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

K250179 · Edan Instruments, Inc. · MHX · Jul 29, 2025 · Cardiovascular

Device Facts

• Record ID: K250179
• Device Name: Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)
• Applicant: Edan Instruments, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Jul 29, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

Patient monitor (CX/UX series) performs continuous monitoring of physiological parameters (ECG, RESP, TEMP, SpO2, PR, NIBP, IBP, CO2, C.O.). Inputs include electrical signals (ECG, RESP), pressure (NIBP, IBP), optical (SpO2), and thermal sensors. Device processes signals via internal algorithms (iCUFS, iFAST for NIBP; arrhythmia/ST analysis for ECG) to calculate vital signs and detect abnormalities. Outputs displayed on screen with audible/visual alarms for clinician review. Used in hospital environments by trained healthcare professionals. Provides real-time data to support clinical decision-making and patient status assessment. Benefits include continuous surveillance and timely notification of physiological changes.

Clinical Evidence

No clinical data required. Substantial equivalence supported by bench testing, including functional and system-level validation, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance testing against consensus standards (e.g., IEC 60601-2-27 for ECG, IEC 80601-2-30 for NIBP, ISO 80601-2-61 for SpO2).

Technological Characteristics

Multi-parameter patient monitor. Sensing principles: Impedance (RESP), Oscillometry (NIBP), Thermodilution (C.O.), Pulse Oximetry (SpO2). Connectivity: Wi-Fi (IEEE 802.11a/b/g/n, 2.4/5GHz). Power: 100-240V AC or rechargeable battery. Software: Embedded firmware for signal processing and alarm management. Standards: IEC 60601-1, IEC 60601-1-8, IEC 60601-2-27, IEC 60601-2-34, IEC 80601-2-30, ISO 80601-2-55, ISO 80601-2-56, ISO 80601-2-61.

Indications for Use

Indicated for monitoring, storing, recording, and reviewing physiological parameters in adults, pediatrics, and neonates. Parameters include ECG, RESP, TEMP, SpO2, PR, NIBP, IBP, CO2, and C.O. Arrhythmia/ST analysis for adults only. NIBP iCUFS for all ages; iFAST for ≥3 years. Both NIBP algorithms indicated for pregnant/pre-eclamptic patients (MAP excluded). Spot Temp (T2A) for >1 year. C.O. for adults only. Not for MRI environments.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Patient Monitor Model iX10, iX12, iX15 (K232962)

Reference Devices

• Vital signs monitor Model iM3 (K180380)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

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"

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

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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 ([e-mail]) or phone [phone] 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

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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 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.

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)

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Traditional 510(k) of iX series Patient Monitor

# 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: [phone]
Fax: [phone]

**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 |

510(k) Summary
K250179

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Traditional 510(k) of iX series Patient Monitor

| 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):

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

## 4. 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.

## 5. Indication for Use

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 ( $\geq 3$ 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.

510(k) Summary

K250179

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Traditional 510(k) of iX series Patient Monitor

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 | <Subject Device>(CX10, CX12, CX15, UX10, UX12, UX15) | <Predicate Device>(iX10, iX12, iX15) |
| --- | --- | --- |
| Manufacturer/K# | Current Submission | K232962 |
| Intended Use/Indications for Use | | |
| Description | 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 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), cardiac output (C.O.), and Anaesthesia gas (AG).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 |

510(k) Summary

K250179

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Traditional 510(k) of iX series Patient Monitor

