(43 days)
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.
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.
The provided text is an FDA 510(k) summary for a Patient Monitor (models LM-8, LM-10, LM-12, LM-15). It primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with general performance standards.
However, the document does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-driven medical device performance study.
Specifically, the document lacks:
- A explicit table of acceptance criteria for algorithm performance (e.g., sensitivity, specificity, F1-score for arrhythmia detection).
- Detailed results of a study demonstrating the device meets specific performance criteria for arrhythmia detection or ST-segment analysis (beyond basic functional checks).
- Information on sample size for test sets directly related to algorithm performance (as opposed to overall device safety/functionality).
- Data provenance, number of experts for ground truth, adjudication methods, or MRMC studies, which are typical for AI/ML device evaluations.
- Training set details for any AI/ML components.
The "Performance data" section refers to "Clinical data" for validation, but these appear to be general functional validation tests on physiological parameters (ECG, RESP, SpO2, NIBP, etc.) to ensure the monitors function as intended, rather than a specific study to validate the performance of the arrhythmia detection and ST Segment analysis algorithm against clinical ground truth. The statement "The clinical data demonstrate that the subject devices perform comparably to the predicate device that is currently marketed for the same intended use" is a high-level conclusion without supporting details beyond the comparative features table.
Based on the provided text, here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a specific table of quantitative acceptance criteria for the arrhythmia detection and ST segment analysis algorithm (e.g., sensitivity, specificity thresholds) and corresponding reported performance metrics. It lists general parameters and their measurement ranges, which are functional specifications, not performance criteria for an arrhythmia detection algorithm.
General device functional specifications (from comparison table, not acceptance criteria for algorithm):
| Parameter | Proposed Device (LM-8, LM-10, LM-12, LM-15) | Predicate Devices (K113623, K131971) | Reported Performance |
|---|---|---|---|
| ECG Parameters | |||
| Lead Mode | 3, 5, 12 Electrodes (depending on model) | 3, 5, 12 Electrodes (depending on model) | Same as predicate |
| Arrhythmia analyses | ASYSTOLE, VFIB/VTAC, COUPLET, VT> 2, BIGEMINY, TRIGEMINY, VENT, R on T, PVC, TACHY, BRADY, MISSED BEATS, IRR, VBRADY, PNC, PNP | Same | Same as predicate (implies detection of these) |
| ST value Measurement Range | -2.0 mV to +2.0 mV | Same | Same as predicate |
| HR Measurement range | ADU: 15-300 bpm, PED/NEO: 15-350 bpm | Same | Same as predicate |
| PVC Range | ADU: (0 to 300) PVCs/min, PED/NEO: (0 to 350) PVCs/min | Not explicitly stated for predicate in comparison table, but "Same" is indicated. | Implied performance within these ranges. |
| RESP Module | |||
| Principle of Operation | Impedance between RA-LL, RA-LA | Same | Same as predicate |
| Measurement Range | Adult: 0-120 rpm, Pediatric/neonate: 0-150 rpm | Same | Same as predicate |
| NIBP Module | |||
| Technique | Oscillometry | Same | Same as predicate |
| Measurement Range | Adult/Pediatric/Neonatal Systolic, Diastolic, Mean ranges provided (e.g., Adult Systolic 40-270) | Same | Same as predicate |
| PR from NIBP Measurement range | 40-240 bpm | Same | Same as predicate |
| SpO2 Module | |||
| Measurement Range | SpO2: 0-100%, Pulse Rate: 25-300 bpm | Same | Same as predicate |
| Temperature Module | |||
| Number of channels | 2 | Same | Same as predicate |
| Measurement Range | 0°C to 50°C (32°F to 122°F) | Same | Same as predicate |
| IBP Module | |||
| Measurement Range | PA/PAWP, CVP/RAP/LAP/ICP, P1/P2 ranges (e.g., P1/P2: -50 to +300 mmHg) | Same | Same as predicate |
| C.O. Module | |||
| Technique | Thermodilution Technique | Same | Same as predicate |
| Measurement Range | C.O.: 0.1-20L/min, TB: 23-43°C, TI: -1-27°C | Same | Same as predicate |
| CO2 Module | |||
| Measure Parameters | EtCO2, FiCO2, AwRR | Same | Same as predicate |
| Measuring Range | CO2: 0-150mmHg, AwRR: 2-150rpm | Same | Same as predicate |
| AG Module | |||
| Measure Parameters | CO2, N2O, O2, HAL, ISO, ENF, SEV, DES, awRR, MAC. | Same | Same as predicate |
| Measuring Range | Ranges for each gas and AwRR (e.g., CO2: 0-25 vol%) | Same | Same as predicate |
The document notes that "The arrhythmia detection and ST Segment analysis are intended for adult and pediatric patients" and that "Clinical tests were performed on the LM-8, LM-12 and LM-15 monitors to validate their performance in terms of ECG...". However, it does not specify what constituted "validation" for these particular algorithmic features or what the performance metrics were. The "Conclusion" states: "The clinical data demonstrate that the subject devices perform comparably to the predicate device that is currently marketed for the same intended use." This is the reported device performance for these features: "comparable to predicate."
