Use of the Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor (Model: DS-7000/7000M/7210/7210M) 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, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), pulse wave, temperature, invasive blood pressure (IBP), cardiac output, carbon dioxide concentration (CO2), nitrous oxide concentration (N20), oxygen concentration (O2), and anesthetic agent concentration (AG). The target populations of the system are adult, pediatric, and neonatal patients with the exception of the ST segment and arrhythmia analysis, for which the target populations are adult and pediatric only. 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-7000 Series Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-7000 Series Patient Monitor is also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.

Device Description

The Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor (Model: DS-7000/7000M/7210/7210M) is meant to acquire and monitor physiological signals from patients. The system is design to be used in ICU, CCU, OR, ER, or Recovery areas of the hospital or clinic. An optional Battery Pack operation allows the DS-7210/7210M to be used to monitor 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 system's recorder.

The DS-7000 Series Patient Monitor allows for the monitoring of ECG, heart rate, respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), plethysmograph, temperature, invasive blood pressure (IBP), and cardiac output. This subject modified DS-7000 Series Patient Monitor extended the NIBP measurement target populations from adult and pediatric to adult. pediatric, and neonatal and the DS-7210/7210M of the DS-7000 Series includes ECG 12 Lead monitoring.

The DS-7000/7000M of the DS-7000 Series Patient Monitor allows for the monitoring of carbon dioxide concentration (CO2), nitrous oxide concentration (N2O), oxygen concentration (O2), and anesthetic agent concentration (AG), which utilizes Criticare Systems technology (K012059), by using the option Multigas Unit (MGU-701/MGU-702) . And, by using the option Unit (HU-71/HU-72/HU-73), invasive blood pressure (up to 6 channels), cardiac output, temperature (up to 3 channels) can be additionally monitored. No new functions for the options are being added and are not the subject of this submission for the DS-7000/7000M.

This subject modified DS-7210/7210M of the DS-7000 series Patient Monitor allows for the monitoring of carbon dioxide concentration (CO2), which utilizes Oridion Medical 1987 Ltd. technology "Microstream"" (K060065), by using the option CO2 measurement unit (MGU-722). Or, by using the option Mainstream CO2 interface Unit (MGU-721), the Capnostat 5 Mainstream CO2 Sensor (K042601) manufactured by Respironics Novametrix, LLC. is allowed to connect to the DS-7210/7210M with serial communication protocol for CO2 monitoring. And, by using the option Unit (HU-71/HU-72/HU-73), invasive blood pressure (up to 5 channels), cardiac output, temperature (up to 3 channels) can be additionally monitored.

For the SpO2 measurement monitoring, the DS-7000 utilizes Nellcor technology (K021090) and the DS-7000M utilizes Masimo one (K033296). No new functions for SpO2 measurement are being added and are not the subject of this submission. This subject modified DS-7210/7210M has the same feature.

The DS-7000 Series Patient Monitor is a self contained monitor which includes a 12.1 inch TFT color LCD display which can display up to 12 (for DS-7000/7000M) or 14 (for DS-7210/7210M) waveforms and up to 20 (for DS-7000/7000M) or 16 (for DS-7210/7210M) numeric displays. Input operation is performed by the touch screen panel, 5 fixed keys (only DS-7000/7000M), or infrared remote-control command (optional). Additional standard features of the DS-7000 Series Patient Monitor include the DS-LAN II connection, which is a proprietary network system based on an Ethernet LAN (K970585), through either a built in Ethernet LAN or external telemetry transmitter (the Fukuda Denshi DS-5000 series telemetry model HLX-501/561, K980728) connection for connection to the Fukuda Denshi Central Station Monitors, a built- in dot matrix thermal printer that can print up to 3 wave forms simultaneously, and an alarm indicator feature on the top of device that alerts to alarm conditions.

The DS-7000/7000M of the DS-7000 Series is small and lightweight at 9.0 kg. The physical dimensions of the device are 324mm (W) x 260mm (H) x 179mm (D). The option Multigas Unit (MGU-701/MGU-702) weight is 1.8 kg. The physical dimensions of the device are 248mm (W) x 138mm (H) x 82mm (D). No weight and physical dimensions are being changed and are not the subject of this submission for the DS-7000/7000M.

The subject modified DS-7210/7210M weight is 9.9 kg. The physical dimensions of the device are 310mm (W) x 351mm (H) x 245mm (D). The option CO2 measurement Unit (MGU-722) weight is 260g and Mainstream CO2 interface unit (MGU-721) weight is 200g. The both physical dimensions of the device are 141.5mm (W) x 41mm (H) x 79mm (D).

For the DS-7000 Series option Unit (HU-71/HU-72/HU-73) weight is 180g. The physical dimensions of the device are 37mm (W) x 99 mm (H) x 90 mm (D). No weight and physical dimensions are being changed and are not the subject of this submission.

