(59 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 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 mechanice 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.
LMPLUS series Patient Monitor including LMPLUS-12, LMPLUS-15 and LMPLUS-17 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 LMPLUS 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 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 LMPLUS series Patient Monitor, the user may select different monitoring parameters in according with their requirements.
LMPLUS-12 configures with 12.1-inch color TFT touch screen, LMPLUS-15 and LMPLUS-17 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 focuses on the 510(k) summary for the CAF Medical Solutions Inc. Patient Monitor (models LMPLUS-12, LMPLUS-15, and LMPLUS-17), demonstrating its substantial equivalence to a predicate device (Edan Instruments, Inc. Patient Monitor, models elite V5, elite V6, and elite V8). The document primarily presents a feature-by-feature comparison and non-clinical performance data, with a brief mention of clinical tests.
Therefore, the information regarding acceptance criteria and the study proving the device meets them will be limited to what is explicitly stated in the document or can be inferred from the provided test types and standards. A full, detailed study proving acceptance criteria for specific performance metrics (like sensitivity, specificity, or inter-reader variability for an AI model) is not present in this type of regulatory submission document, which focuses on substantial equivalence to a predicate rather than a novel AI algorithm.
Based on the provided document, here's what can be extracted and inferred regarding performance and validation:
The document indicates that the device's performance was evaluated against various recognized standards for patient monitors, which inherently define acceptable performance ranges for each physiological parameter. The study primarily aims to show that the new device meets these established standards and performs comparably to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" in the format of a pre-defined threshold that the device must meet for a specific study's outcome (e.g., "sensitivity > X%"). Instead, it shows a feature-by-feature comparison to a predicate device, including various performance specifications (e.g., accuracy, measurement range) that are in line with industry standards for patient monitors. The "Acceptance Criteria" are implicitly defined by the parameters and accuracy/range specifications of the predicate device and the relevant IEC/ISO standards the device claims compliance with. The "Reported Device Performance" for the subject device (LMPLUS models) is stated to be "Same" as the predicate device across all listed specifications.
Here's an illustrative table based on the provided comparison, highlighting key physiological parameters:
| Feature/Parameter | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (LMPLUS Models) | Comparison to Acceptance |
|---|---|---|---|
| ECG Monitor | |||
| Measurement Range (Adult) | 15 to 300 bpm | 15 to 300 bpm | Meets |
| Accuracy | ±1 bpm or ±1%, whichever is greater | ±1 bpm or ±1%, whichever is greater | Meets |
| ST Value Accuracy | -0.8 to +0.8 mV: ±0.02 mV or 10% | -0.8 to +0.8 mV: ±0.02 mV or 10% | Meets |
| RESP Monitor | |||
| Measurement Range (Adult) | 0 to 120 rpm | 0 to 120 rpm | Meets |
| Accuracy (Adult) | 6 to 120 rpm: ±2 rpm | 6 to 120 rpm: ±2 rpm | Meets |
| Temperature Monitor | |||
| Measurement Range | 0 to 50°C | 0 to 50°C | Meets |
| Accuracy | ±0.1°C (±0.2°F) | ±0.1°C (±0.2°F) | Meets |
| SpO2 Monitor | |||
| Measurement Range | 0-100% | 0-100% | Meets |
| Accuracy (Adult/Pediatric, no motion) | 70 to 100%: ±2% | 70 to 100%: ±2% | Meets |
| NIBP Monitor | |||
| Max Mean Error | ±5 mmHg | ±5 mmHg | Meets |
| Max Standard Deviation | 8 mmHg | 8 mmHg | Meets |
| CO2 Monitor (EDAN) | |||
| Accuracy (≤60rpm) | ±2mmHg, 0-40mmHg; ±5%, 41-70mmHg; etc. | ±2mmHg, 0-40mmHg; ±5%, 41-70mmHg; etc. | Meets |
| Other | Compliance with specific IEC/ISO standards | Compliance with specific IEC/ISO standards | Meets |
Note: The table above is a summary of just a few representative parameters from the much larger comparison table (Table 1) in the document. The general "Acceptance Criteria" for all listed parameters are the identical specifications of the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Clinical tests were performed on the LMPLUS 12, LMPLUS 15 and LMPLUS 17 monitors to validate their performance in terms of noninvasive blood pressure (NIBP) and SpO2 accuracy."
However, the specific sample sizes for these clinical tests (number of patients, number of measurements) and the data provenance (e.g., country of origin, retrospective or prospective nature) are not detailed in this 510(k) summary. This level of detail would typically be found in the full test report, which is referenced but not included.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document mentions "clinical tests" for NIBP and SpO2 accuracy. For these types of physiological measurements, the ground truth is typically established by:
- Reference Devices: Using highly accurate, calibrated reference measurement devices.
- Clinical Protocols: Adhering to established clinical protocols for data collection (e.g., for NIBP, a protocol like ISO 81060-2 which often involves comparisons to invasive arterial measurements or calibrated sphygmomanometers by trained healthcare professionals).
There is no mention of human experts being used to establish "ground truth" in the context of interpretation (e.g., radiologists for imaging, unlike an AI algorithm for image analysis). The device measures physiological parameters, and accuracy is validated against established, objective measurement techniques, not expert consensus on qualitative data. Therefore, the concept of "experts establishing ground truth" as it applies to subjective judgments or interpretations (which is common for AI/ML in imaging) is not directly applicable here.
4. Adjudication Method for the Test Set
Given that the clinical tests mentioned are for quantitative physiological parameter accuracy (NIBP and SpO2), adjudication methods like 2+1 or 3+1 (common in studies involving multiple readers for subjective assessments) are not applicable. Accuracy is determined by comparing device readings to a reference standard, not by expert consensus on interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was mentioned or implied.
