(43 days)
Not Found
No
The document describes standard physiological monitoring and processing without mentioning AI or ML algorithms.
No
This device is a patient monitor intended for monitoring, storing, and generating alarms for physiological parameters. It does not provide any therapeutic intervention.
No.
Explanation: The device is described as a "patient monitor" which is used for "monitoring, storing, and to generate alarms for, multiple physiological parameters." While it monitors various parameters, its primary stated purpose is for monitoring and generating alarms, not for providing a definitive diagnosis of a disease or condition. The text also states that clinical data demonstrated the device performed comparably to predicate devices that are "currently marketed for the same intended use," which is patient monitoring.
No
The device description explicitly states that the device "integrates parameter measuring modules, display and recorder in one device," indicating it includes hardware components beyond just software. The performance studies also include electrical safety and biocompatibility testing, which are relevant to hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The description clearly states that this device is a "patient monitor" that measures physiological parameters directly from the patient (ECG, Respiration, SpO2, Blood Pressure, Temperature, CO2, Anesthetic Gas, Cardiac Output). It does not analyze samples taken from the body.
- Intended Use: The intended use is for "monitoring, storing, and to generate alarms for, multiple physiological parameters of adults and pediatrics." This aligns with patient monitoring, not laboratory testing of specimens.
Therefore, this device falls under the category of a patient monitoring device, not an In Vitro Diagnostic.
N/A
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 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.
Product codes (comma separated list FDA assigned to the subject device)
MHX, DST, MLD, DRT, DXN, DSK, FLL, DQA, CCK, CBQ, NHQ, NHP, CBS, CBR, CCL, DSB, BZK, BZQ, DPS, DRG
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 LCD | Difference Parameter |
|---|---|---|
| LM-8 | 8.4 inch | ECG RESP TEMP QuickTEMP SpO2 NIBP IBP CO2 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 3/5-lead ECG |
| LM-15 | 15 inch | ECG RESP TEMP SpO2 NIBP IBP CO2 C.O. AG 3/5/12-lead ECG |
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 and pediatrics.
Intended User / Care Setting
Trained healthcare professionals in hospital environments.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical data:
Biocompatibility testing: The biocompatibility evaluation for the LM-8, LM-12 and LM-15 Patient Monitor were conducted in accordance with the International Standard ISO 10993-1. 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) testing: Electrical safety and EMC testing were conducted on the LM-8, LM-10, LM-12 and LM-15 Patient Monitor device, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1:2005/A1: 2012, IEC 60601-1-8: 2006, IEC 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 IEC 60601-1-2:2007. standard for EMC.
Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Clinical data:
Clinical tests were performed on the LM-8, LM-12 and LM-15 monitors to validate their performance in terms of ECG, RESP, SpO2, NIBP, IBP, TEMP, Quick TEMP, C.O., CO2 and AG.
Key results:
Based on the non-clinical and clinical performance as documented in the system development, the subject devices were found to be substantially equivalent to the predicate device. The non-clinical data support the substantial equivalence of the device and the hardware and software verification and validation demonstrate that the LM-8, LM-10, LM-12 and LM-15 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 LM-8, LM-12 and LM-15 Patient Monitor devices are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
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 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
2
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)
| ☑ Prescription Use (Part 21 CER 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, 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: 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 Tezak |
| 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 LM-8, LM-10, LM-12 and
LM-15 |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Class: | Class II |
| Prior Submission: | No prior submission |
| 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 |
4
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-
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 Devices: | • K113623. Patient Monitor Models iM50 and iM80.
Edan Instruments, Inc. |
| | • K131971. Patient Monitor Models iM60 and iM70.
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
LCD | Difference Parameter |
|-----------------|-------------------|------------------------------------------------------------|
| LM-8 | 8.4 inch | ECG RESP TEMP QuickTEMP SpO2 NIBP IBP CO2
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
3/5-lead ECG |
| LM-15 | 15 inch | ECG RESP TEMP SpO2 NIBP IBP CO2 C.O. AG
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
PREDICATE DEVICE | K131971
PREDICATE DEVICE | COMPARISON
RESULT |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| General Features | | | | |
| 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. | iM80:
The 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 (CO),
Temperature (dual-
TEMP), Expired CO2
and Anesthetic gas
(AG). The monitor is
equipped with alarms
that indicate system
faults (such as loose
or defective
electrodes),
physiologic
parameters that have
exceeded the limits
set by the operator, or
both. | iM60:
The iM60 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 (CO),
Temperature (dual-
TEMP) and Expired
CO2. The monitor is
equipped with
alarms that indicate
system faults (such
as loose or defective
electrodes),
physiologic
parameters that
have exceeded the
limits set by the
operator, or both. | Similar |
| | 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). | | iM70:
The iM70 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 (CO),
Temperature (dual-
TEMP), Expired CO2
and Anesthetic gas
(AG). The monitor is
equipped with
alarms that indicate
custom faults (such | |
| | 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. | iM50:
The 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 monitor is
equipped with alarms
that indicate system
faults (such as loose | | |
| ITEM | PROPOSED DEVICE | K113623
PREDICATE DEVICE | K131971
PREDICATE DEVICE | COMPARISON
RESULT |
| | | or defective
electrodes),
physiologic
parameters that have
exceeded the limits
set by the operator, or
both.
