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Testing of the pulse oximetry portion of the system was conducted according to Nellcor Puritan Bennett's testing protocol. The results of this testing is presented in tabular and graphic format in the appendix. The results of this testing is presented in tabular and graphic format in the appendix.

Testing of the arrhythmia and ST Level portions of the system were conducted according to AAMI Recommended Practice ECAR-1987, "Recommended Practice for Testing and Reporting Performance Results of Ventricular Arrhythmia Detection Algorithms. The results of this testing is presented in tabular format in the appendix.

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.

So, the areas of risk for this device are the same as 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 DS-5300 has taken into account all the above. The device is designed to meet UL 601, CSA 22.2 and AAMI standards for electrical safety for medical equipment to prevent the possibility of excessive electrical leakage current to the patient.

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Conclusion:

: - - -

The conclusions drawn from clinical and laboratory testing of the Fukuda Denshi model DS-5300 Patient Monitor 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 DS-3300 Patient Monitoring System.

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.