(190 days)
The RespArray™ patient monitor is intended to be used for monitoring, storing, 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 monitor is for prescription use only.
The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), and carbon dioxide (CO2).
The arrhythmia detection and ST Segment analysis are intended for adult patients.
The SpO2 (NellcorTM) module is intended to be used for spot-check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR), in motion conditions, and in patients who are well or poorly perfused.
The MicrostreamTM capnography module is intended for continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath (etCO2) and respiration rate (RR).
The monitor also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is not intended for patients up to the age of one year. Allr and ODI are intended for ages 22 and up.
The monitors are not intended for MRI environments.
The RespArray patient monitor (hereinafter called RespArray) 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 "Patient Monitor: RespArray" device. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical trials for de novo clearance or PMA approval. Therefore, the details requested about acceptance criteria, specific study design (like MRMC studies, sample sizes, expert ground truth establishment for AI/algorithm performance), and training set information are not typically found in these types of submissions, as the FDA review here centers on comparing the new device's specifications and performance to an existing, already cleared device.
The document primarily highlights the device's technical specifications and how they compare to a predicate device (Edan Instruments, Inc, Patient Monitor Model X8, X10, X12 - K192514), along with compliance with relevant electrical safety, EMC, and performance standards. It explicitly states "Clinical data: Not applicable."
Given this, I will extract the information that is present in the document and indicate where the requested information is not applicable or not provided within the scope of a 510(k) submission focused on substantial equivalence.
Analysis of the Provided Document for Device Acceptance Criteria and Study Proof
The provided document is a 510(k) premarket notification. For devices cleared via a 510(k), the primary "acceptance criterion" is often substantial equivalence to a legally marketed predicate device, demonstrated through comparative testing and adherence to recognized standards. Direct, explicit "acceptance criteria" presented as quantitative performance targets with a detailed study to prove they are met (as might be seen in AI/ML clearances for algorithms with novel functionalities) are typically not included in this type of submission for a patient monitor.
The "study" that proves the device meets the acceptance criteria is primarily non-clinical performance testing (bench testing) and software verification/validation to show that the device performs as intended and is as safe and effective as its predicate.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria/performance targets with quantitative results in the way one might expect for a new AI/ML algorithm. Instead, it demonstrates performance by stating compliance with recognized consensus standards and by comparing the subject device's specifications to those of its predicate device, showing "similar design features and performance specifications."
The closest representation of "performance" and "acceptance" is the "Predicate Device Comparison" table (pages 5-6). This table implicitly acts as the performance comparison against the predicate device that serves as the "acceptance" benchmark for substantial equivalence.
| Item | Subject Device: RespArray (Reported Device Performance) | Predicate Device: X8 X10 X12 (Implicit Acceptance Criterion/Benchmark) | Comparison Result |
|---|---|---|---|
| Indications for Use | Monitoring, storing, reviewing of, and to generate alarms for multiple physiological parameters (ECG, RESP, TEMP, SpO2, PR, NIBP, CO2) for adults, pediatrics, and neonates in hospital environments. Arrhythmia detection and ST Segment analysis for adult patients. SpO2 for spot-check/continuous monitoring in motion/no motion. Microstream™ capnography for etCO2 and RR. Provides IPI, A/hr, ODI values. Not for MRI. | Very similar, also monitoring, storing, recording, reviewing of, and to generate alarms for multiple physiological parameters (ECG, RESP, TEMP, SpO2, PR, NIBP, invasive blood pressure (IBP), CO2, cardiac output (C.O.)) for adults, pediatrics, neonates in hospital environments. Arrhythmia detection and ST Segment analysis for adult patients. Not for MRI. | Similar (Slight differences, e.g., predicate includes IBP and C.O. vs. subject's more detailed SpO2/CO2 module descriptions and IPI/A/hr/ODI. However, overall intention described as "Similar") |