The arrhythmia
detection and ST
Segment analysis are
not intended for
neonatal patients. | as loose or defective
electrodes),
physiologic
parameters that
have exceeded the
limits set by the
operator, or both. | |
| Contraindications | It is not intended for use in patient's home or
residence, or when it has not been ordered by a
physician. | It is not intended for
use in patient's home
or residence, or when
it has not been
ordered by a
physician. | It is not intended for
use in patient's home
or residence, or
when it has not been
ordered by a
physician. | Same |
| Test Summary | Software testing
Hardware testing
Safety testing
Environment test
Risk analysis
Final validation | Software testing
Hardware testing
Safety testing
Environment test
Risk analysis
Final validation | Software testing
Hardware testing
Safety testing
Environment test
Risk analysis
Final validation | Same |
| Features by Model | | | | |
| Feature | Proposed Models
LM-8 | LM-10 | LM-12 | LM-15 |
| | | Predicate Models | | |
| | | iM50 | iM80 | iM60 |
| | | iM70 | Same | |
| Monitors SpO2
parameters | Yes | Yes | Yes | Yes |
| | | Yes | Yes | Yes |
| | | Yes | Same | |
| Monitor NIBP
parameters | Yes | Yes | Yes | Yes |
| | | Yes | Yes | Yes |
| | | Yes | Same | |
| Monitors ECG
parameters | Yes | Yes | Yes | Yes |
| | | Yes | Yes | Yes |
| | | Yes | Same | |
| Monitor RESP
parameters | Yes | Yes | Yes | Yes |
| | | Yes | Yes | Yes |
| | | Yes | Same | |
| Monitors TEMP
parameters | Yes | Yes | Yes | Yes |
| | | Yes | Yes | Yes |
| | | Yes | Same | |
| Monitors CO2
parameters | Yes | Yes | Yes | Yes |
| | | Yes | Yes | Yes |
| | | Yes | Same | |
| Monitor IBP
parameters | Yes | Yes | Yes | Yes |
| | | Yes | Yes | Yes |
| | | Yes | Same | |
| Monitor C.O.
parameters | No | Yes | Yes | Yes |
| | | No | Yes | Yes |
| | | Yes | Same | |
| Monitors AG
parameters | No | No | Yes | Yes |
| | | No | Yes | No |
| | | Yes | Same | |
Table 1. Comparison with predicate device for Summary
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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 symbol. To the right of the heart rate symbol is the word "lifee" in purple, with the words "medical devices" in red underneath.
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Image /page/8/Picture/0 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" are the words "medical devices" in red.
