The monitors are intended to be used for monitoring, storing, recording, and reviewing of, and to generate alarms for, multiple physiological parameters of adults and pediatrics (including neonates). The monitors are intended for use by trained healthcare professionals in hospital environments.

The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), functional oxygen saturation of arterial hemoglobin (SpO₂), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), and cardiac output (C.O.).

The arrhythmia detection and ST Segment analysis are intended for adult patients.

The NIBP monitoring supports iCUFS algorithm and iFAST algorithm. The iCUFS algorithm is intended for adult, pediatric and neonatal patients. The iFAST algorithm is intended for adult and pediatric patients (≥3 years of age). Both measurement algorithms are also intended for use with pregnant women, including pre-eclamptic patients. NIBP MAP is not applicable to pregnant women.

The Spot Temp with T2A module can only measure temperature of adult and pediatric (> 1 year of age) patients.

The monitors are not intended for MRI environments.

The cardiac output (C.O.) is only intended for adult patients.

Device Description

The CX&UX series Patient Monitor including CX10/CX12/CX15/UX10/UX12/UX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate.

Minor differences from the predicate device are limited to some modifications of monitoring parameter specifications. These updates do not change the fundamental scientific technology of the cleared predicate device and thus do not raise any questions about the safety and effectiveness of the subject device.

AI/ML Overview

The provided FDA 510(k) clearance letter details the device's technical specifications and comparisons to predicate devices, along with the non-clinical performance data and adherence to various IEC and ISO standards. However, it explicitly states: "Clinical data: The subject device did not require new clinical studies to support substantial equivalence."

This means that the submission for this Patient Monitor device (CX10, CX12, CX15, UX10, UX12, UX15) relies on demonstrating substantial equivalence to a legally marketed predicate device (Edan Instruments, Inc., Patient Monitor Model iX10, iX12, iX15, K232962) through non-clinical performance testing and software verification/validation, rather than new clinical trials or studies involving human patients.

Therefore, the requested information regarding acceptance criteria and studies that prove the device meets acceptance criteria through clinical performance (e.g., sample size for test set, expert involvement, MRMC studies, ground truth establishment for test/training sets, effect size of human reader improvement with AI) cannot be extracted from this document, as such clinical studies were explicitly not required for this 510(k) submission.

The document focuses on demonstrating that the new device's technical specifications and performance are similar to the predicate device, and that it complies with relevant safety and performance standards through bench testing.

Here's what can be extracted from the provided text regarding acceptance criteria and the type of study performed, specifically focusing on the non-clinical aspects:

Device: Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)

The acceptance criteria for this device are implicitly tied to its performance meeting the standards and accuracy specifications of the predicate device and relevant international standards. Since no new clinical studies were conducted, the "proof" comes from non-clinical bench testing and software validation.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Bench Testing)

Parameter/Acceptance Criteria Type	Details of Acceptance Criteria (Implicit from Standards Compliance & Predicate Equivalence)	Reported Device Performance (as demonstrated by compliance)
Electrical Safety	Compliance with IEC 60601-1 Edition 3.2 2020-08	Complies with IEC 60601-1 Edition 3.2 2020-08
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2:2014 (Fourth Edition)	Complies with IEC 60601-1-2:2014 (Fourth Edition)
Alarm Systems	Compliance with IEC 60601-1-8:2020 (General requirements, tests, and guidance for alarm systems)	Complies with IEC 60601-1-8:2020
ECG Monitoring Equipment Performance	Compliance with IEC 60601-2-27:2011 (Basic safety and essential performance of electrocardiographic monitoring equipment)	Complies with IEC 60601-2-27:2011
Invasive Blood Pressure Monitoring Performance	Compliance with IEC 60601-2-34:2011 (Basic safety, including essential performance, of invasive blood pressure monitoring equipment)	Complies with IEC 60601-2-34:2011
Automated Non-Invasive Sphygmomanometers Performance	Compliance with IEC 80601-2-30:2018 (Basic safety and essential performance of automated non-invasive sphygmomanometers)	Complies with IEC 80601-2-30:2018
Multifunction Patient Monitoring Performance	Compliance with IEC 80601-2-49:2018 (Basic safety and essential performance of multifunction patient monitoring equipment)	Complies with IEC 80601-2-49:2018
Respiratory Gas Monitors Performance	Compliance with ISO 80601-2-55:2018 (Basic safety and essential performance of respiratory gas monitors)	Complies with ISO 80601-2-55:2018
Clinical Thermometers Performance	Compliance with ISO 80601-2-56:2017+A1:2018 (Basic safety and essential performance of clinical thermometers)	Complies with ISO 80601-2-56:2017+A1:2018
Pulse Oximeter Equipment Performance	Compliance with ISO 80601-2-61:2017 (Basic safety and essential performance of pulse oximeter equipment)	Complies with ISO 80601-2-61:2017
Wireless Coexistence	Compliance with IEEE ANSI USEMCSC C63.27 (Evaluation of Wireless Coexistence)	Complies with IEEE ANSI USEMCSC C63.27
Software Functionality	Compliance with FDA Guidance "Content of Premarket Submissions for Device Software Functions"	Software verification and validation testing conducted and documentation provided as recommended.
Accuracy Specifications (Example: RESP)	6 rpm to 200 rpm: ±2 rpm	Reported as meeting this accuracy specification.
Accuracy Specifications (Example: IBP)	±2% or ±1 mmHg, whichever is greater (excluding sensor error)	Reported as meeting this accuracy specification.