2. Sample sized used for the test set and the data provenance:
- Sample Size for Test Set: Not specified for the "Clinical data" related to ECG/arrhythmia/ST validation. The statement is general: "Clinical tests were performed on the LM-8, LM-12 and LM-15 monitors..."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not specified. The document does not describe how ground truth for arrhythmia or ST segment analysis was established for clinical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study is not mentioned. This device is a monitor, not an AI-assisted diagnostic tool for interpretation by a human reader in the typical sense of an MRMC study for imaging. It provides "arrhythmia detection and ST Segment analysis" algorithms directly to the user.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "Clinical data" statement indicates the monitors' performance was validated. Given the nature of a patient monitor, the arrhythmia and ST segment analysis would inherently be "standalone" algorithmic functions integrated into the device, providing automated analysis. However, specific performance metrics (like sensitivity/specificity of the algorithm itself) from this standalone evaluation are not presented.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not specified. It is generally implied that such devices are validated against accepted physiological measurement standards and potentially manually confirmed ECG interpretations, but the document does not detail this for the arrhythmia/ST segment analysis.
8. The sample size for the training set:
- Not applicable/Not specified. The document does not indicate that the arrhythmia detection or ST segment analysis algorithms utilize machine learning or require a "training set" in the sense of AI/ML development. It's likely these are based on established rule-based or signal processing algorithms, not learned from data.
9. How the ground truth for the training set was established:
- Not applicable. (See #8)
In summary, this 510(k) submission successfully demonstrates substantial equivalence through technical specifications, comparisons to predicate devices, and compliance with general safety and performance standards (e.g., electrical safety, EMC, biocompatibility, software verification/validation). However, it does not detail a specific performance study for its arrhythmia detection and ST segment analysis algorithms in a way that typically applies to AI/ML clearance, which would include explicit acceptance criteria, detailed test set characteristics, and ground truth methodologies. The "clinical data" section is very high-level and only states comparability to predicate devices.
{0}------------------------------------------------
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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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 andLM-15 |
|---|---|
| Regulatory Class: | Class II |
| Prior Submission: | No prior submission |
| Device name, classification andproduct code: | • 870.1025 monitor, physiological, patient (witharrhythmia detection or alarms)/ MHX• 870.1025 Detector and Alarm, Arrhythmia/ DST• 870.1025 Monitor, ST Segment with Alarm/ MLD• 870.2300 Cardiac monitor (includingcardiotachometer and rate alarm)/ DRT• 870.1130 Non-Invasive blood pressure/ DXN• 870.1110 Blood pressure computer/ DSK |
{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 signaltransmitter 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.