This device is a patient monitor, not an AI-assisted diagnostic tool that would involve human readers interpreting cases. Therefore, a study to measure how much human readers improve with AI assistance is not relevant to this type of device and was not performed.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop)
The document does not describe the device as having a distinct "algorithm" component for analysis that would be evaluated in isolation. It's a physiological monitoring device. Its accuracy in measuring parameters like NIBP and SpO2 is its "standalone performance." The clinical tests mentioned (for NIBP and SpO2 accuracy) would indeed be an assessment of the device's ability to accurately measure these parameters independently, which is effectively its standalone performance. The results are implied by the statement "the subject devices perform comparably to the predicate device."
7. Type of Ground Truth Used
For the clinical tests (NIBP and SpO2 accuracy), the ground truth would be established through:
- Reference Standard Measurements: Using a highly accurate and validated reference device (e.g., an invasive arterial line for NIBP, or a co-oximeter for SpO2) or an established standardized method as per relevant ISO standards (e.g., ISO 81060-2 for NIBP).
- Physiological Data: Direct physiological measurements, not pathology, outcomes data, or expert consensus on subjective interpretations.
8. Sample Size for the Training Set
This document describes a conventional patient monitor, not a medical device that utilizes AI/ML requiring a distinct "training set" of data to learn from. Therefore, there is no mention of a training set or its sample size. The device's algorithms for processing physiological signals are based on established engineering principles and signal processing, not machine learning from a large training dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of device, this question is not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
August 1, 2022
CAF Medical Solutions Inc. % Juan Tezak Consultant Compliance 4 Devices 118 W Prive Cr. Delray Beach, Florida 33445
Re: K221616
Trade/Device Name: Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17 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, DST, MLD, DRT, DXN, DSK, FLL, DQA, CCK, CBQ, NHQ, NHP, CBS, CBR, CCL, DRG, DPS Dated: June 3, 2022 Received: June 3, 2022
Dear Juan Tezak:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221616
Device Name
Patient Monitor, models LMPLUS 12, LMPLUS 15 and LMPLUS 17.
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 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 mechanice 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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Image /page/3/Picture/0 description: The image shows the logo for Lifee Medical Devices. The logo consists of a red heart rate line on the left, followed by the word "lifee" in purple. Below the word "lifee" is the phrase "medical devices" in a smaller, red font.
510(k) Summary
Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17 June, 2022
ADMINISTRATIVE INFORMATION
Applicant
CAF Medical Solutions Inc. 17539 Roberts Road, Hockley TX 77477 USA E-mail: c.ortiz@cafmedical.com
Establishment Registration Number
| Official Contact | Oscar Arriaga Yamin |
|---|---|
| Legal Representative | |
| 17539 Roberts Road, Hockley | |
| TX 77477 USA | |
| Phone: +1 713 614 7049 | |
| E-mail: c.ortiz@cafmedical.com |
| Representative/Consultant | Juan Tozak |
|---|---|
| --------------------------- | ------------ |
| Representative/Consultant | Juan Tezak |
|---|---|
| Carlos Marín | |
| Compliance4Devices | |
| 118 W Prive Cr. Delray Beach Fl, 33445 | |
| Phone: +1 561-789-2411 | |
| E-mail: compliance4devices@gmail.com |
DEVICE AND CLASSIFICATION NAME
| Device Trade Name: | Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17 | |
|---|---|---|
| Regulatory Class: | Class II | |
| Prior Submission: | K160981 | |
| Device name, classification andproduct code: | · 870.1025 monitor, physiological, patient (witharrhythmia detection or alarms)/ MHX· 870.1025 Detector and Alarm, Arrhythmia/ DST· 870.1025 Monitor, ST Segment with Alarm/ MLD· 870.2300 Cardiac monitor (includingcardiotachometer and rate alarm)/ DRT· 870.1130 Non-Invasive blood pressure/ DXN· 870.1110 Blood pressure computer/ DSK |
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Image /page/4/Picture/1 description: The image shows the logo for Lifee Medical Devices. The logo consists of a red heart rate line to the left of the word "lifee" in purple. Below the word "lifee" is the phrase "medical devices" in red.
- · 880.2910 Clinical Electronic Thermometers-Temperature Monitor with Probe/ FLL
- · 870.2700 Oximeter, Pulse/ DQA
- · 868.1400 Carbon Dioxide Gas Analyzer/ CCK
- · 868.1500 Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)/ CBQ
- · 868.1500 Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)/NHO
- · 868.1500 Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)/NHQ
- · 868.1500 Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)/NHP
- · 868.1620 Halothane gas analyzer/ CBS
- · 868.1700 Nitrous Oxide gas analyzer/ CBR
- · 868.1720 Oxygen gas analyzer/ CCL
- · 870.2770 Impedance plethysmograph/ DSB
- · 868.1850 Monitoring spirometer/ BZK
- · 868.2375 Monitor, Breathing Frequency/BZQ
- · 870.2340 Electrocardiograph/DPS
- · 870.2910 Radiofrequency physiological signal transmitter and receiver/ DRG
Predicate Device Information
Predicate Device:
K160981. Patient Monitor, models elite V5, elite V6 and elite V8. Edan Instruments, Inc.
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.
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Image /page/5/Picture/0 description: The image shows the logo for Lifee Medical Devices. The logo consists of a red heart-shaped graphic with an EKG waveform on the left, followed by the word "lifee" in a dark purple, rounded sans-serif font. Below "lifee" are the words "medical devices" in a smaller, light red sans-serif font.
Device Description
LMPLUS series Patient Monitor including LMPLUS-12, LMPLUS-15 and LMPLUS-17 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 LMPLUS 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 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 LMPLUS series Patient Monitor, the user may select different monitoring parameters in according with their requirements.
