(163 days)
No
The summary describes standard ECG signal processing and analysis, with no mention of AI or ML terms or methodologies. The validation mentions database testing for interpretation features, which is common for traditional algorithms.
No.
The device is intended for acquiring, processing, and storing ECG signals for analysis and diagnosis of heart diseases, not for providing medical treatment or therapy.
Yes
Explanation: The "Intended Use" section states that "The cardiogram recorded by the SE-1515 PC ECG can help users to analyze and diagnose heart diseases." This clearly indicates a diagnostic function for the device.
No
The device description explicitly states that the SE-1515 consists of "analysis software and sampling boxes" and lists multiple configurations that include wired and wireless sampling boxes, which are hardware components.
Based on the provided information, the SE-1515 PC ECG is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The SE-1515 PC ECG directly acquires electrical signals from the patient's body (ECG signals) through electrodes placed on the skin. It does not analyze biological samples like blood, urine, or tissue.
- The intended use describes acquiring, processing, and storing ECG signals from patients. This is a direct measurement of physiological activity, not an analysis of a biological specimen.
- The device description focuses on hardware (sampling boxes) and software for signal acquisition and analysis. This aligns with a device that interacts directly with the patient.
Therefore, the SE-1515 PC ECG falls under the category of a medical device that performs physiological measurements, but it is not an IVD.
N/A
Intended Use / Indications for 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 is offered to clinicians on an advisory basis only. It is mainly used in the ECG Outpatient Department and Physical Examination Department.
Product codes (comma separated list FDA assigned to the subject device)
DPS
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.
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
Intended User / Care Setting
hospitals and 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)
Non-clinical data:
- Biocompatibility testing: Conducted in accordance with ISO 10993-1, included Cytotoxicity, Skin Sensitization, and Skin Irritation tests. The worst case of the whole system is considered surface contacting for duration of less than 24 hours.
- Electrical safety and electromagnetic compatibility (EMC): Complies with IEC 60601-1:2005/A1: 2012 and IEC 60601-1-2: 2007.
- Bench Testing: Conducted per IEC 60601-2-25: 2011, all results showed pass. ECG interpretation features were also validated by database testing.
- Software Verification and Validation Testing: Conducted with documentation provided per FDA guidance. Software considered "moderate" level of concern.
Clinical data: Not applicable.
Summary: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
EDAN Instrument, Inc. SE-1010, K131819
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Philips Medical Systems, Philips DXL 12/16-lead ECG Algorithm, K132068, Philips Medical Systems, Philips TC70, K113144
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2340 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).
0
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
1
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
2
Indications for Use
510(k) Number (if known) K152427
Device Name PC ECG, model SE-1515
Indications for Use (Describe)
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.
| 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) |
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3
510(K) Summary
Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92
| 1. Submitter: | Edan Instruments, Inc
3/F - B, Nanshan Medical
Equipments Park, Nanhai Rd 1019#,
Shekou, Nanshan Shenzhen,
518067 P.R. China
Tel: +86(0755) 26858736
Fax: +1 (408) 418-4059 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person:
Preparing date: | Queena Chen
December 24, 2015 |
| 2. Device name and
classification: | Device Name: PC ECG
Model: SE-1515
Classification Name/ Product code:
870.2340 Electrocardiograph/DPS
Regulatory Class: Class II |
