(203 days)
No
The document does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies.
No.
The device is a patient monitor, which measures and displays physiological parameters, and generates alarms. It does not perform any therapeutic function.
Yes
The device monitors, stores, records, and generates alarms for multiple physiological parameters, and highlights abnormities, enabling doctors and nurses to address them. This aligns with the concept of providing information to aid in the identification of medical conditions.
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 strongly implies the presence of hardware components for acquiring physiological data, displaying information, and generating alarms, which are not characteristic of a software-only device. The performance studies also mention electrical safety, EMC, and bench testing, further suggesting a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The description clearly states that the device is a patient monitor that measures and monitors physiological parameters directly from the patient (ECG, respiration, temperature, SpO2, NIBP, IBP, CO2, C.O.). It does not perform tests on samples taken from the body.
- Intended Use: The intended use is for monitoring, storing, recording, and generating alarms for these physiological parameters in a hospital setting. This is consistent with a patient monitor, not an IVD.
The device is a patient monitoring device, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The monitors are intended to be used for monitoring, storing, recording 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.
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.).
The arrhythmia detection and ST Segment analysis are intended for adult patients. The monitors are not intended for MRI environments.
Product codes
MHX, DRT, DXN, DSK, FLL, DQA, CCK, DSI, MLD, DSB
Device Description
The X8 X10 X12 Patient Monitor (hereinafter called X series) 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 abnormity so that doctors and nurses can deal with them in time.
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, pediatrics and neonates. The arrhythmia detection and ST Segment analysis are intended for 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical data:
Electrical safety and electromagnetic compatibility (EMC)
X Series Patient Monitors were assessed for conformity with the relevant requirements of the following standards and found to comply:
- ANSI/AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012 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 the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards.
- IEC 60601-1-8:2006 + Am1:2012 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 80601-2-30:2013 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 60601-2-49:2011 Medical electrical equipment –Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
- ISO 80601-2-55: 2011 Medical electrical equipment - part 2-55: particular requirements for the basic safety and essential performance of respiratory gas monitors
- ISO 80601-2-56: 2009 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: 2011 Medical electrical equipment - part 2-61: particular requirements for basic safety and essential performance of pulse oximeter equipment
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 FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Clinical data: Not applicable.
Summary
The non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 2, 2020
Edan Instruments, Inc. Alice Yang Regulatory Engineer #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, 518122 Cn
Re: K192514
Trade/Device Name: Patient Monitor - Models: X8, X10, X12 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, DRT, DXN, DSK, FLL, DQA, CCK, DSI, MLD, DSB Dated: February 27, 2020 Received: March 2, 2020
Dear Alice Yang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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,
LT Stephen Browning 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
2
Indications for Use
510(k) Number (if known) K192514
Device Name Patient Monitor - Models: X8, X10, X12
Indications for Use (Describe)
The monitors are intended to be used for monitoring, storing, recording 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.
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.).
The arrhythmia detection and ST Segment analysis are intended for adult patients. The monitors are not intended for MRI environments.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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."
3
510(K) Summary
Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92
| 1. Submitter: | Edan Instruments, Inc. |
|---|---|
| #15 Jinhui Road, Jinsha Community, | |
| Kengzi Sub-District, Pingshan District, | |
| Shenzhen, 518122 P.R.China. | |
| Tel: +86(0755) 26858736 | |
| Fax: +1 (408) 418-4059 | |
| Contact person: | Alice Yang |
| Preparing date: | September 9, 2019 |
| 2. Device name and classification: | Device Name: Patient Monitor |
| Model: X8,X10,X12 | |
| Classification Name/ Product code: | |
| 21 CFR 870.1025 Monitor, Physiological, Patient(With Arrhythmia Detection | |
| Or Alarms) / MHX | |
| 21 CFR 870.2300 Cardiac monitor (including cardiotachometer and rate alarm)/ | |
| DRT | |
| 21 CFR 870.1130 Non-Invasive blood pressure measurement System/ DXN | |
| 21 CFR 870.1110 Blood pressure computer/ DSK | |
| 21 CFR 880.2910 Clinical Electronic Thermometers-Temperature Monitor with | |
| Probe/ FLL | |
| 21 CFR 870.2700 Oximeter, Pulse/ DQA | |
| 21 CFR 870.1400 Carbon Dioxide Gas Analyzer/ CCK | |
| 21 CFR 870.1025 Detector and Alarm, Arrhythmia/ DSI | |
| 21 CFR 870.1025 Monitor, ST Segment with Alarm/ MLD | |
| 21 CFR 870.2770 Impedance plethysmograph/ DSB | |
| Regulatory Class: Class II | |
| 3. Predicate Device(s): | 1) Edan Instruments, Inc, Patient Monitor Model elite V5 elite V6 elite V8, K160981 (Primary) |
| 2) Shenzhen Mindray Bio-Medical Electronics Co., LTD. BeneVision N Series Patient Monitors, K182075 (Reference) | |
| 3) Shenzhen Mindray Bio-Medical Electronics Co., LTD. Accutorr 7 Vital Signs Monitor, K182821 (Reference) |
4
The X8 X10 X12 Patient Monitor (hereinafter called X series) can perform 4. Device Description: 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 abnormity so that doctors and nurses can deal with them in time. 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, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in hospital environments. 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.). The arrhythmia detection and ST Segment analysis are intended for adult patients. The monitors are not intended for MRI environments.