LMPLUS-12 configures with 12.1-inch color TFT touch screen, LMPLUS-15 and LMPLUS-17 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.
Contraindications:
There are no known contraindications for use.
Equivalence to Marketed Device
The LMPLUS series Patient Monitor is substantially equivalent to the predicate. In further support of a substantial equivalence determination, here-under is a comparison chart with the submitted device and predicate device.
| Feature | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| K # | Current submission | K160981 | |
| 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 | 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 | Same |
| Feature | Subject Device | Predicate Device | Comparison |
| (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. | 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. | ||
| Intendedpatientpopulation | Adult, pediatric and neonatal patients | Adult, pediatric and neonatal patients | Same |
| Intendedapplicationenvironment | Hospital environment. | Hospital environment. | Same |
| 1) 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 to 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 (x0.125),2.5mm/mV (x0.25), 5mm/mV (x0.5), 10mm/mV (x1),20mm/mV (x2), 40mm/mV (x4),AUTO gain | 1.25mm/mV (x0.125),2.5mm/mV (x0.25),5mm/mV (x0.5), 10mm/mV (x1), 20mm/mV (x2),40mm/mV (x4),AUTO gain | Same |
| Sweep | 6.25mm/s, 12.5mm/s,25mm/s, 50mm/s | 6.25mm/s, 12.5mm/s,25mm/s, 50mm/s | Same |
| MeasurementRange | Neonate: 15 to 350 bpmPediatric: 15 to 350 bpm | Neonate: 15 to 350 bpmPediatric: 15 to 350 bpm | Same |
| Feature | Subject Device | Predicate Device | Comparison |
| CMRR(Common ModeRejection Ratio) | Diagnosis: >95dBMonitor: >105dBSurgery: >105dB | Diagnosis: >95dBMonitor: >105dBSurgery: >105dB | Same |
| Accuracy | ±1 bpm or ±1%, whichever isgreater | ±1 bpm or ±1%, whichever isgreater | Same |
| Resolution | 1 bpm | 1 bpm | Same |
| Sensibility | 200μV | 200μV | Same |
| DifferentialInputImpedance | >5ΜΩ | >5ΜΩ | Same |
| Leakage Currentof Patient | <10μΑ | <10μΑ | Same |
| ST valueMeasurementRange | -2.0 mV ~ +2.0 mV | -2.0 mV ~ +2.0 mV | Same |
| Accuracy | -0.8 mV to +0.8 mV: ±0.02 mVor 10%,whichever is greater.Beyond this range: notspecified. | -0.8 mV to +0.8 mV: ±0.02mV or 10%,whichever is greater.Beyond this range: notspecified. | Same |
| Pace | |||
| Pulse Indicator | Amplitude: ±2 mV to ±700 mVWidth: 0.1 ms to 2.0 msAscending time: 10 µs to 100µs | Amplitude: ±2 mV to ±700mVWidth: 0.1 ms to 2.0 msAscending time: 10 µs to100 µs | Same |
| Pulse Rejection | Amplitude: ±2 mV to ±700 mVWidth: 0.1 ms to 2.0 msAscending time: 10 µs to 100µs | Amplitude: ±2 mV to +700mVWidth: 0.1 ms to 2.0 msAscending time: 10 µs to100 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 isgreater | ±1% or 1 bpm, whichever isgreater | Same |
| Resolution | 1 bpm | 1 bpm | Same |
| 2) RESP monitor | |||
| Principle ofOperation | Thoracic impedance | Thoracic impedance | Same |
| Method | Impedance between RA-LL,RA-LA | Impedance between RA-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 |
| MeasurementRange | Adult:0 to 120 rpm | Adult:0 to 120 rpm | Same |
| Feature | Subject Device | Predicate Device | Comparison |
| 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 |
| CalculationType | Manual, Automatic | Manual, Automatic | Same |
| BaselineImpedanceRange | 2000Ω to 2500Ω (with ECGcables of 1 kΩ resistance) | 2000Ω to 2500Ω (with ECGcables of 1 kΩ resistance) | Same |
| MeasuringSensitivity | Within the baselineimpedance range: 0.3Ω | Within the baselineimpedance range: 0.3Ω | Same |
| 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 μΑ | Sinusoid, 62.8 kHz (±10%),<500 μΑ | Same |
| Resolution | 1 rpm | 1 rpm | Same |
| Apnea Alarm | 10s, 15s, 20s, 25s, 30s, 35s,40s | 10s, 15s, 20s, 25s, 30s, 35s,40s | Same |
| 3) Temperature monitor | |||
| Technique | Thermal resistance | Thermal resistance | Same |
| Number ofchannels | 2 | 2 | Same |
| MeasurementRange | 0 to 50°C | 0 to 50°C | Same |
| Accuracy | ±0.1°C (±0.2°F) | ±0.1°C (±0.2°F) | Same |
| Resolution | 0.1°C | 0.1°C | Same |
| 4) SpO2 monitor | |||
| MeasurementRange | 0-100% | 0-100% | Same |
| Accuracy | 70 to 100%: ±2% (measuredwithout motion inadult/pediatric mode).70 to 100%: ±3% (measuredwithout motion in neonatemode).0% to 69%: Not specified. | 70 to 100%: ±2% (measuredwithout motion inadult/pediatric mode).70 to 100%: ±3% (measuredwithout motion in neonatemode).0% to 69%: Not specified. | Same |
| Resolution | 1 % | 1 % | Same |
| 5) PR | |||
| MeasurementRange | 25 bpm to 300 bpm | 25 bpm to 300 bpm | Same |
| Accuracy | ±2bpm | ±2bpm | Same |
| Resolution | 1 bpm | 1 bpm | Same |
| 6) NIBP monitor | |||
| Principle ofOperation | Oscillation | Oscillation | Same |
