Patient Monitor: RespArray
Device Facts
| Record ID | K220308 |
|---|---|
| Device Name | Patient Monitor: RespArray |
| Applicant | Edan Instruments, Inc. |
| Product Code | MHX · Cardiovascular |
| Decision Date | Aug 11, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1025 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended 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 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.
Device Story
RespArray is a multi-parameter patient monitor for continuous monitoring of ECG, respiration, temperature, SpO2, pulse rate, NIBP, and CO2. It processes physiological signals to display real-time data, store measurements, and generate alarms for abnormal conditions. Used in hospital environments by trained healthcare professionals. Includes integrated pulmonary index (IPI), apnea per hour (A/hr), and oxygen desaturation index (ODI) calculations. Clinicians use the visual and audible alarms to guide timely clinical interventions. Benefits include continuous patient surveillance and early detection of physiological deterioration.
Clinical Evidence
No clinical data. Substantial equivalence is supported by bench testing, including functional and system-level performance testing, electrical safety (ANSI/AAMI ES 60601-1), electromagnetic compatibility (IEC 60601-1-2), and software verification and validation.
Technological Characteristics
Class II multi-parameter monitor. Parameters: ECG (3/5 lead), RESP (thoracic impedance), TEMP, SpO2 (Nellcor), NIBP (oscillation), CO2 (Microstream). Connectivity: Wi-Fi. Power: AC and rechargeable battery. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-27, IEC 80601-2-30, ISO 80601-2-55, ISO 80601-2-56, ISO 80601-2-61.
Indications for Use
Indicated for monitoring, storing, and alarming physiological parameters (ECG, RESP, TEMP, SpO2, PR, NIBP, CO2) in adult, pediatric, and neonatal patients in hospital environments by trained healthcare professionals. Arrhythmia/ST analysis for adults only. IPI for patients >1 year; A/hr and ODI for patients >=22 years.
Regulatory Classification
Identification
The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.
Special Controls
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
Predicate Devices
- Patient Monitor Model X8, X10, X12 (K192514)
Reference Devices
- Nellcor Portable SpO2 Patient Monitoring System (K141542)
- Capnostream™ 35 Portable Respiratory Monitor (K200594)
- ePM Series Patient Monitors (K200015)
- IntelliVue Patient Monitors MX750 and MX850 (K210906)
- Patient Monitor, Model: iM50, iM60, iM70, iM80 (K202336)
Related Devices
- K240320 — Patient Monitor (RespArray) · Edan Instruments, Inc. · Jun 28, 2024
- K031124 — POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR · Datex-Ohmeda, Inc. · Dec 4, 2003
- K200015 — ePM Series Patient monitors · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 8, 2020
- K062095 — MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 · Spacelabs Medical, Inc. · Sep 29, 2006
- K113183 — PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500 · Shanghai 3f Electronics Co, Ltd. · Feb 9, 2012
Submission Summary (Full Text)
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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
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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,
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
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# 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) | |
|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| <div> <span> <b> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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# 510(k) Summary
# Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92
| <b>1. Submitter:</b> | Edan Instruments, Inc.<br>#15 Jinhui Road, Jinsha Community,<br>Kengzi Sub-District, Pingshan District,<br>Shenzhen, 518122 P.R.China.<br>Tel: +86(0755) 84513592 |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Contact person:</b> | Joan Wei |
| <b>Preparing date:</b> | August 10, 2022 |
| <b>2. Device name and classification:</b> | 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 |
| <b>3. Predicate Device(s):</b> | 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. |
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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),
