SE-1515 PC ECG is intended to acquire, process and store ECG signals from adult and pediatric patients undergoing stress exercise test or resting test. The SE-1515 PC ECG is intended to be used only in hospitals and healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the SE-1515 PC ECG can help users to analyze and diagnose heart diseases. However, the ECG with measurements is offered to clinicians on an advisory basis only. It is mainly used in the ECG Outpatient Department and Physical Examination Department.

Device Description

SE-1515 is a PC-based ECG designed to acquire, process and store ECG signals and analyze and diagnose heart disease. SE-1515 consists of analysis software and sampling boxes, and has four configurations: Wired 18-lead ECG system, Wired 16-lead ECG system, Wired 12-lead ECG system and Wireless 12-lead ECG system. Wired 18-lead ECG system consists of analysis software and wired DE18 sampling box. Wired 16-lead ECG system consists of analysis software and wired DE15 sampling box. Wired 12-lead ECG system consists of analysis software and wired DP12 sampling box. Wireless 12-lead ECG system contains analysis software, wireless DX12 sampling boxes (DX12 transmitter and DX12 receiver). The communication between DX12 transmitter and DX12 receiver is based on Bluetooth technology. For stress exercise testing, the user should connect a BP monitor and a treadmill or an ergo meter to the PC.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the EDAN Instruments, Inc. PC ECG, model SE-1515, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating
substantial equivalence to predicate devices, not necessarily a detailed clinical
effectiveness study itself. Therefore, specific details about acceptance criteria, ground truth
establishment (especially for a new algorithm), and effect sizes from MRMC studies are often
not explicitly stated in this type of document. The information below is extracted directly
from the text; if a point is not mentioned, it's because the document does not provide it.

Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" but rather compares the performance parameters of the SE-1515 with its predicate devices (SE-1010, Philips DXL 12/16-lead ECG Algorithm, Philips TC70). The implicit acceptance criteria are that the new device's performance should be similar or comparable to the predicate devices, or that any differences do not raise new questions of safety or effectiveness.

Below is a table summarizing the performance comparison, highlighting where quantitative parameters are presented. Since "Remark" column indicates "Same," "Different," or "---", for the purpose of showing "acceptance criteria" and "reported device performance", the "predicate value" can be considered as the implicit acceptance criteria that the new device needs to meet to establish substantial equivalence.