| Adult: | Adult: | Same | |
| Feature | Subject Device | Predicate Device | Comparison |
| MeasurementRange (mmHg) | Systolic 40 to 270 mmHg | Systolic 40 to 270 mmHg | Same |
| Diastolic 10 to 215 mmHg | Diastolic 10 to 215 mmHg | Same | |
| Mean 20 to 235 mmHg | Mean 20 to 235 mmHg | Same | |
| Pediatric: | Pediatric: | Same | |
| Systolic 40 to 230 mmHg | Systolic 40 to 230 mmHg | Same | |
| Diastolic 10 to 180 mmHg | Diastolic 10 to 180 mmHg | Same | |
| Mean 20 to 195 mmHg | Mean 20 to 195 mmHg | Same | |
| Neonate: | Neonate: | Same | |
| Systolic 40 to 135 mmHg | Systolic 40 to 135 mmHg | Same | |
| Diastolic 10 to 100 mmHg | Diastolic 10 to 100 mmHg | Same | |
| Mean 20 to 110 mmHg | Mean 20 to 110 mmHg | Same | |
| Accuracy | Max mean error: ±5 mmHg,Max standard deviation: 8mmHg | Max mean error: ±5 mmHg,Max standard deviation: 8mmHg | Same |
| Resolution | 1mmHg | 1mmHg | Same |
| Overpressureprotection | Adult:297±3mmHg | Adult:297±3mmHg | Same |
| Pediatric:245±3mmHg | Pediatric:245±3mmHg | ||
| Pediatric:147±3mmHg | Pediatric:147±3mmHg | ||
| Mode | Manual, Auto, Continuous | Manual, Auto, Continuous | Same |
| Measuringinterval inAUTO Mode | 1/2/3/4/5/10/15/30/60/90/120/240/ 480min | 1/2/3/4/5/10/15/30/60/90/120/240/ 480min | Same |
| PR from NIBP | |||
| MeasurementRange | 40 bpm to 240bpm | 40 bpm to 240bpm | Same |
| Accuracy | ±3bpm or 3.5%, whichever isgreater | ±3bpm or 3.5%, whicheveris greater | Same |
| 7) IBP monitor | |||
| Technique | Direct invasive measurement | Direct invasivemeasurement | Same |
| MeasurementRange | -50 ~ 300mmHg | -50 ~ 300mmHg | Same |
| Accuracy | ±2% or ±1 mmHg, whichever isgreater (without sensor) | ±2% or ±1 mmHg, whicheveris greater (without sensor) | Same |
| Resolution | 1mmHg | 1mmHg | Same |
| Transducer | 5 (μV/V/mmHg)200 to 3000 Ω | 5 (μV/V/mmHg)200 to 3000 Ω | Same |
| 8) CO2 Monitor | |||
| CO2 Module | |||
| Respironics CAPNOSTAT 5 LoFlo CO2 (Sidestream) | |||
| Technique | Infra-red AbsorptionTechnique | Infra-red AbsorptionTechnique | Same |
| MeasureParameters | EtCO2, FiCO2, AwRR | EtCO2, FiCO2, AwRR | Same |
| Feature | Subject Device | Predicate Device | Comparison |
| CO2Measurementrange | 0 mmHg to 150 mmHg | 0 mmHg to 150 mmHg | Same |
| AwRRMeasurementrange | 2 rpm to 150 rpm | 2 rpm to 150 rpm | Same |
| Accuracy | EDAN:Respiratory rate ≤60rpm:±2mmHg, 0mmHg to40mmHg, ±5% of reading,41mmHg to 70mmHg, ±8% ofreading, 71mmHg to100mmHg, ±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%ofreading, 41 to 70 mmHg, ±8%of reading, 71 to 100 mmHg,±10% of reading, 101 to 150mmHg, ±12% of reading, RR isover 80 rpm. | EDAN:Respiratory rate ≤60rpm:±2mmHg, 0mmHg to40mmHg, ±5% of reading,41mmHg to 70mmHg, ±8%of reading, 71mmHg to100mmHg, ±10% of reading,101mmHg to 150mmHg,Respiratory rate >60rpm:±12% or ±4mmHg ofreading, whichever isgreater.Respironics:±2 mmHg, 0 to 40 mmHg,±5% ofreading, 41 to 70 mmHg,±8% of reading, 71 to 100mmHg, ±10% of reading,101 to 150 mmHg, ±12% ofreading, RR is over 80 rpm. | Same |
| Resolution | 1 mmHg | 1 mmHg | Same |
| Sample flowrate | EDAN: 70ml/min or100ml/min, optional(±15ml/min)Respironics:50 ±10 ml/min | EDAN: 70ml/min or100ml/min, optional(±15ml/min)Respironics:50 ±10 ml/min | Same |
| Apnea AlarmDelay | 10s, 15s, 20s, 25s, 30s, 35s,40s. | 10s, 15s, 20s, 25s, 30s, 35s,40s. | Same |
| Respironics CAPNOSTAT 5 CO2 (Mainstream) | |||
| MeasureParameters | EtCO2, FiCO2, AwRR | EtCO2, FiCO2, AwRR | Same |
| CO2Measurementrange | 0 mmHg to 150 mmHg | 0 mmHg to 150 mmHg | Same |
| AwRRmeasurementrange | 0 rpm to 150 rpm | 0 rpm to 150 rpm | Same |
| Accuracy | ±2 mmHg, 0 to 40 mmHg, ±5%of reading, 41 to 70 mmHg,±8% of reading, 71 to 100mmHg, ±10% of reading, 101to 150 mmHg | ±2 mmHg, 0 to 40 mmHg,±5% of reading, 41 to 70mmHg, ±8% of reading, 71to 100 mmHg, ±10% ofreading, 101 to 150 mmHg | Same |
| Feature | Subject Device | Predicate Device | Comparison |
| AwRRmeasurementaccuracy | $\pm$ 1 rpm | $\pm$ 1 rpm | Same |
| 9) C.O. Temperature | |||
| Measurementmethod | Thermodilution method | Thermodilution method | Same |
| Measurementrange | 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: -1 to 27°C | Same |
| Accuracy | C.O.: $\pm$ 5% or $\pm$ 0.2L/min, whichis greaterTB, TI: $\pm$ 0.1°C (without sensor) | C.O.: $\pm$ 5% or $\pm$ 0.2L/min,which is greaterTB, TI: $\pm$ 0.1°C (withoutsensor) | Same |
| Resolution | C.O.: 0.1L/minTB, TI:0.1°C | C.O.: 0.1L/minTB, TI:0.1°C | Same |
| 10) AG Monitor (Phasein and Drager) | |||
| Technique | Infrared absorption | Infrared absorption | Same |
| Warm-uptime | Full accuracy mode:<20s(Phasein)Full accuracy mode:<450s(Drager) | Full accuracy mode:<20s(Phasein)Full accuracy mode:<450s(Drager) | Same |
| Sample flowrate | 50 $\pm$ 10ml/min(Phasein)200 mL/min $\pm$ 20mL/min(Drager) | 50 $\pm$ 10ml/min(Phasein)200 mL/min $\pm$ 20mL/min(Drager) | Same |