AI/ML Overview

The provided text describes the Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor and its substantial equivalence to predicate devices, but it does not contain a detailed study with specific acceptance criteria and reported device performance in the format requested.

The document primarily focuses on:

Description of the device: Its features, monitored parameters, and intended use.
Predicate device comparison: Stating that it incorporates identical technology and is substantially equivalent.
Safety and environmental testing: Mentioning compliance with various general and individual safety standards, and EMC standards.
Conclusion: Reiterating that it's as safe and effective as predicate devices based on laboratory testing, validation, and risk analysis.

However, it lacks the specific quantitative data, sample sizes, ground truth establishment methods, or expert qualifications that would be detailed in a robust clinical or performance study report.

Therefore, I cannot populate the requested table and answer many of the specific questions directly from the provided text.

Here's a breakdown of what can be extracted or inferred, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Parameter/Characteristic	Acceptance Criteria	Reported Device Performance
Performance	Not explicitly stated in quantitative terms. The document states "all functional and performance specifications were met."	"Final testing for the device included various performance test for the device designed to insure that all functional and performance specifications were met." No specific quantitative results provided.
Safety	Compliance with UL60601-1(IEC60601-1), IEC60601-1-1, IEC60601-1-4, IEC60601-1-8, ISO 14971, ANSI/AAMI EC-13, ANSI/AAMI EC-53, ANSI/AAMI EC-57, ANSI/AAMI SP-10. IEC60601-2-27, IEC60601-2-30, IEC60601-2-34, IEC60601-2-49, EN12470-4, EN980, ISO 9919, ISO 21647	"The DS-7000 Series has also been tested to assure compliance to the requirement of various published standards including the following..." (followed by the list). The document asserts compliance.
EMC	Compliance with IEC 60601-1-2	"EMC standards IEC 60601-1-2" - The document asserts compliance.
Equivalence	Performance "as well or better than the legally marketed predicate devices"	"demonstrates that this device is as safe and effective and performs as well or better than the legally marketed predicate devices, the Fukuda Denshi Model DS-7000/7000M Patient Monitor 510(k) # K081891."

Detailed Answers to Specific Questions:

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: Not specified. The document only mentions "various performance tests" and "final testing."
Data provenance: Not specified. The text indicates "laboratory testing" and testing at an "OEM engineering test facility." This suggests internal testing, but no details on patient data, if any, are provided. It does not mention if the data was retrospective or prospective.

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)

Not applicable. The document describes compliance with technical standards and performance specifications, not diagnostic accuracy requiring expert ground truth in a clinical setting.

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

Not applicable. This type of adjudication is typically for subjective assessments or discrepancy resolution in clinical studies, which is not described here.

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 device is a patient monitor, not an AI-assisted diagnostic tool. The submission focuses on device safety and performance as a monitoring system.

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

Not applicable in the context of an "algorithm only" study. The performance testing mentioned is for the integrated patient monitor system.

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

For a patient monitor, the "ground truth" for performance testing typically refers to validated reference standards or simulated physiological signals that mimic real patient data with known values (e.g., a calibrated simulator for vital signs, or direct physical measurement for electrical safety parameters). The document does not explicitly state the specific type of ground truth used, but it would be based on these established engineering and physiological reference systems.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that would have a separate "training set."

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

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

Summary

{0}------------------------------------------------

K083697
P1/6

MAR 1, 9 2009 Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor (Model: DS-7000/7000M/7210/7210M)

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:

Submitter: Fukuda Denshi USA, Inc. 17725 NE 65th St. Building C Redmond WA, 98052 Tel: 425-881-7737 Fax: 425-869-2018
- Contact Person: Doug Blakely . Director- Regulatory Affairs Fukuda Denshi USA, Inc. 17725 NE 65th St. Building C Redmond WA, 98052 Tel: 210-240-4521 Fax: 408-547-4521 Email: DBlakely@fukuda.com
- Date Prepared: December 12, 2008 .

Device Name :

Proprietary Name : Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor . (Model: DS-7000/7000M/7210/7210M)
Common Name: . Patient Monitor
Product Code: MHX �
Regulation Number: 21 CFR Part 870.1025 .

Class: ●

Review Panel: Cardiovascular .

{1}------------------------------------------------

Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor (Model: DS-7000/7000M/7210/7210M)

Legally Marketed Device:

Fukuda Denshi DynaScope Model DS-7000/7000M Patient Monitor (K081891)

In addition, CO2 measurement optional function of the DS-7210/7210M of the DS-7000 Series utilizes an OEM manufactured module (K060065) and a CO2 Sensor (K042601) that have received separate clearance from the FDA as follows:

The CO2 measurement system used in the DS-7210/7210M is the same as that used in the Oridion Medical 1987 Ltd. model "Capnostream20" cleared under 510(k) # K060065.

The CO2 measurement sensor connected to the DS-7210/7210M is the same as the Respironics Novametrix, LLC. model "Capnostat 5 Mainstream CO2 Sensor" cleared under 510(k) # K042601.

