(312 days)
The monitor is intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitor is intended for use by trained healthcare professionals in hospital environments.
Monitored parameters include: NIBP, SpO2, PR (pulse rate), Quick TEMP/Infrared TEMP.
The monitor is not intended for MRI environments. TEMP module is not intended for neonates.
The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Quick TEMP/Infrared TEMP (TEMP).
• For the Monitor mode, the user can do continuous measurement, monitoring, alarming and manager patient data.
• For the Spot mode, also call spot check mode, the user can measure parameters quickly without creating a patient within the instrument workflow.
• The Round mode is designed to support hospital staff when doing ward rounds. The Round mode is similar as Spot mode. The difference between Round mode and Spot mode is that for one ward round, the iM3 can additionally store one ward round record automatically (the latest measurement) or manually (user can choose the measure results).
iM3 capabilities include storing, displaying measuring data. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately.
The iM3can connect with EDAN's MFM-CMS Central Monitoring System to display the iM3 data on a remote work station. The MFM-CMS system received FDA 510(k) clearance on June 21, 2013(K120727)
The provided text is a 510(k) summary for the Edan Instruments iM3 Vital Signs Monitor, seeking FDA clearance based on substantial equivalence to predicate devices. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device.
The document does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/ML algorithm being developed or tested against a ground truth for diagnostic or prognostic performance. Instead, it discusses the performance as it relates to comparison with a predicate device and compliance with established medical device standards.
Therefore, many of the requested details related to AI/ML validation studies (like sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment for training/test sets) are not applicable to this document as it describes a traditional vital signs monitor seeking 510(k) clearance, not an AI/ML diagnostic or prognostic device.
However, based on the provided text, I can infer and extract information relevant to the device's functional performance criteria and what was demonstrated:
Acceptance Criteria and Reported Device Performance (Inferred from comparison to predicate and standard compliance):
The "acceptance criteria" here are implicitly defined by the performance specifications of the predicate devices and relevant IEC/ISO standards for vital signs monitors. The reported device performance is presented as being "similar" to the predicate and compliant with these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter / Criterion | Acceptance Criteria (from predicate/standards) | Reported iM3 Device Performance |
|---|---|---|
| NIBP (EDAN Module) | ||
| Principle of Operation | Oscillation | Oscillation |
| Measurement Range (Adult) | Systolic 40 to 270 mmHg, Diastolic 10 to 215 mmHg, Mean 20 to 235 mmHg | Systolic 40 to 270 mmHg, Diastolic 10 to 215 mmHg, Mean 20 to 235 mmHg |
| Measurement Range (Ped.) | Systolic 40 to 200 mmHg, Diastolic 10 to 150 mmHg, Mean 20 to 165 mmHg | Systolic 40 to 230 mmHg, Diastolic 10 to 180 mmHg, Mean 20 to 195 mmHg (Note: iM3 measurements are wider, but still within acceptable ranges as per relevant standards) |
| Measurement Range (Neonate) | Systolic 40 to 135 mmHg, Diastolic 10 to 100 mmHg, Mean 20 to 110 mmHg | Systolic 40 to 135 mmHg, Diastolic 10 to 100 mmHg, Mean 20 to 110 mmHg |
| Accuracy | Maximum average error: ±5 mmHg, Maximum standard deviation: 8 mmHg | Maximum average error: ±5 mmHg, Maximum standard deviation: 8 mmHg |
| SpO2 (EDAN Module) | ||
| Measurement Range (SpO2) | 0-100% | 0-100% |
| Saturation Accuracy | Adult/pediatric, non-motion: 70 to 100% ±2 %. Neonate: 70 to 100% ±3% (0-69% unspecified for both) | Adult/pediatric, non-motion: 70 to 100% ±2 %. Neonate: 70 to 100% ±3% (0-69% unspecified for both) |
| Measurement Range (PR) | 25 to 300 bpm | 25 to 300 bpm |
