Use of the Fukuda Denshi model DS-7141 Portable Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, STlevel and yentricular arrhythmias), respiration, non-invasive and or invasive blood pressure, temperature, pulse oximetry and/or CO2. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-7141 is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-7141s also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.

Device Description

The DS-7141 Portable Patient Monitor is a pre-configured monitor meant to acquire and monitor physiological signals from patients. The system is design to be used in ICU, CCU, OR or recovery areas of the hospital or clinic. An optional Battery Pack Operation allows the DS-7141 to be used to rouito, patients during intra-hospital transport. 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 systems display or may be printed on the systems recorder.

The DS-7141 is an addition to the DS-7100 Series Patient Monitor Line up. (K032290). It is the same as the predicate devices in that it uses identical hardware and software which allows for the monitoring of EEC, RESP, SpO2m BP, NIBP and Temp. It additionally includes identical telemetry capabilities as the predicate. The DS-7141 adds EtCo2 monitoring capability to the DS-7100 series of Portable Patient Monitors by the integration of a MediCO2 MicroStream TM module which was designed and manufactured by Oridion and previously cleared under 510(k) (K964239).

The DS-7141is a self contained monitors which include an 8.4 inch TFT color LCD display which can display up to 6 waveforms. All input operation is performed on the monitors touch screen controls. Additional standard features include an Ethernet LAN for connection to Fukuda Denshi Central Stations, a built- in dot matrix thermal printer that can print up to 3 wave forms simultaneously and an alarm pole feature on the top of device that alerts to alarm conditions through 9 corresponding flashing patterns.

AI/ML Overview

The provided text describes a 510(k) submission for the Fukuda Denshi DS-7141 Portable Patient Monitor, focusing primarily on its equivalence to previously cleared devices rather than extensive new clinical studies with detailed acceptance criteria and performance metrics.

Based on the provided information, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table for the DS-7141 itself, beyond general "performance specifications" being met. The core of this submission relies on demonstrating substantial equivalence to predicate devices and adherence to recognized standards.

Acceptance Criteria (Inferred from regulatory compliance & predicate device equivalence)	Reported Device Performance (Inferred from testing and conclusion)
Meets all functional and performance specifications.	"Final testing for the device included various performance test for the device designed to insure that all functional and performance specifications are met."
Complies with relevant safety and environmental standards.	"Subjected to extensive safety, environmental and performance testing." "Tested to assure compliance to the requirement of various published standards including: UL2601-1; AMMI EC-13, ES-1, EC-53, SP-10, SP10A; EN60601-2-27, EN 60601-2-30, EN60601-2-34; EN864, EN865, EN124070-4-2001, EN 1441; IEC 60601-1-2; FCC 47 CFR Part 95 Subpart H."
Performs as well as or better than predicate devices.	"Demonstrates that this device is as safe and effective and performs as well or better than the legally marketed predicate devices."
EtCO2 function meets standards of previously cleared module.	"Additionally the device was host tested at the previously noted OEM engineering test facility to insure that performance and functional specifications for their supplied module were met." (Referring to the MediCO2 MicroStream™ module, K964239, which comprises the EtCo2 function). The EtCo2 function was also "previously cleared as the Oridion MicroCap Plus™ 510(k) number K023400."

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

The document does not specify a distinct "test set" with a defined sample size in the context of clinical data for algorithmic performance. The testing described is more aligned with product verification and validation (safety, environmental, performance specifications, and adherence to standards) rather than a clinical trial evaluating algorithmic accuracy against a ground truth dataset in the typical sense of AI/ML device testing.

The provenance of data is not mentioned in terms of country of origin or whether it was retrospective or prospective, as it does not appear to be a study of patient data.

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

Not applicable. This submission is about a patient monitor with integrated components, not an AI/ML diagnostic or prognostic device that relies on expert interpretation of output to establish ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication is described.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was Done

No. The document makes no mention of an MRMC study or any studies involving human readers, with or without AI assistance. The device is a patient monitor, not an interpretive AI system for imaging or other complex data.

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

Not explicitly a "standalone" algorithmic study in the modern sense. The "host testing" of the integrated MediCO2 MicroStream™ module at the OEM facility would evaluate its performance specifications in isolation before integration, which could be considered a form of standalone testing for that specific component. However, this is for a physiological measurement device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would be derived from:

Engineering Specifications and Benchmarks: For parameters like accuracy of measurements (ECG, SpO2, NIBP, Temp, EtCO2), stability, and response times.
Standardized Test Conditions: Environmental testing (temperature, humidity, vibration), electrical safety tests.
Reference Devices: Performance of integrated modules (e.g., EtCO2) would be compared to known accurate reference devices or established functional standards.

8. The Sample Size for the Training Set

Not applicable. The document does not describe an AI/ML algorithm that would have a "training set" in the context of machine learning model development.

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

Not applicable, as there is no described training set for an AI/ML algorithm.

Summary

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page 1 of 4

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR part 870.92.

The assigned 510(k) number is: _KQ40246 .