83697

{2}------------------------------------------------

Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor (Model: DS-7000/7000M/7210/7210M)

Description:

For the SpO2 measurement monitoring, the DS-7000 utilizes Nellcor technology (K021090) and the DS-7000M utilizes Masimo one (K033296). No new

{3}------------------------------------------------

Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor (Model: DS-7000/7000M/7210/7210M)

functions for SpO2 measurement are being added and are not the subject of this submission. This subject modified DS-7210/7210M has the same feature.

{4}------------------------------------------------

Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor (Model: DS-7000/7000M/7210/7210M)

Statement of Intended Use:

The Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor (Model: DS-7000/7000M/7210/7210M) provides a simple and reliable method to display and document the continuous hemodynamic, cardiovascular observations that are typically required of critically ill patients. These patients; adult, pediatric, and neonate, may be located in a hospitals ICU. CCU. OR. ER, recovery or other critical care area. The DS-7000 Series 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.

The availability of the DS-LAN II connection, through either a built in Ethernet LAN or external telemetry transmitter, allows remote monitoring when combined with the Fukuda Denshi Central Station Monitors. An option battery operation of the 7210/7210M allows a patient to continue to be monitored during intra-hospital transport.

Parameters such as ECG, heart rate, respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), pulse wave, temperature, invasive blood pressure (IBP), cardiac output, carbon dioxide concentration (CO2), nitrous oxide concentration (NoO), oxygen concentration (O2), and anesthetic agent concentration (AG) may be monitored individually or in any grouping required by the clinician.

The Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor is not recommended for home use, when it has not been ordered by a physician.

Technological Characteristics:

The Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor (Model: DS-7000/7000M/7210/7210M) incorporates the identical technology as the predicate devices. The device provides a means with interfacing with a patient, collecting parameter specific physiological data and processing the data for alarm generation, display of numeric values and waveforms at bedside or at a central monitoring station.

{5}------------------------------------------------

K083697
p4/6

Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor (Model: DS-7000/7000M/7210/7210M)

The technology characteristics of the DS-7000 Series Patient Monitor do not affect the safety or efficacy of the device. Any safety issues raised by a software control medical device are either the same issues already addressed by the predicate devices or are addressed the system hazard analysis, or in the system validation.

Testing:

The Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor (Model: DS-7000/7000M/7210/7210M) has been subjected to extensive safety, environmental and performance testing. Final testing for the device included various performance test for the device designed to insure that all functional and performance specifications were met. 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.

The DS-7000 Series has also been tested to assure compliance to the requirement of various published standards including the following:

· General safety standards UL60601-1(IEC60601-1), IEC60601-1-1, IEC60601-1-4, IEC60601-1-8, ISO 14971
· Individual standards ANSI/AAMI EC-13, ANSI/AAMI EC-53, ANSI/AAMI EC-57, ANSI/AAMI SP-10. IEC60601-2-27, IEC60601-2-30, IEC60601-2-34, IEC60601-2-49, EN12470-4, EN980, ISO 9919, ISO 21647
· EMC standards IEC 60601-1-2

Conclusion:

In conclusion, drawing from laboratory testing, validation and risk Analysis, the Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor (Model: DS-7000/7000M/7210/7210M) demonstrates that this device is as safe and effective and performs as well or better than the legally marketed predicate devices, the Fukuda Denshi Model DS-7000/7000M Patient Monitor 510(k) # K081891.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black-and-white design, and the text is in a clear, sans-serif font. The overall design is clean and professional, reflecting the department's role in public health and human services.

Public Health Service

MAR 1 9 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Fukuda Denshi USA, Inc. c/o Mr. Doug Blakely Director -- Regulatory Affairs 17725 NE 65th St. Building C Redmond, WA 98052

Re: K083697

Fukuda Denshi DynaScope Model DS - 7000 Series Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II (Two) Product Code: MHX, (DRT, DXN, DSK, DQA, BZQ, CCK and FFL) Dated: January 26, 2009 Received: January 26, 2009

Dear Mr. Blakely:

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.

{7}------------------------------------------------

Page 2 - Mr. Doug Blakely

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 (OS) 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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

Enclosure

{8}------------------------------------------------

Indications for Use

510(k) Number (if known): K083697

Device Name: Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor Indications For Use:

Use of the Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor (Model: DS-7000/7000M/7210/7210M) 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, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), pulse wave, temperature, invasive blood pressure (IBP), cardiac output, carbon dioxide concentration (CO2), nitrous oxide concentration (N20), oxygen concentration (O2), and anesthetic agent concentration (AG). The target populations of the system are adult, pediatric, and neonatal patients with the exception of the ST segment and arrhythmia analysis, for which the target populations are adult and pediatric only. 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-7000 Series Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-7000 Series Patient Monitor is also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH Office of Device Evaluation (ODE)
	for Beckerman
(Division Sign-Off) Division of Cardiovascular Devices	Page 1 of 1
510(k) Number	K083697

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.