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 V5 V6 V8, K160981). The features that are different from the predicate device.
| Item |
(elite V5, elite V6, elite V8) |
(X8 X10 X12) |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/K# | K160981 | Current Submission |
| Intended Use | | |
| Description | The monitors are intended to be used for monitoring, storing, 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. | 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. |
| | 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.),
anesthetic gas (AG), bispectral index
(BIS), respiration mechanics (RM)
and impedance cardiography (ICG).
BIS is intended for use on adult and | 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.).
The arrhythmia detection and ST Segment |
| | pediatric patients. | analysis are intended for adult patients. |
| ECG monitor
ECG | ICG monitoring is intended for use on
adults only.
The arrhythmia detection and ST
Segment analysis are intended for
adult patients.
The monitors are additionally
intended for use during patient
transport inside hospitals.
3-Lead; 5-Lead; 12-lead
ST segment analysis
Pace detection
Heart Rate(HR)
Arrhythmia Analysis | The monitors are not intended for MRI
environments.
3-Lead; 5-Lead; 6-Lead ; 12-lead
ST segment analysis
Pace detection
Heart Rate(HR)
Arrhythmia Analysis
QT/QTc Analysis |
| | | |
| RESP monitor
Measurement Range | Adult: 0 to 120 rpm | Same |
| | Pediatric/neonate: 0 rpm to 150rpm | |
| Accuracy | Adult: 6 to 120 rpm: $\pm$ 2 rpm, 0 to 5
rpm: not specified
Pediatric/neonate: 6 to 150 rpm: $\pm$ 2
rpm, 0 to 5 rpm: not specified | Same |
| NIBP monitor | | |
| Measurement Range | Measurement range:
Adult Pediatric Neonate | Measurement range:
Adult Pediatric Neonate |
| | Systolic 40-270
40-200
40-135 | Systolic 25-290
25-240
25-140 |
| | Diastolic 10-215
10-150
10-100 | Diastolic 10-250
10-200
10-115 |
| | Mean 20-235
20-165
20-110 | Mean 15-260
15-215
15-125 |
| Accuracy | Maximum average error: ±5mmHg
Maximum standard deviation:
8mmHg | Same |
| Measuring interval in AUTO
Mode | 1/2/3/4/5/10/15/30/60/90/120/240/480
mins | 1/2/3/4/5/10/15/30/60/90/120/180/240/360/480
and User Define |
| PR from NIBP | | |
| Measurement range | 40 to 240 bpm | Same |
| Accuracy | ±3 bpm or ±3.5%, whichever is
greater | Same |
| SpO2 monitor | | |
| Measurement Range | SpO2 0-100%
Pulse Rate 25 to 300 bpm | Same |
| Accuracy | Saturation
Adult/pediatric, non-motion
conditions
70 to 100% ±2 %
0-69% unspecified
Neonate
70 to 100% ±3%
0-69% unspecified
Pulse Rate
Adult and Neonate
±2bpm (non-motion conditions) | Same |
| Temperature monitor | | |
| Measurement Range | 0 to 50°C | Same |
| Accuracy | ±0.1°C(excluding the sensor) | Same |
| IBP monitor | | |
| Accuracy | $\pm$ 2% or $\pm$ 1 mmHg, whichever is
larger | Same |
| C.O. Monitor | | |
| Measurement range | C.O.: 0.1 to 20L/min
TB: 23 to 43°C
TI: -1 to 27°C | Same |
| Accuracy | C.O.: $\pm$ 5% or $\pm$ 0.2L/min, which is
greater
TB,TI: $\pm$ 0.1°C(without sensor) | Same |
| CO2 Monitor | | |
| Measuring Range | 0 mmHg to 150 mmHg (0 % to 20%)
AwRR: 2 rpm to 150 rpm | Same |
| Sample Gas Flowrate | 70 ml/min or 100 ml/min (default),
accuracy: $\pm$ 15 ml/min | Same |
| Accuracy | $\pm$ 2 mmHg, 0 mmHg to 40 mmHg
$\pm$ 5% of reading, 41 mmHg to 70
mmHg
$\pm$ 8% of reading, 71 mmHg to 100
mmHg
$\pm$ 10% of reading, 101 mmHg to 150
mmHg
$\pm$ 12% or $\pm$ 4 mmHg of reading,
whichever is greater | Same |
| Clinical scores | / | MEWS,NEWS |
| Safety Classifications | | |
| Type of protection against
electric shock | Class I | Same |
| The degree of RF | Group 1, Class A | Same |
| Anti-electroshock degree | ECG, RESP, TEMP, IBP, C.O.
CF
NIBP, SpO2, CO2,AG
BF | ECG, RESP, NIBP, SpO2,TEMP, IBP,
C.O. ,CO2
CF |
| Wireless connection | 2.4GHz Module | 2.4GHz and 5G Module |
5
6
7
8
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)
X Series Patient Monitors were assessed for conformity with the relevant requirements of the following standards and found to comply:
- ANSI/AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012 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 the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards.
- IEC 60601-1-8:2006 + Am1:2012 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 80601-2-30:2013 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 60601-2-49:2011 Medical electrical equipment –Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
- ISO 80601-2-55: 2011 Medical electrical equipment - part 2-55: particular requirements for the basic safety and essential performance of respiratory gas monitors
- ISO 80601-2-56: 2009 Medical electrical equipment - part 2-56: particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
9
- ISO 80601-2-61: 2011 Medical electrical equipment - part 2-61: particular requirements for basic safety and essential performance of pulse oximeter equipment
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 FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Clinical data: Not applicable.
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 X series Patient Monitor are substantially equivalent to the predicate device.