(147 days)
No
The summary does not mention AI, ML, or related terms, and the device description focuses on standard physiological monitoring and analysis techniques.
No
The device is a patient monitor, indicated for monitoring, storing, reviewing, and alarming for physiological parameters, not for providing therapy or treatment.
Yes
Explanation: The device is described as "monitoring, storing, reviewing of, and to generate alarms for, multiple physiological parameters" and "capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity". This collection and analysis of physiological data to identify abnormalities falls under the definition of diagnostic purposes, even if it doesn't provide a definitive diagnosis on its own.
No
The device description explicitly states it is a "patient monitor" capable of continuous monitoring of multiple physiological parameters, storing, displaying, analyzing, and controlling measurements, and indicating alarms. This functionality inherently requires hardware components to acquire the physiological data (e.g., ECG leads, SpO2 sensors, NIBP cuffs, CO2 modules). The summary also mentions specific hardware modules like the "SpO2 (Nellcor™) module" and "Microstream™ capnography module." While software is a critical part of the device, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- Device Function: The RespArray patient monitor is described as a device that performs "long-time continuous monitoring of multiple physiological parameters." These parameters (ECG, respiration, temperature, SpO2, pulse rate, NIBP, CO2) are measured directly from the patient's body using sensors and probes.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens or samples taken from the patient.
Therefore, the RespArray patient monitor falls under the category of a patient monitoring device, which is distinct from an in vitro diagnostic device.
N/A
Intended Use / Indications 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 (Nellcor™) 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 Microstream™ 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
MHX, DSI, MLD, DRT, DXN, DSK, FLL, DQA, CCK, 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)
The Resparray Patient Monitors were assessed for conformity with the relevant requirements of the following standards and found to comply:
- ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
- ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] 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 results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards.
- IEC 60601-1-8:2020 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 60601-2-27:2011 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 60601-2-49:2018 Medical electrical equipment –Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
- ISO 80601-2-55:2018 Medical electrical equipment - part 2-55: particular requirements for the basic safety and essential performance of respiratory gas monitors
- ISO 80601-2-56:2017+A1:2018 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
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 Food and Drug Administration Staff, "Content of Premarket Submissions for Device Software Functions".
Clinical data: Not applicable.
Summary
The non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 28, 2024
Edan Instruments, Inc Tracy Yue Regulatory Affairs Engineer 15 Jinhui Road, Jinsha Community, Kengzi Sub-district, Pingshan District, Shenzhen, Guangdong 518122 China
Re: K240320
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, DSI, MLD, DRT, DXN, DSK, FLL, DQA, CCK, DSB Dated: February 2, 2024 Received: May 24, 2024
Dear Tracy Yue:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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.
Kimberly N. Crowley -S
For: Jennifer Shih Kozen Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices
2
OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Patient Monitor (RespArray)
Indications for Use (Describe)
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 hemoglobin (SpO2) and pulse rate (PR), in motion and no motion conditions, and in patients who are well or poorly perfused.
The Microstream™ 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.
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."
4
510(K) Summary
Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92
1. Submitter:
| Applicant: | Edan Instruments, Inc.
#15 Jinhui Road, Jinsha Community,
Kengzi Sub-District, Pingshan District,
Shenzhen, 518122 P.R.China.
Tel: +86(0755) 26858736
Fax: +86(0755) 26882223 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Tracy Yue |
| Contact person: | Tracy Yue |
|---|---|
| Preparing date: | February 02, 2024 |
2. Device name and classification:
| Trade name: | Patient Monitor, Model: RespArray | |||
|---|---|---|---|---|
| Common/Usual Name: | Patient Monitor | |||
| Classification Name: | 21 CFR 870.1025 | |||
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | ||||
| Regulatory class: | Class II | |||
| Primary product code: | MHX-Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms) | |||
| Subsequent product | ||||
| code: | Regulation number/Device | Product Code | ||
| Regulation number/Device | Product Code |
|---|---|
| 21 CFR 870.2340 | |
| Detector and Alarm, Arrhythmia | DSI |
| 21 CFR 870.1025 | |
| Monitor, ST Segment with Alarm | MLD |
| 21 CFR 870.2300 | |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT |
| 21 CFR 870.1130 | |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN |
| 21 CFR 870.1110 | |
| Computer, Blood-Pressure | DSK |
| 21 CFR 880.2910 | |
| Thermometer, Electronic, Clinical | FLL |
| 21 CFR 870.2700 | |
| Oximeter | DQA |
| 21 CFR 870.1400 | |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK |
5
Traditional 510(k) of RespArray Patient Monitor
| 21 CFR 870.2770 | DSB |
|---|---|
| Impedance plethysmograph |
- Predicate Device(s): 1) Edan Instruments, Inc., Patient Monitor, Model: RespArray, K220308 (Primary predicate device)
-
- Edan Instruments, Inc., Vital Signs Monitor, Model: iM3s, iM3As, iM3Bs, iHM3s K202892 (Reference device)
-
- Covidien LLC., MicrostreamTM CO2 NanoPod, K213911 (Reference device)
The RespArray patient monitor (hereinafter called RespArray) can perform long-time 4. Device Description: 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 RespArray™ patient monitor is intended to be used for monitoring, storing, reviewing 5. Indication for Use 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 hemoglobin (SpO2) and pulse rate (PR), in motion and no motion conditions, and in patients who are well or poorly perfused.