| ECG Monitor Lead Mode | 3 Electrodes; 5 Electrodes; | 3 Electrodes; 5 Electrodes; 6 Electrodes ; 10 Electrodes ; | Different (Subject supports fewer lead modes) |
| Arrhythmia Analysis | ASYSTOLE, VFIB/VTAC, COUPLET, VT > 2, BIGEMINY, TRIGEMINY, VENT, R on T, PVC, TACHY, BRADY, MISSED BEATS, IRR, VBRADY, PNC, PNP | Same list of arrhythmia types. | Same |
| RESP Monitor Principle | Thoracic impedance | Thoracic impedance | Same |
| RESP Measurement Range | 0 rpm to 200 rpm | Adult: 0 to 120 rpm; Pediatric/neonate: 0 rpm to 150rpm | Different (Subject has a wider stated range, but the intent is likely overall comparable) |
| NIBP Principle | oscillation | oscillation | Same |
| NIBP Measurement Range | Systolic: Adult 25-290, Pediatric 25-240, Neonate 25-140; Diastolic: Adult 10-250, Pediatric 10-200, Neonate 10-115; Mean: Adult 15-260, Pediatric 15-215, Neonate 15-125 | Same ranges. | Same |
| PR from NIBP Range | 40 bpm to 240 bpm | 40 to 240 bpm | Same |
| Temperature Range | 0 °C to 50 °C (32 °F to 122 °F) | 0 °C to 50 °C (32 °F to 122 °F) | Same |
| Wireless Connection | Wi-Fi | Wi-Fi | Same |
| Power Supply | AC power: Yes; Rechargeable Battery: Yes | AC power: Yes; Rechargeable Battery: Yes | Same |
| CO2 Module | Microstream™ micorMediCO2 EtCO2 (Substantially equivalent to module cleared by K200594) | / (Predicate doesn't specify module, but supports CO2 monitoring) | It is substantial equivalent to the CO2 Module cleared by K200594 |
| SpO2 Module | Nell-1 (Substantially equivalent to module cleared by K141542) | / (Predicate doesn't specify module, but supports SpO2 monitoring) | It is substantial equivalent to the SpO2 Module cleared by K141542 |
The document concludes that "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."
2. Sample size used for the test set and the data provenance
The document states "Clinical data: Not applicable." Therefore, there isn't a "test set" in the sense of patient data used for clinical validation of, for example, an AI algorithm's performance. The "testing" primarily refers to non-clinical bench testing.
- Sample size: Not applicable for patient data test set. For bench testing, samples would be physical devices, components, or simulated signals, but a "sample size" in terms of patient numbers is not provided.
- Data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as no clinical data test set was used/provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Since no clinical data test set was described and "Clinical data: Not applicable" is stated, there was no need for expert ground truth establishment for a test set. This type of information would be relevant for AI/ML device clearances where human expert annotation is part of the ground truth creation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication of ground truth was described.
5. 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
No. The document explicitly states "Clinical data: Not applicable." MRMC studies are typically for evaluating the impact of AI algorithms on human reader performance, which is not the scope of this 510(k) submission for a patient monitor.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a patient monitor with various physiological parameter measurements and alarms. Its "performance" is inherent in its ability to accurately measure these parameters and detect events like arrhythmias. The non-clinical bench testing demonstrated its standalone performance by showing compliance with relevant standards (e.g., IEC 60601-2-27 for ECG, IEC 80601-2-30 for NIBP, ISO 80601-2-61 for pulse oximeter).
While not explicitly called "standalone algorithm performance" in the AI/ML sense, the "Performance testing-Bench" section (page 8) confirms that "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." This demonstrates the device's functional performance in isolation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical bench testing, the "ground truth" would be established by:
- Reference instruments or calibrated signals (e.g., precise electrical signals for ECG, known pressure values for NIBP, calibrated gas mixtures for CO2).
- Standardized measurement protocols defined by the cited IEC/ISO standards.
- Accuracy specifications found within those standards or the device's own specifications.
There's no mention of expert consensus, pathology, or outcomes data as "ground truth" because this is a measurement and alarm device, not a diagnostic imaging AI algorithm, and no clinical data was used for validation in this submission.
8. The sample size for the training set
Not applicable. This device is a patient monitor, not an AI/ML algorithm that undergoes a distinct training phase on a dataset. The underlying algorithms for parameter measurement (e.g., NIBP oscillometric algorithm, arrhythmia detection) are established engineering designs, not typically "trained" in the machine learning sense with large datasets.