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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 Device<br>RespArray | Predicate Device<br>X8 X10 X12 | Comparison<br>Result |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Manufacture<br>r/K# | Current Submission | Edan Instrument, Inc. - K192514 | — |
| Indications for Use | | | |
| Description | The RespArray™ patient monitor is<br>intended to be used for monitoring,<br>storing, reviewing of, and to generate<br>alarms for, multiple physiological<br>parameters of adults, pediatrics and<br>neonates. The monitors are intended for<br>use by trained healthcare professionals<br>in hospital environments.<br>The monitor is for prescription use only.<br>The monitored physiological parameters<br>include: ECG, respiration (RESP),<br>temperature (TEMP), oxygen saturation<br>of arterial blood (SpO2), pulse rate (PR),<br>non-invasive blood pressure (NIBP),<br>and carbon dioxide (CO2).<br>The arrhythmia detection and ST<br>Segment analysis are intended for adult<br>patients.<br>The SpO2 (Nellcor™) module is<br>intended to be used for spot-check or<br>continuous non-invasive monitoring of<br>functional oxygen saturation of arterial | The monitors are intended to be used<br>for monitoring, storing, recording and<br>reviewing of, and to generate alarms<br>for, multiple physiological parameters<br>of adults, pediatrics and neonates. The<br>monitors are intended for use by<br>trained healthcare professionals in<br>hospital environments.<br>The monitored physiological<br>parameters include: ECG, respiration<br>(RESP), temperature (TEMP), oxygen<br>saturation of arterial blood (SpO2),<br>pulse rate (PR), non-invasive blood<br>pressure (NIBP), invasive blood<br>pressure (IBP), carbon dioxide (CO2),<br>cardiac output (C.O.).<br>The arrhythmia detection and ST<br>Segment analysis are intended for adult<br>patients.<br>The monitors are not intended for MRI<br>environments. | Similiar |
| | hemoglobin (SpO2) and pulse rate (PR),<br>in motion and no motion conditions, and<br>in patients who are well or poorly<br>perfused. | | |
| | The MicrostreamTM capnography<br>module is intended for continuous<br>non-invasive monitoring of carbon<br>dioxide concentration of the expired and<br>inspired breath (etCO2) and respiration<br>rate (RR). | | |
| | The monitor also provides the clinician<br>with integrated pulmonary index (IPI),<br>apnea per hour (A/hr) and oxygen<br>desaturation index (ODI) values. IPI is<br>not intended for patients up to the age of<br>one year. A/hr and ODI are intended for<br>age 22 and up. | | |
| | The monitors are not intended for MRI<br>environments. | | |
| ECG monitor | | | |
| Lead Mode | 3 Electrodes; 5 Electrodes; | 3 Electrodes; 5 Electrodes; <b>6 Electrodes</b> ;<br><b>10 Electrodes</b> ; | Different |
| Arrhythmia<br>Analysis | ASYSTOLE, VFIB/VTAC, COUPLET,<br>VT > 2, BIGEMINY, TRIGEMINY,<br>VENT, R on T, PVC, TACHY, BRADY,<br>MISSED BEATS, IRR, VBRADY,<br>PNC, PNP | ASYSTOLE, VFIB/VTAC, COUPLET,<br>VT > 2, BIGEMINY, TRIGEMINY,<br>VENT, R on T, PVC, TACHY, BRADY,<br>MISSED BEATS, IRR, VBRADY, PNC,<br>PNP | Same |
| RESP monitor from ECG | | | |
| Principle of<br>Operation | Thoracic impedance | Thoracic impedance | Same |
| Measurement<br>Range | 0 rpm to 200 rpm | Adult: 0 to 120 rpm<br>Pediatric/neonate: 0 rpm to 150rpm | Different |
| NIBP monitor | | | |
| | | | |
| Principle of<br>Operation | oscillation | oscillation | Same |
| Measurement<br>Range | 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 10-115<br>Mean 15-260 15-215 15-125 | Diastolic 10-250 10-200 10-115<br>Mean 15-260 15-215 15-125 | |
| | | PR from NIBP | |
| Measurement<br>range | 40 bpm to 240 bpm | 40 to 240 bpm | Same |
| | | Temperature monitor | |
| Measurement<br>Range | 0 °C to 50 °C (32 °F to 122 °F) | 0 °C to 50 °C (32 °F to 122 °F) | Same |
| | | Wireless | |
| Wireless<br>connection | Wi-Fi | Wi-Fi | Same |
| | | Power supply | |
| AC power | Yes | Yes | Same |
| Rechargeable<br>Battery | Yes | Yes | Same |
| | | CO2 Monitor | |
| Module | MicrostreamTM micorMediCO2 EtCO2 | / | It is substantial<br>equivalent to<br>the<br>CO2 Module<br>cleared by<br>K200594 |
| | | | |
| | | | |
| | | SpO2 monitor | |
| Module | Nell-1 | / | It is substantial<br>equivalent to<br>the<br>SpO2 Module<br>cleared by<br>K141542 |
| | | | |
| |…
