Patient Monitor, models LM-8, LM-10, LM-12 and LM-15

K221879 · Caf Medical Solutions, Inc. · MHX · Aug 10, 2022 · Cardiovascular

Device Facts

• Record ID: K221879
• Device Name: Patient Monitor, models LM-8, LM-10, LM-12 and LM-15
• Applicant: Caf Medical Solutions, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Aug 10, 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 and pediatrics. The monitors are intended for use by trained healthcare professionals in hospital environments. The LM-8 monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired CO2 and Quick Temperature (Quick TEMP). The LM-10 monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP, NIBP), Cardiac Output (C.O.), Temperature (dual-TEMP) and Expired CO2. The LM-12 monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP, NIBP), Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG). The LM-15 monitor monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP, NIBP), Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG). The arrhythmia detection and ST Segment analysis are intended for adult and pediatric patients. The monitors are not intended for MRI environments.

Device Story

Patient monitors (models LM-8, LM-10, LM-12, LM-15) integrate parameter measuring modules, display, and recorder. Inputs include ECG, RESP, NIBP, SpO2, TEMP, IBP, C.O., CO2, and anesthetic gas. Signals are digitized, processed, and examined for alarm conditions; results presented on color TFT display. Used in hospital environments by trained healthcare professionals. Provides real-time vital sign monitoring and arrhythmia/ST-segment analysis to assist clinicians in patient assessment and alarm management. Compact, portable design with built-in battery for transport.

Clinical Evidence

Clinical tests were performed to validate performance for ECG, RESP, SpO2, NIBP, IBP, TEMP, Quick TEMP, C.O., CO2, and AG. Results demonstrate the subject devices perform comparably to the predicate devices currently marketed for the same intended use.

Technological Characteristics

Integrated patient monitoring system with color TFT display (8.4 to 15 inches). Parameters: ECG (3/5/12-lead), RESP (impedance), SpO2, NIBP (oscillometry), IBP, TEMP, C.O. (thermodilution), CO2, and AG. Connectivity: Wi-Fi (IEEE 802.11 b/g/n, 2.4 GHz). Power: 100-240V AC and rechargeable battery. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 10993-1, IEC 62304, IEC 62366-1, and various ISO 80601-2-xx series for specific modules.

Indications for Use

Indicated for monitoring, storing, and alarming of physiological parameters in adult and pediatric patients. Intended for use by trained healthcare professionals in hospital environments. Not for use in MRI environments.

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 iM50 and iM80 (K113623)
• Patient Monitor Models iM60 and iM70 (K131971)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

August 10, 2022

CAF Medical Solutions Inc. % Juan Tezak Consultant Compliance 4 Device 118 W Prive Cr. Delray Beach, Florida 33445

Re: K221879

Trade/Device Name: Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 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, DSB, BZK, BZQ, DPS, DRG Dated: June 28, 2022 Received: June 28, 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 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) K221879

Device Name Patient Monitor, models LM8, LM10, LM12 and LM15

Indications for Use (Describe)

The monitors are intended to be used for monitoring, storing, and to generate alarms for, multiple physiological parameters of adults and pediatrics. The monitors are intended for use by trained healthcare professionals in hospital environments.

The LM-8 monitor monitors parameters such as ECG (3-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired CO2 and Quick Temperature (Quick TEMP).

The LM-10 monitor monitors parameters such as ECG (3-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP, NIBP), Cardiac Output (C.O.), Temperature (dual-TEMP) and Expired CO2.

The LM-12 monitor monitors parameters such as ECG (3-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 chamels IBP, NIBP), Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG).

The LM-15 monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP, NIBP), Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG).

The arrhythmia detection and ST Segment analysis are intended for adult and pediatric patients.

The monitors are not intended for MRI environments.

Type of Use (Select one or both, as applicable)

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CER 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> 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, lighter red font. The logo is simple and modern, and it conveys a sense of health and well-being.

# 510(k) Summary

## Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 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 Tezak |

| 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 LM-8, LM-10, LM-12 and<br>LM-15 |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Class: | Class II |
| Prior Submission: | No prior submission |
| 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/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." is the phrase "medical devices" in red.

| | • 880.2910 Clinical Electronic Thermometers-<br>Temperature Monitor with Probe/ FLL |
|--------------------|-----------------------------------------------------------------------------------------|
| | • 870.2700 Oximeter, Pulse/ DQA |
| | • 868.1400 Carbon Dioxide Gas Analyzer/ CCK |
| | • 868.1500 Analyzer, Gas, Enflurane, Gaseous-Phase<br>(Anesthetic Concentration)/ CBQ |
| | • 868.1500 Analyzer, Gas, Desflurane, Gaseous-<br>Phase (Anesthetic Concentration)/NHO |
| | • 868.1500 Analyzer, Gas, Isoflurane, Gaseous-Phase<br>(Anesthetic Concentration)/NHQ |
| | • 868.1500 Analyzer, Gas, Sevoflurane, Gaseous-<br>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<br>transmitter and receiver/ DRG |
| | Predicate Device Information |
| Predicate Devices: | • K113623. Patient Monitor Models iM50 and iM80.<br>Edan Instruments, Inc. |
| | • K131971. Patient Monitor Models iM60 and iM70.<br>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 and pediatrics. The monitors are intended for use by trained healthcare professionals in hospital environments.