| Pulse Rate Accuracy | Adult and Neonate: 25 to 300 bpm ±2bpm (non-motion conditions) | Adult and Neonate: 25 to 300 bpm ±2bpm (non-motion conditions) |
| TEMP (EDAN Quick Temp) | ||
| Measurement Range (Monitor) | 25 °C ~45 °C | 25 °C ~45 °C |
| Accuracy (Monitor mode) | ±0.1 °C (25 °C ~ 45 °C) | ±0.1 °C (25 °C ~ 45 °C) |
| Clinical Bias | (-0.2 to -0.4 )°C | (-0.2 to -0.4 )°C |
| Limits of Agreement | 0.49 | 0.49 |
| Electrical Safety | Compliance with: ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-8: 2006, IEC 60601-2-49: 2011, IEC 80601-2-30:2009, ISO 80601-2-56: 2009 and ISO 80601-2-61:2011 standards. | The system complies with specified standards. Coexistence testing was also performed and adheres to FDA guidance on Radio Frequency Wireless Technology in Medical Devices. |
| EMC | Compliance with IEC 60601-1-2: 2014 standard. | The system complies with specified standard. |
| Software | Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | Software verification and validation testing were conducted, and documentation was provided as recommended by FDA guidance. |
2. Sample size used for the test set and the data provenance:
- This document does not specify a "test set" in the context of an AI/ML model, but rather refers to performance validation against established standards.
- The comparison data presented in the tables are physical performance specifications of the device modules, not patient data from a clinical trial in the AI/ML sense. Actual human testing for NIBP, SpO2, and TEMP accuracy would have been done to meet the standards (e.g., ISO 81060-2:2013 for NIBP, ISO 80601-2-61: 2011 for SpO2, ISO 80601-2-56 for TEMP), but the specifics (sample sizes, provenance) are not detailed in this summary. These physical performance tests are typically done in controlled lab settings or with human subjects as required by the specific standard.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable as this is not an AI/ML diagnostic device requiring expert consensus on image interpretation or similar. The "ground truth" for vital signs monitoring validation is typically measured physiological parameters from reference devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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:
- Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device directly measures physiological parameters. Its performance is inherent to its sensors and processing, and the accuracy claims are against reference measurements, not an independent algorithm being evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for the performance claims would be highly accurate reference measurements from precisely calibrated medical devices or established physiological measurement techniques (e.g., intra-arterial blood pressure for NIBP, co-oximetry for SpO2, highly accurate thermometers for TEMP). The document states compliance with relevant ISO/IEC standards which dictate the methods for determining accuracy, including the reference methods.
8. The sample size for the training set:
- Not applicable. This is a vital signs monitor, not a machine learning algorithm that requires a "training set" for its core function.
9. How the ground truth for the training set was established:
- Not applicable.
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December 21, 2018
Edan Instruments, Inc. % Alice Yang Regulatory Engineer Edan Medical 1200 Crossman Ave. Suite 200 Sunnyvale, California 94089
Re: K180380
Trade/Device Name: iM3 vital signs monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MWI, DQA, DXN, FLL Dated: November 21, 2018 Received: November 27, 2018
Dear Alice Yang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stephen C. Browning -S5
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K180380
Device Name iM3 vital signs monitor
Indications for Use (Describe)
The monitor is intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitor is intended for use by trained healthcare professionals in hospital environments.
Monitored parameters include: NIBP, SpO2, PR (pulse rate), Quick TEMP/Infrared TEMP.
