(211 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The device is described as a patient monitor intended for monitoring, storing, and reviewing physiological parameters and generating alarms, which are diagnostic and monitoring functions, not therapeutic.
Yes
The device monitors, stores, and reviews multiple physiological parameters (like ECG, respiration, temperature, SpO2, NIBP, etc.) and generates alarms for abnormalities, which are used by healthcare professionals to assess a patient's condition. This function of identifying and displaying information about a patient's health status aligns with the purpose of a diagnostic device.
No
The device description explicitly states it is a "Patient Monitor" and describes its capabilities for continuous monitoring, storing, displaying, analyzing, and controlling measurements, and indicating alarms. This indicates a hardware device with integrated software, not a software-only device. The performance studies also include electrical safety, EMC, and performance testing, which are typical for hardware devices.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- This device directly monitors physiological parameters of the human body (ECG, respiration, temperature, SpO2, NIBP, etc.). It's a patient monitor, not a device that analyzes samples.
The description clearly states its purpose is to monitor, store, review, and generate alarms for these physiological parameters in real-time on the patient.
N/A
Intended Use / Indications for Use
The iX series Patient Monitors including iX10, iX12, iX15 are intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults and pediatics (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 is intended for adult, pediatric and neonatal patients. The iFAST algorithm is intended for adult and pediatic 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.
Product codes
MHX, DPS, DSI, MLD, DRT, DXN, DSK, FLL, DQA, CCK, CBS, CBR, CCL, CBQ, NHO, NHQ, NHP
Device Description
The iX series Patient Monitors including iX10, iX12, iX15 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults and pediatrics (including neonates).
Arrhythmia detection and ST Segment analysis are intended for adult patients.
NIBP iCUFS algorithm: adult, pediatric and neonatal patients.
NIBP iFAST algorithm: adult and pediatric patients (≥3 years of age).
Spot Temp with T2A module: adult and pediatric (> 1 year of age) patients.
Cardiac output (C.O.): adult patients.
Intended User / Care Setting
Trained healthcare professionals in hospital environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The Quick Temp Module (T2A) clinical investigation: evaluated 142 valid cases of sublingual and axillary temperature, which were performed on the following two age groups: >1 and 1 year old to 73 years old. The total number of hyperthermia subjects shall be no less than 30% and no more than 50% of all subjects in the selected age group.
Summary of Performance Studies
Study Type: Non-clinical (electrical safety, EMC, functional, system level, software verification and validation) and Clinical (TEMP measurement).
Sample Size: Clinical accuracy study evaluated 142 valid cases for TEMP measurement.
Key Results:
Non-clinical performance: iX Series Patient Monitors were assessed for conformity with relevant standards and found to comply. Functional and system level testing showed that the subject device meets its accuracy specification and relevant consensus standards. Software verification and validation testing were conducted.
Clinical performance: The temperature measurement function of the T2A module in Predict mode meets the requirements of standard ISO 80601-2-56:2017+AMD1:2018 for temperature measurement and meets the acceptance criteria in clinical protocol. No discomfort symptoms or adverse reactions were reported.
Overall Conclusion: Both the clinical and non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate device. The performance data demonstrates that iX series Patient Monitor are substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K211475, K180380, K202892, K220308, K182075
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 19, 2024
Edan Instruments, Inc Tracy Yue Regulatory Affairs Engineer 15 Jinhui Road, Jinsha Community, Kengzi Sub-district Pingshan District Shenzhen. Shenzhen 518122 China
Re: K232962
Trade/Device Name: Patient Monitor (iX10, iX12, iX15) 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, CCK, CBS, CBR, CCL, CBQ, NHO, NHQ, NHP Dated: March 22, 2024 Received: March 22, 2024
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.
1
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" (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 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-reportingcombination-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.
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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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).
Sincerely,
Jennifer W. Shih -S
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices
2
Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232962
Device Name Patient Monitor, Model: iX10, iX12, iX15
Indications for Use (Describe)
The iX series Patient Monitors including iX10, iX12, iX15 are intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults and pediatics (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 is intended for adult, pediatric and neonatal patients. The iFAST algorithm is intended for adult and pediatic 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) |
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."