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

Sample Size: Not applicable in terms of human subjects or patient data test sets, as "new clinical studies" were not required. The "test set" refers to bench testing and functional system-level validation. The specific number of test cycles or a detailed breakdown of test cases for bench testing is not provided in this summary.
Data Provenance: The data primarily originates from Edan Instruments Inc. (Shenzhen, Guangdong, China) through internal engineering and quality assurance processes for non-clinical bench testing and software validation. It is not patient data, so concepts like "retrospective or prospective" do not apply.

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

Not applicable for clinical ground truth: Since no clinical studies were performed requiring human interpretation or diagnosis for a test set, no medical experts (e.g., radiologists) were used to establish ground truth in this context.
Internal experts: Bench testing and software validation would have involved engineers and quality assurance professionals, whose qualifications are implicit in the quality system (21 CFR Part 820) but not specified in detail here.

4. Adjudication Method for the Test Set:

Not applicable: Adjudication methods (e.g., 2+1, 3+1) are relevant for clinical studies involving multiple readers. This was not a clinical study. Bench testing relies on established technical specifications and standard compliance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No: No MRMC study was performed as no new clinical studies were required or conducted. Therefore, there's no effect size of human readers improving with AI assistance. The device is a patient monitor, not an AI-assisted diagnostic tool.

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

Yes (for the technical components): The "performance testing-Bench" effectively represents a standalone evaluation of the device's functional components (ECG, NIBP, SpO2, etc.) and software against defined technical specifications and standards. The "software verification and validation testing" also represents a standalone evaluation of the algorithm and software functions. The specific algorithms (e.g., iCUFS, iFAST for NIBP, arrhythmia analysis logic) are tested independently for their accuracy against known inputs or reference standards as part of bench testing.

7. The Type of Ground Truth Used:

Technical/Reference Standards: For the bench testing, the "ground truth" would be derived from:
- Reference standards/simulators: Calibrated medical equipment, physiological simulators, and test signals (e.g., known ECG waveforms, simulated blood pressure readings, temperature standards) are used to provide the "true" values against which the device's measurements are compared.
- Defined specifications: The device's internal design specifications and the requirements of the referenced IEC/ISO standards serve as the "ground truth" for compliance testing.
Not clinical ground truth: No expert consensus, pathology, or outcomes data from real patients were used for establishing ground truth for this submission.

8. The Sample Size for the Training Set:

Not applicable: The device is a patient monitor, not a machine learning/AI algorithm that typically undergoes a distinct "training" phase with a large dataset. Its functionality is based on established physiological measurement principles and programmed algorithms. Any internal calibration or algorithm refinement would be part of the product development process, not a dedicated "training set" in the AI/ML sense.

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

Not applicable: As there was no "training set" in the context of an AI/ML model, the concept of establishing ground truth for it does not apply to this 510(k) submission.

In summary, this 510(k) clearance relies on demonstrating that the new Patient Monitor is substantially equivalent to a previously cleared predicate device, primarily through robust non-clinical bench testing and software validation, proving compliance with established medical device standards and functional specifications. No new clinical studies with patient data were required or conducted for this specific submission.

