(45 days)
Not Found
No
The description mentions "advanced digital filtering technique" and "interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only," but does not explicitly mention AI or ML, nor does it describe any training or test sets typically associated with such technologies. The filtering and interpretation appear to be based on traditional signal processing and pre-programmed algorithms.
No
The device is an electrocardiograph used to acquire and analyze ECG signals for diagnosis, not to provide therapy.
Yes
The device is described as an electrocardiograph whose recorded cardiogram "can help users to analyze and diagnose heart disease." This directly indicates its role in providing information for diagnostic purposes.
No
The device description explicitly details hardware components such as a touch screen, keypad, thermal printer, ECG board, MCU, and various physical interfaces (Ethernet, WIFI, RS232). It describes the physical process of acquiring and processing ECG signals using these hardware elements.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body. The description clearly states that the LE-12CH electrocardiograph acquires ECG signals from the patient's body surface using electrodes. It does not involve the analysis of blood, urine, tissue, or any other sample removed from the patient.
- The device measures electrical activity. Electrocardiographs measure the electrical activity of the heart. This is a physiological measurement taken directly from the patient, not an analysis of a biological sample.
- The intended use is for acquiring and analyzing ECG signals. The purpose is to help users analyze and diagnose heart disease based on these electrical signals.
Therefore, the LE-12CH electrocardiograph falls under the category of a medical device that performs a physiological measurement, not an IVD.
N/A
Intended Use / Indications for Use
The intended use of LE-12CH electrocardiograph is to acquire ECG signals from adult and pediatric patients (beginning at birth through 21 years of age) through body surface FCG electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healtheare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.
Product codes
DPS
Device Description
CAF Medical's LE-12CH electrocardiograph device is a twelve-channel electrocardiograph, which features a user-friendly design, a high-resolution 8.4-inch (800*600) TFT LCD touch screen, an alphanumeric keypad and an optimized workflow.
The LE-12CH electrocardiograph can acquire 12-channel waveforms simultaneously, and can also print the 12-channel electrocardiograph waveforms simultaneously, using a 216 mm wide thermal printer.
An advanced digital filtering technique has been used in the LE-12CH device, including a baseline anti-drift filter, AC noise filter (50/60 Hz), EMG filter and low-pass filter, which can help the user record the ECG more clearly.
The LE-12CH electrocardiograph works by sampling the ECG signal from the patient's skin surface using special electrodes. This signal is then amplified and sampled in A/D format by the ECG board. The ECG board transfers the data to the system's MCU via UART. The MCU filters the data, sends it to the LCD, prints the waveforms on paper and stores the data in memory. This log can be stored in flash memory or sent to the PC via Ethernet, WIFI or RS232. During the examination, no substances are given to or removed from the patient. The LE-12CH electrocardiograph supports cardiac stress testing.
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
adult and pediatric patients (beginning at birth through 21 years of age)
Intended User / Care Setting
hospitals or healthcare facilities by doctors and trained healthcare professionals.
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)
The LE-12CH was tested to evaluate its performance based on the following standards:
IEC 60601-1 ((2005) + Amd. 1 (2012))
IEC 60601-1-2 (Edition 4.0 2014)
IEC 60601-2-25 (Edition 2.0 2011)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K171942, Edan Instruments, Inc.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 25, 2022
CAF Medical Solutions Inc. % Juan Tezak Consultant Compliance 4 Devices 118 W Prive Cr. Delray Beach, Florida 33445
Re: K220362
Trade/Device Name: LE-12CH Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: February 8, 2022 Received: February 8, 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.