4
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 |
| Contact person: | Tracy Yue |
|---|---|
| Preparing date: | September 21, 2023 |
2. Device name and classification:
| Trade name: | Patient Monitor, Model: iX10, iX12, iX15 | ||||
|---|---|---|---|---|---|
| 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 DPS |
| 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 |
5
| 21 CFR 868.2375
| Monitor, Breathing Frequency | BZQ |
|---|---|
| 21 CFR 870.1400 | |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK |
| 21 CFR 868.1620 | |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic | |
| Conc.) | CBS |
| 21 CFR 868.1700 | |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic | |
| Conc.) | CBR |
| 21 CFR 868.1720 | |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL |
| 21 CFR 868.1500 | |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic | |
| Concentration) | CBQ |
| 21 CFR 868.1500 | |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic | |
| Concentration) | NHO |
| 21 CFR 868.1500 | |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic | |
| Concentration) | NHQ |
| 21 CFR 868.1500 | |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic | |
| Concentration) | NHP |
3. Predicate Device(s):
-
- Edan Instruments, Inc., Patient Monitor Model iM50, iM60, iM70, iM80, K202336 (Primary)
-
- Shenzhen Mindray Bio-Medical Electronics Co., LTD., VS9 Vital Signs Monitor, K211475 (Reference)
-
- Edan Instruments, Inc., Vital signs monitor Model iM3, K180380 (Reference)
-
- Edan Instruments, Inc., Vital signs monitor Model iM3s, K202892 (Reference)
-
- Edan Instruments, Inc., Patient Monitor Model RespArray, K220308 (Reference)
-
- Shenzhen Mindray Bio-Medical Electronics Co., LTD., BeneVision N Series Patient Monitors, K182075 (Reference)
6
| 4. Device Description: | The iX series Patient Monitors including iX10, iX12, iX15 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. |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5. Indication for Use | The iX series Patient Monitors including iX10, iX12, iX15 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 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. |
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 iM50, iM60, iM70, iM80, K202336).
Note: "/" means no such functions in predicate device.
| K# | Subject Device
(iX10, iX12, iX15) | Predicate Device
(iM50, iM60, iM70, iM80) |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K232962 | K232336 | K202336 |
| Description | The iX series Patient Monitors
including iX10, iX12, iX15 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 | The monitors are intended to be used for
monitoring, storing, recording, and
reviewing of, and to generate alarms for,
multiple physiological parameters of adults,
pediatrics and neonates. The monitors are
intended for use by trained healthcare
professionals in hospital environments. |
| | 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 monitored physiological parameters
include: ECG, respiration (RESP),
temperature (TEMP), oxygen saturation of
arterial blood (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 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 monitors are not intended for MRI
environments. |
| | 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. | |
| 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 |
| | | The arrhythmia detection algorithm is the same as predicate device K202336 |
| 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 us to 100 us | Amplitude: ±2 mV to ±700 mV
Width: 0.1 ms to 2.0 ms
Ascending time: 10 us to 100 us |
| PVC | | |
| Range | ADU: (0 to 300) PVCs/ min | ADU: (0 to 300) PVCs/ min |
| | PED/NEO: (0 to 350) PVCs/ min | PED/NEO: (0 to 350) PVCs/ min |
| HR | | |
| Measurement range | ADU: 15 bpm to 300 bpm | ADU: 15 bpm to 300 bpm |
| | PED/NEO: 15 bpm to 350 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
△ QTc Range: -600 ms ~ 600 ms | QT Range: 200 ms ~ 800 ms
QTc Range :200ms ~ 800 ms
△ 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 | 0 rpm to 200 rpm | Adult: 0 to 120 rpm
Pediatric/neonate: 0 rpm to 150rpm |
| NIBP module (EDAN) | | |
| Technique | Oscillometry | Oscillometry |
| Measurement Mode | iCUFS, iFAST | iCUFS |
| EDAN-NIBP(iCUFS) | | |
| Intended users | Adult, pediatric, neonates | Adult, pediatric, neonates |
| Measuring parameter | SYS, DIA, MAP, PR | |
| Measurement Range | Adult Pediatric Neonate
Systolic 25-290 25-240 25-140
Diastolic 10-250 10-200 10-115
Mean 15-260 15-215 15-125 | Adult Pediatric Neonate
Systolic 25-290 25-240 25-140
Diastolic 10-250 10-200 10-115
Mean 15-260 15-215 15-125 |
| PR from NIBP | | |
| Measurement range | 40 bpm to 240 bpm | 40 to 240 bpm |
| EDAN-NIBP(iFAST) | | |
| Intended users | Adult, pediatric | |
| Measuring parameter | SYS, DIA, MAP | |
| Measurement Range | Adult Mode:
SYS: 25 mmHg to 290 mmHg
DIA: 10 mmHg to 250 mmHg
MAP: 15 mmHg to 260 mmHg | |
| | | |
| | | |
| | | |
| | Pediatric Mode: | |
| | SYS: 25 mmHg to 240 mmHg | |
7
8
9
| DIA: 10 mmHg to 200 mmHg | ||||
|---|---|---|---|---|
| MAP: 15 mmHg to 215 mmHg | ||||