Summary

FDA 510(k) Clearance Letter - Patient Monitor

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

July 29, 2025

Edan Instruments Inc.
Tracy Yue
Official Correspondent
#15 Jinhui Road, Jinsha Community, Kengzi Sub-District,
Pingshan District
Shenzhen, Guangdong 518122
China

Re: K250179
Trade/Device Name: Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)
Regulation Number: 21 CFR 870.1025
Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm)
Regulatory Class: Class II
Product Code: MHX, DPS, DSI, MLD, DRT, DXN, DSK, FLL, DQA, BZQ, CCK, CCL
Dated: July 7, 2025
Received: July 1, 2025

Dear Tracy Yue:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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K250179 - Tracy Yue Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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K250179 - Tracy Yue Page 3

Sincerely,

JENNIFER W. SHIH -S

Jennifer Kozen
Assistant Director
Division of Cardiac Electrophysiology,
Diagnostics, and Monitoring Devices
Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K250179

Device Name
Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)

Indications for Use (Describe)

The arrhythmia detection and ST Segment analysis are intended for adult patients.

The Spot Temp with T2A module can only measure temperature of adult and pediatric (> 1 year of age) patients.

The monitors are not intended for MRI environments.

The cardiac output (C.O.) is only intended for adult patients.

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

510(K) Summary

Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92

1. Submitter:

Applicant: Edan Instruments, Inc.
#15 Jinhui Road, Jinsha Community,
Kengzi Sub-District, Pingshan District,
Shenzhen, 518122 P.R.China.
Tel: +86(0755) 26858736
Fax: +86(0755) 26882223

Contact person: Tracy Yue
Preparing date: July 25, 2025

2. Device name and classification:

Trade name: Patient Monitor, Model: CX10, CX12, CX15, UX10, UX12, UX15
Common/Usual Name: Patient Monitor
Classification Name: 21 CFR 870.1025
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Regulatory class: Class II
Primary product code: MHX-Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Subsequent product code:

Regulation number/Device	Product Code
21 CFR 868.2375 Electrocardiograph	DPS
21 CFR 870.2340 Detector and Alarm, Arrhythmia	DSI
21 CFR 870.1025 Monitor, ST Segment with Alarm	MLD
21 CFR 870.2300 Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT
21 CFR 870.1130 System, Measurement, Blood-Pressure, Non-Invasive	DXN
21 CFR 870.1110 Computer, Blood-Pressure	DSK
21 CFR 880.2910 Thermometer, Electronic, Clinical	FLL
21 CFR 870.2700 Oximeter	DQA

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Regulation number/Device	Product Code
21 CFR 868.2375 Monitor, Breathing Frequency	BZQ
21 CFR 870.1400 Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK
21 CFR 868.1720 Analyzer, Gas, Oxygen, Gaseous-Phase	CCL

3. Predicate Device(s):

Edan Instruments, Inc., Patient Monitor Model iX10, iX12, iX15, K232962 (Primary Predicate)
Edan Instruments, Inc., Vital signs monitor Model iM3, K180380 (Reference)

4. Device Description:

5. Indication for Use

The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), and cardiac output (C.O.).

The arrhythmia detection and ST Segment analysis are intended for adult patients.

The Spot Temp with T2A module can only measure temperature of adult and pediatric (> 1 year of age) patients.

The monitors are not intended for MRI environments.

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The cardiac output (C.O.) is only intended for adult patients.

6. Predicate Device Comparison

The table below compares the indication for use and key technological feature of the subject devices to the predicate device (Patient Monitor Model iX10, iX12, iX15, K232962).

Item	(CX10, CX12, CX15, UX10, UX12, UX15)	(iX10, iX12, iX15)
Manufacturer/K#	Current Submission	K232962

Intended Use/Indications for Use

Description

Subject Device:
The monitors are intended to be used for monitoring, storing, recording, and reviewing of, and to generate alarms for, multiple physiological parameters of adults and pediatrics (including neonates). The monitors are intended for use by trained healthcare professionals in hospital environments.

The arrhythmia detection and ST Segment analysis are intended for adult patients.

The Spot Temp with T2A module can only measure temperature of adult and pediatric (> 1 year of age) patients.

Predicate Device:
The monitors are intended to be used for monitoring, storing, recording, and reviewing of, and to generate alarms for, multiple physiological parameters of adults and pediatrics (including neonates). The monitors are intended for use by trained healthcare professionals in hospital environments.

The arrhythmia detection and ST Segment analysis are intended for adult patients.

The Spot Temp with T2A module can only

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The monitors are not intended for MRI environments.

The cardiac output (C.O.) is only intended for adult patients.

measure temperature of adult and pediatric (> 1 year of age) patients.