The monitor is not intended for MRI environments. TEMP module is not intended for neonates.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92
| 1. Submitter: | Edan Instruments, Inc. |
|---|---|
| #15 Jinhui Road, Jinsha Community, | |
| Kengzi Sub-District, Pingshan District, | |
| Shenzhen, 518122 P.R.China. | |
| Tel: +86(0755) 26858736 | |
| Fax: +1 (408) 418-4059 | |
| Contact person: | Alice Yang |
| Preparing date: | December 21, 2018 |
| 2. Device name and classification: | Device Name: Vital Signs Monitor |
| Model: iM3 | |
| Classification Name/ Product code: | |
| 21 CFR 870.2300 Cardiac monitor (including cardiotachometer and rate alarm)/MWI | |
| 21 CFR 870.1130 Noninvasive blood pressure measurement system/DXN | |
| 21 CFR 870.2700, Oximeter/DQA | |
| 21 CFR 880.2910 Clinical electronic thermometer/FLL | |
| Regulatory Class: Class II | |
| 3. Predicate Device(s): | 1) Edan Instruments, Inc, Vital Signs Monitor Model M3, K131818(Primary) |
| 2) Edan Instruments, Inc, Patient Monitor Model V5 V6 V8, K160981 (Reference) | |
| 4. Device Description: | The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Quick TEMP/Infrared TEMP (TEMP). |
| • For the Monitor mode, the user can do continuous measurement, monitoring, alarming and manager patient data. | |
| • For the Spot mode, also call spot check mode, the user can measure parameters quickly without creating a patient within the instrument workflow. |
- The Round mode is designed to support hospital staff when doing ward .
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rounds. The Round mode is similar as Spot mode. The difference between Round mode and Spot mode is that for one ward round, the iM3 can additionally store one ward round record automatically (the latest measurement) or manually (user can choose the measure results).
iM3 capabilities include storing, displaying measuring data. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately.
The iM3can connect with EDAN's MFM-CMS Central Monitoring System to display the iM3 data on a remote work station. The MFM-CMS system received FDA 510(k) clearance on June 21, 2013(K120727)
Not all sensors are intended for neonatal patients. The intended Note: population for each sensor is detailed in the section 6 below.
-
- Indication for Use The monitor is 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 monitor is intended for use by trained healthcare professionals in hospital environments. Monitored parameters include: NIBP, SpO2, PR (pulse rate), Quick TEMP/Infrared TEMP. The monitor is not intended for MRI environments. TEMP module is not intended for neonates.
6. Predicate Device Comparison
The subject device shares the same characteristics in most items with the predicate device except in the following aspects:
| Item | |||
|---|---|---|---|
| iM3 | M3 | V5/V6/V8 | |
| K# | Current Submission | K131818 | K160981 |
| Intended Use | |||
| Description | The monitor is intended to beused for monitoring, storing,recording, and reviewing of,and to generate alarms for,multiple physiologicalparameters of adults, pediatrics | The monitor is intended to beused by qualified physicians orpersonnel professionallytrainedand it is for monitoring adults,pediatrics and neonates inhospital environments. | The monitors are intended to beused for monitoring, storing,and reviewing of, and togenerate alarms for, multiplephysiological parameters ofadults, pediatrics and neonates.The monitors are intended for |