| ITEM | PROPOSED DEVICE | | | K113623
PREDICATE DEVICE | | K131971
PREDICATE DEVICE | | COMPARISON
RESULT | |
|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------|----------------|-----------------------------|---------------|-----------------------------|----------------|----------------------|--|
| User
may select different
monitoring
parameters in
according with the
requirement | Yes | No | No | Yes | Yes | No | No | Same | |
| Screen size | 8.4
inches | 10.4
inches | 12.1
inches | 15
inches | 8.4
inches | 10.4
inches | 12.1
inches | Same | |
| Touch screen | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Same | |
| Supports online
software update and
networking | No | No | No | Yes | No | No | No | Same | |
| Alarms to indicate
system failures
and/or out-of-range
parameters. | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Same | |
| EDAN SP02 module
available for this
model | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Same | |
| Nellcor SP02 module
available for this
model | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Same | |
| EDAN NIBP module
available for this
model | No | No | Yes | Yes | No | No | Yes | Same | |
| OMROM M3600
module for NIBP
available for this
model | No | No | Yes | Yes | No | No | Yes | Same | |
| Suntech NIBP module
available for this
model | No | No | No | Yes | No | No | No | Same | |
| Parameters by Module | | | | | | | | | |
| ECG module | | | | | | | | | |
| Lead Mode | 3 Electrodes; 5 Electrodes and 12 Electrodes. | | | | | | | Same | |
| Arrhythmia
analyses | ASYSTOLE, VFIB/VTAC, COUPLET, VT> 2,
BIGEMINY, TRIGEMINY, VENT, R on T, PVC,
TACHY, BRADY, MISSED BEATS, IRR, VBRADY,
PNC, PNP | | | | | | | Same | |
| ST value | | | | | | | | | |
| Measurement
Range | -2.0 mV to +2.0 mV | | | | | | | Same | |
| Pace | | | | | | | | | |
| Pulse Indicator | Amplitude: ±2 mV to ±700 mV
Width: 0.1 ms to 2.0 ms
Ascending time: 10 µs to 100 µs | | | | | | | Same | |
| PVC | | | | | | | | | |
| Range | ADU: (0 to 300) PVCs/ min
PED/NEO: (0 to 350) PVCs/ min | | | | | | | Same | |
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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 rate waveform on the left, followed by the word "lifee" in purple. Below the word "lifee" are the words "medical devices" in red.
| ITEM | PROPOSED DEVICE | K113623
PREDICATE DEVICE | K131971
PREDICATE DEVICE | COMPARISON
RESULT | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------|----------------------|--|--|--|--|--|--|--|--|--|--|--|--|---------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|------|
| HR | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Measurement
range | ADU: 15 bpm to 300 bpm
PED/NEO: 15 bpm to 350 bpm | ADU: 15 bpm to 300 bpm
PED/NEO: 15 bpm to 350 bpm | | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| RESP module | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Principle of
Operation | Impedance between RA-LL, RA-LA | Impedance between RA-LL, RA-LA | | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Measurement
Range | Adult: 0 to 120 rpm
Pediatric/neonate: 0 to 150 rpm | Adult: 0 to 120 rpm
Pediatric/neonate: 0 to 150 rpm | | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| NIBP module (EDAN) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Technique | Oscillometry | Oscillometry | | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Measurement
Range | Measurement range:
AdultPediatri cNeonat eSystolic40-27040-25040-135Diastoli c10-21510-20010-100Mean20-23520-23520-110 | | | | | | | | | | | | | | | | Measurement range:
AdultPediat ricNeonat eSystolic40-27040-25040-135Diastoli c10-21510-20010-100Mean20-23520-23520-110 | | | | | | | | | | | | | | | | | Same |
| PR from NIBP | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Measurement
range | 40 bpm to 240 bpm | 40 bpm to 240 bpm | | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| SpO2 module (EDAN) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Measurement
Range | SpO2: 0% to 100%
Pulse Rate: 25 to 300 bpm | SpO2: 0% to 100%
Pulse Rate: 25 to 300 bpm | | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Temperature module | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Number of
channels | 2 | 2 | | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Measurement
Range | 0°C to 50°C (32°F to 122°F) | 0°C to 50°C (32°F to 122°F) | | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| IBP module | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Measurement
Range | PA/PAWP: (-6 to +120) mmHg
CVP/RAP/LAP/ICP: (-10 to +40) mmHg
P1/P2: (-50 to +300) mmHg | PA/PAWP: (-6 to +120) mmHg
CVP/RAP/LAP/ICP: (-10 to +40) mmHg
P1/P2: (-50 to +300) mmHg | | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| C.O. Module | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Technique | Thermodilution Technique | Thermodilution Technique | | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Measurement
range | C.O.: 0.1 to 20L/min
TB: 23°C to 43°C (73.4°F to 109.4°F)
TI: -1°C to 27°C (30.2°F to 80.6°F) | C.O.: 0.1 to 20L/min
TB: 23°C to 43°C (73.4°F to 109.4°F)
TI: -1°C to 27°C (30.2°F to 80.6°F) | | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| CO2 Module | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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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 with an EKG line running through it, followed by the word "lifee" in purple. Below the word "lifee" is the phrase "medical devices" in red.
