(259 days)
The monitors are intended to be used for monitoring, storing, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended 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.), anesthetic gas (AG), bispectral index (BIS), respiration mechanics (RM) and impedance cardiography (ICG).
BIS is intended for use on adult and pediatric patients.
ICG monitoring is intended for use on adults only.
The arrhythmia detection and ST Segment analysis are intended for adult patients.
The monitors are additionally intended for use during patient transport inside hospitals.
The monitors are not intended for MRI environments.
V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time.
The V series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP(respiration), CO2, IBP, C.O. and AG(anesthetic gas), RM(respiratory mechanics), BIS(bispectral index) and ICG(impedance cardiography).
The above is the maximum configuration for V series Patient Monitor, the user may select different monitoring parameters in according with their requirements.
elite V5 configures with 12.1-inch color TFT touch screen , elite V6 and elite V8 with same screen except different sizes 15-inch and 17-inch separately. Three models are all build-in Lithium-ion battery, support software upgrade online and networking.
The provided document is a 510(k) Premarket Notification for the Edan Instruments, Inc. Patient Monitor (models elite V5, elite V6, and elite V8). It does not contain primary study data with reported performance metrics against specific acceptance criteria for most of the listed physiological parameters. Instead, it focuses on demonstrating substantial equivalence to predicate devices by comparing specifications and stating compliance with relevant standards.
However, based on the information provided, specifically in the "Comparison to Primary Predicate elite V8" and "Comparison to the predicate device BeneView T8" tables, we can extract the acceptance criteria (from the "Proposed device" column, implying these were the target specifications) and the "reported device performance" as being equivalent to these criteria where a "Same" or "Similar" justification is provided and no specific performance numbers are listed for the proposed device, or where identical specifications are listed for both proposed and predicate devices.
Here's an attempt to structure the information, focusing on the comparison tables as they implicitly define the acceptance criteria by stating the proposed device meets or is similar to the predicate's established performance:
1. Table of Acceptance Criteria and Reported Device Performance
Since the document is a 510(k) submission focused on substantial equivalence, specific "acceptance criteria" for performance are broadly defined by the specifications of the predicate devices and compliance with recognized standards. The "reported device performance" is then claimed to meet or be similar to these specifications. Below is a selection of parameters from the comparison tables, structured to reflect this.
| Parameter (Module) | Acceptance Criteria (from Predicate/Proposed Spec) | Reported Device Performance (as per claim of similarity/equivalence) | Justification/Notes |
|---|---|---|---|
| ECG Monitor | |||
| HR Measurement Range (Adult) | 15 to 300 bpm | 15 to 300 bpm | Same as predicate. |
| HR Accuracy | ±1 bpm or ±1%, whichever is greater | ±1 bpm or ±1%, whichever is greater | Same as predicate. |
| ST Measurement Range | -2.0 mV ~ +2.0 mV | -2.0 mV ~ +2.0 mV | Same as predicate. |
| ST Accuracy | -0.8 mV to +0.8 mV: ±0.02 mV or 10%, whichever is greater. Beyond this range: not specified. | -0.8 mV to +0.8 mV: ±0.02 mV or 10%, whichever is greater. Beyond this range: not specified. | Same as predicate. |
| RESP Monitor | |||
| RR Measurement Range (Adult) | 0 to 120 rpm | 0 to 120 rpm | Same as predicate. |
| RR Accuracy (Adult) | 6 to 120 rpm: ±2 rpm, 0 to 5 rpm: not specified (for elite V8 predicate) 7 to 150 rpm: ±2 rpm or ±2%, whichever is greater (for BeneView T8 predicate) | Adult: 6 to 120 rpm: ±2 rpm, 0 to 5 rpm: not specified Similar to BeneView T8, implying within predicate's performance range. | Claimed as "Same" or "Similar" to predicates. For BeneView T8 comparison, specific accuracy differs slightly but deemed "Similar." Proposed device claims better accuracy than one predicate. |
| Apnea Alarm | 10s, 15s, 20s, 25s, 30s, 35s, 40s | 10s, 15s, 20s, 25s, 30s, 35s, 40s | Same as predicate. |
| NIBP Monitor | |||
| Overall Accuracy | Max mean error: ±5 mmHg, Max standard deviation: 8 mmHg | Max mean error: ±5 mmHg, Max standard deviation: 8 mmHg | Same as predicate. |
| Overpressure Protection (Pediatric) | 240±3mmHg (from BeneView T8 predicate) | 245±3mmHg (proposed Edan device) | Deemed "Similar". Slightly higher value for proposed device. |
| PR from NIBP Accuracy | ±3bpm or 3.5%, whichever is greater (from elite V8 predicate) ±3bpm or ±3%, whichever is greater (from BeneView T8 predicate) | ±3bpm or 3.5%, whichever is greater (proposed Edan device) | Deemed "Same" or "Similar" to predicates. Ranges vary slightly between predicate types. |
| SpO2 Monitor (EDAN) | |||
| Accuracy (Adult/Pediatric, no motion) | 70 to 100%: ±2% | 70 to 100%: ±2% | Same as predicate. |
| Accuracy (Neonates, no motion) | 70 to 100%: ±3% | 70 to 100%: ±3% | Same as predicate. |
| PR Accuracy | ±2bpm (Elite V8 predicate) ±3 bpm (measured without motion), ±5 bpm (measured with motion) (BeneView T8 predicate) | ±2bpm (proposed Edan device) | Deemed "Similar" between predicates, implying satisfactory performance. |
| Temperature Monitor | |||
| Accuracy | ±0.1°C (±0.2 °F) | ±0.1°C (±0.2 °F) | Same as predicate. |
| IBP Monitor | |||
| Accuracy | ±2% or ±1 mmHg, whichever is greater (without sensor) | ±2% or ±1 mmHg, whichever is greater (without sensor) | Same as predicate. |
| CO2 Monitor (Sidestream) | |||
| CO2 Measurement Range | 0 mmHg to 150 mmHg (proposed and elite V8 predicate) 0 to 99 mmHg (BeneView T8 predicate) | 0 mmHg to 150 mmHg (proposed Edan device) | Deemed "Similar" to predicates. Proposed device range is better than BeneView T8. |
| AwRR Accuracy | EDAN: Respiratory rate ≤60rpm: ± 2mmHg, 0mmHg to 40mmHg, ± 5% of reading, 41mmHg to 70mmHg, ± 8% of reading, 71mmHg to 100mmHg, ± 10% of reading, 101mmHg to 150mmHg, Respiratory rate >60rpm: ±12% or ± 4mmHg of reading, whichever is greater. Respironics: ± 2 mmHg, 0 to 40 mmHg, ± 5 % of reading, 41 to 70 mmHg, ± 8 % of reading, 71 to 100 mmHg, ± 10 % of reading, 101 to 150 mmHg, ± 12% of reading, RR is over 80 rpm (Proposed device in comparison to BeneView T8) | This detailed accuracy is listed as the proposed device's performance. BeneView T8 predicate had a simpler accuracy spec (0 to 38 mmHg: ±2 mmHg, 39 to 99 mmHg: ±5% of the reading+0.08% of (the reading-38)). | The proposed device offers specific accuracy tiers based on RR and CO2 levels, differing markedly from one predicate but is explicitly stated as the device's performance. |
| AG Monitor | |||
| Warm-up time | < 20s for full accuracy mode (Phasein module) < 450s for full accuracy mode (Drager module) 10 min for BeneView T8 predicate | < 20s (Phasein) / < 450s (Drager) | Deemed "Similar". Proposed device's specific modules (Phasein, Drager) have better or comparable warm-up times. |
| ICG | |||
| C.O. Measurement Range | 0 L/min~30 L/min (proposed) 1.4 to 15 L/min (BeneView T8 predicate) | 0 L/min~30 L/min | Deemed "Similar." Proposed device has a wider measurement range. |
| RM | |||
| Flow Accuracy (Adult) | 0.5 L/min or ± 3% of reading, whichever is greater (proposed) 1.5 L/min or ±10% of the reading, whichever is greater (BeneView T8 predicate) | 0.5 L/min or ± 3% of reading, whichever is greater | Deemed "Similar" but the proposed device indicates significantly better accuracy for Flow. |
| TVe/TVi Accuracy (Adult) | ± 10.0 mL or ± 5% of reading, whichever is greater (proposed) ±10% or 15 ml, whichever is greater (BeneView T8 predicate) | ± 10.0 mL or ± 5% of reading, whichever is greater | Deemed "Similar" but the proposed device indicates significantly better accuracy for Tidal Volume. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states "Clinical data: Not applicable." This indicates that the substantial equivalence determination was based entirely on non-clinical data, primarily engineering tests and comparisons to predicate device specifications. Therefore, there is no specific test set sample size or data provenance (country of origin, retrospective/prospective) derived from clinical studies presented in this 510(k) summary. The verification and validation testing mentioned would have been internal engineering and laboratory tests, not human subject clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given the statement "Clinical data: Not applicable," no clinical test sets with ground truth established by medical experts are detailed in this 510(k) summary. The ground truth for engineering and laboratory verification would be established by controlled test conditions and reference equipment, not clinical experts.