| MeasurementRange andAccuracy | Range (%REL) | Accuracy(%ABS) | Same |
| CO2 | |||
| Phasein | |||
| Sidestream:0 to 15 vol%15 to 25vol% | Sidestream:$\pm$ (0.2 vol% +2% ofreading)Unspecified | Same | |
| Mainstream:0 to 10 vol%10 to 15vol%15 to 25vol% | Mainstream:$\pm$ (0.2 vol% +2% ofreading)$\pm$ (0.3 vol% +2% ofreading)Unspecified |
Table 1. Comparison with predicate device for Summary
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Image /page/6/Picture/0 description: The image shows the logo for Lifee Medical Devices. The logo consists of a red heart-shaped electrocardiogram symbol on the left, followed by the word "lifee." in purple. Below the word "lifee." are the words "medical devices" in red.
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Image /page/7/Picture/0 description: The image shows the logo for Lifee Medical Devices. On the left is a red heart rate monitor symbol. To the right of the symbol is the word "lifee" in purple, and below that is the phrase "medical devices" in red.
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Image /page/8/Picture/0 description: The image shows the logo for Lifee Medical Devices. To the left of the logo is a red heart rate graphic. To the right of the graphic is the word "lifee" in purple, with the words "medical devices" in red underneath.
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Image /page/9/Picture/0 description: The image shows the logo for Lifee Medical Devices. The logo consists of a red heart-shaped line drawing on the left, followed by the word "lifee." in purple. Below the word "lifee." are the words "medical devices" in a smaller font, also in purple.
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Image /page/10/Picture/0 description: The image shows the logo for Lifee Medical Devices. The logo consists of a red heart rate waveform on the left, followed by the word "lifee" in purple. Below the word "lifee" are the words "medical devices" in a smaller, red font.
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Image /page/11/Picture/0 description: The image shows the logo for Lifee Medical Devices. To the left of the logo is a red heart rate symbol. To the right of the symbol is the word "lifee" in purple, with the words "medical devices" in red underneath.
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Image /page/12/Picture/1 description: The image shows the logo for Lifee Medical Devices. On the left is a red heart rate monitor symbol. To the right of the heart rate monitor is the word "lifee" in a dark purple color. Underneath the word "lifee" are the words "medical devices" in a light red color.
| Feature | Subject Device | Predicate Device | Comparison | ||
|---|---|---|---|---|---|
| Drager | Drager | ||||
| 0 to 13.6Vol% | $\pm$ (0.43 Vol%+ 8% rel.) | 0 to 13.6Vol% | $\pm$ (0.43Vol% + 8% rel.) | Same | |
| O2 | O2 | ||||
| Phasein (Sidestream &Mainstream) | Phasein (Sidestream &Mainstream) | ||||
| 0 to 100 vol% | $\pm$ (1 vol% +2% ofreading) | 0 to 100 vol% | $\pm$ (1 vol% +2% ofreading) | Same | |
| Drager | Drager | ||||
| 0 to 100Vol% | $\pm$ (2.5 Vol% +2.5% rel.) | 0 to 100Vol% | $\pm$ (2.5 Vol%+ 2.5% rel.) | Same | |
| N2O | N2O | ||||
| Phasein (Sidestream &Mainstream) | Phasein (Sidestream &Mainstream) | Same | |||
| 0 to 100vol% | $\pm$ (2 vol% +2% ofreading) | 0 to 100vol% | $\pm$ (2 vol% +2% ofreading) | Same | |
| Drager | Drager | ||||
| 0 to 100Vol% | $\pm$ (2 Vol% + 8% rel.) | 0 to 100Vol% | $\pm$ (2 Vol% +8% rel.) | Same | |
| Des | Des | ||||
| Phasein (Sidestream &Mainstream) | |||||
| 0 to 22 vol %22 to 25 vol% | $\pm$ (0.15 vol%+ 5% ofreading)Unspecified | 0 to 22 vol%22 to 25 vol% | $\pm$ (0.15 vol%+ 5% ofreading)Unspecified | Same | |
| Drager | Drager | ||||
| 0 to 20 Vol% | $\pm$ (0.2 Vol% +15% rel.) | 0 to 20Vol% | $\pm$ (0.2 Vol%+ 15% rel.) | Same | |
| Sev | Sev | ||||
| Phasein (Sidestream &Mainstream) | |||||
| 0 to 10 vol %10 to 25 vol% | $\pm$ (0.15 vol%+ 5% ofreading)Unspecified | 0 to 10 vol%10 to 25 vol% | $\pm$ (0.15 vol%+ 5% ofreading)Unspecified | Same | |
| Drager | Drager | ||||
| 0 to 10 Vol% | $\pm$ (0.2 Vol% +15% rel.) | 0 to 10Vol% | $\pm$ (0.2 Vol%+ 15% rel.) | Same | |
| Enf | Enf | ||||
| Phasein (Sidestream &Mainstream) | |||||
| 0 to 8 vol %8 to 25 vol % | $\pm$ (0.15 vol%+ 5% ofreading)Unspecified | 0 to 8 vol %8 to 25 vol% | $\pm$ (0.15 vol%+ 5% ofreading)Unspecified | Same | |
| Drager | Drager |
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Image /page/13/Picture/0 description: The image shows the logo for Lifee Medical Devices. To the left of the logo is a red heart rate monitor symbol. To the right of the symbol is the word "lifee" in purple, with the words "medical devices" in red underneath.
