(190 days)
No
The summary does not mention AI, ML, or related terms, and the device description focuses on standard physiological monitoring functions.
No
The device is described as a "patient monitor" used for "monitoring, storing, of, and to generate alarms for, multiple physiological parameters," not for treating a condition.
No
This device is described as a "patient monitor" which monitors and stores physiological parameters and generates alarms. While monitoring and detecting abnormalities are components of diagnosis, the primary function described is monitoring and alarming, rather than providing a medical diagnosis. The device description explicitly states it is for "monitoring," "storing," "displaying," "analyzing," and "controlling measurements," and it "will indicate alarms in case of abnormity." It does not state that it is used to diagnose a medical condition.
No
The device description explicitly states it is a "patient monitor" and lists multiple physiological parameters it monitors (ECG, respiration, temperature, SpO2, etc.). These parameters are typically measured by hardware sensors and components integrated into a physical device, not solely through software. The performance studies also mention electrical safety, EMC, and bench testing, which are indicative of a hardware device.
Based on the provided information, the RespArray™ patient monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body (in vitro).
- RespArray Function: The RespArray monitor directly measures physiological parameters from the patient's body (in vivo). It uses sensors and modules attached to the patient to monitor things like ECG, respiration, temperature, SpO2, NIBP, and CO2.
The device description and intended use clearly indicate that it is a patient monitor for real-time, non-invasive monitoring of vital signs directly from the patient, not for analyzing samples in a lab setting.
N/A
Intended Use / Indications for Use
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. A/hr and ODI are intended for ages 22 and up.
The monitors are not intended for MRI environments.
Product codes (comma separated list FDA assigned to the subject device)
MHX, DRT, DXN, DSK, FLL, DQA, CCK, MLD, DSI, DSB
Device Description
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.
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.
IPI is not intended for patients up to the age of one year. A/hr and ODI are intended for ages 22 and up.
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)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K141542, K200594, K200015, K210906, K202336
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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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
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) |
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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 Device
RespArray | Predicate Device
X8 X10 X12 | Comparison
Result |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Manufacture
r/K# | Current Submission | Edan Instrument, Inc. - K192514 | — |
| Indications for Use | | | |
| Description | 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 (Nellcor™) module is
intended to be used for spot-check or
continuous non-invasive monitoring of
functional oxygen saturation of arterial | 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. | Similiar |
| | 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),
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
age 22 and up. | | |
| | The monitors are not intended for MRI
environments. | | |
| ECG monitor | | | |
| Lead Mode | 3 Electrodes; 5 Electrodes; | 3 Electrodes; 5 Electrodes; 6 Electrodes ;
10 Electrodes ; | Different |
| Arrhythmia
Analysis | 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 of
Operation | Thoracic impedance | Thoracic impedance | Same |
| Measurement
Range | 0 rpm to 200 rpm | Adult: 0 to 120 rpm
Pediatric/neonate: 0 rpm to 150rpm | Different |
| NIBP monitor | | | |
| | | | |
| Principle of
Operation | oscillation | oscillation | Same |
| Measurement
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
Mean 15-260 15-215 15-125 | Diastolic 10-250 10-200 10-115
Mean 15-260 15-215 15-125 | |
| | | PR from NIBP | |
| Measurement
range | 40 bpm to 240 bpm | 40 to 240 bpm | Same |
| | | Temperature monitor | |
| Measurement
Range | 0 °C to 50 °C (32 °F to 122 °F) | 0 °C to 50 °C (32 °F to 122 °F) | Same |
| | | Wireless | |
| Wireless
connection | Wi-Fi | Wi-Fi | Same |
| | | Power supply | |
| AC power | Yes | Yes | Same |
| Rechargeable
Battery | Yes | Yes | Same |
| | | CO2 Monitor | |
| Module | MicrostreamTM micorMediCO2 EtCO2 | / | It is substantial
equivalent to
the
CO2 Module
cleared by
K200594 |
| | | | |
| | | | |
| | | SpO2 monitor | |
| Module | Nell-1 | / | It is substantial
equivalent to
the
SpO2 Module
cleared by
K141542 |
| | | | |
| | | | |
| | | | |
| | | | |
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.