| 3. Predicate Device(s): | 1) EDAN Instrument, Inc. SE-1010, K131819 (Primary)
2) Philips Medical Systems, Philips DXL 12/16-lead ECG
Algorithm, K132068 (Reference)
3) Philips Medical Systems, Philips TC70, K113144(Reference) |
| 4. Reason for
Submission | 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 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. |
| 7. 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. |
4
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 and | |||
| Physical Examination | |||
| Department. | advisory basis only. | ||
| High/Low Pass | |||
| Filters | DFT Filter: | ||
| 0.01 Hz/0.05 Hz/0.32 Hz/0.67 Hz | |||
| AC Filter: 50 Hz/60 Hz/Off | |||
| EMG Filter: | |||
| 25 Hz/35 Hz/45 Hz/Off | |||
| Low Pass Filter: | |||
| 300 Hz/270 Hz/150 Hz/100 Hz/75 | |||
| Hz | DFT Filter: weak/strong | ||
| AC Filter: 50 Hz/60 Hz/Off | |||
| Low Pass/EMG Filter: | |||
| 25 Hz/35 Hz/45 Hz/75 Hz/100 | |||
| Hz/150 Hz | Different | ||
| Sampling Box | |||
| ---- | DE15 | DP12 | ---- |
| Classification | |||
| Anti-electric-sho | |||
| ck type | Class II | Class II | Same |
| Anti-electric-sho | |||
| ck degree | Type CF with defibrillation-proof | Type CF with | |
| defibrillation-proof | Same | ||
| Lead number | 16-lead | 12-lead | Different |
| Degree of | |||
| protection | |||
| against harmful | |||
| ingress of water | Sealed equipment without | ||
| waterproof | Sealed equipment without | ||
| waterproof | 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 |
| 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 |
| Frequency | |||
| Response | 0.01 Hz~300 Hz | 0.05 Hz ~ 150 Hz | Different |
| Input Impedance | ≥100 MΩ | >50 ΜΩ | Different |
| Dynamic Range | AC Differential ± 5 mV, DC | ||
| offset ±600 mV | AC Differential ± 5 mV, DC | ||
| offset ±600 mV | Same | ||
| System Noise | ≤12.5μ Vp-p | ≤12.5μ Vp-p | Same |
| Common Mode | |||
| Rejection | ≥140 dB(AC ON) | ||
| ≥123 dB(AC OFF) | >110 dB | Different | |
| Pace Detect | ±750 uV~±700 mV @ 50 us ~2.0 | ||
| ms | ±2 to ±700 mV @ 0.1 ms to | ||
| 2.0 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 BPM | ||
| DE18 | 30 BPM ~300 BPM, ±1 BPM | ||
| DP12 | Same | ||
| Classification | |||
| Anti-electric-sho | |||
| ck type | Class II | Class II | Same |
| Anti-electric-sho | |||
| ck degree | Type CF with defibrillation-proof | Type CF with | |
| defibrillation-proof | Same | ||
| Lead number | 18-lead | 12-lead | Different |
| Degree of | |||
| protection | |||
| against harmful | |||
| ingress of water | Sealed equipment without | ||
| waterproof | Sealed equipment without | ||
| waterproof | 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 |
| 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 |
| Frequency | |||
| Response | 0.01 Hz~300 Hz | 0.05 Hz ~ 150 Hz | Different |
| Input Impedance | ≥100 ΜΩ | >50 ΜΩ | Different |
| Dynamic Range | AC Differential ± 5 mV, DC | ||
| offset ±600 mV | AC Differential ± 5 mV, DC | ||
| offset ±600 mV | Same | ||
| System Noise | ≤12.5μ Vp-p | ≤12.5μ Vp-p | Same |
| Common Mode | |||
| Rejection | ≥140 dB (AC ON) | ||
| ≥123 dB (AC OFF) | >110 dB | Different | |
| Pace Detect | ±750 uV~±700 mV @ 50 us ~2.0 | ||
| ms | ±2 to ±700 mV @ 0.1 ms to | ||
| 2.0 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-sho | |||
| ck type | Class II | Class II | Same |
| Anti-electric-sho | |||
| ck degree | Type CF with defibrillation-proof | Type CF with | |
| defibrillation-proof | Same | ||
| Lead number | 12-lead | 12-lead | Same |
| protection | |||
| against harmful | |||
| ingress of water | protection against ingress of water | protection against ingress of water | |
| Degree of safety | |||
| of application in | |||
| the presence of | |||
| flammable gas | Not suitable for use in the | ||
| presence of a flammable | |||
| anesthetic mixture with air or with | |||
| oxygen or nitrous oxide | Not suitable for use in the | ||
| presence of a flammable | |||
| anesthetic mixture with air or | |||
| with 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 |
| Frequency | |||
| Response | 0.05 Hz ~ 150 Hz (-3 dB) | 0.05 Hz ~ 150 Hz (-3 dB) | Same |
| Input Impedance | >50 MΩ @ 10 Hz, defibrillator | ||
| protected | >50 MΩ @ 10 Hz, defibrillator | ||
| protected | Same | ||
| Dynamic Range | AC Differential ± 5 mV, DC | ||
