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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the LE-12CH device:

Based on the provided FDA 510(k) summary for the LE-12CH Electrocardiograph, the submission primarily relies on demonstrating substantial equivalence to a predicate device (K171942. Electrocardiograph with models SE-12, SE-12 Express, SE-1200 and SE-1200 Express. Edan Instruments, Inc.). This means the acceptance criteria are largely aligned with proving that the LE-12CH performs as safely and effectively as the predicate device based on common industry standards and performance specifications.

The document does not describe a specific clinical study (like an MRMC study or standalone algorithm performance study with a test set and ground truth) in the way one might expect for a novel AI/ML-driven diagnostic device. Instead, it details non-clinical testing to ensure compliance with relevant performance and safety standards, and then performs a comparison to the predicate device's specifications.

Therefore, many of the requested fields regarding detailed study methodology (sample size, data provenance, expert consensus, adjudication, effect size) are not applicable in the context of this 510(k) submission as it focuses on demonstrating equivalence through non-clinical means and direct comparison of specifications.

Here's the breakdown of the information that can be extracted or inferred:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the safety and performance standards the device was tested against and by the specifications matching the predicate device. The "reported device performance" is essentially that it meets these standards and matches the predicate.

Acceptance Criterion (Implicit)	Reported Device Performance
Safety Standards Compliance	Meets IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25.
Anti-electric-shock type	Class I with internal power supply (Same as predicate)
Anti-electric-shock degree	Type CF (Same as predicate)
Degree of protection against harmful ingress of water	Ordinary equipment (Sealed equipment without liquid proof) (Same as predicate)
Disinfection/sterilization method	Refer to the user manual for details (Same as predicate)
Degree of safety of application in presence of flammable gas	Equipment not suitable for use in the presence of flammable gas (Same as predicate)
Working mode	Continuous operation (Same as predicate)
EMC	CISPR 11 Group 1, Class A (Same as predicate)
Ingress rating	IPX0 (Same as predicate)
Environmental Specifications
Temperature (Transport & Storage)	-20ºC (-4ºF) ~ +55ºC (+131ºF) (Same as predicate)
Temperature (Working)	+5ºC (+41ºF) ~ +40ºC (+104ºF) (Same as predicate)
Relative Humidity (Transport & Storage)	25%~93% Non-Condensing (Same as predicate)
Relative Humidity (Working)	25% RH ~ 80% RH Non-Condensing (Same as predicate)
Atmospheric Pressure (Transport & Storage)	700 hPa ~1060 hPa (Same as predicate)
Atmospheric Pressure (Working)	860 hPa ~1060 hPa (Same as predicate)
Power Supply Specifications
Mains Supply (Operating Voltage, Frequency, Input Current/Power)	100V-240V~, 50 Hz / 60 Hz, 0.9-0.4A / 96VA (Same as predicate)
Built-in Lithium Battery Pack (Rated voltage)	14.8 V (Same as predicate)
Built-in Lithium Battery Pack (Rated capacity)	5000mAh (Matching the higher capacity predicate model, SE-12 Express & SE-1200 Express)
Battery working duration	~5 hours, ~2.5 hours continuous print (manual), ~350 ECG reports (auto) (Matching the higher-performing predicate model, SE-12 Express & SE-1200 Express)
Performance Specifications
Recorder (Type)	Thermal dot-matrix recorder (Same as predicate)
Printing Density	8 dots per mm / 200 dots per inch (amplitude axes), 40 dots per mm / 1000 dots per inch (time axes, @25mm/s) (Same as predicate)
Recorder Paper (Types)	Folded thermal paper: 210mm×295mm×100pages, 215mm×280mm×100pages (Optional); Rolled thermal paper: 210mm×30m (Optional) (Same as predicate)
Effective Width	210mm (Same as predicate)
Paper Speed	5mm/s, 6.25mm/s, 10mm/s, 12.5mm/s, 25mm/s, 50mm/s (±3%) (Same as predicate)
Accuracy of data	±5% (x-axis), ±5%(y-axis) (Same as predicate)
HR Recognition (Technique)	Peak-Peak Detection (Same as predicate)
HR Range	30 BPM ~ 300 BPM (Same as predicate)
HR Accuracy	±1 BPM (Same as predicate)
Leads	Standard 12 leads (Same as predicate)
Acquisition Mode	Simultaneously 12 leads (Same as predicate)
A/D Resolution	24 bits (Same as predicate)
Resolution	2.52uV/LSB (Same as predicate)
Time Constant	≥ 3.2 s (Same as predicate)
Frequency Response	0.01Hz ~ 300 Hz (-3 dB) (Same as predicate)
Gain	1.25,2.5, 5, 10, 20, 10/5, AGC (mm/mV) (Same as predicate)
Input Impedance	≥100MΩ(10Hz) (Same as predicate)
Input Circuit Current	≤0.01μA (Same as predicate)
Input Voltage Range	≤±5 mVpp (Same as predicate)
Calibration Voltage	1mV±2% (Same as predicate)
DC Offset Voltage	±600 mV (Same as predicate)
Noise	≤12.5 µVp-p (Same as predicate)
Multi-channel Crosstalk	≤0.5 mm (Same as predicate)
Filter (AC, EMG, Lowpass)	Match predicate specifications (AC: On/Off; EMG: 25Hz/35Hz/45Hz/OFF; LOWPASS: 300Hz/270Hz/150Hz/100Hz/75Hz)
CMRR	≥140dB (AC ON), ≥123dB (AC OFF) (Same as predicate)
Sampling Frequency	16000Hz (Same as predicate)
Pacemaker Detection (Amplitude, Width, Sampling Frequency)	Match predicate specifications (Amplitude: ±750uV to ±700 mV; Width: 50μs to 2.0 ms; Sampling Frequency: 16,000/sec/channel)
Input	≥100 kΩ; Sensitivity 10 mm/V±5%; Single ended (Same as predicate)
Output	≤100Ω; Sensitivity 1 V/mV ±5%; Single ended (Same as predicate)
Biocompatibility Standards	Compliant with ISO 10993-1, ISO 10993-5, ISO 10993-10.
Software Validation Guidance	Compliant with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Level of Concern "Moderate"."