Item (Device Component)	Acceptance Criteria (Predicate Value, where applicable)	Reported Device Performance (SE-1515)
DE15 Sampling Box
DFT Filter	weak/strong	0.01 Hz/0.05 Hz/0.32 Hz/0.67 Hz
Low Pass/EMG Filter	25 Hz/35 Hz/45 Hz/75 Hz/100 Hz/150 Hz	300 Hz/270 Hz/150 Hz/100 Hz/75 Hz (Low Pass Filter); 25 Hz/35 Hz/45 Hz/Off (EMG Filter)
Lead number	12-lead	16-lead
Sampling Rate	1 kHz /channel	16 kHz /channel
Resolution	2.52 µV/LSB @ 1 kHz	0.1575 µV/LSB @ 1 kHz
Frequency Response	0.05 Hz ~ 150 Hz	0.01 Hz~300 Hz
Input Impedance	>50 MΩ	≥100 MΩ
Common Mode Rejection	>110 dB	≥140 dB(AC ON) / ≥123 dB(AC OFF)
Pace Detect	±2 to ±700 mV @ 0.1 ms to 2.0 ms	±750 uV~±700 mV @ 50 us ~2.0 ms
DE18 Sampling Box
DFT Filter	weak/strong	0.01 Hz/0.05 Hz/0.32 Hz/0.67 Hz
Low Pass/EMG Filter	25 Hz/35 Hz/45 Hz/75 Hz/100 Hz/150 Hz	300 Hz/270 Hz/150 Hz/100 Hz/75 Hz (Low Pass Filter); 25 Hz/35 Hz/45 Hz/Off (EMG Filter)
Lead number	12-lead	18-lead
Sampling Rate	1 kHz /channel	16 kHz /channel
Resolution	2.52 µV/LSB @ 1 kHz	0.1575 µV/LSB @ 1 kHz
Frequency Response	0.05 Hz ~ 150 Hz	0.01 Hz~300 Hz
Input Impedance	>50 MΩ	≥100 MΩ
Common Mode Rejection	>110 dB	≥140 dB (AC ON) / ≥123 dB (AC OFF)
Pace Detect	±2 to ±700 mV @ 0.1 ms to 2.0 ms	±750 uV~±700 mV @ 50 us ~2.0 ms
DP12 Sampling Box
Sampling Rate	1,000 /sec/channel	1,000 /sec/channel
Resolution	2.52 µV/LSB @ 1 kHz	2.52 µV/LSB @ 1 kHz
Time Constant	≥3.2 s	≥3.2 s
Frequency Response	0.05 Hz ~ 150 Hz (-3 dB)	0.05 Hz ~ 150 Hz (-3 dB)
Input Impedance	>50 MΩ @ 10 Hz, defibrillator protected	>50 MΩ @ 10 Hz, defibrillator protected
Dynamic Range	AC Differential ± 5 mV, DC offset ±600 mV	AC Differential ± 5 mV, DC offset ±600 mV
System Noise	≤12.5 µVp-p	≤12.5 µVp-p
Common Mode Rejection	>110 dB	>110 dB
Pace Detect	±2 to ±700 mV@0.1 to 2.0 ms	±2 to ±700 mV@0.1 to 2.0 ms
ESD Sensitivity	±6 kV contact / ±8 kV air	±6 kV contact / ±8 kV air
Heart Rate Meter	30 BPM ~300 BPM, ±1 BPM	30 BPM ~300 BPM, ±1 BPM
DX12 Sampling Box
All listed parameters (Sampling Rate, Resolution, Time Constant, Frequency Response, Input Impedance, Dynamic Range, System Noise, Common Mode Rejection, Pace Detect, ESD Sensitivity, Heart Rate Meter, Transmitting Frequency, Frequency Band, Modulation Type, Transmitting Power)	Matches predicate	Matches predicate
Analysis Software
Operating system	Windows XP SP2/SP3, Vista, Windows 7	Windows XP SP2/SP3 (32/64 bit), Windows 7 SP1 (32/64 bit) or Windows 8 (32/64 bit)

Study Information:

Sample size used for the test set and the data provenance:
- The document mentions "database testing" for ECG interpretation features but does not specify the sample size for this test set or the provenance (country of origin, retrospective/prospective nature) of the data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The document refers to "ECG interpretation features... validated by database testing," but details on the ground truth establishment for this validation are absent.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
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:
- An MRMC comparative effectiveness study, particularly one measuring human reader improvement with AI assistance, was not indicated. The comparison is mainly against predicate devices, focusing on technical specifications and substantial equivalence, not algorithm-assisted human reading.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The document states, "ECG interpretation features were also validated by database testing." This implies a standalone performance evaluation of the algorithm against a database, though details are missing. The device's indications for use also state that the "ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only," suggesting a standalone interpretive function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "ECG interpretation features," the document mentions "database testing." However, the specific type of ground truth used within this database (e.g., expert consensus diagnoses, correlation with patient outcomes, or other clinical data) is not specified.
The sample size for the training set:
- The document does not specify a training set and its size. The validation focuses on the device's performance and ECG interpretation features using "database testing."
How the ground truth for the training set was established:
- Since no training set is explicitly mentioned or described, the method for establishing its ground truth is also not provided.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 5, 2016

Edan Instruments. Inc. % Doug Worth Sr. Dir. US RA/QA Edan Medical 1200 Crossman Ave. Suite 200 Sunnyvale, California 94086

Re: K152427

Trade/Device Name: PC ECG, model SE-1515 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: December 24, 2015 Received: December 28, 2015

Dear Doug Worth:

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. 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 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 (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mitchell Stein