4. Adjudication Method for the Test Set
As there were no clinical test sets for which ground truth was established by experts, no adjudication method is applicable or described in this document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or described. The submission focuses on device specifications and compliance with standards rather than human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
The document does not describe a standalone algorithm-only performance study. The device is a patient monitor, implying an integrated system with sensors and display. Its performance is assessed against recognized standards for medical electrical equipment and comparison to predicate devices, not as a standalone algorithm in isolation.
7. Type of Ground Truth Used
For the non-clinical testing (biocompatibility, electrical safety, EMC, software V&V), the "ground truth" would be defined by recognized industry standards (e.g., ISO, IEC) and the specifications of the predicate devices. Compliance with these standards and equivalence to predicate performance constitutes the basis for the substantial equivalence claim. There is no mention of pathology, expert consensus (in a clinical sense), or outcomes data used as ground truth for this submission.
8. Sample Size for the Training Set
No training set is mentioned as this is a medical device (patient monitor) focusing on hardware and integrated software for physiological parameter measurement, not an AI/machine learning model that typically requires a large training set for development. The software verification and validation are for the device's operational software, not an AI component that learns from data.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned or applicable in the context of this traditional medical device submission, the question of how its ground truth was established is not relevant here.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2016
Edan Instruments, Inc. % Doug Worth Edan Medical 1200 Crossman Ave. Suite 200 Sunnyvale, California 94089
Re: K160981 Trade/Device Name: Patient Monitor, models elite V5, elite V6 and elite V8 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, DRT, CBQ, DXN, DSK, CBR, DQA, NHO, CBS, NHQ, NHP, CCK, DSB, CCL, BZQ, BZK, DPS, FLL, DRG, MLD Dated: November 30, 2016 Received: November 30, 2016
Dear Doug Worth:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mude Jellm
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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Indications for Use
510(k) Number (if known) K160981
Device Name
Patient Monitor, models elite V5, elite V6 and elite V8
Indications for Use (Describe)
The monitors are intended to be used for monitoring, storing, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended 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.), anesthetic gas (AG), bispectral index (BIS), respiration mechanics (RM) and impedance cardiography (ICG).
BIS is intended for use on adult and pediatric patients.
ICG monitoring is intended for use on adults only.
The arrhythmia detection and ST Segment analysis are intended for adult patients.
The monitors are additionally intended for use during patient transport inside hospitals.
The monitors are not intended for MRI environments.
| 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, Inc3/F - B, Nanshan MedicalEquipments Park, Nanhai Rd 1019#,Shekou, Nanshan Shenzhen,518067 P.R. ChinaTel: +86(0755) 26858736Fax: +1 (408) 418-4059 |
|---|---|
| Contact person: | Queena Chen |
| Preparing date: | March 30, 2016 |
| 2. Device name andclassification: | Device Name: Patient MonitorModel: elite V5, elite V6, elite V8Classification Name/ Product code:870.1025 monitor, physiological, patient(with arrhythmiadetection or alarms)/ MHX870.1025 Detector and Alarm, Arrhythmia/ DSI870.1025 Monitor, ST Segment with Alarm/ MLD870.2300 Cardiac monitor (including cardiotachometer and ratealarm)/ DRT870.1130 Non-Invasive blood pressure/ DXN870.1110 Blood pressure computer/ DSK880.2910 Clinical Electronic Thermometers-TemperatureMonitor with Probe/ FLL870.2700 Oximeter, Pulse/ DQA868.1400 Carbon Dioxide Gas Analyzer/ CCK868.1500 Analyzer, Gas, Enflurane, Gaseous-Phase (AnestheticConcentration)/ CBQ868.1500 Analyzer, Gas, Desflurane, Gaseous-Phase(Anesthetic Concentration)/NHO868.1500 Analyzer, Gas, Isoflurane, Gaseous-Phase (AnestheticConcentration)/NHQ868.1500 Analyzer, Gas, Sevoflurane, Gaseous-Phase(Anesthetic Concentration)/NHP868.1620 Halothane gas analyzer/ CBS868.1700 Nitrous Oxide gas analyzer/ CBR868.1720 Oxygen gas analyzer/ CCL |
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| 3.Premarket Notification Class III Certification and Summary | 870.2770 Impedance plethysmograph/ DSB868.1850 Monitoring spirometer/ BZK868.2375 Monitor, Breathing Frequency/BZQ870.2340 Electrocardiograph/DPS870.2910 Radiofrequency physiological signal transmitter and receiver/ DRGRegulatory Class: Class IINot applicable, the subject device is Class II. |
|---|---|
| 4. Predicate Device(s): | 1) Edan Instruments, Inc. / Patient Monitor Model elite V8/ K1201732) Shenzhen Mindray Bio-Medical Electronics Co., Ltd/ BeneView T8 /K092449.3) Edan Instruments, Inc. / iM70/ K131971 |
| 5. Reason for Submission | Modification for previous product elite V8 and introduce two new models elite V5 and elite V6. |
| 6. Pre-Submission, IDE | Not applicable, there is no prior submission. |
| 7. Device Description: | V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time.The V series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP(respiration), CO2, IBP, C.O. and AG(anesthetic gas), RM(respiratory mechanics), BIS(bispectral index) and ICG(impedance cardiography).The above is the maximum configuration for V series Patient Monitor, the user may select different monitoring parameters in according with their requirements.elite V5 configures with 12.1-inch color TFT touch screen , elite V6 and elite V8 with same screen except different sizes |
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15-inch and 17-inch separately. Three models are all build-in Lithium-ion battery, support software upgrade online and networking.
- Intended Use: The monitors are intended to be used for monitoring, storing, 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.), anesthetic gas (AG), bispectral index (BIS), respiration mechanics (RM) and impedance cardiography (ICG).
BIS is intended for use on adult and pediatric patients.
ICG monitoring is intended for use on adults only.
The arrhythmia detection and ST Segment analysis are intended for adult patients.
The monitors are additionally intended for use during patient transport inside hospitals.
The monitors are not intended for MRI environments.
9. Predicate Device Comparison
The subject devices share the same characteristics in all items with the predicate device, concluding from using the same technology and principle. All the technological differences existed between the subject and predicate devices are only some performance parameters improvement, for example accuracy for RESP Module is better, minor differences on NIBP module, different measurement range, accuracy and Sample flow rate for CO2 module and different Warm-up time, Sample flow rate, measurement range, accuracy for AG module. Please refer to the following tables for details.
