Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard multi-parameter patient monitor and does not mention any AI or ML capabilities in its description, intended use, or performance studies.

Therapeutic

No.

The device is described as a patient monitor that measures and displays multiple physiological parameters and generates alarms, but it does not treat or directly intervene in a patient's condition.

Diagnostic

Yes

Explanation: The device monitors multiple physiological parameters and provides alarms for abnormalities, which helps healthcare professionals diagnose and manage patient conditions. For instance, it performs "arrhythmia detection and ST Segment analysis," which are diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the LMPLUS series Patient Monitor is a physical device that includes a screen, built-in battery, and is configured with different physical parameter modules to perform monitoring. This indicates it is a hardware device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The tests are performed outside the body (in vitro).
Device Function: The LMPLUS series Patient Monitor is designed to monitor physiological parameters directly from the patient's body (in vivo). It uses sensors and modules attached to the patient to measure things like heart rate, blood pressure, oxygen saturation, etc.
Intended Use: The intended use clearly states "monitoring... multiple physiological parameters of adults, pediatrics and neonates." This is a description of in vivo monitoring, not in vitro testing of samples.

The device is a patient monitor, which is a type of medical device used for continuous or intermittent monitoring of a patient's vital signs and other physiological data.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 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.

Product codes

MHX, DST, MLD, DRT, DXN, DSK, FLL, DQA, CCK, CBQ, NHQ, NHP, CBS, CBR, CCL, DRG, DPS

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adults, pediatrics and neonates.

Intended User / Care Setting

Trained healthcare professionals in hospital environments. The monitors are additionally intended for use during patient transport inside hospitals.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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.

Key Metrics

Not Found

Predicate Device(s)

K160981

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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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.

1

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 and
product code:	· 870.1025 monitor, physiological, patient (with
arrhythmia detection or alarms)/ MHX
· 870.1025 Detector and Alarm, Arrhythmia/ DST
· 870.1025 Monitor, ST Segment with Alarm/ MLD
· 870.2300 Cardiac monitor (including
cardiotachometer 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.
Intended
patient
population	Adult, pediatric and neonatal patients	Adult, pediatric and neonatal patients	Same
Intended
application
environment	Hospital environment.	Hospital environment.	Same
1) ECG monitor
Lead Mode	3-Lead: I, II, III
5-Leads: I, II, III, aVR, aVL, aVF, V
12-leads: I, II, III, aVR, aVL, aVF, V1 to V6	3-Lead: I, II, III
5-Leads: I, II, III, aVR, aVL, aVF, V
12-leads: I, II, III, aVR, aVL, aVF, V1 to V6	Same
Lead Naming
Style	AHA, IEC	AHA, IEC	Same
Display
Sensitivity	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
Measurement
Range	Neonate: 15 to 350 bpm
Pediatric: 15 to 350 bpm	Neonate: 15 to 350 bpm
Pediatric: 15 to 350 bpm	Same
Feature	Subject Device	Predicate Device	Comparison
CMRR
(Common Mode
Rejection Ratio)	Diagnosis: >95dB
Monitor: >105dB
Surgery: >105dB	Diagnosis: >95dB
Monitor: >105dB
Surgery: >105dB	Same
Accuracy	±1 bpm or ±1%, whichever is
greater	±1 bpm or ±1%, whichever is
greater	Same
Resolution	1 bpm	1 bpm	Same
Sensibility	200μV	200μV	Same
Differential
Input
Impedance	>5ΜΩ	>5ΜΩ	Same
Leakage Current
of Patient	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. | 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.

Pediatric:
0.75 L/min to 100 L/min

Neonatal:
0.25 L/min to 30 L/min | Adult:
2.0 L/min to 180 L/min

Pediatric:
0.75 L/min to 100 L/min

Neonatal:
0.25 L/min to 30 L/min | Same |
| Accuracy | Adult:
0.5 L/min or $\pm$ 3% of reading,
whichever is greater

Pediatric: | Adult:
0.5 L/min or $\pm$ 3% of reading, whichever is greater

Pediatric:
0.3 L/min to 20 L/min

Neonatal:
0.1 L/min to 3 L/min | Adult:
1 L/min to 30.00 L/min

Pediatric:
0.3 L/min to 20 L/min

Pediatric: ± 3.0 mL or ± 5% of reading, whichever is greater

Neonatal: ± 1.0 mL or ± 5% of reading, whichever is greater | Adult: ± 10.0 mL or ± 5% of reading, whichever is greater

Pediatric: ± 3.0 mL or ± 5% of reading, whichever is greater

Pediatric/Neonate:
0 rpm to 150 rpm | Adult:
0 rpm to 120 rpm