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152427

Device Name PC ECG, model SE-1515

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(K) Summary

Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92

1. Submitter:	Edan Instruments, Inc3/F - B, Nanshan MedicalEquipments Park, Nanhai Rd 1019#,Shekou, Nanshan Shenzhen,518067 P.R. ChinaTel: +86(0755) 26858736Fax: +1 (408) 418-4059
Contact person:Preparing date:	Queena ChenDecember 24, 2015
2. Device name andclassification:	Device Name: PC ECGModel: SE-1515Classification Name/ Product code:870.2340 Electrocardiograph/DPSRegulatory Class: Class II
3. Predicate Device(s):	1) EDAN Instrument, Inc. SE-1010, K131819 (Primary)2) Philips Medical Systems, Philips DXL 12/16-lead ECGAlgorithm, K132068 (Reference)3) Philips Medical Systems, Philips TC70, K113144(Reference)
4. Reason forSubmission	New product.
5. Pre-Submission,IDE	Not applicable, there is no prior submission.
6. Device Description:	SE-1515 is a PC-based ECG designed to acquire, process andstore ECG signals and analyze and diagnose heart disease.SE-1515 consists of analysis software and sampling boxes, andhas four configurations: Wired 18-lead ECG system, Wired16-lead ECG system, Wired 12-lead ECG system and Wireless12-lead ECG system.Wired 18-lead ECG system consists of analysis software andwired DE18 sampling box.Wired 16-lead ECG system consists of analysis software andwired DE15 sampling box. Wired 12-lead ECG system consistsof analysis software and wired DP12 sampling box. Wireless
	12-lead ECG system contains analysis software, wireless DX12sampling boxes (DX12 transmitter and DX12 receiver). Thecommunication between DX12 transmitter and DX12 receiveris based on Bluetooth technology.For stress exercise testing, the user should connect a BPmonitor and a treadmill or an ergo meter to the PC.
7. Intended Use:	SE-1515 PC ECG is intended to acquire, process and store ECGsignals from adult and pediatric patients undergoing stressexercise test or resting test. The SE-1515 PC ECG is intendedto be used only in hospitals and healthcare facilities by doctorsand trained healthcare professionals. The cardiogram recordedby the SE-1515 PC ECG can help users to analyze and diagnoseheart diseases. However, the ECG with measurements andinterpretive statements is offered to clinicians on an advisorybasis only.

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8. Predicate Device Comparison

The subject devices share the same characteristics in all items with the predicate device, concluding from using the same technology and principle. All the technological differences existed between the subject and predicate devices are only some performance parameters items, which are shown in the following tables in details.