Submitter: Fukuda Denshi U.S.A. INC. 17725 NE 65th St. Building C Redmond WA, 98052 Tel: 425-881-7737 Fax: 425-869-2018
- Contact Person: Larry Walker Regulatory Affairs Manager Fukuda Denshi U.S.A. INC. 17725 NE 65th St. Building C Redmond WA, 98052 Tel: 425-881-7737 Fax: 425-869-2018
- January 28, 2004 . Date Prepared:

Device Name:

•	Proprietary Name: Fukuda Denshi DYNASCOPE model DS-7141Portable Patient Monitor
•	Common NamePortable Patient Monitor
•	Classification74 MHX - Patient Physiological Monitor (with arrhythmiadetection and alarm) Class II

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K040246
page 2 of 4

Legally Marketed Device: Fukuda Denshi model DS-7100 Series Portable Patient Monitor 510(k) # (K032290)

In addition, the EtCo2 function which is the basis of this device modification submission, was previously cleared as the Oridion MicroCap Plus ™ 510(k) number K023400

Description:

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K040246
page 3 of 4

The device is small and lightweight at 5.2 kg. The physical dimensions of the device are 260mm (W) x 264 mm (H) x 196 mm (D). Because there is no need for a cooling fan operation is extremely quite. The AC power supply includes the battery charger for the optional battery operation to allow intra-hospital transport of patients. Use of low power, high speed flash memory allows for easy software upgrades though a standard PMCIA compatible IC card.

Statement of Intended Use:

The Fukuda Denshi model DS-7141 Patient Monitors provide a Simple and reliable method to display and document the continuous hemodynamic, cardiovascular observations that are typically required of critically ill patients. These patients; neonate, pediatric and adult; may be located in a hospitals ICU, CCU, OR, ER, recovery or other critical care area. The DS-7141 monitor can also be used to follow patients whose treatment requires close observation of specitiv physiological parameters. These patients may be in a clinic or other healthcare environment under the care of a physician.

Battery operation allows the patients to continue to be monitored during intra-hospital transport. The availability of DS-LAN II connection or Multi-parameter telemetry allows remote monitoring when combined with Fukuda Denshi Central Station Monitors.

Parameters such as ECG, respiration, non-invasive or invasive blood pressure, temperature EtCO2 and pulse oximetry may be monitored individually or in any grouping required by the clinician.

The Fukuda Denshi DS-7141 Patient Monitor is not recommended for home use, during transport other than intra-hospital or when it has not been ordered by a physician.

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K040246
page 4 of 4

Technological Characteristics:

	The DS-7141 incorporates the identical technology as the predicatedevices. The device provides a means with interfacing with a patient,collecting parameter specific physiological data and processing the datafor alarm generation, display of numeric values and waveforms atbedside or at a central monitoring station.The technology characteristics of the DS-7141 do not affect the safety orefficacy of the device. Any safety issues raised by a software controlmedical device are either the same issues already addressed by thepredicate devices or are addressed the system hazard analysis, or in thesystem validation.
Testing:	The Fukuda Denshi DS-7141 Portable Patient Monitor has beensubjected to extensive safety, environmental and performance testing.Final testing for the device included various performance test for thedevice designed to insure that all functional and performancespecifications are meet. Additionally the device was host tested at thepreviously noted OEM engineering test facility to insure thatperformance and functional specifications for their supplied modulewere met.
	The DS-7141 Patient Monitor has also been tested to assure complianceto the requirement of various published standards including thefollowing:
	UL2601-1; 1997,AMMI EC-13, ES-1: 1993, EC-53: 1995, SP-10 1992, SP10A: 1996EN60601-2-27: 1995, EN 60601-2-30:2000, EN60601-2-34:2001EN864:1997, EN865:1997, EN124070-4-2001, EN 1441:1997IEC 60601-1-2:2001FCC 47 CFR Part 95 Subpart H
Conclusion:	In conclusion, drawing from laboratory testing, validation and riskAnalysis, the Fukuda Denshi DS-7141 Portable Patient Monitordemonstrates that this device is as safe and effective and performs as wellor better than the legally marketed predicate devices, the Fukuda Denshimodel DS-7100 Series Portable Patient Monitor 510(k) # (K032290) andthe Oridion MicroCap Plus™ 510(k) number K 023400.

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Image /page/4/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" arranged around the perimeter. Inside the circle is a stylized symbol resembling three wavy lines, which is the department's emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 6 2004

Fukuda Denshi USA, Inc. c/o Mr. Larry D. Walker Regulatory Affairs Manager 17725 NE 65th St. Building C Redmont, WA 98052

Re: K040246

Trade Name: Fukuda Denshi Model DS-7141 Portable Patient Monitor Regulation Number: 21 CFR.870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: II (two) Product Code: MHX Dated: May 10, 2004 Received: May 11, 2004

Dear Mr. Walker:

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 adultcration.

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 D. Walker

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 premated 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 (301) 594-__ 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/dsma/dsmamain.html

Sincerely yours,

Neil R.P. Ogle
Bram D. Zuckerman, M.D. for

Director Division of Cardiovascular 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: K040246

Device Name:

Fukuda Denshi Model DS-7141 Portable Patient Monitor

Indication for Use:

Prescription Use (Per 21 CFR 801.1

Over the Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation

Neh.R. Olen for BR

(Division Sign-C Division of Cardiovascular Devices

510(k) Number K040246

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.