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Comparison to Primary Predicate elite V8
| Item | Proposed device(elite V5, elite V6, elite V8) | Predicate device(elite V8) | Justification | |
|---|---|---|---|---|
| K# | Current Submission | K120173 | — | |
| Intended use | ||||
| Description | The monitors are intended to be used formonitoring, storing, and reviewing of,and to generate alarms for, multiplephysiological parameters of adults,pediatrics and neonates. The monitorsare intended for use by trainedhealthcare professionals in hospitalenvironments.The monitored physiological parametersinclude: ECG, respiration (RESP),temperature (TEMP), oxygen saturationof arterial blood (SpO2), pulse rate (PR),non-invasive blood pressure (NIBP),invasive blood pressure (IBP), carbondioxide (CO2), cardiac output (C.O.),anesthetic gas (AG), bispectral index(BIS), respiration mechanics (RM) andimpedance cardiography (ICG).BIS is intended for use on adult andpediatric patients.ICG monitoring is intended for use onadults only.The arrhythmia detection and STSegment analysis are intended for adultpatients.The monitors are additionally intendedfor use during patient transport insidehospitals.The monitors are not intended for MRIenvironments. | The monitor monitors parameterssuch as ECG (3-lead, 5-leadselectable), Respiration (RESP),Functional arterial oxygen saturation(SpO2), Invasive or noninvasiveblood pressure (dual-IBP, NIBP),Temperature (dual-TEMP), ExpiredCO2.The monitor is equipped with alarmsthat indicate system faults (such asloose or defective electrodes).physiologic parameters that haveexceeded the limits set by theoperator, or both.The arrhythmia detection and STSegment analysis are not intended forneonatal patients. | Similar | |
| Intended patientpopulation | adult, pediatric and neonatal patients | adult, pediatric and neonatal patients | Same | |
| Intendedapplicationenvironment | Hospital environment. | Hospital environment. | Similar | |
| ECG monitor | ||||
| Lead Mode | 3-Lead: I, II, III5-Leads: I, II, III, aVR, aVL, aVF, V12-leads: I, II, III, aVR, aVL, aVF, V1 toV6 | 3-Lead: I, II, III5-Leads: I, II, III, aVR, aVL, aVF, V12-leads: I, II, III, aVR, aVL, aVF,V1 to V6 | Same | |
| Lead NamingStyle | AHA, IEC | AHA, IEC | Same | |
| DisplaySensitivity | 1.25mm/mV (×0.125), 2.5mm/mV(×0.25), 5mm/mV (×0.5), 10mm/mV(×1), 20mm/mV (×2), 40mm/mV (×4),AUTO gain | 1.25 mm/mV (X0.125), 2.5 mm/mV(X0.25), 5 mm/mV (X0.5),10 mm/mV (X1), 20 mm/mV (X2),40 mm/mV (X4), Auto | Same | |
| Sweep | 6.25mm/s, 12.5mm/s, 25mm/s, 50mm/s | 6.25 mm/s, 12.5 mm/s, 25 mm/s, 50mm/s | Same | |
| MeasurementRange | Neonate: 15 to 350 bpmPediatric: 15 to 350 bpmAdult: 15 to 300 bpm | Neonate: 15 to 350 bpmPediatric: 15 to 350 bpmAdult: 15 to 300 bpm | Same | |
| CMRR(Common ModeRejection Ratio) | Diagnosis: >95dBMonitor: >105dBSurgery: >105dB | Diagnosis: >95dB (the Notch filter isoff)Monitor: >105dB (the Notch filter ison)Surgery: >105dB (the Notch filter ison) | Similar | |
| Accuracy | ±1 bpm or ±1%, whichever isgreater | ±1 bpm or ±1%, whichever isgreater | Same | |
| Resolution | 1 bpm | 1 bpm | Same | |
| Sensibility | 200μV | 200µV (lead II) | Same | |
| Differential InputImpedance | >5MΩ | ≥5 MΩ | Same | |
| Leakage Currentof Patient | <10μΑ | <10 μΑ | Same | |
| ST value | ||||
| MeasurementRange | -2.0 mV ~ +2.0 mV | -2.0 mV ~ +2.0 mV | Same | |
| Accuracy | -0.8 mV to +0.8 mV: ±0.02 mV or 10%,whichever is greater.Beyond this range: not specified. | -0.8 to 0.8 mV: Beyond thisrange:±0.02 mV or ±10%, whicheveris greater. Not specified. | Same | |
| Pace | ||||
| Pulse Indicator | Amplitude: ±2 mV to ±700 mVWidth: 0.1 ms to2.0 msAscending time: 10 µs to 100 µs | Amplitude: ±2 to ±700 mVWidth: 0.1 to 2 msRise time: 10 to 100 µs | Same | |
| Pulse Rejection | Amplitude: ±2 mV to ±700 mVWidth: 0.1 ms to 2.0 msAscending time: 10 µs to 100 µs | Amplitude: ±2 to ±700 mVWidth: 0.1 to 2 msRise time: 10 to 100 µs | Same | |
| HR | ||||
| Measurement range | Neonate: 15 to 350 bpmPediatric: 15 to 350 bpmAdult: 15 to 300 bpm | Neonate: 15 to 350 bpmPediatric: 15 to 350 bpmAdult: 15 to 300 bpm | Same | |
| Accuracy | ±1% or 1 bpm, whichever is greater | ±1 bpm or ±1%, whichever is greater | Same | |
| Resolution | 1 bpm | 1 bpm | Same | |
| RESP monitor | ||||
| Principle of Operation | Thoracic impedance | Trans-thoracic impedance | Same | |
| Measurement Range | Adult: 0 to 120 rpmPediatric/neonate: 0 rpm to 150rpm | Adult: 0 to 120 rpmPediatric/neonate: 0 to 150 rpm | Same | |
| Accuracy | Adult: 6 to 120 rpm: ±2 rpm, 0 to 5 rpm: not specifiedPediatric/neonate: 6 to 150 rpm: ±2 rpm, 0 to 5 rpm: not specified | Adult: 6 to 120 rpm: ±2 rpm, 0 to 5 rpm: not specifiedPediatric/neonate: 6 to 150 rpm: ±2 rpm, 0 to 5 rpm: not specified | Same | |
| Resolution | 1 rpm | 1 rpm | Same | |
| Waveform bandwidth | 0.2Hz to 2.5Hz (-3dB) | 0.2Hz to 2.5Hz (-3dB) | Same | |
| Apnea Alarm | 10s, 15s, 20s, 25s, 30s, 35s, 40s; | 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s | Same | |
| NIBP monitor(EDAN Module) | ||||
| oscillation | oscillation | Same | ||
| Adult | Adult | Similar | ||
| Systolic 40 to 270 mmHgDiastolic 10 to 215 mmHgMean 20 to 235 mmHg | Systolic 40 to 270 mmHgDiastolic 10 to 215 mmHgMean 20 to 235 mmHg | |||
| Pediatric | Pediatric | |||
| Measurement Range(mmHg) | Systolic 40 to 230 mmHgDiastolic 10 to180 mmHgMean 20 to 195 mmHg | Systolic 40 to 200 mmHgDiastolic 10 to150 mmHgMean 20 to 165 mmHg | ||
| Neonate | Neonate | |||
| Systolic 40 to 135 mmHgDiastolic 10 to 100 mmHgMean 20 to 110 mmHg | Systolic 40 to 135 mmHgDiastolic 10 to 100 mmHgMean 20 to 110 mmHg | |||
| Accuracy | Max mean error: ±5 mmHg, Maxstandard deviation: 8 mmHg | Max mean error: ±5 mmHgMax standard deviation: 8 mmHg | Same | |
| Resolution | 1mmHg | 1mmHg | Same | |
| Adult | 297+3mmHg | 297+3mmHg | Same | |
| Overpressure protection | Pediatric | 245+3mmHg | 240+3mmHg | Similar |
| Pediatric | 147+3mmHg | 147+3mmHg | Same | |
| Mode | Manual, Auto, Continuous | Manual, Auto, Continuous | Same | |
| interval in AUTO | min | 0 min | ||
| Mode | ||||
| PR from NIBP | ||||
| Measurementrange | 40 bpm to 240bpm | 40 to 240 bpm | ||
| Accuracy | ±3bpm or 3.5%, whichever isgreater(EDAN); | ±3bpm or 3.5%, whichever isgreater | ||
| SpO2 monitor(EDAN) | ||||
| MeasurementRange | 0-100% | 0-100% | Same | |
| Accuracy | 70 to 100%: ±2% (measured withoutmotion in adult/pediatricmode)70 to 100%: ±3% (measured withoutmotion in neonate mode)0% to 69%: Not specified. | 70 to 100%: ±2% (measured withoutmotion in adult/pediatricmode)70 to 100%: ±3% (measured withoutmotion in neonate mode)0% to 69%: Not specified. | Same | |
| Resolution | 1 % | 1% | Same | |
| PR | ||||
| MeasurementRange | 25 bpm to 300 bpm | 25 bpm to 300 bpm | ||
| Accuracy | ±2bpm | ±2bpm | ||
| Resolution | 1 bpm | 1 bpm | Same | |