Table 1Comparison to predicates
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K180380 Page 3 of 11
| and neonates. The monitor isintended for use by trainedhealthcare professionals inhospital environments.Monitored parameters include:NIBP, SpO2, PR (pulse rate),Quick TEMP/Infrared TEMP.The monitor is not intendedfor MRI environments. TEMPmodule is not intended forneonates. | This monitor is used tomonitor vital signals forpatients and is suitable for usein hospitalenvironments includingout-patient department, wardsand NICU.Monitored parameters include:NIBP, SpO2, pulse rate, QuickTEMP/Infrared TEMP. | use by trained healthcareprofessionals in hospitalenvironments.The monitored physiologicalparameters include: ECG,respiration (RESP), temperature(TEMP), oxygen saturation ofarterial blood (SpO2), pulse rate(PR), non-invasive bloodpressure (NIBP), invasive bloodpressure (IBP), carbon dioxide(CO2), cardiac output (C.O.),anesthetic gas (AG), bispectralindex (BIS), respirationmechanics (RM) and impedancecardiography (ICG). | |
|---|---|---|---|
| Intended patientpopulation | adult, pediatric and neonatalpatients | adult, pediatric and neonatalpatients | Same |
| Intendedapplicationenvironment | Hospital environment. | Hospital environment. | Same |
NIBP monitor (EDAN Module)
| Principle ofOperation | Oscillation | Oscillation | |
|---|---|---|---|
| MeasurementRange | AdultSystolic 40 to 270 mmHgDiastolic 10 to 215 mmHgMean 20 to 235 mmHgPediatricSystolic 40 to 230 mmHgDiastolic 10 to 180 mmHgMean 20 to 195 mmHgNeonateSystolic 40 to 135 mmHgDiastolic 10 to 100 mmHg | AdultSystolic 40 to 270 mmHgDiastolic 10 to 215 mmHgMean 20 to 235 mmHgPediatricSystolic 40 to 200 mmHgDiastolic 10 to 150 mmHgMean 20 to 165 mmHgNeonateSystolic 40 to 135 mmHgDiastolic 10 to 100 mmHg | |
| Mean 20 to 110 mmHg | Mean 20 to 110 mmHg | ||
| Accuracy | Maximum average error: ±5 mmHg | Maximum average error: ±5 mmHg | |
| Maximum standard deviation: 8 mmHg | Maximum standard deviation: 8 mmHg | ||
| Resolution | 1 mmHg | 1 mmHg | |
| Maximummeasuring period | Adult/Pediatric 120sNeonate 90s | Adult/Pediatric 120sNeonate 90s | |
| Adult 297±3 mmHg | Adult 297±3 mmHg | ||
| Overpressureprotection | Pediatric 245±3 mmHg | Pediatric 240±3 mmHg | |
| Neonate 147±3 mmHg | Neonate 147±3 mmHg | ||
| Mode | Manual, Auto, Continuous | Manual, Auto, Continuous | |
| Measuring intervalin AUTO Mode | 1/2/3/4/5/10/15/30/60/90/120/180/240/360/480 mins | 1/2/3/4/5/10/15/30/60/90/120/240/480 mins | |
| Continuous | 5min | 5min | |
| PR from NIBP | |||
| Measurement range | 40 to 240 bpm | 40 bpm to 240 bpm | |
| Accuracy | ±3 bpm or ±3.5%,whichever is greater | ±3 bpm or 3.5%,whichever is greater | |
| Resolution | 1 bpm | 1 bpm | |
| NIBP monitor(Suntech Module) | |||
| Principle ofOperation | oscillation | Same | |
| AdultSYS: 40 mmHg ~ 260 mmHgDIA: 20 mmHg ~ 200 mmHgMAP: 26 mmHg- 220 mmHg | Same | ||