| ITEM | PROPOSED DEVICE | K113623
PREDICATE DEVICE | K131971
PREDICATE DEVICE | COMPARISON
RESULT |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Intended Patient | Adult, pediatric, neonatal | Adult, pediatric, neonatal | Adult, pediatric, neonatal | Same |
| Measure
Parameters | EtCO2, FiCO2, AwRR | EtCO2, FiCO2, AwRR | EtCO2, FiCO2, AwRR | Same |
| Measuring Range | CO2: 0mmHg to 150mmHg (0 % to 20%)
AwRR: 2rpm to 150rpm | CO2: 0mmHg to 150mmHg (0 % to 20%)
AwRR: 2rpm to 150rpm | CO2: 0mmHg to 150mmHg (0 % to 20%)
AwRR: 2rpm to 150rpm | Same |
| AG module (EDAN G7 module) | | | | |
| Measure
Parameters | CO2, N2O, O2, HAL, ISO, ENF, SEV, DES, awRR, MAC. | CO2, N2O, O2, HAL, ISO, ENF, SEV, DES, awRR, MAC. | CO2, N2O, O2, HAL, ISO, ENF, SEV, DES, awRR, MAC. | Same |
| Measuring Range | CO2: 0 to 25 vol%
O2: 0 to 100 vol%
N₂O: 0 to 100 vol%
HAL, ENF, ISO, SEV, DES: 0-25 vol%
AwRR: 0 rpm to 150 rpm | CO2: 0 to 25 vol%
O2: 0 to 100 vol%
N₂O: 0 to 100 vol%
HAL, ENF, ISO, SEV, DES: 0-25 vol%
AwRR: 0 rpm to 150 rpm | CO2: 0 to 25 vol%
O2: 0 to 100 vol%
N₂O: 0 to 100 vol%
HAL, ENF, ISO, SEV, DES: 0-25 vol%
AwRR: 0 rpm to 150 rpm | Same |
| Other Features | | | | |
| | WI-FI | | | |
| IEEE | 802.11 b/g/n | 802.11 b/g/n | 802.11 b/g/n | Same |
| Frequency Band | 2.4 GHz ISM band | 2.4 GHz ISM band | 2.4 GHz ISM band | Same |
| Power supply | | | | |
| AC power | | | | |
| Requirement | 100-240V~, 50/60Hz | 100-240V~, 50/60Hz | 100-240V~, 50/60Hz | Same |
| Battery | | | | |
| Rechargeable
Battery | Yes | Yes | Yes | Same |
Performance data:
Non-clinical data:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testinq
The biocompatibility evaluation for the LM-8, LM-12 and LM-15 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
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Image /page/11/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 red.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the LM-8, LM-10, LM-12 and LM-15 Patient Monitor device, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1:2005/A1: 2012, IEC 60601-1-8: 2006, IEC 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 IEC 60601-1-2:2007. standard for EMC.
| Table 2. Standards compliance | |
|---|---|
| Standard | Conclusion |
| IEC 60601-1 IEC Medical electrical equipment - Part 1: General requirements for basic safety and essential performance ((2005) + Amd. 1 (2012)). | Pass |
| IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (Edition 4.0 2014). | Pass |
| IEC 60601-1-8 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. (Edition 2.1 2012). | Pass |
| IEC 60601-2-34 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety, including essential performance, of invasive blood pressure monitoring equipment. Edition 3.0 2011-05. | Pass |
| IEC 62304 Medical device software - Software life cycle processes (2006 (First Edition) + A1:2015). | Pass |
| IEC 62366-1 Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1. (2015+AMD1:2020 (Consolidated Text)). | Pass |
| ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (3rd Edition 2010). | Pass |
| ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. (3rd Edition 2010). | Pass |
| IEC 80601-2-30 Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers. (Edition 2.0 2018). | Pass |
| ISO 80601-2-55 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors. (2nd edition 2018). | Pass |
| ISO 80601-2-56 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. (2nd edition 2017 [Including: Amendment 1-2018]). | Pass |
| ISO 80601-2-61 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment. (2nd edition 2017 - Corrected version 2018). | Pass |
| IEC 60601-2-49 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment. (Ed. 2.0 b:2011) | Pass |
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Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Clinical data:
Clinical tests were performed on the LM-8, LM-12 and LM-15 monitors to validate their performance in terms of ECG, RESP, SpO2, NIBP, IBP, TEMP, Quick TEMP, C.O., CO2 and AG.
Summary
Based on the non-clinical and clinical performance as documented in the system development, the subject devices were found to be substantially equivalent to the predicate device.
Conclusion
The non-clinical data support the substantial equivalence of the device and the hardware and software verification and validation demonstrate that the LM-8, LM-10, LM-12 and LM-15 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 LM-8, LM-12 and LM-15 Patient Monitor devices are substantially equivalent to the predicate devices.