The LM-8 monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired CO2 and Quick Temperature (Quick TEMP).

The LM-10 monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP, NIBP), Cardiac Output (C.O.), Temperature (dual-TEMP) and Expired CO2.

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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 with a jagged line running through it, followed by the word "lifee" in purple, and the words "medical devices" in red below it. The logo is simple and modern, and it conveys the company's focus on medical devices related to the heart.

The LM-12 monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP, NIBP), Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG).

The LM-15 monitor monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP, NIBP), Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG).

The arrhythmia detection and ST Segment analysis are intended for adult and pediatric patients.

The monitors are not intended for MRI environments.

## Device Description

LM-8, LM-10, LM-12 and LM-15, patient monitor integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Replaceable built-in battery facilitates patient transport. Large high-resolution display provides clear view of 10 waveforms and full monitoring parameters. Patient Monitor can monitor vital signal such as ECG, respiration (RESP), non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), temperature (TEMP), invasive blood pressure (IBP), cardiac output (C.O.), CO2 and anesthetic gas (AG). Those signals are digitized, processed and examined for alarm conditions, after that presents all those information on the color TFT display. The monitor also provides advantageous operating control for the user.

LM-8, LM-10, LM-12 and LM-15, patient monitor have the same intended use. The differences are as follows:

| Patient Monitor | Difference<br>LCD | Difference Parameter |
|-----------------|-------------------|------------------------------------------------------------|
| LM-8 | 8.4 inch | ECG RESP TEMP QuickTEMP SpO2 NIBP IBP CO2<br>3/5-lead ECG |
| LM-10 | 10.4 inch | ECG RESP TEMP SpO2 NIBP IBP CO2 C.O. 3/5-lead ECG |
| LM-12 | 12.1 inch | ECG RESP TEMP SpO2 NIBP IBP CO2 C.O. AG<br>3/5-lead ECG |
| LM-15 | 15 inch | ECG RESP TEMP SpO2 NIBP IBP CO2 C.O. AG<br>3/5/12-lead ECG |

## Contraindications:

There are no known contraindications for use.

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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 rate line on the left, followed by the word "lifee" in purple. Below the word "lifee" are the words "medical devices" in a smaller, red font.

### Equivalence to Marketed Device

Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 is substantially equivalent to the predicated. In further support of a substantial equivalence determination, here-under is a comparison chart with the submitted device and predicate device.