Study Details (as per request, with N/A for non-applicable fields)

Sample size used for the test set and the data provenance:
- Not Applicable. The submission does not describe a clinical "test set" in the context of an algorithm's performance evaluation with patient data. It relies on non-clinical testing against standards and direct comparison of technical specifications to a predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As no clinical test set requiring expert ground truth was documented, this information is not provided. The device includes "interpreted ECG with measurements and interpretive statements... Offered to clinicians on an advisory basis only," indicating that the device's interpretation is assistive and not designed to replace expert diagnosis directly without human review.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set with human adjudication was described.
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. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the subject device to the predicate device." Therefore, no MRMC study was conducted or reported.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, not in the sense of a clinical performance study. The device itself is an electrocardiograph that acquires and processes ECG signals, providing interpreted ECG with measurements and interpretive statements. This processing is inherent to the device's function, but its "standalone performance" isn't evaluated as a diagnostic algorithm through a dedicated clinical study with ground truth. Its performance is demonstrated by meeting IEC standards and matching the predicate's technical specifications. The interpretations are explicitly "advisory only."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For the purpose of this 510(k), ground truth for specific disease diagnoses from patient data was not established or used to evaluate the device's interpretive statements in a clinical performance study. The "ground truth" here is compliance with established engineering and safety standards (e.g., accuracy of heart rate detection against known input signals, filter performance) and the technical specifications of a legally marketed predicate device.
The sample size for the training set:
- Not Applicable. The document provides no information on a training set, as it does not describe a machine learning algorithm that requires training data. The device's "advanced digital filtering technique" is a more traditional signal processing methodology, not explicitly stated as an AI/ML algorithm requiring a training set for its interpretive functionality.
How the ground truth for the training set was established:
- Not Applicable. As there is no described training set, this information is not provided.

Summary

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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

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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

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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 NameLE-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 atbirth through 21 vears of age) through body surface FCG electrocardiograph is only intended to be used inhospitals or healthcare facilities by doctors and trained healtheare professionals. The cardiogram recorded by theelectrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG withmeasurements 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 thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to:Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff(@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

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.