| Feature | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| 0 to 10 Vol%IsoPhasein (Sidestream & Mainstream) | $\pm$ (0.2 Vol% + 15% rel.) | Same | |
| 0 to 10 Vol% | $\pm$ (0.2 Vol% + 15% rel.) | ||
| 0 to 8 vol %8 to 25 vol % | $\pm$ (0.15 vol% + 5% of reading) Unspecified | Same | |
| 0 to 8 vol %8 to 25 vol % | $\pm$ (0.15 vol% + 5% of reading) Unspecified | ||
| Drager0 to 8.5 Vol%Hal | $\pm$ (0.2 Vol% + 15% rel.) | Same | |
| Drager0 to 8.5 Vol%Hal | $\pm$ (0.2 Vol% + 15% rel.) | ||
| Phasein (Sidestream & Mainstream) | |||
| 0 to 8 vol %8 to 25 vol % | $\pm$ (0.15 vol% + 5% of reading) Unspecified | Same | |
| 0 to 8 vol %8 to 25 vol % | $\pm$ (0.15 vol% + 5% of reading) Unspecified | ||
| Drager0 to 8.5 Vol% | $\pm$ (0.2 Vol% +15% rel.) | Same | |
| Drager0 to 8.5 Vol% | $\pm$ (0.2 Vol% +15% rel.) | ||
| 11) 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, 12.5mm/s,25mm/s, 50mm/s | 6.25mm/s, 12.5mm/s,25mm/s, 50mm/s | Same |
| Noise (EEGWaveform) | <0.3μV (0.25Hz~50Hz) | <0.3μV (0.25Hz~50Hz) | Same |
| EEG bandwidth | 0.25Hz~50Hz | 0.25Hz~50Hz | Same |
| 12) RM | |||
| Frequencyresponse | >10Hz | >10Hz | Same |
| Flow | |||
| 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:2.0 L/min to 180 L/minPediatric:0.75 L/min to 100 L/minNeonatal:0.25 L/min to 30 L/min | Same |
| Accuracy | Adult:0.5 L/min or $\pm$ 3% of reading,whichever is greaterPediatric: | Adult:0.5 L/min or $\pm$ 3% of reading, whichever is greaterPediatric: | Same |
| Feature | Subject Device | Predicate Device | Comparison |
| 0.25 L/min or ± 3% of reading, whichever is greater | 0.25 L/min or ± 3% of reading, whichever is greater | ||
| Neonatal:0.125 L/min or ± 3% of reading, whichever is greater | Neonatal:0.125 L/min or ± 3% of reading, whichever is greater | ||
| Resolution | 1.0 L/min | 1.0 L/min | Same |
| Paw (or Airway Pressure) | |||
| Measurement range | -120 cmH2O to 120 cmH2O | -120 cmH2O to 120 cmH2O | Same |
| Accuracy | 0.5 cmH2O or ± 2% of reading, whichever is greater | 0.5 cmH2O or ± 2% of reading, whichever is greater | Same |
| Resolution | 1 cmH2O | 1 cmH2O | Same |
| MVe/MVi | |||
| Measurement range | 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:1 L/min to 30.00 L/minPediatric:0.3 L/min to 20 L/minNeonatal:0.1 L/min to 3 L/min | Same |
| Accuracy | Adult: 0.1 L/minPediatric: 0.1 L/minNeonatal: 0.1 L/min | Adult: 0.1 L/minPediatric: 0.1 L/minNeonatal: 0.1 L/min | Same |
| TVe/TVi | |||
| Measurement range | Adult: 40 mL to 2500 mLPediatric: 6 mL to 750 mLNeonatal: 2 mL to 100 mL | Adult: 40 mL to 2500 mLPediatric: 6 mL to 750 mLNeonatal: 2 mL to 100 mL | Same |
| Resolution | 1.0 mL | 1.0 mL | Same |
| Accuracy | Adult: ± 10.0 mL or ± 5% of reading, whichever is greaterPediatric: ± 3.0 mL or ± 5% of reading, whichever is greaterNeonatal: ± 1.0 mL or ± 5% of reading, whichever is greater | Adult: ± 10.0 mL or ± 5% of reading, whichever is greaterPediatric: ± 3.0 mL or ± 5% of reading, whichever is greaterNeonatal: ± 1.0 mL or ± 5% of reading, whichever is greater | Same |
| 12) RR (RM) | |||
| Measurement range | Adult:0 rpm to 120 rpmPediatric/Neonate:0 rpm to 150 rpm | Adult:0 rpm to 120 rpmPediatric/Neonate:0 rpm to 150 rpm | Same |
| Accuracy | Adult:6 to 120 rpm: ±2 rpm | Adult:6 to 120 rpm: ±2 rpm | Same |
| 0 to 5 rpm: not specified | 0 to 5 rpm: not specified | ||
| Feature | Subject Device | Predicate Device | Comparison |
| Pediatric/Neonate:Pediatric/Neonate: | |||
| 6 to 150 rpm: ±2 rpm | 6 to 150 rpm: ±2 rpm | ||
| 0 to 5 rpm: not specified | 0 to 5 rpm: not specified | ||
| Resolution | 1 rpm | 1 rpm | Same |
| Gain Selection | x0.25, x0.5, x1, x2, x3, x4, 5x5 | x0.25, x0.5, x1, x2, x3, x4, | Same |
| 5x5 | |||
| 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 Alarm | 10 s, 15 s, 20 s, 25 s, 30 s,35 s, 40 s; default value is 20 s. | 10 s, 15 s, 20 s, 25 s, 30 s,35 s, 40 s; default value is 20 s. | Same |
| 13) ICG | |||
| Technique | Thoracic electricalbioimpedance | Thoracic electricalbioimpedance | Same |
| Measurement | SV: 0 ml/beat | SV: 0 ml/beat | Same |
| Accuracy | SV: UndefinedHR: ±2bpmC.O.: Undefined | SV: UndefinedHR: ±2bpmC.O.: Undefined | Same |
| WI-FI | |||
| IEEE | 802.11b/g/n | 802.11b/g/n | Same |
| Frequency Band | 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 |
| Typical TransmitPower (±2 dBm) | 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/nOFDM | Same |
| Care and Cleaning | |||