9. How the ground truth for the training set was established
Not applicable, as there is no specific "training set" for an AI/ML algorithm described. The "ground truth" for the development and calibration of the monitor's measurement algorithms would have been established through engineering principles, laboratory testing with calibrated instruments, and referencing physiological models and data, but this is part of the device's fundamental design and not a separate "training set" as understood in current AI/ML contexts.
{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.
August 11, 2022
Edan Instruments, Inc. Joan Wei Regulatory Engineer #15 Jinhui Road,Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, Guangdong 518122 China
Re: K220308
Trade/Device Name: Patient Monitor: RespArray 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, MLD, DSI, DSB Dated: July 1, 2022 Received: July 11, 2022
Dear Joan. Wei:
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,
Jennifer Shih 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K220308
Device Name Patient Monitor (RespArray)
Indications for Use (Describe)
The RespArray™ patient monitor is intended to be used for monitoring, storing, 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 monitor is for prescription use only.
The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), and carbon dioxide (CO2).
The arrhythmia detection and ST Segment analysis are intended for adult patients.
The SpO2 (NellcorTM) module is intended to be used for spot-check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR), in motion conditions, and in patients who are well or poorly perfused.
The MicrostreamTM capnography module is intended for continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath (etCO2) and respiration rate (RR).
The monitor also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is not intended for patients up to the age of one year. Allr and ODI are intended for ages 22 and up.
The monitors are not intended for MRI environments.
| 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."
{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) 84513592 |
|---|---|
| Contact person: | Joan Wei |
| Preparing date: | August 10, 2022 |
| 2. Device name and classification: | Device Name: Patient Monitor |
| Model: RespArray | |
| 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 X8, X10, X12 - K192514 (Primary) |
| 2) Covidien LP, Nellcor Portable SpO2 Patient Monitoring System - K141542 (Reference) | |
| 3) Capnostream™ 35 Portable Respiratory Monitor - K200594 (Reference) | |
| 4) SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. |
{4}------------------------------------------------
ePM Series Patient Monitors (including ePM 10/ePM 12/ePM 15/ ePM 10M/ePM 12M/ePM 15M monitors) - K200015 (Reference). 5) Philips Medizin Systeme Boeblingen GmbH .IntelliVue Patient Monitors MX750 and MX850 and IntelliVue 4-Slot Module Rack FMX-4 -K210906 (Reference). 6) Edan Instruments, Inc. Patient Monitor, Model: iM50, iM60, iM70, iM80 - K202336 (Reference) The RespArray patient monitor (hereinafter called RespArray) 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 RespArray™ patient monitor is intended to be used for monitoring, storing,
- 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 monitor is for prescription use only.
The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), and carbon dioxide (CO2).
The arrhythmia detection and ST Segment analysis are intended for adult patients.
The SpO2 (NellcorTM) module is intended to be used for spot-check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR), in motion and no motion conditions, and in patients who are well or poorly perfused.
The MicrostreamTM capnography module is intended for continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath (etCO2) and respiration rate (RR).
The monitor also provides the clinician with integrated pulmonary index (IPI),
{5}------------------------------------------------
apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is not intended for patients up to the age of one year. A/hr and ODI are intended for ages 22 and up.
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 X8, X10, X12 - K192514).
