(203 days)
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.
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.
The provided text is a 510(k) Premarket Notification summary for the Edan Instruments, Inc. Patient Monitor (Models X8, X10, X12). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study of an AI algorithm's performance.
Therefore, the information required to answer the prompt (acceptance criteria, study details for an AI algorithm, expert ground truth, MRMC study, standalone performance, training set details) is not present in the provided document. The document describes a traditional medical device (patient monitor) and its compliance with general safety and performance standards.
Here's a breakdown of why the requested information cannot be extracted from the given text:
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Table of acceptance criteria and reported device performance: The document lists various physiological parameters (ECG, RESP, NIBP, SpO2, Temp, IBP, CO2, C.O.) and their measurement ranges and accuracies, comparing them to a predicate device. These are performance specifications, not "acceptance criteria" in the context of an AI algorithm's performance study. There's no specific numerical performance target for an AI algorithm provided.
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Sample size used for the test set and the data provenance: Not applicable. The document refers to "bench testing" and "software verification and validation testing," which are not described as using specific test sets of patient data for AI algorithm evaluation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment by experts is relevant for AI algorithm studies, which are not detailed here.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This pertains to expert review in AI studies, which is not described.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. No MRMC study is mentioned. This device is a patient monitor, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No standalone algorithm performance is described. The device's "arrhythmia detection and ST Segment analysis" are features of the patient monitor, not explicitly a separate AI algorithm being evaluated for standalone performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for the device's measurements (e.g., blood pressure accuracy) would be derived from calibrated reference instruments, not expert consensus or pathology in the context of an AI algorithm.
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The sample size for the training set: Not applicable. There is no mention of a training set for an AI algorithm.
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How the ground truth for the training set was established: Not applicable. There is no mention of a training set for an AI algorithm.
In summary, the provided FDA 510(k) summary for the Edan Instruments, Inc. Patient Monitor focuses on establishing substantial equivalence to existing predicate devices based on design features, performance specifications (e.g., accuracy of physiological measurements), and compliance with electrical safety and EMC standards. It does not describe a study involving an AI algorithm that would require the detailed information requested in the prompt.
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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
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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
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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)
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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) |
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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 physiologicalparameters include: ECG, respiration(RESP), temperature (TEMP),oxygen saturation of arterial blood(SpO2), pulse rate (PR), non-invasiveblood pressure (NIBP), invasiveblood 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 parametersinclude: ECG, respiration (RESP), temperature(TEMP), oxygen saturation of arterial blood(SpO2), pulse rate (PR), non-invasive bloodpressure (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 monitorECG | ICG monitoring is intended for use onadults only.The arrhythmia detection and STSegment analysis are intended foradult patients.The monitors are additionallyintended for use during patienttransport inside hospitals.3-Lead; 5-Lead; 12-leadST segment analysisPace detectionHeart Rate(HR)Arrhythmia Analysis | The monitors are not intended for MRIenvironments.3-Lead; 5-Lead; 6-Lead ; 12-leadST segment analysisPace detectionHeart Rate(HR)Arrhythmia AnalysisQT/QTc Analysis |
| RESP monitorMeasurement Range | Adult: 0 to 120 rpm | Same |
| Pediatric/neonate: 0 rpm to 150rpm | ||
| Accuracy | Adult: 6 to 120 rpm: $\pm$ 2 rpm, 0 to 5rpm: not specifiedPediatric/neonate: 6 to 150 rpm: $\pm$ 2rpm, 0 to 5 rpm: not specified | Same |
| NIBP monitor | ||
| Measurement Range | Measurement range:Adult Pediatric Neonate | Measurement range:Adult Pediatric Neonate |
| Systolic 40-27040-20040-135 | Systolic 25-29025-24025-140 | |
| Diastolic 10-21510-15010-100 | Diastolic 10-25010-20010-115 | |
| Mean 20-23520-16520-110 | Mean 15-26015-21515-125 | |
| Accuracy | Maximum average error: ±5mmHgMaximum standard deviation:8mmHg | Same |
| Measuring interval in AUTOMode | 1/2/3/4/5/10/15/30/60/90/120/240/480mins | 1/2/3/4/5/10/15/30/60/90/120/180/240/360/480and User Define |
| PR from NIBP | ||
| Measurement range | 40 to 240 bpm | Same |
| Accuracy | ±3 bpm or ±3.5%, whichever isgreater | Same |
| SpO2 monitor | ||
| Measurement Range | SpO2 0-100%Pulse Rate 25 to 300 bpm | Same |
| Accuracy | SaturationAdult/pediatric, non-motionconditions70 to 100% ±2 %0-69% unspecifiedNeonate70 to 100% ±3%0-69% unspecifiedPulse RateAdult 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 islarger | Same |
| C.O. Monitor | ||
| Measurement range | C.O.: 0.1 to 20L/minTB: 23 to 43°CTI: -1 to 27°C | Same |
| Accuracy | C.O.: $\pm$ 5% or $\pm$ 0.2L/min, which isgreaterTB,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 70mmHg$\pm$ 8% of reading, 71 mmHg to 100mmHg$\pm$ 10% of reading, 101 mmHg to 150mmHg$\pm$ 12% or $\pm$ 4 mmHg of reading,whichever is greater | Same |
| Clinical scores | / | MEWS,NEWS |
| Safety Classifications | ||
| Type of protection againstelectric shock | Class I | Same |
| The degree of RF | Group 1, Class A | Same |
| Anti-electroshock degree | ECG, RESP, TEMP, IBP, C.O.CFNIBP, SpO2, CO2,AGBF | ECG, RESP, NIBP, SpO2,TEMP, IBP,C.O. ,CO2CF |
| Wireless connection | 2.4GHz Module | 2.4GHz and 5G Module |
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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
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- 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.
§ 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.