Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17

K221616 · Caf Medical Solutions, Inc. · MHX · Aug 1, 2022 · Cardiovascular

Device Facts

• Record ID: K221616
• Device Name: Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17
• Applicant: Caf Medical Solutions, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Aug 1, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

LMPLUS series (12, 15, 17-inch models) are multi-parameter patient monitors for continuous physiological monitoring in hospital settings. Devices accept inputs via various modules (ECG, SpO2, NIBP, IBP, CO2, AG, BIS, ICG, etc.). Data is processed to display waveforms, trends, and measurements; system triggers visual/audible alarms for abnormal conditions. Operated by clinicians (doctors/nurses) to facilitate timely intervention. Features include internal Li-ion battery, networking, and online software upgrades. Output allows clinicians to review patient status, arrhythmia, and diagnostic data, supporting clinical decision-making and patient safety during monitoring and transport.

Clinical Evidence

Clinical testing performed to validate NIBP and SpO2 accuracy. Results demonstrate performance comparable to the predicate device. No specific sensitivity/specificity metrics provided in the summary; overall safety and effectiveness profile deemed similar to predicate.

Technological Characteristics

Modular patient monitor with 12.1, 15, or 17-inch TFT touch screens. Parameters: ECG, RESP, TEMP, SpO2, NIBP, IBP, CO2, C.O., AG, BIS, RM, ICG. Connectivity: Networked, Wi-Fi (802.11b/g/n). Power: AC 100-240V and internal Li-ion battery. Safety: Class I, IPX1. Standards: IEC 60601-1, IEC 60601-1-2 (EMC), ISO 10993-1 (biocompatibility). Software: Major level of concern, supports online upgrades.

Indications for Use

Indicated for monitoring, storing, and alarming of physiological parameters (ECG, RESP, TEMP, SpO2, PR, NIBP, IBP, CO2, C.O., AG, BIS, RM, ICG) in adult, pediatric, and neonatal patients. BIS indicated for adults/pediatrics; ICG, arrhythmia detection, and ST-segment analysis indicated for adults only. For use by trained healthcare professionals in hospital environments, including transport.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Patient Monitor, models elite V5, elite V6 and elite V8 (K160981)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [e-mail]

## Establishment Registration Number

| Official Contact | Oscar Arriaga Yamin |
|------------------|--------------------------------|
| | Legal Representative |
| | 17539 Roberts Road, Hockley |
| | TX 77477 USA |
| | Phone: [phone] |
| | E-mail: [e-mail] |

| Representative/Consultant | Juan Tozak |
|---------------------------|------------|
|---------------------------|------------|

| Representative/Consultant | Juan Tezak |
|---------------------------|----------------------------------------|
| | Carlos Marín |
| | Compliance4Devices |
| | 118 W Prive Cr. Delray Beach Fl, 33445 |
| | Phone: [phone] |
| | E-mail: [e-mail] |