| Recommendedcleaningagents | Mild neutral detergentEthanol (75%)Isopropanol (70%) | Mild neutral detergentEthanol (75%)Isopropanol (70%) | Same |
| Recommendedtypes ofdisinfectingagents | Ethanol (75%)Isopropanol (70%)Cidex OPA (High leveldisinfection of intracavitarytemperature probe only) | Ethanol (75%)Isopropanol (70%)Cidex OPA (High leveldisinfection of intracavitarytemperature probe only) | Same |
| Cleaning | Surface-clean the monitorwith a soft cloth dampenedwith the cleaning solution | Surface-clean the monitorwith a soft cloth dampenedwith the cleaning solution | Same |
| Disinfecting | Following hospital's policy | Following hospital's policy | Same |
| Safety Classifications | |||
| Type ofprotectionagainst electricshock | Class I | Class I | Same |
| IngressProtection | IPX1 | IPX1 | Same |
| Feature | Subject Device | Predicate Device | Comparison |
| 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,CO2, AG, BIS,RM, ICG | BF | BF | Same |
| Electrical & Mechanical safety & Thermal safety Standards | |||
| GeneralStandards | IEC 60601-1:2005 | IEC 60601-1:2005 | Same |
| EMC Standards | IEC 60601-1-2:2007 | IEC 60601-1-2:2007 | Same |
| AlarmStandards | IEC 60601-1-8:2006 | IEC 60601-1-8:2006 | Same |
| BiocompatibilityStandards | ISO 10993-1:2009 | ISO 10993-1:2009 | Same |
| SoftwareStandards | IEC 62304:2006 | IEC 62304:2006 | Same |
| Special Standards | |||
| Basic safety andessentialperformance forpatient monitor | IEC 60601-2-49: 2011 | IEC 60601-2-49: 2011 | Same |
| ECG | IEC 60601-2-27: 2011IEC 60601-2-25: 2011 | IEC 60601-2-27: 2011IEC 60601-2-25: 2011 | Same |
| NIBP | IEC 80601-2-30: 2009ISO 81060-2 | IEC 80601-2-30: 2009ISO 81060-2 | Same |
| IBP | IEC 60601-2-34: 2011 | IEC 60601-2-34: 2011 | Same |
| AG, CO2 | ISO 80601-2-55 | ISO 80601-2-55 | Same |
| TEMP | ISO 80601-2-56EN12470-4:2000 | ISO 80601-2-56EN12470-4:2000 | Same |
| Power supply | |||
| AC powerRequirement | 100-240V, 50/60Hz | 100-240V, 50/60Hz | Same |
| Battery | |||
| RechargeableBattery | Yes | Yes | Same |
| Operation characteristic | |||
| Installation anduse | Portable EquipmentFix Equipment (when thesystem is installed on WallMounting Bracket) | Portable EquipmentFix Equipment (when thesystem is installed on WallMounting Bracket) | Same |
| Working System | Continuous operation | Continuous operation | Same |
| Physical Characteristics | |||
| Weight | LMPLUS-12: <6.2kgLMPLUS-15: <7.5kgLMPLUS-17: <14kg | LMPLUS-12: <6.2kgLMPLUS-15: <7.5kgLMPLUS-17: <14kg | Same |
| Dimensions | LMPLUS-12: 333±2 mm (L) x289±2 mm (H)x 211±2mm (W) | LMPLUS-12: 333±2 mm (L) x289±2 mm (H)x 211±2mm (W) | Same |
| Feature | Subject Device | Predicate Device | Comparison |
| LMPLUS-15: 384±2 mm (L) x320±2 mm (H)x 213±2mm (W)LMPLUS-17: 425 mm (L) x 245 mm(W)x 382 mm (H) | LMPLUS-15: 384±2 mm (L) x320±2 mm (H)x 213±2mm (W)LMPLUS-17: 425 mm (L) x 245 mm(W)x 382 mm (H) | ||
| LCD | LMPLUS-12: 12.1 inches LCDLMPLUS-15: 15 inches LCDLMPLUS-17: 17 inches LCD | LMPLUS-12: 12.1 inches LCDLMPLUS-15: 15 inches LCDLMPLUS-17: 17 inches LCD | Same |
| LCD Resolution | LMPLUS-12: 800 x 600LMPLUS-15: 1024 x 768LMPLUS-17: 1280 x 1024 | LMPLUS-12: 800 x 600LMPLUS-15: 1024 x 768LMPLUS-17: 1280 x 1024 | Same |
| Environmental Specifications | |||
| Temperature | |||
| Working | +0°C to +40°C | +0°C to +40°C | Same |
| Transport andStorage | -20°C to +55°C | -20°C to +55°C | Same |
| Humidity | |||
| Working | 15% to 95% (non-condensing) | 15% to 95% (non-condensing) | Same |
| Transport andStorage | 15% to 95% (non-condensing) | 15% to 95% (non-condensing) | Same |
| 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 powerindicator | 1(green) | 1(green) | Same |
| Batteryindicator | 1(green) | 1(green) | Same |
| Speaker | Yes | Yes | Same |
| Recorder | Yes | Yes | Same |
| Data Storage | Trend, NIBP MeasurementReview, Alarm Review,Arrhythmia Review, 12-LeadDiagnosis Review, Full-disclosure waveforms | Trend, NIBP MeasurementReview, Alarm Review,Arrhythmia Review, 12-LeadDiagnosis Review, Full-disclosure waveforms | Same |
| Interface | USB/VGA/Network/Nursecall/DefibrillatorSynchronization/AnalogOutput/SD/PAM/DVI/RS232 | USB/VGA/Network/Nursecall/DefibrillatorSynchronization/AnalogOutput/SD/PAM/DVI/RS232 | Same |
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Image /page/14/Picture/0 description: The image shows the logo for Lifee Medical Devices. To the left of the logo is a red heart rate monitor symbol. To the right of the symbol is the word "lifee" in purple, with the words "medical devices" in a smaller font below the word "lifee".