| SpO2 monitor(Nellcor) | ||||
| Module | Nellcor Module | Nellcor Module | Same | |
| Temperature monitor | ||||
| Technique | Thermal resistance | Thermal resistance | Same | |
| Number ofchannels | 2 | 2 | Same | |
| MeasurementRange | 0 to 50°C | 0 to 50℃ | Same | |
| Accuracy | ±0.1ºC (±0.2 ºF) | ±0.1ºC (±0.2 ºF) | Same | |
| Resolution | 0.1°C | 0.1 °C | Same | |
| C.O. Temperature | ||||
| Measurementmethod | Thermodilution method | Thermodilution method | Same | |
| Measurementrange | C.O.: 0.1 to 20L/minTB: 23 to 43 ℃TI: -1 to 27°C | C.O.: 0.1 to 20L/minTB: 23 to 43 ℃TI: -1 to 27°C | Same | |
| Accuracy | C.O .: ±5% or ±0.2L/min, which is | C.O .: ±5% or ±0.2L/min, which is | Same | |
| greater | greater | |||
| TB,TI: ±0.1°C(without sensor) | TB,TI: ±0.1°C(without sensor) | |||
| Resolution | C.O.: 0.1L/minTB,TI:0.1 °C | C.O.: 0.1L/minTB,TI:0.1 °C | Same | |
| IBP monitor | ||||
| Technique | Direct invasive measurement | Direct invasive measurement | Same | |
| MeasurementRange | -50~300mmHg | -50~300mmHg | Same | |
| Accuracy | ±2% or ±1 mmHg, whichever is greater(without sensor) | ±2% or ±1 mmHg, whichever isgreater (without sensor) | Same | |
| Resolution | 1mmHg | 1mmHg | Same | |
| 5 (μV/V/mmHg) | 5 (μV/V/mmHg) | |||
| Transducer | 200 to 3000 Ω | 300 to 3000 Ω | Same | |
| CO2 Monitor(Respironics) | ||||
| CO2 Module | Respironics CAPNOSTAT 5 LoFloCO2(Sidestream) | Respironics CAPNOSTAT 5 LoFloCO2(Sidestream) | Same | |
| MeasureParameters | Respironics CAPNOSTAT 5 CO2( Mainstream CO2 ) | Respironics CAPNOSTAT 5 CO2( Mainstream CO2 ) | Same | |
| AG Monitor (Phasein) | ||||
| Technique | Phasein AG | Phasein AG | Same | |
| Justificationofdifference | Proposed devices and the predicate device use the same module, so has the same specification. | |||
| Safety Classifications | ||||
| Type ofprotectionagainst electricshock | Class I | Class I | Same | |
| IngressProtection | IPX1 | IPX1 | Same | |
| The degree of RF | Group 1, Class A | Group 1, Class A | Same | |
| The degree of protection against electric shock | ||||
| ECG, RESP,TEMP, IBP, C.O. | CF | CF | Same | |
| ICG, NIBP,SpO2, | BF | CF | Same | |
| CO2, AG, BIS,RM, ICG | BF | BF | Same | |
| Electrical & Mechanical safety & Thermal safety Standards | ||||
| General Standards | IEC 60601-1:2005 | IEC 60601-1: | Similar | |
| EMC Standards | IEC 60601-1-2:2007 | 1988+A1:1991+A2:1995IEC60601-1-2: 2001+A1:2004 | ||
| Alarm Standards | IEC 60601-1-8:2006 | IEC60601-1-8:2003 | ||
| BiocompatibilityStandards | ISO 10993-1:2009 | ISO 10993-1:2003 | ||
| Software Standards | IEC 62304:2006 | IEC 62304:2006 | ||
| Special Standards | ||||
| basic safety andessential performancefor patient monitor | IEC 60601-2-49: 2011 | IEC 60601-2-49: 2001 | Similar | |
| ECG | IEC 60601-2-27: 2011IEC 60601-2-25: 2011 | IEC 60601-2-27:2005IEC 60601-2-25: 1999SP10 | ||
| NIBP | IEC 80601-2-30: 2009ISO 81060-2 | IEC60601-2-30:2000 | ||
| IBP | IEC 60601-2-34: 2011 | IEC60601-2-34:2000 | ||
| AG, CO2 | ISO 80601-2-55 | ISO21647 :2004 | ||
| TEMP | ISO 80601-2-56EN12470-4:2000 | EN12470-4:2000 | ||
| Power supply | ||||
| AC power | ||||
| Requirement | 100-240V, 50/60Hz | 100-240V, 50/60 Hz | Same | |
| Battery | ||||
| RechargeableBattery | Yes | Yes | Same | |
| Operation characteristic | ||||
| Installation and use | Portable EquipmentFix Equipment (when the system isinstalled on Wall MountingBracket) | Portable EquipmentFix Equipment (when the system isinstalled on Wall Mounting Bracket) | Same | |
| Working System | Continuous operation | Continuous operation | Same | |
| Physical Characteristics | ||||
| Weight | elite V5 : <6.2kgelite V6: <7.5kgelite V8: <14kg | <14kg | Similar | |
| Dimensions | elite V5 : 333±2 mm (L) × 289±2mm (H)× 211±2mm (W)elite V6: 384±2 mm (L) × 320±2mm (H)× 213±2mm (W) | 425 mm (L) × 245 mm (W)× 382mm (H) | ||
| (W)× 382 mm (H) | ||||
| LCD | elite V5: 12.1 inches LCDelite V6: 15 inches LCDelite V8: 17 inches LCD | 17inch LCD | ||
| LCD Resolution | elite V5: 800x600elite V6: 1024*768elite V8: 1280 *1024 | 1280×1024 pixels | ||
| Environmental Specifications | ||||
| Temperature | ||||
| Working | +0°C to +40°C | +5°C to +40°C | Similar | |
| Transport andStorage | -20°C to +55°C | -20°C to +55°C | Similar | |
| Humidity | ||||
| Working | 15% to 95% (non-condensing) | 25% ~ 80% (no coagulate) | Similar | |
| Transport andStorage | 15% to 95% (non-condensing) | 25% ~ 93% (no coagulate) | Similar | |
| Altitude | ||||
| Working | 860hPa to 1060hPa | 860hPa to 1060hPa | Same | |
| Transport andStorage | 700hPa to 1060hPa | 700hPa to 1060hPa | Same | |
| Other function | ||||
| Indicators | ||||
| Alarm indicator | 3(red/yellow/blue) | 3(red/yellow/blue) | Same | |
| AC power indicator | 1(green) | 1(green) | Same | |
| Battery indicator | 1(green) | 1(green/ yellow) | Same | |
| Speaker | Yes | Yes | Same | |
| Recorder | Yes | Yes | Same | |
| Data Storage | Trend, NIBP Measurement Review,Alarm Review ,Arrhythmia Review,12-Lead Diagnosis Review,Full-disclosure waveforms | Trend, NIBP Measurement Review,Alarm Review ,Arrhythmia Review,12-Lead Diagnosis Review,Full-disclosure waveforms | Same | |
| Interface | USB/VGA/Network/Nursecall/DefibrillatorSynchronization/AnalogOutput/SD/PAM/DVI/RS232 port | USB/VGA/Network/Nursecall/DefibrillatorSynchronization/AnalogOutput/SD/PAM/DVI/RS232 port | Same | |
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
K160981
{12}------------------------------------------------
Comparison to the predicate device BeneView T8
| Item | Proposed device(elite V5, elite V6, elite V8) | Predicate device(BeneView T8) | Justification |
|---|---|---|---|
| ------ | --------------------------------------------------- | ----------------------------------- | --------------- |
{13}------------------------------------------------
K160981 p.11/28
| K# | Current Submission | K092449 | p.11/28 |
|---|---|---|---|
| Intended use | |||