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
1
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 mediation-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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Exp
See
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
| Indications for Use | See PRA Statement below. | |
|---|---|---|
| 510(k) Number (if known) | ||
| K220362 | ||
| Device Name | ||
| LE-12CH | ||
| Indications for Use (Describe) | ||
| Type of Use (Select one or both, as applicable) | The intended use of LE-12CH electrocardiograph is to acquire ECG signals from adult and pediatric patients (beginning at | |
| birth through 21 vears of age) through body surface FCG electrocardiograph is only intended to be used in | ||
| hospitals or healthcare facilities by doctors and trained healtheare professionals. The cardiogram recorded by the | ||
| electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with | ||
| measurements and interpretive statements is offered to clinicians on an advisory basis only. | ||
| > Prescription Use (Part 21 CFR 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." | ||
| FORM FDA 3881 (6/20) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 |
PSC Publishing Services (S
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510(k) Summary
LE-12CH February, 2022
ADMINISTRATIVE INFORMATION
Applicant
CAF Medical Solutions Inc. 17539 Roberts Road, Hockley TX 77477 USA E-mail: c.ortiz@cafmedical.com Phone: +1 713 614 7049
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 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: | LE-12CH |
|---|---|
| Common Name: | Electrocardiograph |
| Classification Regulation: | 21 CFR 870.2340 |
| Classification Name: | Electrocardiograph |
| Device Classification: | Class II |
| Classification Panel: | Cardiovascular |
| Product Code: | DPS |
| Prior Submission: | No Prior Submission |
Predicate Device Information
Predicate Device:
K171942. Electrocardiograph with models SE-12, SE-12 Express, SE-1200 and SE-1200 Express. Edan Instruments, Inc.
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Intended Use / Indications for Use
The intended use of LE-12CH electrocardiograph is to acquire ECG signals from adult and pediatric patients (beginning at birth through 21 years of age) through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.
Device Description
CAF Medical's LE-12CH electrocardiograph device is a twelve-channel electrocardiograph, which features a user-friendly design, a high-resolution 8.4-inch (800*600) TFT LCD touch screen, an alphanumeric keypad and an optimized workflow.
The LE-12CH electrocardiograph can acquire 12-channel waveforms simultaneously, and can also print the 12-channel electrocardiograph waveforms simultaneously, using a 216 mm wide thermal printer.
An advanced digital filtering technique has been used in the LE-12CH device, including a baseline anti-drift filter, AC noise filter (50/60 Hz), EMG filter and low-pass filter, which can help the user record the ECG more clearly.
The LE-12CH electrocardiograph works by sampling the ECG signal from the patient's skin surface using special electrodes. This signal is then amplified and sampled in A/D format by the ECG board. The ECG board transfers the data to the system's MCU via UART. The MCU filters the data, sends it to the LCD, prints the waveforms on paper and stores the data in memory. This log can be stored in flash memory or sent to the PC via Ethernet, WIFI or RS232. During the examination, no substances are given to or removed from the patient. The LE-12CH electrocardiograph supports cardiac stress testing.
Contraindications:
There are no known contraindications for use.
Equivalence to Marketed Device
LE-12CH is substantially equivalent to the predicate device. In further support of a substantial equivalence determination, here-under is a comparison chart with the subject device and predicate device.