{5}------------------------------------------------
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 | DifferenceLCD | Difference Parameter |
|---|---|---|
| LM-8 | 8.4 inch | ECG RESP TEMP QuickTEMP SpO2 NIBP IBP CO23/5-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. AG3/5-lead ECG |
| LM-15 | 15 inch | ECG RESP TEMP SpO2 NIBP IBP CO2 C.O. AG3/5/12-lead ECG |
Contraindications:
There are no known contraindications for use.
{6}------------------------------------------------
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 | K113623PREDICATE DEVICE | K131971PREDICATE DEVICE | COMPARISONRESULT |
|---|---|---|---|---|
| General Features | ||||
| Intended Use | The monitors are intended to be used formonitoring, storing, and reviewing of, and togenerate alarms for, multiple physiologicalparameters of adults and pediatrics. The monitorsare intended for use by trained healthcareprofessionals in hospital environments. | iM80:The monitor monitorsparameters such asECG (3-lead, 5-lead,12-lead selectable),Respiration (RESP),Functional arterialoxygen saturation(SpO2), Invasive ornoninvasive bloodpressure (2/4channels IBP NIBP),Cardiac Output (CO),Temperature (dual-TEMP), Expired CO2and Anesthetic gas(AG). The monitor isequipped with alarmsthat indicate systemfaults (such as looseor defectiveelectrodes),physiologicparameters that haveexceeded the limitsset by the operator, orboth. | iM60:The iM60 monitormonitors parameterssuch as ECG (3-lead,5-lead selectable),Respiration (RESP),Functional arterialoxygen saturation(SpO2), Invasive ornoninvasive bloodpressure (2/4channels IBP NIBP),Cardiac Output (CO),Temperature (dual-TEMP) and ExpiredCO2. The monitor isequipped withalarms that indicatesystem faults (suchas loose or defectiveelectrodes),physiologicparameters thathave exceeded thelimits set by theoperator, or both. | Similar |
| The LM-8 monitor monitors parameters such asECG (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 andQuick Temperature (Quick TEMP). | ||||
| The LM-10 monitor monitors parameters such asECG (3-lead, 5-lead selectable), Respiration (RESP),Functional arterial oxygen saturation (SpO2),Invasive or noninvasive blood pressure (2/4channels IBP, NIBP), Cardiac Output (C.O.),Temperature (dual-TEMP) and Expired CO2. | ||||
| The LM-12 monitor monitors parameters such asECG (3-lead, 5-lead selectable), Respiration (RESP),Functional arterial oxygen saturation (SpO2),Invasive or noninvasive blood pressure (2/4channels IBP, NIBP), Cardiac Output (C.O.),Temperature (dual-TEMP), Expired CO2 andAnesthetic gas (AG). | iM70:The iM70 monitormonitors parameterssuch as ECG (3-lead,5-lead selectable),Respiration (RESP),Functional arterialoxygen saturation(SpO2), Invasive ornoninvasive bloodpressure (2/4channels IBP NIBP),Cardiac Output (CO),Temperature (dual-TEMP), Expired CO2and Anesthetic gas(AG). The monitor isequipped withalarms that indicatecustom faults (such | |||
| The LM-15 monitor monitors parameters such asECG (3-lead, 5-lead, 12-lead selectable),Respiration (RESP), Functional arterial oxygensaturation (SpO2), Invasive or noninvasive bloodpressure (2/4 channels IBP, NIBP), Cardiac Output(C.O.), Temperature (dual-TEMP), Expired CO2 andAnesthetic gas (AG).The arrhythmia detection and ST Segment analysisare intended for adult and pediatric patients.The monitors are not intended for MRIenvironments. | iM50:The monitor monitorsparameters such asECG (3-lead, 5-leadselectable),Respiration (RESP),Functional arterialoxygen saturation(SpO2), Invasive ornoninvasive bloodpressure (dual-IBP,NIBP), Temperature(dual-TEMP), ExpiredCO2 and QuickTemperature (QuickTEMP). The monitor isequipped with alarmsthat indicate systemfaults (such as loose | |||