### 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 and<br>product code: | · 870.1025 monitor, physiological, patient (with<br>arrhythmia detection or alarms)/ MHX<br>· 870.1025 Detector and Alarm, Arrhythmia/ DST<br>· 870.1025 Monitor, ST Segment with Alarm/ MLD<br>· 870.2300 Cardiac monitor (including<br>cardiotachometer and rate alarm)/ DRT<br>· 870.1130 Non-Invasive blood pressure/ DXN<br>· 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).<br>BIS is intended for use on adult and pediatric patients.<br>ICG monitoring is intended for use on adults only.<br>The arrhythmia detection and ST Segment analysis are intended for adult patients.<br>The monitors are additionally intended for use during patient transport inside hospitals.<br>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).<br>BIS is intended for use on adult and pediatric patients.<br>ICG monitoring is intended for use on adults only.<br>The arrhythmia detection and ST Segment analysis are intended for adult patients.<br>The monitors are additionally intended for use during patient transport inside hospitals.<br>The monitors are not intended for MRI environments. | |
| Intended<br>patient<br>population | Adult, pediatric and neonatal patients | Adult, pediatric and neonatal patients | Same |
| Intended<br>application<br>environment | Hospital environment. | Hospital environment. | Same |
| 1) ECG monitor | | | |
| Lead Mode | 3-Lead: I, II, III<br>5-Leads: I, II, III, aVR, aVL, aVF, V<br>12-leads: I, II, III, aVR, aVL, aVF, V1 to V6 | 3-Lead: I, II, III<br>5-Leads: I, II, III, aVR, aVL, aVF, V<br>12-leads: I, II, III, aVR, aVL, aVF, V1 to V6 | Same |
| Lead Naming<br>Style | AHA, IEC | AHA, IEC | Same |
| Display<br>Sensitivity | 1.25mm/mV (x0.125),<br>2.5mm/mV (x0.25), 5mm/mV (x0.5), 10mm/mV (x1),<br>20mm/mV (x2), 40mm/mV (x4),<br>AUTO gain | 1.25mm/mV (x0.125),<br>2.5mm/mV (x0.25),<br>5mm/mV (x0.5), 10mm/mV (x1), 20mm/mV (x2),<br>40mm/mV (x4),<br>AUTO gain | Same |
| Sweep | 6.25mm/s, 12.5mm/s,<br>25mm/s, 50mm/s | 6.25mm/s, 12.5mm/s,<br>25mm/s, 50mm/s | Same |
| Measurement<br>Range | Neonate: 15 to 350 bpm<br>Pediatric: 15 to 350 bpm | Neonate: 15 to 350 bpm<br>Pediatric: 15 to 350 bpm | Same |
| Feature | Subject Device | Predicate Device | Comparison |
| CMRR<br>(Common Mode<br>Rejection Ratio) | Diagnosis: >95dB<br>Monitor: >105dB<br>Surgery: >105dB | Diagnosis: >95dB<br>Monitor: >105dB<br>Surgery: >105dB | Same |
| Accuracy | ±1 bpm or ±1%, whichever is<br>greater | ±1 bpm or ±1%, whichever is<br>greater | Same |
| Resolution | 1 bpm | 1 bpm | Same |
| Sensibility | 200μV | 200μV | Same |
| Differential<br>Input<br>Impedance | >5ΜΩ | >5ΜΩ | Same |
| Leakage Current<br>of Patient | <10μΑ | <10μΑ | Same |
| ST value<br>Measurement<br>Range | -2.0 mV ~ +2.0 mV | -2.0 mV ~ +2.0 mV | Same |
| Accuracy | -0.8 mV to +0.8 mV: ±0.02 mV<br>or 10%,<br>whichever is greater.<br>Beyond this range: not<br>specified. | -0.8 mV to +0.8 mV: ±0.02<br>mV or 10%,<br>whichever is greater.<br>Beyond this range: not<br>specified. | Same |
| Pace | | | |
| Pulse Indicator | Amplitude: ±2 mV to ±700 mV<br>Width: 0.1 ms to 2.0 ms<br>Ascending time: 10 µs to 100<br>µs | Amplitude: ±2 mV to ±700<br>mV<br>Width: 0.1 ms to 2.0 ms<br>Ascending time: 10 µs to<br>100 µs | Same |
| Pulse Rejection | Amplitude: ±2 mV to ±700 mV<br>Width: 0.1 ms to 2.0 ms<br>Ascending time: 10 µs to 100<br>µs | Amplitude: ±2 mV to +700<br>mV<br>Width: 0.1 ms to 2.0 ms<br>Ascending time: 10 µs to<br>100 µs | Same |
| HR | | | |
| Measurement<br>range | Neonate: 15 to 350 bpm<br>Pediatric: 15 to 350 bpm<br>Adult: 15 to 300 bpm | Neonate: 15 to 350 bpm<br>Pediatric: 15 to 350 bpm<br>Adult: 15 to 300 bpm | Same |
| Accuracy | ±1% or 1 bpm, whichever is<br>greater | ±1% or 1 bpm, whichever is<br>greater | Same |
| Resolution | 1 bpm | 1 bpm | Same |
| 2) RESP monitor | | | |
| Principle of<br>Operation | Thoracic impedance | Thoracic impedance | Same |
| Method | Impedance between RA-LL,<br>RA-LA | Impedance between RA-LL,<br>RA-LA | Same |
| Measurement<br>lead | Options are lead I and II.<br>The default is lead II. | Options are lead I and II.<br>The default is lead II. | Same |
| Measurement<br>Range | Adult:<br>0 to 120 rpm | Adult:<br>0 to 120 rpm | Same |
| Feature | Subject Device | Predicate Device | Comparison |
| Accuracy | Adult:<br>6 to 120 rpm: ±2 rpm,<br>0 to 5 rpm: not specified<br><br>Pediatric/neonate:<br>6 to 150 rpm: ±2 rpm,<br>0 to 5 rpm: not specified | Adult:<br>6 to 120 rpm: ±2 rpm,<br>0 to 5 rpm: not specified<br><br>Pediatric/neonate:<br>6 to 150 rpm: ±2 rpm,<br>0 to 5 rpm: not specified | Same |
| Calculation<br>Type | Manual, Automatic | Manual, Automatic | Same |
| Baseline<br>Impedance<br>Range | 2000Ω to 2500Ω (with ECG<br>cables of 1 kΩ resistance) | 2000Ω to 2500Ω (with ECG<br>cables of 1 kΩ resistance) | Same |
| Measuring<br>Sensitivity | Within the baseline<br>impedance range: 0.3Ω | Within the baseline<br>impedance range: 0.3Ω | Same |
| Waveform<br>Bandwidth | 0.2 Hz to 2.5 Hz (-3 dB) | 0.2 Hz to 2.5 Hz (-3 dB) | Same |
| Respiration<br>Excitation<br>Waveform | Sinusoid, 62.8 kHz (±10%),<br><500 μΑ | Sinusoid, 62.8 kHz (±10%),<br><500 μΑ | Same |
| Resolution | 1 rpm | 1 rpm | Same |
| Apnea Alarm | 10s, 15s, 20s, 25s, 30s, 35s,<br>40s | 10s, 15s, 20s, 25s, 30s, 35s,<br>40s | Same |
| 3) Temperature monitor | | | |
| Technique | Thermal resistance | Thermal resistance | Same |
| Number of<br>channels | 2 | 2 | Same |
| Measurement<br>Range | 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 | | | |
| Measurement<br>Range | 0-100%…