Item	SE-1515	SE-1010	Remark
510(k) Number	Current Submission	K131819	----
Indications for Use
Intended use	SE-1515 PC ECG is intended to acquire process and store ECG signals from adult and pediatric patients undergoing stress exercise test or resting test. The SE-1515 PC ECG is intended to be used only in hospitals and healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the SE-1515 PC ECG can help users to analyze and diagnose heart diseases. However, the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. It is mainly used in the ECG	SE-1010 is a PC-based diagnostic tool intended to acquire, process and store ECG signals from adult and pediatric patients undergoing stress exercise test or resting test. PC ECG is intended to be used only in hospitals and healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-1010 can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinicians on an	Different
	Outpatient Department andPhysical ExaminationDepartment.	advisory basis only.
High/Low PassFilters	DFT Filter:0.01 Hz/0.05 Hz/0.32 Hz/0.67 HzAC Filter: 50 Hz/60 Hz/OffEMG Filter:25 Hz/35 Hz/45 Hz/OffLow Pass Filter:300 Hz/270 Hz/150 Hz/100 Hz/75Hz	DFT Filter: weak/strongAC Filter: 50 Hz/60 Hz/OffLow Pass/EMG Filter:25 Hz/35 Hz/45 Hz/75 Hz/100Hz/150 Hz	Different
Sampling Box
----	DE15	DP12	----
Classification
Anti-electric-shock type	Class II	Class II	Same
Anti-electric-shock degree	Type CF with defibrillation-proof	Type CF withdefibrillation-proof	Same
Lead number	16-lead	12-lead	Different
Degree ofprotectionagainst harmfulingress of water	Sealed equipment withoutwaterproof	Sealed equipment withoutwaterproof	Same
Degree of safetyof application inthe presence offlammable gas	Equipment not suitable for use inthe presence of flammable gas	Equipment not suitable for usein the presence of flammablegas	Same
Working mode	Continuous operation	Continuous operation	Same
Processing
Sampling Rate	16 kHz /channel	1 kHz /channel	Different
Resolution	0.1575 µV/LSB @ 1 kHz	2.52 µV/LSB @ 1 kHz	Different
Time Constant	>3.2 s	≥3.2 s	Same
FrequencyResponse	0.01 Hz~300 Hz	0.05 Hz ~ 150 Hz	Different
Input Impedance	≥100 MΩ	>50 ΜΩ	Different
Dynamic Range	AC Differential ± 5 mV, DCoffset ±600 mV	AC Differential ± 5 mV, DCoffset ±600 mV	Same
System Noise	≤12.5μ Vp-p	≤12.5μ Vp-p	Same
Common ModeRejection	≥140 dB(AC ON)≥123 dB(AC OFF)	>110 dB	Different
Pace Detect	±750 uV~±700 mV @ 50 us ~2.0ms	±2 to ±700 mV @ 0.1 ms to2.0 ms	Different
ESD Sensitivity	+6 kV contact	+6 kV contact	Same
	±8 kV air	±8 kV air
Heart Rate Meter	30 BPM ~300 BPM, ±1 BPMDE18	30 BPM ~300 BPM, ±1 BPMDP12	Same
Classification
Anti-electric-shock type	Class II	Class II	Same
Anti-electric-shock degree	Type CF with defibrillation-proof	Type CF withdefibrillation-proof	Same
Lead number	18-lead	12-lead	Different
Degree ofprotectionagainst harmfulingress of water	Sealed equipment withoutwaterproof	Sealed equipment withoutwaterproof	Same
Degree of safetyof application inthe presence offlammable gas	Equipment not suitable for use inthe presence of flammable gas	Equipment not suitable for usein the presence of flammablegas	Same
Working mode	Continuous operation	Continuous operation	Same
Processing
Sampling Rate	16 kHz /channel	1 kHz /channel	Different
Resolution	0.1575 µV/LSB @ 1 kHz	2.52 µV/LSB @ 1 kHz	Different
Time Constant	≥3.2 s	≥3.2 s	Same
FrequencyResponse	0.01 Hz~300 Hz	0.05 Hz ~ 150 Hz	Different
Input Impedance	≥100 ΜΩ	>50 ΜΩ	Different
Dynamic Range	AC Differential ± 5 mV, DCoffset ±600 mV	AC Differential ± 5 mV, DCoffset ±600 mV	Same
System Noise	≤12.5μ Vp-p	≤12.5μ Vp-p	Same
Common ModeRejection	≥140 dB (AC ON)≥123 dB (AC OFF)	>110 dB	Different
Pace Detect	±750 uV~±700 mV @ 50 us ~2.0ms	±2 to ±700 mV @ 0.1 ms to2.0 ms	Different
ESD Sensitivity	±6 kV contact±8 kV air	±6 kV contact±8 kV air	Same
Heart Rate Meter	30 BPM ~300 BPM, ±1 BPM	30 BPM~300 BPM, ±1 BPM	Same
DP12 Sampling Box
Classification
Anti-electric-shock type	Class II	Class II	Same
Anti-electric-shock degree	Type CF with defibrillation-proof	Type CF withdefibrillation-proof	Same
Lead number	12-lead	12-lead	Same