| ITEM | PROPOSED DEVICE | K113623PREDICATE DEVICE | K131971PREDICATE DEVICE | COMPARISONRESULT |
| or defectiveelectrodes),physiologicparameters that haveexceeded the limitsset by the operator, orboth.The arrhythmiadetection and STSegment analysis arenot intended forneonatal patients. | as loose or defectiveelectrodes),physiologicparameters thathave exceeded thelimits set by theoperator, or both. | |||
| Contraindications | It is not intended for use in patient's home orresidence, or when it has not been ordered by aphysician. | It is not intended foruse in patient's homeor residence, or whenit has not beenordered by aphysician. | It is not intended foruse in patient's homeor residence, orwhen it has not beenordered by aphysician. | Same |
| Test Summary | Software testingHardware testingSafety testingEnvironment testRisk analysisFinal validation | Software testingHardware testingSafety testingEnvironment testRisk analysisFinal validation | Software testingHardware testingSafety testingEnvironment testRisk analysisFinal validation | Same |
| Features by Model | ||||
| Feature | Proposed ModelsLM-8 | LM-10 | LM-12 | LM-15 |
| Predicate Models | ||||
| iM50 | iM80 | iM60 | ||
| iM70 | Same | |||
| Monitors SpO2parameters | Yes | Yes | Yes | Yes |
| Yes | Yes | Yes | ||
| Yes | Same | |||
| Monitor NIBPparameters | Yes | Yes | Yes | Yes |
| Yes | Yes | Yes | ||
| Yes | Same | |||
| Monitors ECGparameters | Yes | Yes | Yes | Yes |
| Yes | Yes | Yes | ||
| Yes | Same | |||
| Monitor RESPparameters | Yes | Yes | Yes | Yes |
| Yes | Yes | Yes | ||
| Yes | Same | |||
| Monitors TEMPparameters | Yes | Yes | Yes | Yes |
| Yes | Yes | Yes | ||
| Yes | Same | |||
| Monitors CO2parameters | Yes | Yes | Yes | Yes |
| Yes | Yes | Yes | ||
| Yes | Same | |||
| Monitor IBPparameters | Yes | Yes | Yes | Yes |
| Yes | Yes | Yes | ||
| Yes | Same | |||
| Monitor C.O.parameters | No | Yes | Yes | Yes |
| No | Yes | Yes | ||
| Yes | Same | |||
| Monitors AGparameters | No | No | Yes | Yes |
| No | Yes | No | ||
| Yes | Same |
Table 1. Comparison with predicate device for Summary
{7}------------------------------------------------
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.
{8}------------------------------------------------
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 | K113623PREDICATE DEVICE | K131971PREDICATE DEVICE | COMPARISONRESULT | |||||
|---|---|---|---|---|---|---|---|---|---|
| Usermay select differentmonitoringparameters inaccording with therequirement | Yes | No | No | Yes | Yes | No | No | Same | |
| Screen size | 8.4inches | 10.4inches | 12.1inches | 15inches | 8.4inches | 10.4inches | 12.1inches | Same | |
| Touch screen | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Same | |
| Supports onlinesoftware update andnetworking | No | No | No | Yes | No | No | No | Same | |
| Alarms to indicatesystem failuresand/or out-of-rangeparameters. | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Same | |
| EDAN SP02 moduleavailable for thismodel | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Same | |
| Nellcor SP02 moduleavailable for thismodel | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Same | |
| EDAN NIBP moduleavailable for thismodel | No | No | Yes | Yes | No | No | Yes | Same | |
| OMROM M3600module for NIBPavailable for thismodel | No | No | Yes | Yes | No | No | Yes | Same | |
| Suntech NIBP moduleavailable for thismodel | No | No | No | Yes | No | No | No | Same | |
| Parameters by Module | |||||||||
| ECG module | |||||||||
| Lead Mode | 3 Electrodes; 5 Electrodes and 12 Electrodes. | Same | |||||||