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Image /page/15/Picture/0 description: The image shows the logo for Lifee Medical Devices. The logo consists of a red heart rate symbol on the left, followed by the word "lifee" in purple. Below the word "lifee" is the phrase "medical devices" in a smaller, lighter font.
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Image /page/16/Picture/0 description: The image shows the logo for Lifee Medical Devices. To the left of the company name is a red heart rate monitor symbol. The company name is in purple, with the words "medical devices" in a smaller font below the name.
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Image /page/17/Picture/0 description: The image shows the logo for Lifee Medical Devices. On the left is a red heart-shaped design made of jagged lines. To the right of the heart is the word "lifee" in a dark purple color. Below the word "lifee" are the words "medical devices" in a smaller, light red font.
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Image /page/18/Picture/0 description: The image shows the logo for Lifee Medical Devices. The logo consists of a red heart rate line on the left, followed by the word "lifee" in purple. Below the word "lifee" is the phrase "medical devices" in a smaller, lighter font.
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 LMPLUS-12, LMPLUS-15 and LMPLUS-17 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. The tests performed are as follows:
Cytotoxicity Skin Sensitization Skin Irritation
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the LMPLUS-12, LMPLUS-15 and LMPLUS-17 Patient Monitor device, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1:2012, 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 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.
Table 2 Standards compliance
| Standards | Conclusion |
|---|---|
| IEC 60601-1-8 - Medical electrical equipment - Part 1-8: Generalrequirements for basic safety and essential performance - CollateralStandard: General requirements, tests and guidance for alarmsystems in medical electrical equipment and medical electricalsystems- Test report of elite LMPLUS 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 LMPLUS 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 eliteLMPLUS 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 eliteLMPLUS series 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 ofelite LMPLUS series (2011) - (This standard is not recognized byFDA) | Pass |
| IEC 80601-2-30 - Medical electrical equipment - Part 2-30: Particularrequirements for the basic safety and essential performance ofautomated non-invasive sphygmomanometers - Test Report of eliteLMPLUS series | Pass |
| ISO 80601-2-55 - Medical electrical equipment - Part 2-55: Particularrequirements for the basic safety and essential performance ofrespiratory gas monitors - Test Report of elite LMPLUS 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 ofelite LMPLUS series. | Pass |
| ISO 80601-2-61 - Medical electrical equipment - Part 2-61: Particularrequirements for basic safety and essential performance of pulseoximeter equipment - Test Report of elite LMPLUS series | Pass |
| IEC62366 - Medical devices - Application of usability engineering to | Pass |
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Image /page/19/Picture/0 description: The image shows the logo for Lifee Medical Devices. To the left of the logo is a red heart rate symbol. To the right of the heart rate symbol is the word "lifee" in purple. Below the word "lifee" is the phrase "medical devices" in red.
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.
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Image /page/20/Picture/0 description: The image shows the logo for Lifee Medical Devices. The logo consists of a red heart rate waveform on the left, followed by the word "lifee" in purple. Below the word "lifee" are the words "medical devices" in red.
Clinical data:
Clinical tests were performed on the LMPLUS 12, LMPLUS 15 and LMPLUS 17 monitors to validate their performance in terms of noninvasive blood pressure (NIBP) and SpO2 accuracy.
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.
Conclusion
The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the LMPLUS-12, LMPLUS-15 and LMPLUS-17 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 LMPLUS-12, LMPLUS-15 and LMPLUS-17 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.