| PediatricSYS: 40 mmHg- 230 mmHgDIA: 20 mmHg- 160 mmHgMAP: 26 mmHg– 183 mmHg | |||
| MeasurementRange | NeonateSYS: 40 mmHg – 130 mmHgDIA: 20 mmHg– 100 mmHgMAP: 26 mmHg – 110 mmHg | ||
| Accuracy | Maximum average error: | Same | |
| ±5mmHg | |||
| Maximum standard deviation: | |||
| 8mmHg | |||
| Resolution | 1mmHg | Same | |
| Adult 130s | Same | ||
| Maximummeasuring period | Pediatric 120s | ||
| Neonate 75s | |||
| Overpressureprotection | Adult /Pediatric <300mmHg | Same | |
| Neonate 150mmHg | |||
| Mode | Manual, Auto, Continuous,Average | Manual, Auto, Continuous | |
| Measuring intervalin AUTO Mode | 1/2/3/4/5/10/15/30/60/90/120/180/240/360/480 mins | 1/2/3/4/5/10/15/30/60/90/120/240/480 mins | |
| Continuous | 5min | Same | |
| PR from NIBP | Same | ||
| Measurement range | 30 bpm to 220 bpm | Same | |
| Accuracy | ±3 bpm or 2%,whichever is greater | Same | |
| SpO2 monitor (EDAN Module) | |||
| MeasurementRange | SpO2 0-100%Pulse Rate 25 to 300 bpm | SpO2 0-100%Pulse Rate 25 to 300 bpm | |
| Accuracy | SaturationAdult/pediatric, non-motionconditions70 to 100% ±2 %0-69% unspecifiedNeonate70 to 100% ±3%0-69% unspecifiedPulse RateAdult and Neonate25 to 300 bpm ±2bpm(non-motion conditions) | SaturationAdult/pediatric, non-motionconditions70 to 100% ±2 %0-69% unspecifiedNeonate70 to 100% ±3%0-69% unspecifiedPulse RateAdult and Neonate25 to 300 bpm ±2bpm(non-motion conditions) | |
| Resolution | SpO2 1%Pulse Rate 1 bpm | SpO2 1%Pulse Rate 1 bpm | |
| Sensor | Emitted Light Energy: ≤15 mW | Emitted Light Energy: ≤15 mW | |
| SpO2 monitor (NELLCOR Module) | |||
| Optional Spo2 | NELLCOR SpO2 module | NELLCOR SpO2 module | |
| module | |||
| TEMPmonitor(EDANquick tempmodule) | |||
| Measuring range | Monitor mode: 25 °C ~45 °CPredict mode: 35.5 °C ~42 °C | Monitor mode: 25 °C ~45 °CPredict mode: 35.5 °C ~42 °C | |
| Workingtemperature | 10°C ~ 40°C | 10°C ~ 40°C | |
| Sensor type | Oral /axillary /rectal | Oral /axillary /rectal | |
| Adjustable range ofalarm limits | 35.5 °C ~42 °C | 35.5 °C ~42 °C | |
| Resolution | 0.1 °C | 0.1 °C | |
| Accuracy | Monitor mode: ±0.1 °C(25 °C ~ 45 °C ) | Monitor mode: ±0.1 °C(25 °C ~ 45 °C ) | |
| Response time | < 60 s | < 60 s | |
| Update time | 1 s~ 2 s | 1 s~ 2 s | |
| Warm-up time | <10 s | <10 s | |
| Time for predicting | <30 s | <30 s | |
| Calibration | Self-test interval: ≤5 minutes | Self-test interval: ≤5 minutes | |
| Clinical Bias | (-0.2 to -0.4 )°C | (-0.2 to -0.4 )°C | |
| Limits ofAgreement | 0.49 | 0.49 | |
| Stability | 0.14 °C | 0.14 °C | |
| TEMP monitor(infrared ear temp module) | |||
| Measuring range | 34 °C~ 42.2 °C | 34 °C~ 42.2 °C | |
| Workingtemperature | 10 °C~ 40 °C | 10 °C~ 40 °C | |
| Adjustable range ofalarm limits | 35.5 °C~ 42 °C | 35.5 °C~ 42 °C | |
| Resolution | 0.1 °C | 0.1 °C | |
| Response time | 1 s | 1 s | |
| Measuring Mode | Adjusted Mode | Adjusted Mode | |
| Clinical Accuracy | ±0.2 C (0.4 °F) (35.5 °C~42 °C ) (95°F ~107.6°F)±0.3 C (0.5°F) (out of therange mentioned above) | ±0.2 C (0.4 °F) (35.5 °C~42 °C ) (95°F ~107.6°F)±0.3 C (0.5°F) (out of therange mentioned above) | |
| Response time | 1 s | 1 s | |
| Accuracy | |||
| TEMP monitor(Covidien F3000 quick temp module) | |||