| SpO2 module(EDAN) | ||||
| Measurement Range | SpO2 | 0% to 100% | SpO2 | 0% to 100% |
| Pulse Rate | 25 to 300 bpm | Pulse Rate | 25 to 300 bpm | |
| Nellcor SpO2 module is the same as K202336 | ||||
| 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 | ||||
| Measurement site: oral/axillary/rectal | ||||
| Quick Temp (T2A | ||||
| module) | Monitor mode: 25 °C ~45 °C | |||
| Predict mode: 35.5 °C ~42 °C | ||||
| Accuracy (Monitor mode): 0.1 °C (25 °C ~ | ||||
| 45 °C) | ||||
| The Quick Temp (T2A) module is similar to K180380, and the performance of the Predict mode of the module is | ||||
| validated by the clinical trial. | ||||
| Infrared Temp | ||||
| (TAT-5000S-RS232 | ||||
| Thermometer) | Measuring Range : 16 °C~ 43 °C (61 °F ~ | |||
| 110 °F) | ||||
| The Infrared Temp module is the same as K202892 | ||||
| The Quick Temp module and Infrared Temp module is applicable to iX10 and iX12 | ||||
| IBP module | ||||
| ART, Ao, UAP, BAP, FAP, LV, P1-P4: (-50 to | ||||
| +400) mmHg | Art: (0 to +300) mmHg | |||
| Measurement Range | PA/PAWP: (-6 to +120) mmHg | PA/PAWP: (-6 to +120) mmHg | ||
| CVP/RAP/LAP/ICP: (-10 to +40) mmHg | CVP/RAP/LAP/ICP: (-10 to +40) mmHg | P1/P2: (-50 to +300) mmHg | ||
| C.O. Module | ||||
| Technique | Thermodilution Technique | Thermodilution Technique | ||
| C.O.: 0.1 to 20L/min | C.O.: 0.1 to 20L/min | |||
| Measurement range | TB: 23 °C to 43 °C(73.4 °F to 109.4 °F) | 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) | 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 150 mmHg (0 % to 20%) | CO2:0 mmHg to 150 mmHg (0 % to 20%) | ||
| AwRR: 0 rpm to 150 rpm | AwRR: 2 rpm to 150 rpm | |||
| Respironics and Masimo CO2 module are the same as K202336 | ||||
| AG module (EDAN G7 module) | ||||
| Measure Parameters | CO2、N2O、O2、HAL、ISO、ENF、SEV、 | CO2、N2O、O2、HAL、ISO、ENF、SEV、 |
10
| DES、AwRR、MAC | DES、AwRR、MAC | |
|---|---|---|
| Measuring Range | CO2: 0%~15Vol % | CO2: 0%~15Vol % |
| N2O: 0%~100 Vol % | N2O: 0%~100 Vol % | |
| HAL/ISO: 0%-8Vol % | HAL/ISO: 0%-8Vol % | |
| ENF: 0%-8 Vol % | ENF: 0%-8 Vol % | |
| SEV: 0%-10 Vol % | SEV: 0%-10 Vol % | |
| DES: 0%-20 Vol % | DES: 0%-20 Vol % | |
| O2: 0%~100 Vol % | O2: 0%~100 Vol % | |
| AwRR: 2rpm-100rpm | AwRR: 2rpm-100rpm | |
| Masimo AG module are the same as K202336 | ||
| 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 |
| e-Link | ||
| e-Link | Bluetooth Low Energy 4.0 | / |
| 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 device have similar design features and performance specifications. The technological differences between the subject and predicate device do not raise different questions of safety or effectiveness.
7. Performance Data:
Non-clinical data:
Electrical safety and electromagnetic compatibility (EMC)
iX Series Patient Monitors were assessed for conformity with the relevant requirements of the following standards and found to comply:
- ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
- IEC 60601-1-2:2014+A1:2020 Medical electrical equipment Part 1-2: General requirements for basic ● safety and essential performance – Collateral Standard: electromagnetic disturbances – Requirements and tests.
11
Performance testing-Bench
Edan has conducted functional and system level testing to validate the performance of the results of 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 60601-2-25:2011 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
- 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 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 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 60601-2-49:2018 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 C63.27:2017 American National Standard for Evaluation of Wireless Coexistence
- ANSI AAMI EC57:2012 Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms
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:
To meet the requirements for the validity and accuracy of the TEMP measurement of the Quick Temp Module (T2A), EDAN conducted clinical investigation according to the requirements of the standard ISO 80601-2-56
12
Second edition 2017-03 + AMD1:2018: Medical electrical equipment- Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. A clinical accuracy study evaluated 142 valid cases of sublingual and axillary temperature, which were performed on the following two age groups: >1 and 1 year old to 73 years old. The total number of hyperthermia subjects shall be no less than 30% and no more than 50% of all subjects in the selected age group. Statistical results show that, the temperature measurement function of the T2A module in Predict mode meets the requirements of standard ISO 80601-2-56:2017+AMD1:2018 for temperature measurement and meets the acceptance criteria in clinical protocol. During the entire clinical trial, all subjects are in good condition, and none of the subjects have discomfort symptoms or adverse reactions.
Summarv
Both the clinical and non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate device.
8. Conclusion
The performance data demonstrates that iX series Patient Monitor are substantially equivalent to the predicate device.