The monitors are not intended for MRI environments.

The cardiac output (C.O.) is only intended for adult patients.

ECG module

Parameter	Subject Device	Predicate Device
Lead Mode	3 Electrodes; 5 Electrodes; 6 Electrodes; 10 Electrodes	3 Electrodes; 5 Electrodes; 6 Electrodes; 10 Electrodes
Arrhythmia analyses	ASYSTOLE, VFIB/VTAC, COUPLET, VT > 2, BIGEMINY, TRIGEMINY, VENT, R on T, PVC, TACHY, BRADY, MISSED BEATS, IRR, VBRADY, PNC, PNP	ASYSTOLE, VFIB/VTAC, COUPLET, VT > 2, BIGEMINY, TRIGEMINY, VENT, R on T, PVC, TACHY, BRADY, MISSED BEATS, IRR, VBRADY, PNC, PNP

ST value

Parameter	Subject Device	Predicate Device
Measurement Range	-2.0 mV to +2.0 mV	-2.0 mV to +2.0 mV

Pace

Parameter	Subject Device	Predicate Device
Pulse Indicator	Amplitude: ±2 mV to ±700 mVWidth: 0.1 ms to 2.0 msAscending time: 10 μs to 100 μs	Amplitude: ±2 mV to ±700 mVWidth: 0.1 ms to 2.0 msAscending time: 10 μs to 100 μs

PVC

Parameter	Subject Device	Predicate Device
Range	ADU: (0 to 300) PVCs/ minPED/NEO: (0 to 350) PVCs/ min	ADU: (0 to 300) PVCs/ minPED/NEO: (0 to 350) PVCs/ min

HR

Parameter	Subject Device	Predicate Device
Measurement range	ADU: 15 bpm to 300 bpmPED/NEO: 15 bpm to 350 bpm	ADU: 15 bpm to 300 bpmPED/NEO: 15 bpm to 350 bpm

QT Analysis

Parameter	Subject Device	Predicate Device
QT/QTc/ΔQTc measurement	QT Range: 200 ms ~ 800 msQTc Range :200ms ~ 800 msΔQTc Range: -600 ms ~ 600 ms	QT Range: 200 ms ~ 800 msQTc Range :200ms ~ 800 msΔQTc Range: -600 ms ~ 600 ms

RESP module

Parameter	Subject Device	Predicate Device
Principle of Operation	Impedance between RA-LL, RA-LA	Impedance between RA-LL, RA-LA
Measurement Range	6 rpm to 200 rpm	0 rpm to 200 rpm
Accuracy	6 rpm to 200 rpm: ±2 rpm	6 rpm to 200 rpm: ±2 rpm0 rpm to 5 rpm: not specified

NIBP module (EDAN)

Parameter	Subject Device	Predicate Device
Technique	Oscillometry	Oscillometry
Measurement Mode	iCUFS, iFAST	iCUFS, iFAST

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Parameter	Subject Device	Predicate Device
Intended population	iCUFS: Adult, pediatric, neonatesiFAST: Adult, pediatric	iCUFS: Adult, pediatric, neonatesiFAST: Adult, pediatric

Measurement Range (mmHg)

	Subject Device	Predicate Device
	Adult	Pediatric
Systolic	25-290	25-240
Diastolic	10-250	10-200
MAP	15-260	15-215

PR from NIBP

Parameter	Subject Device	Predicate Device
Measurement range	40 bpm to 240 bpm	40 bpm to 240 bpm

SpO2 module(EDAN)

Parameter	Subject Device	Predicate Device
Measurement Range	0% to 100%	0% to 100%

PR from SpO2

Parameter	Subject Device	Predicate Device
Measurement Range	20 bpm to 300 bpm	25 bpm to 300 bpm

Temperature(TEMP) module

Parameter	Subject Device	Predicate Device
Number of channels	2	2
Measurement Range	0°C to 50°C(32°F to 122°F)	0°C to 50°C(32°F to 122°F)

Spot Temp Module

Subject Device:
EDAN T2A

Measurement site: oral/axillary
Monitor mode: 25°C ~ 45°C
Predict mode: 35.5°C ~ 42°C
Accuracy (Monitor mode): 0.1°C (25°C ~ 45°C)

F3000 module

Measurement site: oral/axillary/rectal
Monitor mode: 30°C~43°C
Predict mode: 35°C ~43°C
Accuracy (Monitor mode): ±0.1°C

Predicate Device:

Measurement site: oral/axillary
Monitor mode: 25°C ~ 45°C
Predict mode: 35.5°C ~ 42°C
Accuracy (Monitor mode): 0.1°C (25°C ~ 45°C)

The T2A module is the same as K232962
The F3000 module is similar to K180380
The Spot Temp module is applicable to CX10/CX12 and UX10/UX12.