| Description | The monitors are intended to be usedfor monitoring, storing, and reviewingof, and to generate alarms for, multiplephysiological parameters of adults,pediatrics and neonates. The monitorsare intended for use by trainedhealthcare professionals in hospitalenvironments.The monitored physiologicalparameters include: ECG, respiration(RESP), temperature (TEMP), oxygensaturation of arterial blood (SpO2),pulse rate (PR), non-invasive bloodpressure (NIBP), invasive bloodpressure (IBP), carbon dioxide (CO2),cardiac output (C.O.), anesthetic gas(AG), bispectral index (BIS),respiration mechanics (RM) andimpedance cardiography (ICG).BIS is intended for use on adult andpediatric patients.ICG monitoring is intended for use onadults only.The arrhythmia detection and STSegment analysis are intended for adultpatients.The monitors are additionally intendedfor use during patient transport insidehospitals.The monitors are not intended for MRIenvironments. | This patient monitor is intendedto be used for monitoring,displaying, reviewing, storingandtransferring of multiplephysiological parametersincluding ECG, heart rate (HR),respiration(Resp), temperature (Temp),SpO2, pulse rate (PR),non-invasive blood pressure(NIBP),invasive blood pressure (IBP),cardiac output (C.O.), carbondioxide (CO2), oxygen (O2),anesthetic gas (AG), impedancecardiograph (ICG), bispectralindex (BIS) and respirationmechanics (RM) of single adult,pediatric and neonatal patients.Interpretation of resting 12-leadECG and C.O. monitoring arerestricted to adult patients only.The ICG is only for use on adultpatients who meet the followingrequirements: height: 122to 229 cm, weight: 30 to 159 kg.The arrhythmia detection,ST-segment, BIS and RMmonitor are not intended forneonatal patients.This monitor is to be used inhealthcare facilities by clinicalprofessionals or under theirdirection. It is not intended forhelicopter transport, hospitalambulance, or home use. | Similar |
| Intendedpatientpopulation | adult, pediatric and neonatal patients | adult, pediatric and neonatalpatients | Same |
| Intendedapplicationenvironment | Hospital environment. | It is not intended for helicoptertransport, hospital ambulance, orhome use. | Similar |
| ECG monitor | |||
| Lead Mode | 3-Lead: I, II, III5-Leads: I, II, III, aVR, aVL, aVF, V12-leads: I, II, III, aVR, aVL, aVF, V1to V6 | 3-Lead: I, II, III5-Leads: I, II, III, aVR, aVL,aVF, V12-leads: I, II, III, aVR, aVL,aVF, V1 to V6 | Same |
| Lead NamingStyle | AHA, IEC | AHA, IEC | Same |
| DisplaySensitivity | 1.25mm/mV (×0.125), 2.5mm/mV(×0.25), 5mm/mV (×0.5), 10mm/mV(×1), 20mm/mV (×2), 40mm/mV (×4),AUTO gain | 1.25 mm/mV (X0.125), 2.5mm/mV (X0.25), 5 mm/mV(X0.5),10 mm/mV (X1), 20 mm/mV(X2), 40 mm/mV (X4), Auto | Same |
| Sweep | 6.25mm/s, 12.5mm/s, 25mm/s, 50mm/s | 6.25 mm/s, 12.5 mm/s, 25 mm/s,50 mm/s | Same |
| MeasurementRange | Neonate: 15 to 350 bpmPediatric: 15 to 350 bpmAdult: 15 to 300 bpm | Neonate: 15 to 350 bpmPediatric: 15 to 350 bpmAdult: 15 to 300 bpm | Same |
| CMRR(CommonModeRejectionRatio) | Diagnosis: >95dBMonitor: >105dBSurgery: >105dB | Diagnostic mode: ≥90 dB theNotch filter is offMonitor mode: ≥105 dB theNotch filter is offSurgical mode: ≥105 dB theNotch filter is off | Similar |
| Accuracy | ±1 bpm or ±1%, whichever isgreater | ±1 bpm or ±1%, whicheveris greater | Same |
| Resolution | 1 bpm | 1 bpm | Same |
| Sensibility | 200μV | 200μV (lead II) | Same |
| DifferentialInputImpedance | >5MΩ | ≥5 ΜΩ | Same |
| LeakageCurrent ofPatient | <10μΑ | <10 μΑ | Same |
| ST value | |||
| MeasurementRange | -2.0 mV ~ +2.0 mV | -2.0 mV ~ +2.0 mV | Same |
| Accuracy | -0.8 mV to +0.8 mV: ±0.02 mV or 10%,whichever is greater.Beyond this range: not specified. | -0.8 to 0.8 mV: Beyond thisrange:±0.02 mV or ±10%,whichever is greater. Not | Same |
{14}------------------------------------------------
K160981 p.12/28
{15}------------------------------------------------
| specified. | |||||
|---|---|---|---|---|---|
| Pace | |||||
| PulseIndicator | Amplitude: ±2 mV to +700 mVWidth: 0.1 ms to2.0 msAscending time: 10 µs to 100 µs | Amplitude: ±2 to +700 mVWidth: 0.1 to 2 msRise time: 10 to 100 µs | Same | ||
| PulseRejection | Amplitude: ±2 mV to +700 mVWidth: 0.1 ms to 2.0 msAscending time: 10 µs to 100 µs | Amplitude: ±2 to ±700 mVWidth: 0.1 to 2 msRise time: 10 to 100 µs | Same | ||
| HR | |||||
| Measurementrange | Neonate: 15 to 350 bpmPediatric: 15 to 350 bpmAdult: 15 to 300 bpm | Neonate: 15 to 350 bpmPediatric: 15 to 350 bpmAdult: 15 to 300 bpm | Same | ||
| Accuracy | ±1% or 1 bpm, whichever is greater | ±1 bpm or ±1%, whichever is greater | Same | ||
| Resolution | 1 bpm | 1 bpm | Same | ||
| RESP monitor | |||||
| Principle ofOperation | Thoracic impedance | Trans-thoracic impedance | Same | ||
| MeasurementRange | Adult: 0 to 120 rpmPediatric/neonate: 0 rpm to 150rpm | Adult: 0 to 120 rpmPediatric/neonate: 0 to 150 rpm | Same | ||
| Accuracy | Adult: 6 to 120 rpm: ±2 rpm, 0 to 5rpm: not specifiedPediatric/neonate: 6 to 150 rpm: ±2rpm, 0 to 5 rpm: not specified | 7 to 150 rpm: ±2 rpm or ±2%,whichever is greater0 to 6 rpm: Not specified. | Similar | ||
| Resolution | 1 rpm | 1 rpm | Same | ||
| Waveformbandwidth | 0.2Hz to 2.5Hz (-3dB) | 0.2 to 2 Hz (-3 dB) | Similar | ||
| Apnea Alarm | 10s, 15s, 20s, 25s, 30s, 35s, 40s; | 10 s, 15 s, 20 s, 25 s, 30 s, 35 s,40 s | Same | ||
| NIBP monitor | |||||
| Principle ofOperation | oscillation (EDAN, M3600, SunTechNIBP ) | oscillation | Same | ||
| MeasurementRange(mm Hg) | AdultSystolic | EDAN NIBPM3600SunTechNIBP | 40 mmHgto 270mmHg60 mmHgto 250mmHg60 mmHg ~250 mmHg | 40 to 270 | Similar |
| ic | to 215mmHg | ||||
| M3600 | 40 mmHgto 200mmHg | ||||
| SunTechNIBP | 30 mmHg ~190 mmHg | ||||
| Mean | EDAN NIBP | 20 mmHgto 235mmHg | 20 to 230 | ||
| M3600 | 45 mmHgto 235mmHg | ||||
| SunTechNIBP | 40 mmHg ~210 mmHg | ||||
| Pediatric | |||||
| Systolicc | EDAN NIBP | 40 mmHgto 230mmHg | 40 to 200 | ||
| M3600 | 60 mmHgto 250mmHg | ||||
| SunTechNIBP | 40 mmHg ~230 mmHg | ||||
| Diastolic | EDAN NIBP | 10 mmHgto 180mmHg | 10 to 150 | ||
| M3600 | 40 mmHgto 200mmHg | ||||
| SunTechNIBP | 20 mmHg ~160 mmHg | ||||
| Mean | EDAN NIBP | 20 mmHgto 195mmHg | 20 to 165 | ||
| M3600 | 45 mmHgto 235mmHg | ||||
| SunTechNIBP | 30 mmHg ~175 mmHg | ||||
| Neonate | |||||
| Systolicc | EDANNIBP | 40 mmHg to135 mmHg | 40 to 135 | ||
| M3600 | 40 mmHg to | ||||
| 120 mmHg | |||||
| SunTech | 40 mmHg ~ | ||||
| NIBP | 130 mmHg | ||||
| Diastolic | EDAN | 10 mmHg to | 10 to 100 | ||
| NIBP | 100 mmHg | ||||
| M3600 | 20 mmHg to90 mmHg | ||||
| SunTech | 20 mmHg ~ 90 mmHg | ||||
| EDAN | 20 mmHg to | ||||
| NIBP | 110 mmHg | ||||
| M3600 | 30 mmHg to100 mmHg | 20 to 110 | |||
| Mean | SunTech | 30 mmHg ~100 mmHg | |||
| Accuracy | Max mean error: ±5 mmHg,Maxstandard deviation: 8mmHg(EDAN,M3600, SunTech); | Max mean error: ±5 mmHgMax standard deviation: 8 mmHg | Same | ||
| Resolution | 1mmHg(EDAN, M3600, SunTech); | 1mmHg | Same | ||
| Overpressureprotection | Adult | 297±3mmHg(EDAN)<300mmHg(M3600,SunTech) | 297±3mmHg | Similar | |
| Pediatric | 245±3mmHg(EDAN)<300mmHg(M3600,SunTech) | 240±3mmHg | |||
| Pediatric | 147±3mmHg(EDAN)<150mmHg(M3600,SunTech) | 147±3mmHg | |||
| Mode | Manual, Auto, Continuous | Manual, Auto and STAT | Similar | ||
| Measuringinterval inAUTO Mode | 1/2/3/4/5/10/15/30/60/90/120/240/480 min(EDAN)1/2/3/4/5/10/15/30/60/90 min, 2/4/8h(M3600)1/2/3/4/5/10/15/30/60/90/120/240/480 min(SunTech) | 1, 2, 2.5, 3, 5, 10, 15, 20, 30, 60, 90, 120, 180, 240 or 480 min | Similar | ||
| PR from NIBP | |||||
| Measurementrange | 40 bpm to 240bpm(EDAN);Adult/ Pediatric mode: 40bpm to 200bpm,Neonatal mode: 40 bpm to 240bpm (M3600);30 bpm ~220bpm(SunTech) | 40 to 240 bpm | Similar | ||
| Accuracy | ±3bpm or 3.5%, whichever is greater(EDAN); | ±3bpm or ±3%, whichever is greater | Similar |