The Microstream™ capnography module is intended for continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath and carbon dioxide concentration of the exhaled breath and inspired (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.
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 RespArray, K220308).
6
| Item |
RespArray |
RespArray | Comparison
Result |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacture
r/K# | Current Submission | Edan Instrument.Inc/K220308 | — |
| 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 (Nellcor™) 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 | 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
hemoglobin (SpO2) and pulse rate | Same |
| | (PR), in motion and no motion
conditions, and in patients who are
well or poorly perfused.
The Microstream™ capnography
module is intended for continuous | (PR), in motion and no motion
conditions, and in patients who are
well or poorly perfused.
The Microstream™ 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. | 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. | |
| | ECG monitor | | |
| Lead Mode | 3 Electrodes; 5 Electrodes; | 3 Electrodes; 5 Electrodes; | Same |
| 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 | 0 rpm to 200 rpm | Same |
| | NIBP monitor | | |
| Principle of Operation | oscillation | oscillation | Same |
| Measurement Range | Measurement range:
Adult Pediatric Neonate
Systolic 25-290 25-240 25-140
Diastolic 10-250 10-200 10-115
Mean 15-260 15-215 15-125 | Measurement range:
Adult Pediatric Neonate
Systolic 25-290 25-240 25-140
Diastolic 10-250 10-200 10-115
Mean 15-260 15-215 15-125 | Same |
| PR from NIBP | | | |
| Measurement range | 40 bpm to 240 bpm | Same | |
| Continuous TEMP | | | |
| Measurement Range | 0 °C to 50 °C (32 °F to 122 °F) | Same | |
| SpO2 monitor | | | |
| Module | Nell-1 | Same | |
| Spot Temp | | | |
| Measuring Range | 16 °C ~ 43 °C (61 °F ~ 110 °F) | The added spot temp is substantial equivalent to the Spot Temp Module cleared in K202892 | |
| Power supply | | | |
| AC power | 100 V to 240 V~
50 Hz/60 Hz | Same | |
| Rechargeable Battery | Yes | Same | |
| Battery Capacity | 6800 mAh | The battery comply with IEC 62133-2. | |
| CO2 Monitor | | | |
| Module | Microstream™ NanoMediCO2 EtCO2 | The changed CO2 module is substantial equivalent to the CO2 module cleared in | |
7
8
As seen in the comparison tables, the subject and predicate devices have similar design features and performance specifications. The technological differences between the subject and predicate devices do not raise different questions of safety or effectiveness.
7. Performance Data:
Non-clinical data:
Electrical safety and electromagnetic compatibility (EMC)
The Resparray Patient Monitors were assessed for conformity with the relevant requirements of the following 510(k)_Summary 5 / 7
9
standards and found to comply:
- ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
- ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] 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 results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards.
- IEC 60601-1-8:2020 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 60601-2-27:2011 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 60601-2-49:2018 Medical electrical equipment –Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
- ISO 80601-2-55:2018 Medical electrical equipment - part 2-55: particular requirements for the basic safety and essential performance of respiratory gas monitors
- ISO 80601-2-56:2017+A1:2018 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
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 Food and Drug Administration Staff, "Content of Premarket Submissions for Device Software Functions".
Clinical data: Not applicable.
Summary
510(k)_Summary
10
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 RespArray Patient Monitor is substantially equivalent to the predicate device.