IBP module

Parameter	Subject Device	Predicate Device
Channel	2	iX15: 4 channelsiX10/iX12: 2 channels
Measurement Range	(-50 to +360) mmHg	ART, Ao, UAP, BAP, FAP, LV, P1-P4: (-50 to +400) mmHgPA/PAWP: (-6 to +120) mmHgCVP/RAP/LAP/ICP: (-10 to +40) mmHg
Accuracy	±2% or ±1 mmHg, whichever is greater (excluding sensor error)	±2% or ±1 mmHg, whichever is greaterICP:0 mmHg to 40 mmHg: ±2% or ±1 mmHg, whichever is greater;

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-10 mmHg to -1 mmHg: undefined

C.O. Module

Parameter	Subject Device	Predicate Device
Technique	Thermodilution Technique	Thermodilution Technique
Measurement range	C.O.: 0.1 to 20L/minTB: 23°C to 43°C(73.4°F to 109.4°F)TI: -1°C to 27°C(30.2°F to 80.6°F)	C.O.: 0.1 to 20L/minTB: 23°C to 43°C(73.4°F to 109.4°F)TI: -1°C to 27°C(30.2°F to 80.6°F)

CO2 Module (EDAN G2)

Parameter	Subject Device	Predicate Device
Intended Patient	Adult, pediatric, neonatal	Adult, pediatric, neonatal
Measure Parameters	EtCO2, FiCO2, AwRR	EtCO2, FiCO2, AwRR
Measuring Range	CO2: 0 mmHg to 152 mmHg (0% to 20%)AwRR: 0 rpm to 150 rpm	CO2: 0 mmHg to 150 mmHg (0% to 20%)AwRR: 0 rpm to 150 rpm

Wi-Fi

Parameter	Subject Device	Predicate Device
IEEE	802.11a/b/g/n	802.11a/b/g/n
Frequency Band	2.4 GHz ISM band & 5G ISM band	2.4 GHz ISM band & 5G ISM band

Power supply

Parameter	Subject Device	Predicate Device
AC power Requirement	100-240V, 50/60Hz	100-240V, 50/60Hz
Battery Rechargeable Battery	Yes	Yes

As seen in the comparison tables, the subject and predicate devices have similar design features and performance specifications. The technological differences between the subject and predicate devices do not raise different questions of safety or effectiveness.

7. Performance Data:

Non-clinical data:

Electrical safety and electromagnetic compatibility (EMC)

CX&UX Series Patient Monitors were assessed for conformity with the relevant requirements of the following standards and found to comply:

IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION-Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014 (Fourth Edition) Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: electromagnetic disturbances – Requirements and tests.

Performance testing-Bench

Edan has conducted functional and system level testing to validate the performance of the devices. The results of

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the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards.

IEC 60601-1-8:2020 Medical electrical equipment - part 1-8: general requirements for basic safety and essential performance - collateral standard: general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-2-27:2011 Medical electrical equipment--Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
IEC 60601-2-34:2011 Medical electrical equipment - part 2-34: particular requirements for the basic safety, including essential performance, of invasive blood pressure monitoring equipment
IEC 80601-2-30:2018 Medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
IEC 80601-2-49:2018 Medical electrical equipment –Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
ISO 80601-2-55:2018 Medical electrical equipment - part 2-55: particular requirements for the basic safety and essential performance of respiratory gas monitors
ISO 80601-2-56:2017+A1:2018 Medical electrical equipment - part 2-56: particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
ISO 80601-2-61:2017 Medical electrical equipment - part 2-61: particular requirements for basic safety and essential performance of pulse oximeter equipment
IEEE ANSI USEMCSC C63.27 American National Standard for Evaluation of Wireless Coexistence.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and Food and Drug Administration Staff, "Content of Premarket Submissions for Device Software Functions".

Clinical data: The subject device did not require new clinical studies to support substantial equivalence.

Summary

The non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate device.

8. Conclusion

The bench testing data and software verification and validation demonstrate that CX&UX series Patient Monitor is substantially equivalent to the predicate device.

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.