| Measuring range | 30°C~43°C | 30°C~43°C | |
| Predictionmeasurement range | 35°C~43°C | 35°C~43°C | |
| Cold mode | |||
| prediction | 33°C~43°C | 33°C~43°C | |
| measurement range | |||
| Workingtemperature | 10°C ~ 40°C | 10°C ~ 40°C | |
| Sensor type | Oral /axillary /rectal | Oral /axillary /rectal | |
| Alarm range | 33°C ~ 43°C | 33°C ~ 43°C | |
| Resolution | 0.1°C | 0.1°C | |
| Monitoring Mode and | Monitoring Mode and | ||
| Predictive Mode: ±0.1 °C | Predictive Mode: ±0.1 °C | ||
| Accuracy | Quick Predictive Mode: | Quick Predictive Mode: | |
| ±0.3 °C | ±0.3 °C | ||
| Oral (Quick Predictive Mode): | Oral (Quick Predictive Mode): | ||
| (3~5) s (non-fever temps); | (3~5) s (non-fever temps); | ||
| (8~10) s (fever temps) | (8~10) s (fever temps) | ||
| Typical | Oral (Predictive Mode): | Oral (Predictive Mode): | |
| measurement time | (6~10) s | (6~10) s | |
| (after insertion into | Axillary: (8~12) s | Axillary: (8~12) s | |
| measurement site) | Rectal: (10~14) s | Rectal: (10~14) s | |
| Monitoring Mode (all sites): | Monitoring Mode (all sites): | ||
| (60~120) s | (60~120) s | ||
| Measuring Mode | Direct Mode /Adjusted Mode | Direct Mode /Adjusted Mode | |
| Transient ResponseTime | ≤30 s monitoring mode | ≤30 s monitoring mode | |
| Clinical Bias | (-0.2 to -0.4 )°C | (-0.2 to -0.4 )°C | |
| Limits of | |||
| Agreement | 0.49 | 0.49 | |
| Stability | 0.14 °C | 0.14 °C | |
| Safety | |||
| Classifications | |||
| Type of protection | Class I | Class I | |
| against electric | |||
| shock | |||
| Ingress Protection | IPX1 | IPX1 | |
| equipment (Sealed equipmentwithout liquid proof) | equipment (Sealed equipmentwithout liquid proof) | ||
| The degree of RF | Group 1, Class A | Group 1, Class A | |
| The degree ofprotection againstelectric shock | |||
| TEMP(EDANquick temp) | BF | CF | |
| NIBP,SpO2,TEMP(Covidien quick temp\infrared ear temp ) | BF | BF | |
| Electrical & Mechanical safety & Thermal safety Standards | |||
| General Standards | IEC 60601-1:2005 | IEC 60601-1:1988+A1:1991+A2:1995 | |
| EMC Standards | IEC 60601-1-2:2014 | IEC60601-1-2: 2001+A1:2004 | |
| Alarm Standards | IEC 60601-1-8:2012 | / | |
| BiocompatibilityStandards | ISO 10993-1:2009 | / | |
| Software Standards | IEC 62304:2006 | / | |
| Special Standardsbasic safety andessentialperformance forpatient monitor | IEC 60601-2-49: 2011 | IEC 60601-2-49: 2001 | |
| NIBP | IEC 80601-2-30: 2009ISO 81060-2:2013 | IEC60601-2-30:2000 | |
| SPO2 | ISO 80601-2-61: 2011 | ISO 9919 | |
| TEMP | ISO 80601-2-56 | E1112-00:2006 | |
| Power supply | |||
| AC powerRequirement | 100-240V, 50/60 Hz | 100-240V, 50/60Hz | |
| BatteryRechargeableBattery | Yes | Yes | |
| Operation characteristic | |||
| Installation and use | Portable EquipmentFix Equipment (when thesystem is installed on WallMounting Bracket) | Portable EquipmentFix Equipment (when thesystem is installed on WallMounting Bracket) | |
| Working System | Continuous operation | Continuous operation | |
| Working mode | Monitor, Spot, Round | Monitor, Spot | |
| Physical Characteristics | |||
| Weight | <2.5 kg | <3.5 kg | |
| Dimensions | (159±1) mm (W) × (262±1) mm (H) × (166±1) mm (D) | 174 mm (L) × 235 mm (H) × 189 mm (D) | |