Table 1. Comparison with predicate device for Summary
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| ITEM | PREDICATE DEVICE | PROPOSED DEVICE | COMPARISON |
|---|---|---|---|
| K# | SE-1200 EXPRESS | ||
| K171942 | LE-12CH | ||
| K220362 | RESULT | ||
| Intended Use / | |||
| Indications for Use | The intended use of SE-12 series | ||
| electrocardiograph is to acquire ECG | |||
| signals from adult and pediatric | |||
| patient (beginning at birth through | |||
| 21 years of age) through body | |||
| surface ECG | |||
| electrodes. The electrocardiograph is | |||
| only intended to be used in hospitals | |||
| or healthcare facilities by doctors and | |||
| trained healthcare professionals. The | |||
| cardiogram recorded by the | |||
| electrocardiograph can help users to | |||
| analyze and diagnose heart disease. | |||
| However, the interpreted ECG with | |||
| measurements and interpretive | |||
| statements is offered to clinicians on | |||
| an advisory basis | |||
| only. | The intended use of LE-12CH | ||
| electrocardiograph is to acquire ECG | |||
| signals from adult and pediatric | |||
| patient (beginning at birth through | |||
| 21 years of age) through body | |||
| surface ECG | |||
| electrodes. The electrocardiograph is | |||
| only intended to be used in hospitals | |||
| or healthcare facilities by doctors and | |||
| trained healthcare professionals. The | |||
| cardiogram recorded by the | |||
| electrocardiograph can help users to | |||
| analyze and diagnose heart disease. | |||
| However, the interpreted ECG with | |||
| measurements and interpretive | |||
| statements is offered to clinicians on | |||
| an advisory basis | |||
| only. | Same | ||
| Safety Specifications | |||
| Safety Standards | IEC 60601-1:2005/A1:2012 EN 60601- | ||
| 1:2006/A1:2013 IEC 60601-1-2:2007 | |||
| EN 60601-1-2:2007/AC:2010 IEC/EN | |||
| 60601-2-25 | IEC 60601-1 ((2005) + Amd. 1 (2012)) | ||
| IEC 60601-1-2 (Edition 4.0 2014) | |||
| IEC 60601-2-25 (Edition 2.0 2011) | Same | ||
| Anti-electric-shock | |||
| type: | Class I with internal power | ||
| supply | Class I with internal power | ||
| supply | Same | ||
| Anti-electric-shock | |||
| degree: | Type CF | Type CF | Same |
| Degree of protection | |||
| against harmful | |||
| ingress of | |||
| water: | Ordinary equipment (Sealed | ||
| equipment without liquid proof) | Ordinary equipment (Sealed | ||
| equipment without liquid proof) | Same | ||
| Disinfection/sterilizati | |||
| on method: | Refer to the user manual for | ||
| details | Refer to the user manual for | ||
| details | Same | ||
| Degree of safety of | |||
| application in the | |||
| presence of | |||
| flammable gas: | Equipment not suitable for use in the | ||
| presence of flammable gas | Equipment not suitable for use in the | ||
| presence of flammable gas | Same | ||
| Working mode: | Continuous operation | Continuous operation | Same |
| EMC: | CISPR 11 Group 1, Class A | CISPR 11 Group 1, Class A | Same |
| Ingress rating | IPX0 | IPX0 | Same |
| Environment Specifications | |||
| Temperature | |||
| Transport & | |||
| Storage | -20ºC (-4ºF) ~ +55ºC (+131ºF) | -20ºC (-4ºF) ~ +55ºC (+131ºF) | Same |
| Working | +5ºC (+41ºF) ~ +40ºC (+104ºF) | +5ºC (+41ºF) ~ +40ºC (+104ºF) | Same |
| Relative Humidity: | |||
| Transport & Storage | 25%~93% | ||