protectionagainst harmfulingress of water	protection against ingress of water	protection against ingress of water
Degree of safetyof application inthe presence offlammable gas	Not suitable for use in thepresence of a flammableanesthetic mixture with air or withoxygen or nitrous oxide	Not suitable for use in thepresence of a flammableanesthetic mixture with air orwith oxygen or nitrous oxide	Same
Working mode	Continuous operation	Continuous operation	Same
Processing
Sampling Rate	1,000 /sec/channel	1,000 /sec/channel	Same
Resolution	2.52 $ μ $ V/LSB @ 1 kHz	2.52 $ μ $ V/LSB @ 1 kHz	Same
Time Constant	$ ≥ $ 3.2 s	$ ≥ $ 3.2 s	Same
FrequencyResponse	0.05 Hz ~ 150 Hz (-3 dB)	0.05 Hz ~ 150 Hz (-3 dB)	Same
Input Impedance	>50 MΩ @ 10 Hz, defibrillatorprotected	>50 MΩ @ 10 Hz, defibrillatorprotected	Same
Dynamic Range	AC Differential ± 5 mV, DCoffset ±600 mV	AC Differential ± 5 mV, DCoffset ±600 mV	Same
SystemNoise	$ ≤ $ 12.5 $ μ $ Vp-p	$ ≤ $ 12.5 $ μ $ Vp-p	Same
Common ModeRejection	>110 dB	>110 dB	Same
Pace Detect	±2 to ±700 mV@0.1 to 2.0 ms	±2 to ±700 mV@0.1 to 2.0 ms	Same
ESD Sensitivity	±6 kV contact±8 kV air	±6 kV contact±8 kV air	Same
Heart Rate Meter	30 BPM ~300 BPM, ±1 BPM	30 BPM ~300 BPM, ±1 BPM	Same
DX12 Sampling Box
Classification
Anti-electric-shocktype	Class II	Class II	Same
Anti-electric-shock degree	Type CF with defibrillation-proof	Type CF withdefibrillation-proof	Same
Lead number	12-lead	12-lead	Same
Degree ofprotectionagainst harmfulingress of water	Enclosed equipment withoutprotection against ingress of water	Enclosed equipment withoutprotection against ingress of water	Same
Degree of safetyof application inthe presence offlammable gas	Not suitable for use in thepresence of a flammableanesthetic mixture with air or withoxygen or nitrous oxide	Not suitable for use in thepresence of a flammableanesthetic mixture with air orwith oxygen or nitrous oxide	Same
Working mode	Continuous operation	Continuous operation	Same
Processing
Sampling Rate	10,000/sec/channel	10,000/sec/channel	Same
Resolution	2.52 $ μ $ V/LSB @ 500 Hz	2.52 $ μ $ V/LSB @ 500 Hz	Same
Time Constant	$ ≥ $ 3.2 s	$ ≥ $ 3.2 s	Same
Frequency Response	0.05 Hz ~ 150 Hz (-3 dB)	0.05 Hz ~ 150 Hz (-3 dB)	Same
Input Impedance	$ ≥ $ 20 M $ Ω $ @ 10 Hz, defibrillator protected	$ ≥ $ 20 M $ Ω $ @ 10 Hz, defibrillator protected	Same
Dynamic Range	AC Differential $ ± $ 5mV, DC offset $ ± $ 500 mV	AC Differential $ ± $ 5mV, DC offset $ ± $ 500 mV	Same
System Noise	$ ≤ $ 15 $ μ $ Vp-p	$ ≤ $ 15 $ μ $ Vp-p	Same
Common Mode Rejection	$ ≥ $ 100 dB	$ ≥ $ 100 dB	Same
Pace Detect	$ ± $ 2 to $ ± $ 500 mV@0.1 to 2.0 ms	$ ± $ 2 to $ ± $ 500 mV@0.1 to 2.0 ms	Same
ESD Sensitivity	$ ± $ 6 kV contact$ ± $ 8 kV air	$ ± $ 6 kV contact$ ± $ 8 kV air	Same
Heart Rate Meter	30 BPM ~300 BPM, $ ± $ 1 BPM	30 BPM ~300 BPM, $ ± $ 1 BPM	Same
Transmitting Frequency	2402-2480Hz	2402-2480Hz	Same
Frequency Band	2402-2480Hz	2402-2480Hz	Same
Modulation Type	FHSS	FHSS	Same
Transmitting Power	4.65dBM	4.65dBM	Same
Analysis Software
Operating system	Windows XP SP2/SP3 (32/64 bit), Windows 7 SP1 (32/64 bit) or Windows 8 (32/64 bit)	Windows XP PROFESSIONAL SP2/SP3, Windows Vista (32/64 bit) or Windows 7 (32/64 bit)	Different