| ITEM | PROPOSED DEVICE | K113623<br>PREDICATE DEVICE | K131971<br>PREDICATE DEVICE | COMPARISON<br>RESULT |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| General Features | | | | |
| Intended Use | The monitors are intended to be used for<br>monitoring, storing, and reviewing of, and to<br>generate alarms for, multiple physiological<br>parameters of adults and pediatrics. The monitors<br>are intended for use by trained healthcare<br>professionals in hospital environments. | iM80:<br>The monitor monitors<br>parameters such as<br>ECG (3-lead, 5-lead,<br>12-lead selectable),<br>Respiration (RESP),<br>Functional arterial<br>oxygen saturation<br>(SpO2), Invasive or<br>noninvasive blood<br>pressure (2/4<br>channels IBP NIBP),<br>Cardiac Output (CO),<br>Temperature (dual-<br>TEMP), Expired CO2<br>and Anesthetic gas<br>(AG). The monitor is<br>equipped with alarms<br>that indicate system<br>faults (such as loose<br>or defective<br>electrodes),<br>physiologic<br>parameters that have<br>exceeded the limits<br>set by the operator, or<br>both. | iM60:<br>The iM60 monitor<br>monitors parameters<br>such as ECG (3-lead,<br>5-lead selectable),<br>Respiration (RESP),<br>Functional arterial<br>oxygen saturation<br>(SpO2), Invasive or<br>noninvasive blood<br>pressure (2/4<br>channels IBP NIBP),<br>Cardiac Output (CO),<br>Temperature (dual-<br>TEMP) and Expired<br>CO2. The monitor is<br>equipped with<br>alarms that indicate<br>system faults (such<br>as loose or defective<br>electrodes),<br>physiologic<br>parameters that<br>have exceeded the<br>limits set by the<br>operator, or both. | Similar |
| | The LM-8 monitor monitors parameters such as<br>ECG (3-lead, 5-lead selectable), Respiration (RESP),<br>Functional arterial oxygen saturation (SpO2),<br>Invasive or noninvasive blood pressure (dual-IBP,<br>NIBP), Temperature (dual-TEMP), Expired CO2 and<br>Quick Temperature (Quick TEMP). | | | |
| | The LM-10 monitor monitors parameters such as<br>ECG (3-lead, 5-lead selectable), Respiration (RESP),<br>Functional arterial oxygen saturation (SpO2),<br>Invasive or noninvasive blood pressure (2/4<br>channels IBP, NIBP), Cardiac Output (C.O.),<br>Temperature (dual-TEMP) and Expired CO2. | | | |
| | The LM-12 monitor monitors parameters such as<br>ECG (3-lead, 5-lead selectable), Respiration (RESP),<br>Functional arterial oxygen saturation (SpO2),<br>Invasive or noninvasive blood pressure (2/4<br>channels IBP, NIBP), Cardiac Output (C.O.),<br>Temperature (dual-TEMP), Expired CO2 and<br>Anesthetic gas (AG). | | iM70:<br>The iM70 monitor<br>monitors parameters<br>such as ECG (3-lead,<br>5-lead selectable),<br>Respiration (RESP),<br>Functional arterial<br>oxygen saturation<br>(SpO2), Invasive or<br>noninvasive blood<br>pressure (2/4<br>channels IBP NIBP),<br>Cardiac Output (CO),<br>Temperature (dual-<br>TEMP), Expired CO2<br>and Anesthetic gas<br>(AG). The monitor is<br>equipped with<br>alarms that indicate<br>custom faults (such | |
| | The LM-15 monitor monitors parameters such as<br>ECG (3-lead, 5-lead, 12-lead selectable),<br>Respiration (RESP), Functional arterial oxygen<br>saturation (SpO2), Invasive or noninvasive blood<br>pressure (2/4 channels IBP, NIBP), Cardiac Output<br>(C.O.), Temperature (dual-TEMP), Expired CO2 and<br>Anesthetic gas (AG).<br><br>The arrhythmia detection and ST Segment analysis<br>are intended for adult and pediatric patients.<br><br>The monitors are not intended for MRI<br>environments. | iM50:<br>The monitor monitors<br>parameters such as<br>ECG (3-lead, 5-lead<br>selectable),<br>Respiration (RESP),<br>Functional arterial<br>oxygen saturation<br>(SpO2), Invasive or<br>noninvasive blood<br>pressure (dual-IBP,<br>NIBP), Temperature<br>(dual-TEMP), Expired<br>CO2 and Quick<br>Temperature (Quick<br>TEMP). The monitor is<br>equipped with alarms<br>that indicate system<br>faults (such as loose | | |
| ITEM | PROPOSED DEVICE | K113623<br>PREDICATE DEVICE | K131971<br>PREDICATE DEVICE | COMPARISON<br>RESULT |
| | | or defective<br>electrodes),<br>physiologic<br>parameters that have<br>exceeded the limits<br>set by the operator, or<br>both.<br><br>The arrhythmia<br>detection and ST<br>Segment analysis are<br>not intended for<br>neonatal patients. | as loose or defective<br>electrodes),<br>physiologic<br>parameters that<br>have exceeded the<br>limits set by the<br>operator, or both. | |
| Contraindications | It is not intended for use in patient's home or<br>residence, or when it has not been ordered by a<br>physician. | It is not intended for<br>use in patient's home<br>or residence, or when<br>it has not been<br>ordered by a<br>physician. | It is not intended for<br>use in patient's home<br>or residence, or<br>when it has not been<br>ordered by a<br>physician. | Same |
| Test Summary | Software testing<br>Hardware testing<br>Safety testing<br>Environment test<br>Risk analysis<br>Final validation | Software testing<br>Hardware testing<br>Safety testing<br>Environment test<br>Risk analysis<br>Final validation | Software testing<br>Hardware testing<br>Safety testing<br>Environment test<br>Risk analysis<br>Final validation | Same |
| Features by Model | | | | |
| Feature | Proposed Models<br>LM-8 | LM-10 | LM-12 | LM-15 |
| | | Predicate Models | | |
| | | iM50 | iM80 | iM60 |
| | | iM70 | Same | |
| Monitors SpO2<br>parameters | Yes | Yes | Yes | Yes |
| | | Yes | Yes | Yes |
| | | Yes | Same | |
| Monitor NIBP<br>parameters | Yes | Yes | Yes | Yes |
| | | Yes | Yes | Yes |
| | | Yes | Same | |
| Monitors ECG<br>parameters | Yes | Yes | Yes | Yes |
| | | Yes | Yes | Yes |
| | | Yes | Same | |
| Monitor RESP<br>parameters | Yes | Yes | Yes | Yes |
| | | Yes | Yes | Yes |
| | | Yes | Same | |
| Monitors TEMP<br>parameters | Yes | Yes | Yes | Yes |
| | | Yes | Yes | Yes |
| | | Yes | Same | |
| Monitors CO2<br>parameters | Yes | Yes | Yes | Yes |
| | | Yes | Yes | Yes |
| | | Yes | Same | |
| Monitor IBP<br>parameters | Yes | Yes | Yes | Yes |
| | | Yes | Yes…