| Non-Condensing | 25%~93% | ||
| Non-Condensing | Same | ||
| ITEM | PREDICATE DEVICE | ||
| SE-1200 EXPRESS | PROPOSED DEVICE | ||
| LE-12CH | COMPARISON | ||
| RESULT | |||
| Working | 25% RH ~ 80% RH | ||
| Non-Condensing | 25% RH ~ 80% RH | ||
| Non-Condensing | Same | ||
| Atmospheric Pressure: | |||
| Transport & | |||
| Storage | 700 hPa ~1060 hPa | 700 hPa ~1060 hPa | |
| Working | 860 hPa ~1060 hPa | 860 hPa ~1060 hPa | Same |
| Power Supply Specifications | |||
| Mains Supply: | Operating Voltage =100V-240V~ | Operating Voltage =100V-240V~ | |
| Operating frequency = 50 Hz / 60 Hz | Operating frequency = 50 Hz / 60 Hz | ||
| Input Current = 0.9-0.4A | |||
| Or Input power = 96VA | Input Current = 0.9-0.4A | ||
| Or Input power = 96VA | |||
| Built-in Lithium | Rated voltage = 14.8 V | Rated voltage = 14.8 V | Same |
| Battery Pack: | SE-12 Express&SE-1200 Express: | ||
| Rated capacity = 5000mAh | |||
| SE-12& SE-1200: Rated capacity = | |||
| 2500mAh | Rated capacity = 5000mAh | Same | |
| When the battery is fully charged, SE- | |||
| 12& SE-1200can work normally | |||
| about4hours, and it can continually | |||
| print about 1.5 hours in the manual | |||
| mode or print about300 ECG reports | |||
| of 3×4+1Rin the auto mode; SE-12 | |||
| Express& SE-1200 Express can work | |||
| normally about 5 hours, and it can | |||
| continually print about 2.5 hours in | |||
| the manual mode or print about 350 | |||
| ECG reports of 3×4+1Rin the auto | |||
| mode. | When the battery is fully charged, L- | ||
| 12 CH can work normally about 5 | |||
| hours, and it can continually print | |||
| about 2.5 hours in the manual mode | |||
| or print about 350 ECG reports of | |||
| 3×4+1Rin the auto mode. | |||
| Performance Specifications | |||
| Recording | |||
| Recorder: | Thermal dot-matrix recorder | Thermal dot-matrix recorder | |
| Printing Density | 8 dots per mm / 200 dots per inch | ||
| (amplitude axes) | |||
| 40 dots per mm / 1000 dots per inch | |||
| (time axes, @25mm/s) | 8 dots per mm / 200 dots per inch | ||
| (amplitude axes) | |||
| 40 dots per mm / 1000 dots per inch | |||
| (time axes, @25mm/s) | Same | ||
| Recorder Paper: | Folded thermal paper: | ||
| 210mm×295mm×100pages Folded | |||
| thermal paper: | |||
| 215mm×280mm×100pages | |||
| (Optional) | |||
| Rolled thermal paper: 210mm×30m | |||
| (Optional) | Folded thermal paper: | ||
| 210mm×295mm×100pages Folded | |||
| thermal paper: | |||
| 215mm×280mm×100pages | |||
| (Optional) | |||
| Rolled thermal paper: 210mm×30m | |||
| (Optional) | Same | ||
| Effective Width: | 210mm | 210mm | Same |
| Paper Speed: | 5mm/s, 6.25mm/s, 10mm/s, | ||
| 12.5mm/s, 25mm/s, 50mm/s | |||
| (±3%) | 5mm/s, 6.25mm/s, 10mm/s, | ||
| 12.5mm/s, 25mm/s, 50mm/s | |||
| (±3%) | Same | ||
| Accuracy of data: | ±5% (x-axis), ±5%(y-axis) | ±5% (x-axis), ±5%(y-axis) | Same |
| ITEM | PREDICATE DEVICE | ||
| SE-1200 EXPRESS | PROPOSED DEVICE | ||
| LE-12CH | COMPARISON | ||
| RESULT | |||
| HR Recognition | |||
| Technique: | Peak-Peak Detection | Peak-Peak Detection | Same |
| HR Range: | 30 BPM ~ 300 BPM | 30 BPM ~ 300 BPM | Same |
| Accuracy: | ±1 BPM | ±1 BPM | Same |
| Leads: | Standard 12 leads | Standard 12 leads | Same |
| Acquisition | |||
| Mode: | Simultaneously 12 leads | Simultaneously 12 leads | Same |
| A/D | 24 bits | 24 bits | Same |