Safety requirements	Tested for compliance with IEC 62304	Tested for compliance with IEC 62304	Same
Vector loop	Support the FRANK sampling and Calculating VCG.Can show the FRANK leads X,Y,Z wave and median complexes of the orthogonal FRANK leads X,Y,Z as well as the vector loops in three plans	Support the FRANK sampling and Calculating VCG.Can show the FRANK leads X,Y,Z wave and median complexes of the orthogonal FRANK leads X,Y,Z as well as the vector loops in three plans.	Same
Resting ECG
Measuring the ECG	Amplitudes(mV),intervals(ms) nd slopes(mV/s) can be ensured on all ECG waveforms	Amplitudes(mV),intervals(ms) nd slopes(mV/s) can be ensured on all ECG waveforms	Same
Reanalysis	Manually change the	Manually change the	Same
	measurement marks of mediansand the interpretation result	measurement marks ofmedians and the interpretationresult
Interpretationlibrary	Has Interpretation library and canedit	Has Interpretation library andcan edit	Same
Exercise Test
Test Phase	each protocol has three phase:pretest, exercise, recovery	each protocol has three phase:pretest, exercise, recovery	Same
Pretest Phase	Consists of stages configured ineach protocol. Commonly usedstages are: supine, standing,hyperventilation, warm-up	Consists of stages configuredin each protocol. Commonlyused stages are: supine,standing, hyperventilation,warm-up	Same
ExercisePhase	The selected protocol will controlthe treadmill or bicycleergo-meter	The selected protocol willcontrol the treadmill or bicycleergo-meter	Same
Recovery phase	The clock begins timing therecovery phase. In recovery, thetreadmill speed and grade or thebicycle load will changeaccording to the protocolconfiguration	The clock begins timing therecovery phase. In recovery, thetreadmill speed and gradeor the bicycle load will changeaccording to the protocolconfiguration	Same
Full disclosureECG	Can save the full disclosure ECGand print either the entire full 1disclosure ECG or only a selectedsegment	Can save the full disclosureECG and print either the entirefull 1 disclosure ECG or only aselected segment	Same
Final reports	Configured report, tabularsummary, graded exercisesummary report, selected mediansreport, sample cardiac cycles,trend report ST/HR Slope, ECGstrips	Configured report, tabularsummary, graded exercisesummary report, selectedmedians report, sample cardiaccycles, trend report ST/HRSlope, ECG strips	Same
Writer
WriterTechnology	laser printer or jet printer	laser printer or jet printer	Same
WriterAmplitudeAccuracy	±5%	±5%	Same
Paper Size	A4, Letter	A4, Letter	Same
Environmental Specifications
Temperature
Operating	+5 ~+40	+5 ~+40	Same
Transport/Storage	DP12/DE15 ECG sampling box:-40°C (-8°F) ~ +55°C (+131°F)	DP12 sampling box:-40°C (-8°F) ~ +55°C (+131°F)	Same
DX12 ECG sampling box:-20°C (-4°F)~+55°C (+131°F)		DX12 ECG sampling box:-20°C (-4°F)~+55°C (+131°F)
Humidity
Operating	25% to 80% RH	25% to 80% RH	Same
Transport/Storage	non-condensing 25% to 93% RHnon-condensing	non-condensing 25% to 93% RH non-condensing	Same
Pressure
Operating	860 hPa ~1060 hPa	860 hPa ~1060 hPa	Same
Transport/Storage	700 hPa ~1060 hPa	700 hPa ~1060 hPa	Same