{16}------------------------------------------------
{17}------------------------------------------------
{18}------------------------------------------------
| ± 2 bpm or 2% of the readings(M3600);±3bpm or ±2%, whichever isgreater(SunTech); | |||
|---|---|---|---|
| SpO2 monitor(EDAN) | |||
| Measurement Range | 0-100% | 0-100% | Same |
| Accuracy | 70 to 100%: ±2% (measured withoutmotion in adult/pediatricmode)70 to 100%: ±3% (measured withoutmotion in neonate mode)0% to 69%: Not specified. | 70 to 100%: ±2% (measuredwithout motion in adult/pediatricmode)70 to 100%: ±3% (measuredwithout motion in neonatemode)70 to 100%: ±3% (measuredwith motion)0% to 69%: Not specified. | Same |
| Resolution | 1 % | 1% | Same |
| PR | |||
| Measurement Range | 25 bpm to 300 bpm | 20 to 254 bpm | Similar |
| Accuracy | ±2bpm | ±3 bpm (measured withoutmotion)±5 bpm (measured with motion) | Similar |
| Resolution | 1 bpm | 1 bpm | Same |
| SpO2 monitor(Nellcor) | |||
| Module | Nellcor Module | Nellcor Module | Same |
| Temperature monitor | |||
| Technique | Thermal resistance | Thermal resistance | Same |
| Number of channels | 2 | 2 | Same |
| Measurement Range | 0 to 50°C | 0 to 50°C | Same |
| Accuracy | ±0.1°C (±0.2 °F) | ±0.1 °C or ±0.2 °F (withoutprobe) | Same |
| Resolution | 0.1°C | 0.1°C | Same |
| C.O. Temperature | |||
| Measurement method | Thermodilution method | Thermodilution method | Same |
| Measurement range | C.O.: 0.1 to 20L/minTB: 23 to 43°CTI: -1 to 27°C | C.O.: 0.1 to 20L/minTB: 23 to 43°CTI: 0 to 27°C | Similar |
| Accuracy | C.O.: ±5% or ±0.2L/min, which is greaterTB,TI: ±0.1°C(without sensor) | C.O.: ±5% or ±0.1L/min, which is greaterTB,TI: ±0.1°C(without sensor) | Same |
| Resolution | C.O.: 0.1L/minTB.TI:0.1°C | C.O.: 0.1L/minTB.TI:0.1°C | Same |
{19}------------------------------------------------
IBP monitor
| Technique | Direct invasive measurement | Direct invasive measurement | Same |
|---|---|---|---|
| MeasurementRange | -50~300mmHg | -50~300mmHg | Same |
| Accuracy | ±2% or ±1 mmHg, whichever is greater(without sensor) | ±2% or ±1 mmHg, whichever is greater (without sensor) | Same |
| Resolution | 1 mmHg | 1 mmHg | Same |
| Transducer | 5 (μV/V/mmHg)200 to 3000 Ω | 5 (μV/V/mmHg)300 to 3000 Ω | Same |
CO2 Monitor(EDAD CO2 Module(Sidestream), Respironics
CAPNOSTAT 5 LoFlo CO2(Sidestream))
| Technique | Infra-red Absorption Technique | Infra-red Absorption Technique | Same |
|---|---|---|---|
| MeasureParameters | EtCO2, FiCO2, AwRR | EtCO2, FiCO2, AwRR | Same |
| CO2Measurementrange | 0 mmHg to 150 mmHg | 0 to 99 mmHg | Similar |
| AwRRMeasurementrange | 2 rpm to 150 rpm | 0 to 150 rpm | Similar |
| Accuracy | EDAN:Respiratory rate ≤60rpm: ± 2mmHg,0mmHg to 40mmHg, ± 5% ofreading, 41mmHg to 70mmHg, ± 8%of reading, 71mmHg to 100mmHg, ±10% of reading, 101mmHg to150mmHg,Respiratory rate >60rpm: ±12% or ±4mmHg of reading, whichever isgreaterRespironics:± 2 mmHg, 0 to 40 mmHg, ± 5 % ofreading, 41 to 70 mmHg, ± 8 % ofreading, 71 to 100 mmHg, ± 10 % ofreading, 101 to 150 mmHg, ± 12% ofreading, RR is over 80 rpm | 0 to 38 mmHg: ±2 mmHg39 to 99 mmHg: ±5% of thereading+0.08% of (thereading-38) | Similar |
{20}------------------------------------------------
| Resolution | 1 mmHg | 1 mmHg | Same |
|---|---|---|---|
| Sample flow rate | EDAN:70ml/min or 100ml/min, optional (±15ml/min)Respironics :50 ±10 ml/min | $50_{-7.5}^{+15}$ ml/min | Similar |
| Apnea Alarm Delay | 10s, 15s, 20s, 25s, 30s, 35s, 40s; | 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s | Same |
CO2 Monitor ( Respironics CAPNOSTAT 5 CO2 ( Mainstream CO2 )
| MeasureParameters | EtCO2, FiCO2, AwRR | EtCO2, FiCO2, AwRR | Same |
|---|---|---|---|
| CO2Measurementrange | 0 mmHg to 150 mmHg | 0 to 150 mmHg | Same |
| AwRRmeasurementrange | 0 rpm to 150 rpm | 0 to 150 rpm | Same |
| Accuracy | ± 2 mmHg, 0 to 40 mmHg, ± 5 % ofreading, 41 to 70 mmHg, ± 8 % ofreading, 71 to 100 mmHg, ± 10 % ofreading, 101 to 150 mmHg | 0 to 40 mmHg: ±2 mmHg41 to 70 mmHg: ±5% of thereading71 to 100 mmHg: ±8% of thereading101 to 150 mmHg: ±10% of thereading | Similar |
| Resolution | 1 mmHg | 1 mmHg | Same |
| awRRmeasurementaccuracy | ± 1 rpm | 1 rpm | Same |
AG Monitor(Phasein and Drager)
| Technique | Infrared absorption | Infrared absorption | Same | |||||
|---|---|---|---|---|---|---|---|---|
| Warm-up time | Full accuracy mode: $< 20s$ (Phasein)Full accuracy mode: $< 450 s$ (Drager) | Full accuracy mode: 10 min | Similar | |||||
| Sample flow rate | $50\pm10$ ml/min(Phasein)$200$ mL/min $\pm20$ mL/min(Drager) | Adult, pediatric: 120, 150, 200 ml/minNeonate: 70, 90, 120 ml/minAccuracy: $\pm10$ ml/min or $\pm10$ %, whichever is greater | Similar | |||||
| MeasurementRange andAccuracy | Phasein | Range(%REL) | Accuracy(%ABS) | Range (%REL) | Accuracy(%ABS) | Similar | ||
| CO | Phasein | Sidest | 0 to 15 vol% | $\pm$ (0.2 vol% + 2% of | 0 to 11 to 5 | $\pm$ 0.1$\pm$ 0.2 | Similar |
{21}------------------------------------------------
K160981 p.19/28
| 2 | ream | 15 to 25vol% | ±(0.3 vol% +reading) | 5 to 7 | ±0.3 | |
|---|---|---|---|---|---|---|
| Unspecified | 7 to 10 | ±0.5 | ||||
| Mainstream | 0 to 10vol% | ±(0.2 vol% +2% ofreading) | >10 | Notspecified | ||
| 10 to15vol% | ±(0.3 vol% +2% ofreading) | |||||
| 15 to 25vol% | ±(0.3 vol% +2% ofreading) | |||||
| Unspecified | ||||||
| Drager | 0 to13.6Vol% | ±(0.43 Vol% +8% rel.) | ||||
| O2 | Phasein(Sidestream) | 0 to 100vol % | ±(1 vol% +2% ofreading) | 0 to 2525 to 8080 to 100 | ±1±2±3 | |
| Drager | 0 to 100Vol% | ±(2.5 Vol% +2.5% rel.) | ||||
| N2O | Phasein(Sidestream&Mainstream) | 0 to 100vol% | ±(2 vol% +2% ofreading) | 0 to 2020 to 100 | ±2±3 | |
| Drager | 0 to 100Vol% | ±(2 Vol% +8% rel.) | ||||
| Des | Phasein(Sidestream&Mainstream) | 0 to 22vol % | ±(0.15 vol% +5% ofreading) | 0 to 11 to 55 to 1010 to 15 | ±0.15±0.2±0.4±0.6 | |
| 22 to 25vol % | Unspecified | |||||
| Drager | 0 to 20Vol% | ±(0.2 Vol% +15% rel.) | 15 to 18>18 | ±1Notspecified | ||
| Sev | Phasein(Sidestream&Mainstream) | 0 to 10vol % | ±(0.15 vol% +5% ofreading) | 0 to 11 to 55 to 8>8 | ±0.15±0.2±0.4Notspecified | |
| Drager | 0 to 10Vol% | ±(0.2 Vol% +15% rel.) | ||||
| Enf | Phasein(Sidestream&Mainstream) | 0 to 8vol % | ±(0.15 vol% +5% ofreading) | 0 to 11 to 5>5 | ±0.15±0.2Notspecified | |
| Drager | 0 to 10 | ±(0.2 Vol% + |
{22}------------------------------------------------
| Vol% | 15% rel.) | |||||||
|---|---|---|---|---|---|---|---|---|
| Iso | Phasein(Sidestream&Mainstream) | 0 to 8 vol %8 to 25 vol % | ±(0.15 vol% +5% ofreading)Unspecified | 0 to 11 to 5>5 | ±0.15±0.2Notspecified | |||
| Hal | Phasein(Sidestream&Mainstream) | 0 to 8 vol %8 to 25 vol % | ±(0.15 vol% +5% ofreading)Unspecified | 0 to 11 to 5>5 | ±0.15±0.2Notspecified | |||
| Drager | 0 to 8.5 Vol% | ±(0.2 Vol% +15% rel.) | ||||||