| Resolution: | 2.52uV/LSB | 2.52uV/LSB | Same |
| Time Constant: | ≥ 3.2 s | ≥ 3.2 s | Same |
| Frequency | |||
| Response: | 0.01Hz ~ 300 Hz (-3 dB) | 0.01Hz ~ 300 Hz (-3 dB) | Same |
| Gain: | 1.25,2.5, 5, 10, 20, 10/5, AGC | ||
| (mm/mV) | 1.25,2.5, 5, 10, 20, 10/5, AGC | ||
| (mm/mV) | Same | ||
| Input Impedance: | ≥100MΩ(10Hz) | ≥100MΩ(10Hz) | Same |
| Input Circuit | |||
| Current: | ≤0.01μA | ≤0.01μA | Same |
| Input Voltage | |||
| Range | ≤±5 mVpp | ≤±5 mVpp | Same |
| Calibration | |||
| Voltage: | 1mV±2% | 1mV±2% | Same |
| DC Offset | |||
| Voltage: | ±600 mV | ±600 mV | Same |
| Noise: | ≤12.5 µVp-p | ≤12.5 µVp-p | Same |
| Multi-channel | |||
| Crosstalk | ≤0.5 mm | ≤0.5 mm | Same |
| Filter | AC Filter: On / Off | AC Filter: On / Off | Same |
| EMG Filter: 25Hz / 35Hz / 45Hz | |||
| / OFF | EMG Filter: 25Hz / 35Hz / 45Hz | ||
| / OFF | Same | ||
| LOWPASS Filter:300Hz/ 270Hz/1 | |||
| 50Hz / 100Hz / 75Hz | LOWPASS Filter:300Hz/ 270Hz/1 | ||
| 50Hz / 100Hz / 75Hz | Same | ||
| CMRR | ≥140dB (AC ON) | ||
| ≥123dB (AC OFF) | ≥140dB (AC ON) | ||
| ≥123dB (AC OFF) | Same | ||
| Sampling | |||
| Frequency | 16000Hz | 16000Hz | Same |
| Pacemaker Detection | |||
| Amplitude | ±750uVto ±700 mV | ±750uVto ±700 mV | Same |
| Width | 50μs to 2.0 ms | 50μs to 2.0 ms | Same |
| Sampling Frequency | 16,000/sec/channel | 16,000/sec/channel | Same |
| Input | ≥100 kΩ; Sensitivity 10 mm/V±5%; | ||
| Single ended | ≥100 kΩ; Sensitivity 10 mm/V±5%; | ||
| Single ended | Same | ||
| Output | ≤100Ω; Sensitivity 1 V/mV ±5%; | ||
| Single ended | ≤100Ω; Sensitivity 1 V/mV ±5%; | ||
| Single ended | Same | ||
| Standard | Title | ||
| Biocompatibility | ISO 10993-1 | Biological Evaluation of Medical Device – Part 1: Evaluation and | |
| Testing within a Risk Management Process | |||
| ISO 10993-5 | Biological Evaluation of Medical Device - Test for in vitro cytotoxicity | ||
| ISO 10993-10 | Biological Evaluation of Medical Device – Part 10: Test for irritation | ||
| and skin sensitization | |||
| EMC | IEC 60601-1 | IEC Medical electrical equipment - Part 1: General requirements for | |
| basic safety and essential performance | |||
| 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 | |||
| Bench Testing | IEC 60601-2-25 | Medical electrical equipment - Part 2-25: Particular requirements | |
| for the basic safety and essential performance of | |||
| electrocardiographs | |||
| Software Validation | Guidance for the Content of Premarket Submissions for Software | ||
| Contained in Medical Devices. Level of Concern "Moderate" |
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Non-Clinical Testing Summary
The LE-12CH was tested to evaluate its performance based on the following standards:
Table 2. Standards compliance
Clinical Testing Summary
Clinical testing was not required to demonstrate the substantial equivalence of the subject device to the predicate device.
Conclusion
Based on the information presented in this 510(k) premarket notification, the LE-12CH is considered substantially equivalent (as safe, as effective and performs as well as) to the currently marketed device, K171942 Electrocardiograph SE-1200 Express, cited in this submission. Any differences noted between the LE-12CH and the predicate device do not impact safety or effectiveness based on the successfully conducted testing of the subject device.