| Item | Subject DeviceRespArray | Predicate DeviceX8 X10 X12 | ComparisonResult |
|---|---|---|---|
| Manufacturer/K# | Current Submission | Edan Instrument, Inc. - K192514 | — |
| Indications for Use | |||
| Description | The RespArray™ patient monitor isintended to be used for monitoring,storing, reviewing of, and to generatealarms for, multiple physiologicalparameters of adults, pediatrics andneonates. The monitors are intended foruse by trained healthcare professionalsin hospital environments.The monitor is for prescription use only.The monitored physiological parametersinclude: ECG, respiration (RESP),temperature (TEMP), oxygen saturationof arterial blood (SpO2), pulse rate (PR),non-invasive blood pressure (NIBP),and carbon dioxide (CO2).The arrhythmia detection and STSegment analysis are intended for adultpatients.The SpO2 (Nellcor™) module isintended to be used for spot-check orcontinuous non-invasive monitoring offunctional oxygen saturation of arterial | The monitors are intended to be usedfor monitoring, storing, recording andreviewing of, and to generate alarmsfor, multiple physiological parametersof adults, pediatrics and neonates. Themonitors are intended for use bytrained healthcare professionals inhospital environments.The monitored physiologicalparameters include: ECG, respiration(RESP), temperature (TEMP), oxygensaturation of arterial blood (SpO2),pulse rate (PR), non-invasive bloodpressure (NIBP), invasive bloodpressure (IBP), carbon dioxide (CO2),cardiac output (C.O.).The arrhythmia detection and STSegment analysis are intended for adultpatients.The monitors are not intended for MRIenvironments. | Similiar |
| hemoglobin (SpO2) and pulse rate (PR),in motion and no motion conditions, andin patients who are well or poorlyperfused. | |||
| The MicrostreamTM capnographymodule is intended for continuousnon-invasive monitoring of carbondioxide concentration of the expired andinspired breath (etCO2) and respirationrate (RR). | |||
| The monitor also provides the clinicianwith integrated pulmonary index (IPI),apnea per hour (A/hr) and oxygendesaturation index (ODI) values. IPI isnot intended for patients up to the age ofone year. A/hr and ODI are intended forage 22 and up. | |||
| The monitors are not intended for MRIenvironments. | |||
| ECG monitor | |||
| Lead Mode | 3 Electrodes; 5 Electrodes; | 3 Electrodes; 5 Electrodes; 6 Electrodes ;10 Electrodes ; | Different |
| ArrhythmiaAnalysis | 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 | Same |
| RESP monitor from ECG | |||
| Principle ofOperation | Thoracic impedance | Thoracic impedance | Same |
| MeasurementRange | 0 rpm to 200 rpm | Adult: 0 to 120 rpmPediatric/neonate: 0 rpm to 150rpm | Different |
| NIBP monitor | |||
| Principle ofOperation | oscillation | oscillation | Same |
| MeasurementRange | Measurement range: | Measurement range: | |
| Adult Pediatric Neonate | Adult Pediatric Neonate | ||
| Systolic 25-290 25-240 25-140 | Systolic 25-290 25-240 25-140 | same | |
| Diastolic 10-250 10-200 10-115Mean 15-260 15-215 15-125 | Diastolic 10-250 10-200 10-115Mean 15-260 15-215 15-125 | ||
| PR from NIBP | |||
| Measurementrange | 40 bpm to 240 bpm | 40 to 240 bpm | Same |
| Temperature monitor | |||
| MeasurementRange | 0 °C to 50 °C (32 °F to 122 °F) | 0 °C to 50 °C (32 °F to 122 °F) | Same |
| Wireless | |||
| Wirelessconnection | Wi-Fi | Wi-Fi | Same |
| Power supply | |||
| AC power | Yes | Yes | Same |
| RechargeableBattery | Yes | Yes | Same |
| CO2 Monitor | |||
| Module | MicrostreamTM micorMediCO2 EtCO2 | / | It is substantialequivalent totheCO2 Modulecleared byK200594 |
| SpO2 monitor | |||
| Module | Nell-1 | / | It is substantialequivalent totheSpO2 Modulecleared byK141542 |
{6}------------------------------------------------
{7}------------------------------------------------
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.
{8}------------------------------------------------
7. Performance Data:
Non-clinical data:
Electrical safety and electromagnetic compatibility (EMC)
RespArray 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.
- AIM Standard 7351731:2017 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard
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 60601-1-8:2006 + 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 ?
- 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 60601-2-49:2011 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: 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 EC53:2013/(R)2020 ECG trunk cables and patient leadwires
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by
{9}------------------------------------------------
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 device is substantially equivalent to the predicate device.
8. Conclusion
The bench testing data and software verification and validation demonstrate that Patient Monitor RespArray 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.