Table 1: Comparison between SE-1515 and SE-1010

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Table 2: Comparison between SE-1515 and DXL 12/16-lead ECG Algorithm

Item	SE-1515	Philips DXL 12/16-lead ECG Algorithm	Remark
510(k) Number	Current Submission	K132068	---
Intended use	SE-1515 PC ECG is intendedto acquire process and storeECG signals from adult andpediatric patients undergoingstress exercise test or restingtest. The SE-1515 PC ECG isintended to be used only inhospitals and healthcarefacilities by doctors and trainedhealthcare professionals. Thecardiogram recorded by theSE-1515 PC ECG can helpusers to analyze and diagnoseheart diseases. However, theECG with measurements andinterpretive statements isoffered to clinicians on anadvisory basis only. It ismainly used in the ECGOutpatient Department andPhysical ExaminationDepartment.	To analyze multi-channel ECGsignals from adult and pediatricpatients with algorithms thatprovide measurements, datapresentations, graphicalpresentations and interpretationsfor review by the user.The interpreted ECG withmeasurements and interpretivestatements is offered to theclinician on an advisory basisonly. It is to be used inconjunction with the clinician'sknowledge of the patient, theresults of the physicalexamination, the ECG tracings,and other clinical findings. Aqualified physician is asked toover read and validate (or change)the computer generated ECGinterpretation.Where the clinician decides toevaluate the electrocardiogram ofadult and pediatric patients as partof decisions regarding possiblediagnosis, potential treatment,effectiveness of treatment or torule-out causes for symptoms.	Different
Lead Number	12/15/16	12/16	Different

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Item	SE-1515	Philips TC70	Remark
510(k) Number	Current Submission	K113144	---
Intended use	SE-1515 PC ECG is intendedto acquire process and storeECG signals from adult andpediatric patients undergoingstress exercise test or restingtest. The SE-1515 PC ECG isintended to be used only inhospitals and healthcarefacilities by doctors and trainedhealthcare professionals. Thecardiogram recorded by theSE-1515 PC ECG can helpusers to analyze and diagnoseheart diseases. However, theECG with measurements andinterpretive statements isoffered to clinicians on anadvisory basis only. It ismainly used in the ECGOutpatient Department andPhysical ExaminationDepartment.	To acquire multi-channel ECUsignals from adult and pediatricpatients from body surface ECGelectrodes and to record, display,analyze and store these ECUsignals for review by the user. Tobe used in healthcare facilities bytrained healthcare professionals.Analysis of the ECU signals isaccomplished with algorithms thatprovide measurements, datapresentations, graphicalpresentations and interpretationsfor review by the user.The interpreted EGG withmeasurements and interpretivestatements is offered to theclinician on an advisory basisonly. It is to be used inconjunction with the clinician'sknowledge of the patient, theresults of the physicalexamination, the EGG tracings,and other clinical findings. Aqualified physician is asked toover read and validate (or change)the computer generated ECGinterpretation.	Different
Lead Number	12/15/16/18	12/16/18	Different

Table 3: Comparison between SE-1515 and Philips TC70

As seen in the comparison tables, the subject and predicate devices have similar design features and performance specifications. The main technological differences between the subject and predicate devices are minor differences, and do not raise different questions of safety or effectiveness. As demonstrated in the non-clinical testing, the different technological characteristics do not affect the safety and effectiveness of the Edan SE-1515 PC ECG.

9. Performance Data:

Non-clinical data:

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

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The biocompatibility evaluation for SE-1515 PC ECG device is 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 surface contacting for duration of less than 24 hours. And the battery of testing included the following tests:

Cytotoxicity .
. Skin Sensitization
Skin Irritation

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the SE-1515 PC ECG device, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1:2005/A1: 2012 standard for safety and the IEC 60601-1-2: 2007 standard for EMC.

Bench Testing

Bench testing was conducted per IEC 60601-2-25: 2011, and all the results show pass. ECG interpretation features were also validated by database testing.

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 "moderate" level of concern, since a failure or latent flaw in the software will not directly result in serious injury or death to the patient or operator, and the software device is an accessory to a medical device that has a Moderate Level of Concern.

Clinical data: Not applicable.

Summary

Based on the non-clinical and clinical performance as documented in the system development, the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device.

10. Conclusion

The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that SE-1515 PC ECG device should perform as intended in the specified use conditions, and all the 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 SE-1515 PC ECG device is substantially equivalent to the predicate devices.

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).