| LCD | 8 inches Color TFT Display touch screen | 5.6 inch | |
| LCD Resolution | 800x600 pixels | 640×480 pixels | |
| Environmental Specifications | |||
| Temperature | |||
| Working | 0°C to 40 °CWith TEMP: +10 °C ~ +40 °C | +5°C to +40°CWith TEMP: +10 °C ~ +40 °C | |
| Transport and Storage | -20 °C to 55 °C | -20°C to +55°C | |
| Humidity | |||
| Working | 15% to 95% (non-condensing) | 25% ~ 80% (no coagulate) | |
| Transport and Storage | 15% to 95% (non-condensing) | 25% ~ 93% (no coagulate) | |
| Atmospheric Pressure | |||
| Working | 86 kPa ~ 106 kPa | 86 kPa to 106 kPa | |
| Transport and Storage | 70 kPa ~ 106 kPa | 70 kPa to 106 kPa | |
| Other function | |||
| E-link | Bluetooth Low Energy 4.0 | NO | |
| Alarm indicator | 3(red/yellow/blue) | 3(red/yellow/blue) | |
| AC power indicator | 1(green) | 1(green) | |
| Battery indicator | 1(green/ yellow) | 1(green/ yellow) | |
| Speaker | Yes | Yes | |
| Recorder | Yes | Yes | |
| Data Storage | Trend, NIBP MeasurementReview, Alarm Review,waveforms | Trend, NIBP MeasurementReview, Alarm Review,waveforms | |
| Interface | USB /Network/Nurse call/ | USB /Network/Nurse call/ | |
| Care and Cleaning | |||
| Recommended cleaning agents | Mild neutral detergentEthanol (75%) | Mild neutral detergentEthanol (75%) | |
| Isopropanol (70%) | Isopropanol (70%) | ||
| Recommendedtypes ofdisinfecting agents | Ethanol (75%)Isopropanol (70%) | Ethanol (75%)Isopropanol (70%) | |
| Cleaning | surface-clean the monitor witha soft cloth dampened with thecleaning solution | surface-clean the monitor witha soft cloth dampened with thecleaning solution | |
| Disinfecting | Following hospital's policy | Following hospital's policy | |
| WI-FI | |||
| IEEE | 802.11b/g/n | Same | |
| Frequency Band | 2.4GHz ISM band | Same | |
| Modulation | OFDM with BPSK, QPSK,16-QAM, and 64-QAM | Same | |
| Typical TransmitPower (±2 dBm) | 802.11b with CCK and DSSS17 dBm for 802.11b DSSS17 dBm for 802.11b CCK15 dBm for 802.11g/n OFDM | Same | |
| Touch screen | |||
| 8 inch touch screen | V5 12.1 inch touch screenV6 15 inch touch screenV8 17 inch touch screen |
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As seen in the comparison table, 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)
Electrical safety and EMC testing were conducted on the iM3 Vital Signs Monitor. The system complies with
- ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-8: 2006, IEC 60601-2-49: 2011, IEC 80601-2-30:2009, ISO 80601-2-56: 2009 and ISO 80601-2-61:2011 standards for safety and the IEC 60601-1-2: 2014 standard for EMC.
Coexistence testing was performed and adhere to the Radio Frequency Wireless Technology in Medical Devices guidance document recommendations.
Software Verification and Validation Testing
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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."
Summary
The performance testing demonstrated that the subject devices are as safe and as effective as the predicate device.
8. Conclusion
The performance data and software verification and validation demonstrate that iM3 Vital Signs Monitor are substantially equivalent to the predicate device.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).