| Drager | 0 to 8.5 Vol% | ±(0.2 Vol% +15% rel.) | ||||||
| ICG | ||||||||
| Technique | Thoracic electrical bioimpedance | Thoracic electricalbioimpedance (TEB) | Same | |||||
| Measurementrange | SV: 0 ml/beat | SV: 5 to 250 ml/beatHR: 44 to 185 bpmC.O.: 1.4 to 15 L/min | Similar | |||||
| Accuracy | SV: UndefinedHR: ±2bpmC.O.: Undefined | SV: Not specified.HR: ±2 bpmC.O.: Not specified. | Same | |||||
| BIS | ||||||||
| Technique | Bispectral index | Bispectral index | Same | |||||
| Measuredparameters | EEGBIS: 0 to 100 | EEGBIS: 0 to 100 | Same | |||||
| Impedancerange | 0 to 999 kΩ | 0 to 999 kΩ | Same | |||||
| Sweep speed | 6.25mm/s,50mm/s | 12.5mm/s, | 25mm/s, | 6.25 mm/s, 12.5 mm/s, 25 mm/sor 50 mm/s | Same | |||
| Noise (EEGWaveform) | <0.3 $\mu$ V (0.25Hz~50Hz) | <0.3 $\mu$ V (0.25Hz~50Hz) | Same | |||||
| EEGbandwidth | 0.25Hz~50Hz | 0.25 to 100 Hz | Same | |||||
| RM | ||||||||
| Frequencyresponse | >10Hz | ≥30 Hz | Similar | |||||
| Flow |
{23}------------------------------------------------
| Measurement | |||
|---|---|---|---|
| Measurementrange | Adult: 2.0 L/min to 180 L/minPediatric: 0.75 L/min to 100 L/minNeonatal: 0.25 L/min to 30 L/min | Adult/pediatric*: ± (2 to 120) L/minInfant: ± (0.5 to 30) L/min | Similar |
| Accuracy | Adult: 0.5 L/min or ± 3% of reading,whichever is greaterPediatric: 0.25 L/min or ± 3% ofreading, whichever is greaterNeonatal: 0.125 L/min or ± 3% ofreading, whichever is greater | Adult/pediatric*: 1.5 L/min or±10% of the reading, whicheveris greaterInfant: 0.5 L/min or ±10% of thereading, whichever is greater | |
| Resolution | 1.0 L/min | 0.1 L/min | |
| Paw(or Airway Pressure) | |||
| Measurementrange | -120 cmH2O to 120 cmH2O | -20 to 120 cmH2O | Similar |
| Accuracy | 0.5 cmH2O or ± 2% of reading,whichever is greater | ±3% | |
| Resolution | 1 cmH2O | 0.1 cmH2O | |
| MVe/MVi | |||
| Measurementrange | Adult: 1 L/min to 30.00 L/minPediatric: 0.3 L/min to 20 L/minNeonatal: 0.1 L/min to 3 L/min | Adult/Pediatric*: 2 to 60 L/minInfant: 0.5 to 15 L/min | Similar |
| Accuracy | Adult: 0.1 L/minPediatric: 0.1 L/minNeonatal: 0.1 L/min | ±10%×reading | |
| TVe/TVi | |||
| Measurementrange | Adult: 40 mL to 2500 mLPediatric: 6 mL to 750 mLNeonatal: 2 mL to 100 mL | Adult/Pediatric*: 100 to 1500mlInfant: 20 to 500 ml | Similar |
| Resolution | 1.0 mL | 1 ml | |
| Accuracy | Adult: ± 10.0 mL or ± 5% of reading,whichever is greaterPediatric: ± 3.0 mL or ± 5% ofreading, whichever is greaterNeonatal: ± 1.0 mL or ± 5% ofreading, whichever is greater | Adult/pediatric*: ±10% or 15ml, whichever is greaterInfant: ±10% or 6 ml, whicheveris greater | |
| RR (RM) | |||
| Measurementrange | 2 rpm to 150 rpm | 4 to 120 rpm | Similar |
| Accuracy | ± 1 rpm | 4 to 99 rpm ±1 rpm100 to 120 rpm ±2 rpm | |
| Safety Classifications |
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| Type ofprotectionagainst electricshock | Class I | Class I | Same | |
|---|---|---|---|---|
| IngressProtection | IPX1 | IPX1 | Same | |
| The degree ofRF | Group 1, Class A | Group 1, Class A | Same | |
| The degree of protection against electric shock | ||||
| ECG, RESP,TEMP, IBP,C.O. | CF | CF | Same | |
| ICG, NIBP,SpO2, | BF | CF | Similar | |
| CO2, AG, BIS,RM, ICG | BF | BF | Same | |
| Electrical & Mechanical safety & Thermal safety Standards | ||||
| GeneralStandards | IEC 60601-1:2005 | IEC 60601-1:1988+A1:1991+A2:1995 | Similar | |
| EMCStandards | IEC 60601-1-2:2007 | IEC60601-1-2: 2001+A1:2004 | ||
| AlarmStandards | IEC 60601-1-8:2006 | IEC60601-1-8:2003 | ||
| Biocompatibility Standards | ISO 10993-1:2009 | ISO 10993-1:2003 | ||
| SoftwareStandards | IEC 62304:2006 | IEC 62304:2006 | ||
| Special Standards | ||||
| basic safetyand essentialperformancefor patientmonitor | IEC 60601-2-49: 2011 | IEC 60601-2-49: 2001 | Similar | |
| ECG | IEC 60601-2-27: 2011IEC 60601-2-25: 2011 | IEC 60601-2-27:2005IEC 60601-2-25: 1999 | ||
| NIBP | IEC 80601-2-30: 2009ISO 81060-2 | IEC60601-2-30:2000 | ||
| IBP | IEC 60601-2-34: 2011 | IEC60601-2-34:2000 | ||
| AG, CO2, RM | ISO 80601-2-55 | ISO21647:2004 | ||
| TEMP | ISO 80601-2-56EN12470-4:2000 | EN12470-4:2000 | ||
| Power supply | ||||
| AC power | ||||
| Requirement | 100-240V, 50/60Hz | 100-240V, 50/60 Hz | Same | |
| Battery | ||||
| Rechargeable Battery | Yes | Yes | Same | |
| Operation characteristic | ||||
| Installation and use | Portable EquipmentFix Equipment (when the system isinstalled on Wall Mounting Bracket) | Portable EquipmentFix Equipment (when thesystem is installed on WallMounting Bracket) | Same | |
| Working System | Continuous operation | Continuous operation | Same | |
| Physical Characteristics | ||||
| Weight | elite V5 : <6.2kgelite V6: <7.5kgelite V8: <14kg | <14.5 kg | Similar | |
| Dimensions | elite V5 : 333±2 mm (L) × 289±2 mm(H)× 211±2mm (W)elite V6: 384±2 mm (L) × 320±2 mm(H)× 213±2mm (W)elite V8: 425 mm (L) × 245 mm (W)×382 mm (H) | 400×370×193 mm | ||
| LCD | elite V5: 12.1 inches LCDelite V6: 15 inches LCDelite V8: 17 inches LCD | 17inch LCD | ||
| LCD Resolution | elite V5: 800x600elite V6: 1024*768elite V8: 1280 *1024 | 1280×1024 pixels | ||
| Environmental Specifications | ||||
| Temperature | ||||
| Working | +0°C to +40°C | 5 to 40 | Similar | |
| Transport and Storage | -20°C to +55°C | 20 to 60 | ||
| Humidity | ||||
| Working | 15% to 95% (non-condensing) | 15% to 95% (non-condensing) | Same | |
| Transport and Storage | 15% to 95% (non-condensing) | 10% to 95%(non-condensing) | Similar | |
| Altitude | ||||
| Working | 860hPa to 1060hPa | 425 to 809mmHg | Similar | |
| Transport and | 700hPa to 1060hPa | 120 to 809mmHg |
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| Storage | |||
|---|---|---|---|
| Other function | |||
| Indicators | |||
| Alarmindicator | 3(red/yellow/blue) | 3(red/yellow/blue) | Same |
| AC powerindicator | 1(green) | 1(green) | Same |
| Batteryindicator | 1(green) | 1(green/ yellow) | Same |
| Speaker | Yes | Yes | Same |
| Recorder | Yes | Yes | Same |
| Data Storage | Trend, NIBP Measurement Review,Alarm Review ,Arrhythmia Review,12-Lead Diagnosis Review,Full-disclosure waveforms | Trends, Parameter alarms, Arrh.events, NIBP measurements,Interpretation of resting12-lead ECG results,Full-disclosure waveforms | Similar |
| Interface | USB/VGA/Network/Nursecall/DefibrillatorSynchronization/AnalogOutput/SD/PAM/DVI/RS232 port | USB/Network/Nursecall/Micro-Dt/Network/CIS/SMR/CF/DVI port | Similar |
Comparison to the predicate iM70
| Item | Proposed deviceselite V5, elite V6, elite V8 | Predicate deviceiM70 | Justification |
|---|---|---|---|
| K# | Current Submission | K131971 | — |
| RESP | — | — | — |
| Patient | Adult pediatric neonate | Adult pediatric neonate | Same |
| Method | Impedance betweenRA-LL, RA-LA | Impedance betweenRA-LL, RA-LA | Same |
| Measurementlead | Options are lead I and II.The default is lead II. | Options are lead I and II.The default is lead II. | Same |