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 EXPRESSK171942	LE-12CHK220362	RESULT
Intended Use /Indications for Use	The intended use of SE-12 serieselectrocardiograph is to acquire ECGsignals from adult and pediatricpatient (beginning at birth through21 years of age) through bodysurface ECGelectrodes. The electrocardiograph isonly intended to be used in hospitalsor healthcare facilities by doctors andtrained healthcare professionals. Thecardiogram recorded by theelectrocardiograph can help users toanalyze and diagnose heart disease.However, the interpreted ECG withmeasurements and interpretivestatements is offered to clinicians onan advisory basisonly.	The intended use of LE-12CHelectrocardiograph is to acquire ECGsignals from adult and pediatricpatient (beginning at birth through21 years of age) through bodysurface ECGelectrodes. The electrocardiograph isonly intended to be used in hospitalsor healthcare facilities by doctors andtrained healthcare professionals. Thecardiogram recorded by theelectrocardiograph can help users toanalyze and diagnose heart disease.However, the interpreted ECG withmeasurements and interpretivestatements is offered to clinicians onan advisory basisonly.	Same
Safety Specifications
Safety Standards	IEC 60601-1:2005/A1:2012 EN 60601-1:2006/A1:2013 IEC 60601-1-2:2007EN 60601-1-2:2007/AC:2010 IEC/EN60601-2-25	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-shocktype:	Class I with internal powersupply	Class I with internal powersupply	Same
Anti-electric-shockdegree:	Type CF	Type CF	Same
Degree of protectionagainst harmfulingress ofwater:	Ordinary equipment (Sealedequipment without liquid proof)	Ordinary equipment (Sealedequipment without liquid proof)	Same
Disinfection/sterilization method:	Refer to the user manual fordetails	Refer to the user manual fordetails	Same
Degree of safety ofapplication in thepresence offlammable gas:	Equipment not suitable for use in thepresence of flammable gas	Equipment not suitable for use in thepresence 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 DEVICESE-1200 EXPRESS	PROPOSED DEVICELE-12CH	COMPARISONRESULT
Working	25% RH ~ 80% RHNon-Condensing	25% RH ~ 80% RHNon-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 = 0.9-0.4AOr Input power = 96VA	Input Current = 0.9-0.4AOr 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 = 5000mAhSE-12& SE-1200: Rated capacity =2500mAh	Rated capacity = 5000mAh	Same
		When the battery is fully charged, SE-12& SE-1200can work normallyabout4hours, and it can continuallyprint about 1.5 hours in the manualmode or print about300 ECG reportsof 3×4+1Rin the auto mode; SE-12Express& SE-1200 Express can worknormally about 5 hours, and it cancontinually print about 2.5 hours inthe manual mode or print about 350ECG reports of 3×4+1Rin the automode.	When the battery is fully charged, L-12 CH can work normally about 5hours, and it can continually printabout 2.5 hours in the manual modeor print about 350 ECG reports of3×4+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 Foldedthermal paper:215mm×280mm×100pages(Optional)Rolled thermal paper: 210mm×30m(Optional)	Folded thermal paper:210mm×295mm×100pages Foldedthermal 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 DEVICESE-1200 EXPRESS	PROPOSED DEVICELE-12CH	COMPARISONRESULT
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
AcquisitionMode:	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
FrequencyResponse:	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 CircuitCurrent:	≤0.01μA	≤0.01μA	Same
Input VoltageRange	≤±5 mVpp	≤±5 mVpp	Same
CalibrationVoltage:	1mV±2%	1mV±2%	Same
DC OffsetVoltage:	±600 mV	±600 mV	Same
Noise:	≤12.5 µVp-p	≤12.5 µVp-p	Same
Multi-channelCrosstalk	≤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/150Hz / 100Hz / 75Hz	LOWPASS Filter:300Hz/ 270Hz/150Hz / 100Hz / 75Hz	Same
CMRR	≥140dB (AC ON)≥123dB (AC OFF)	≥140dB (AC ON)≥123dB (AC OFF)	Same
SamplingFrequency	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 andTesting 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 irritationand skin sensitization
EMC	IEC 60601-1	IEC Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance
	IEC 60601-1-2	Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral Standard:Electromagnetic disturbances - Requirements and tests
Bench Testing	IEC 60601-2-25	Medical electrical equipment - Part 2-25: Particular requirementsfor the basic safety and essential performance ofelectrocardiographs
Software Validation		Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices. Level of Concern "Moderate"

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Image /page/7/Picture/0 description: The image shows the logo for Lifee Medical Devices. The logo consists of a red heart rate symbol on the left, followed by the word "lifee" in purple. Below the word "lifee" are the words "medical devices" in a smaller, lighter font.

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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.

Regulation Number and Section

§ 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).