| | 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 | | |
| 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 | | |
| Measurement Range | -2.0 mV to +2.0 mV | -2.0 mV to +2.0 mV |
| Pace | | |
| Pulse Indicator | Amplitude: ±2 mV to ±700 mV
Width: 0.1 ms to 2.0 ms
Ascending time: 10 μs to 100 μs | Amplitude: ±2 mV to ±700 mV
Width: 0.1 ms to 2.0 ms
Ascending time: 10 μs to 100 μs |
| PVC | | |
| Range | ADU: (0 to 300) PVCs/ min
PED/NEO: (0 to 350) PVCs/ min | ADU: (0 to 300) PVCs/ min
PED/NEO: (0 to 350) PVCs/ min |
| HR | | |
| Measurement range | ADU: 15 bpm to 300 bpm
PED/NEO: 15 bpm to 350 bpm | ADU: 15 bpm to 300 bpm
PED/NEO: 15 bpm to 350 bpm |
| QT Analysis | | |
| QT/QTc/ΔQTc measurement | QT Range: 200 ms ~ 800 ms
QTc Range: 200ms ~ 800 ms
Δ QTc Range: -600 ms ~ 600 ms | QT Range: 200 ms ~ 800 ms
QTc Range: 200ms ~ 800 ms
Δ QTc Range: -600 ms ~ 600 ms |
| RESP module | | |
| 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 rpm
0 rpm to 5 rpm: not specified |
| NIBP module (EDAN) | | |
| Technique | Oscillometry | Oscillometry |
| Measurement Mode | iCUFS, iFAST | iCUFS, iFAST |

510(k) Summary

K250179

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Traditional 510(k) of iX series Patient Monitor

| Intended population | iCUFS: Adult, pediatric, neonates
iFAST: Adult, pediatric | | | iCUFS: Adult, pediatric, neonates
iFAST: Adult, pediatric | | |
| --- | --- | --- | --- | --- | --- | --- |
| Measurement Range (mmHg) | Adult Pediatric Neonate | | | Adult Pediatric Neonate | | |
| | Systolic 25-290 25-240 25-140 | | | Systolic 25-290 25-240 25-140 | | |
| | Diastolic 10-250 10-200 10-115 | | | Diastolic 10-250 10-200 10-115 | | |
| | MAP 15-260 15-215 15-125 | | | MAP 15-260 15-215 15-125 | | |
| PR from NIBP | | | | | | |
| Measurement range | 40 bpm to 240 bpm | | | 40 bpm to 240 bpm | | |
| SpO2 module(EDAN) | | | | | | |
| Measurement Range | 0% to 100% | | | 0% to 100% | | |
| PR from SpO2 | | | | | | |
| Measurement Range | 20 bpm to 300 bpm | | | 25 bpm to 300 bpm | | |
| Temperature(TEMP) module | | | | | | |
| 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 | | | | | | |
| 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) | | | 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 | | | / | | |
| 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 | | | | | | |
| Channel | 2 | | | iX15: 4 channels
iX10/iX12: 2 channels | | |
| Measurement Range | (-50 to +360) mmHg | | | ART, Ao, UAP, BAP, FAP, LV, P1-P4: (-50 to +400) mmHg
PA/PAWP: (-6 to +120) mmHg
CVP/RAP/LAP/ICP: (-10 to +40) mmHg | | |
| Accuracy | ±2% or ±1 mmHg, whichever is greater
(excluding sensor error) | | | ±2 % or ±1 mmHg, whichever is greater
ICP: 0 mmHg to 40 mmHg: ±2 % or ±1 mmHg, whichever is greater; | | |

510(k) Summary

K250179

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Traditional 510(k) of iX series Patient Monitor

| | | -10 mmHg to -1 mmHg: undefined |
| --- | --- | --- |
| C.O. Module | | |
| Technique | Thermodilution Technique | Thermodilution Technique |
| Measurement range | C.O.: 0.1 to 20L/min
TB: 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/min
TB: 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) | | |
| 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 | | |
| IEEE | 802.11a/b/g/n | 802.11a/b/g/n |
| Frequency Band | 2.4 GHz ISM band & 5 G ISM band | 2.4 GHz ISM band & 5 G ISM band |
| Power supply | | |
| AC power | | |
| Requirement | 100-240V, 50/60Hz | 100-240V, 50/60 Hz |
| 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&amp;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

510(k) Summary

K250179

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Traditional
510(k)
of iX series Patient Monitor

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&amp;UX series Patient Monitor is substantially equivalent to the predicate device.

510(k) Summary

K250179