| CalculationType | Manual, Automatic | Manual, Automatic | Same |
| BaselineImpedanceRange | 200 Ω to 2500 Ω (withECG cables of 1 K Ωresistance) | 200 Ω to 2500 Ω (withECG cables of 1 K Ωresistance) | Same |
| MeasuringSensitivity | Within the baselineimpedance range: 0.3 Ω | Within the baselineimpedance range: 0.3 Ω | Same |
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| WaveformBandwidth | 0.2 Hz to 2.5 Hz (-3 dB) | 0.2 Hz to 2.5 Hz (-3 dB) | Same | ||
|---|---|---|---|---|---|
| RespirationExcitationWaveform | Sinusoid, 62.8 kHz( ±10%), <500 μ A | Sinusoid, 62.8 kHz( ±10%), <500 μ A | Same | ||
| RR Measuring Range | |||||
| Adult | 0 rpm to120 rpm | 0 rpm to120 rpm | Same | ||
| Neo/Ped | 0 rpm to150 rpm | 0 rpm to150 rpm | Same | ||
| Resolution | l rpm | 1 rpm | Same | ||
| Accuracy | |||||
| Adult | 6 to 120 rpm: 土2 rpm0 to 5 rpm: not specified | 6 to 120 rpm: 土2 rpm0 to 5 rpm: not specified | Same | ||
| Neo/Ped | 6 to 150 rpm: 土2 rpm0 to 5 rpm: not specified | 6 to 150 rpm: 土2 rpm0 to 5 rpm: not specified | Same | ||
| GainSelection | x0.25, x0.5, x1, x2, x3, x4,૪૨ | x0.25, x0.5, x1, x2, x3, x4,૪૨ | Same | ||
| Sweep | 6.25 mm/s, 12.5 mm/s, 25mm/s, 50 mm/s | 6.25 mm/s, 12.5 mm/s, 25mm/s, 50 mm/s | Same | ||
| Apnea AlarmTime Setup | 10 s, 15 s, 20 s, 25 s, 30 s,35 s, 40 s; default value is20 s. | 10 s, 15 s, 20 s, 25 s, 30 s,35 s, 40 s; default value is20 s. | Same | ||
| WI-FI | |||||
| IEEE | 802.11b/g/n | 802.11b/g/n | Same | ||
| FrequencyBand | 2.4GHz ISM band | 2.4GHz ISM band | Same | ||
| Modulation | OFDM with BPSK, QPSK,16-QAM, and 64-QAM802.11b with CCK and DSSS | OFDM with BPSK, QPSK,16-QAM, and 64-QAM802.11b with CCK and DSSS | Same | ||
| TypicalTransmitPower (±2dBm) | 17 dBm for 802.11b DSSS17 dBm for 802.11b CCK15 dBm for 802.11g/n OFDM | 17 dBm for 802.11b DSSS17 dBm for 802.11b CCK15 dBm for 802.11g/n OFDM | Same | ||
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| Care and Cleaning | |||
|---|---|---|---|
| Recommended cleaning agents | Mild neutral detergentEthanol (75%)Isopropanol (70%) | Mild neutral detergentEthanol (75%)Isopropanol (70%) | Same |
| Recommended types of disinfecting agents | Ethanol (75%)Isopropanol (70%)Cidex OPA (High level disinfection of intracavitary temperature probe only) | Ethanol (75%)Isopropanol (70%)Cidex OPA (High level disinfection of intracavitary temperature probe only) | Same |
| Cleaning | surface-clean the monitor witha soft cloth dampened withthe cleaning solution | surface-clean the monitor witha soft cloth dampened withthe cleaning solution | Same |
| Disinfecting | Following hospital's policy | Following hospital's policy | Same |
All the differences don't affect the safety and effectiveness which is concluded after all the required testing, so no safety and effectiveness issues relating to the patient monitor come into conclusion.
10. Performance Data:
Non-clinical data:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the elite V5, elite V6 and elite V8 Patient Monitor were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for a duration of less than 24 hours. And the battery of testing included the following tests:
- Cytotoxicity
- Skin Sensitization
- Skin Irritation
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the elite V5, elite V6 and elite V8 Patient Monitor device, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1:2005/A1: 2012, IEC 60601-1-8: 2006, IEC 60601-2-25: 2011, IEC 60601-2-27: 2011, ANSI/AAMI EC57: 2012, IEC 80601-2-30: 2009, IEC 60601-2-34: 2011 , IEC 60601-2-49: 2011, ISO 80601-2-55: 2011, ISO
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80601-2-56: 2009, ISO 80601-2-61: 2011 and ISO 81060-2: 2013 standards for safety and the IEC 60601-1-2:2007 standard for EMC.
| standards | conclusion |
|---|---|
| IEC60601-1-8 - Medical electrical equipment - Part 1-8: Generalrequirements for basic safety and essential performance - CollateralStandard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems- Test reportof elite V series (2006). | Pass |
| IEC 60601-2-25 Medical electrical equipment - Part 2-25: Particularrequirements for the basic safety and essential performance ofelectrocardiographs - Test Report of elite V series (2011 ) | Pass |
| · IEC 60601-2-27 Medical electrical equipment - Part 2-27: Particularrequirements for the basic safety and essential performance ofelectrocardiographic monitoring equipment - Test Report of elite V series(2011) | Pass |
| IEC 60601-2-34 - Medical electrical equipment - Part 2-34: Particularrequirements for the basic safety, including essential performance, ofinvasive blood pressure monitoring equipment - Test Report of elite Vseries (2011 | Pass |
| IEC60601-2-49 - Medical electrical equipment Part 2-49: Particularrequirements for the basic safety and essential performance ofmultifunction patient monitoring equipment - Test Report of elite Vseries(2011) - (This standard is not recognized by FDA) | Pass |
| IEC 80601-2-30 - Medical electrical equipment - Part 2-30: Particularrequirements for the basic safety and essential performance of automatednon-invasive sphygmomanometers - Test Report of elite V series | Pass |
| ISO 80601-2-55 - Medical electrical equipment - Part 2-55: Particularrequirements for the basic safety and essential performance of respiratorygas monitors - Test Report of elite V series | Pass |
| ISO 80601-2-56 - Medical electrical equipment - Part 2-56: Particularrequirements for basic safety and essential performance of clinicalthermometers for body temperature measurement - Test Report of elite Vseries. | Pass |
| ISO 80601-2-61 - Medical electrical equipment - Part 2-61: Particularrequirements for basic safety and essential performance of pulse oximeterequipment - Test Report of elite V series | Pass |
| IEC62366 - Medical devices - Application of usability engineering to | Pass |
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medical devices - Test Report of elite V Series
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." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Clinical data:
Not applicable.
Summary
Based on the non-clinical and clinical performance as documented in the system development, the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device.
11. Conclusion
The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the elite V5, elite V6 and elite V8 Patient Monitor device should perform as intended in the specified use conditions. The clinical data demonstrate that the subject devices perform comparably to the predicate device that is currently marketed for the same intended use. In other words, the subject the elite V5, elite V6 and elite V8 Patient Monitor devices are substantially equivalent to the predicate devices.
§ 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.