| Arrhythmiaanalyses | ASYSTOLE, VFIB/VTAC, COUPLET, VT> 2,BIGEMINY, TRIGEMINY, VENT, R on T, PVC,TACHY, BRADY, MISSED BEATS, IRR, VBRADY,PNC, PNP | Same | |||||||
| ST value | |||||||||
| MeasurementRange | -2.0 mV to +2.0 mV | Same | |||||||
| Pace | |||||||||
| Pulse Indicator | Amplitude: ±2 mV to ±700 mVWidth: 0.1 ms to 2.0 msAscending time: 10 µs to 100 µs | Same | |||||||
| PVC | |||||||||
| Range | ADU: (0 to 300) PVCs/ minPED/NEO: (0 to 350) PVCs/ min | Same |
{9}------------------------------------------------
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 | K113623PREDICATE DEVICE | K131971PREDICATE DEVICE | COMPARISONRESULT | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HR | ||||||||||||||||||||||||||||||||||
| Measurementrange | ADU: 15 bpm to 300 bpmPED/NEO: 15 bpm to 350 bpm | ADU: 15 bpm to 300 bpmPED/NEO: 15 bpm to 350 bpm | Same | |||||||||||||||||||||||||||||||
| RESP module | ||||||||||||||||||||||||||||||||||
| Principle ofOperation | Impedance between RA-LL, RA-LA | Impedance between RA-LL, RA-LA | Same | |||||||||||||||||||||||||||||||
| MeasurementRange | Adult: 0 to 120 rpmPediatric/neonate: 0 to 150 rpm | Adult: 0 to 120 rpmPediatric/neonate: 0 to 150 rpm | Same | |||||||||||||||||||||||||||||||
| NIBP module (EDAN) | ||||||||||||||||||||||||||||||||||
| Technique | Oscillometry | Oscillometry | Same | |||||||||||||||||||||||||||||||
| MeasurementRange | 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 | ||||||||||||||||||||||||||||||||||
| Measurementrange | 40 bpm to 240 bpm | 40 bpm to 240 bpm | Same | |||||||||||||||||||||||||||||||
| SpO2 module (EDAN) | ||||||||||||||||||||||||||||||||||
| MeasurementRange | SpO2: 0% to 100%Pulse Rate: 25 to 300 bpm | SpO2: 0% to 100%Pulse Rate: 25 to 300 bpm | Same | |||||||||||||||||||||||||||||||
| Temperature module | ||||||||||||||||||||||||||||||||||
| Number ofchannels | 2 | 2 | Same | |||||||||||||||||||||||||||||||
| MeasurementRange | 0°C to 50°C (32°F to 122°F) | 0°C to 50°C (32°F to 122°F) | Same | |||||||||||||||||||||||||||||||
| IBP module | ||||||||||||||||||||||||||||||||||
| MeasurementRange | PA/PAWP: (-6 to +120) mmHgCVP/RAP/LAP/ICP: (-10 to +40) mmHgP1/P2: (-50 to +300) mmHg | PA/PAWP: (-6 to +120) mmHgCVP/RAP/LAP/ICP: (-10 to +40) mmHgP1/P2: (-50 to +300) mmHg | Same | |||||||||||||||||||||||||||||||
| C.O. Module | ||||||||||||||||||||||||||||||||||
| Technique | Thermodilution Technique | Thermodilution Technique | Same | |||||||||||||||||||||||||||||||
| Measurementrange | C.O.: 0.1 to 20L/minTB: 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/minTB: 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 |
{10}------------------------------------------------
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 | K113623PREDICATE DEVICE | K131971PREDICATE DEVICE | COMPARISONRESULT |
|---|---|---|---|---|
| Intended Patient | Adult, pediatric, neonatal | Adult, pediatric, neonatal | Adult, pediatric, neonatal | Same |
| MeasureParameters | 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) | ||||
| MeasureParameters | 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 | ||||
| RechargeableBattery | 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
{11}------------------------------------------------
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 |
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the logo for Lifee Medical Devices. The logo consists of a red heartbeat symbol on the left, followed by the word "lifee" in purple. Below the word "lifee" are the words "medical devices" in a smaller, red font.
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.
§ 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.