| offset ±600 mV | AC Differential ± 5 mV, DC | ||
| offset ±600 mV | Same | ||
| System | |||
| Noise | $ ≤ $ 12.5 $ μ $ Vp-p | $ ≤ $ 12.5 $ μ $ Vp-p | Same |
| Common Mode | |||
| Rejection | >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-sho | |||
| ck | |||
| type | Class II | Class II | Same |
| Anti-electric-sho | |||
| ck degree | Type CF with defibrillation-proof | Type CF with | |
| defibrillation-proof | Same | ||
| Lead number | 12-lead | 12-lead | Same |
| Degree of | |||
| protection | |||
| against harmful | |||
| ingress of water | Enclosed equipment without | ||
| protection against ingress of water | Enclosed equipment without | ||
| protection against ingress of water | Same | ||
| Degree of safety | |||
| of application in | |||
| the presence of | |||
| flammable gas | Not suitable for use in the | ||
| presence of a flammable | |||
| anesthetic mixture with air or with | |||
| oxygen or nitrous oxide | Not suitable for use in the | ||
| presence of a flammable | |||
| anesthetic mixture with air or | |||
| with 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 medians | |||
| and the interpretation result | measurement marks of | ||
| medians and the interpretation | |||
| result | |||
| Interpretation | |||
| library | Has Interpretation library and can | ||
| edit | Has Interpretation library and | ||
| can 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 in | ||
| each protocol. Commonly used | |||
| stages are: supine, standing, | |||
| hyperventilation, warm-up | Consists of stages configured | ||
| in each protocol. Commonly | |||
| used stages are: supine, | |||
| standing, hyperventilation, | |||
| warm-up | Same | ||
| Exercise | |||
| Phase | The selected protocol will control | ||
| the treadmill or bicycle | |||
| ergo-meter | The selected protocol will | ||
| control the treadmill or bicycle | |||
| ergo-meter | Same | ||
| Recovery phase | The clock begins timing the | ||
| recovery phase. In recovery, the | |||
| treadmill speed and grade or the | |||
| bicycle load will change | |||
| according to the protocol | |||
| configuration | The clock begins timing the | ||
| recovery phase. In recovery, the | |||
| treadmill speed and grade | |||
| or the bicycle load will change | |||
| according to the protocol | |||
| configuration | Same | ||
| Full disclosure | |||
| ECG | Can save the full disclosure ECG | ||
| and print either the entire full 1 | |||
| disclosure ECG or only a selected | |||
| segment | Can save the full disclosure | ||
| ECG and print either the entire | |||
| full 1 disclosure ECG or only a | |||
| selected segment | Same | ||
| Final reports | Configured report, tabular | ||
| summary, graded exercise | |||
| summary report, selected medians | |||
| report, sample cardiac cycles, | |||
| trend report ST/HR Slope, ECG | |||
| strips | Configured report, tabular | ||
| summary, graded exercise | |||
| summary report, selected | |||
| medians report, sample cardiac | |||
| cycles, trend report ST/HR | |||
| Slope, ECG strips | Same | ||
| Writer | |||
| Writer | |||
| Technology | laser printer or jet printer | laser printer or jet printer | Same |
| Writer | |||
| Amplitude | |||
| Accuracy | ±5% | ±5% | Same |
| Paper Size | A4, Letter | A4, Letter | Same |
| Environmental Specifications | |||
| Temperature | |||
| Operating | +5 ~+40 | +5 ~+40 | Same |
| Transport/Storag | |||
| e | 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% RH | ||
| non-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
5
6
7
8
9
10
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 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 | |||
| Outpatient Department and | |||
| Physical Examination | |||
| Department. | To analyze multi-channel ECG | ||
| signals from adult and pediatric | |||
| patients with algorithms that | |||
| provide measurements, data | |||
| presentations, graphical | |||
| presentations and interpretations | |||
| for review by the user. | |||
| The interpreted ECG with | |||
| measurements and interpretive | |||
| statements is offered to the | |||
| clinician on an advisory basis | |||
| only. It is to be used in | |||
| conjunction with the clinician's | |||
| knowledge of the patient, the | |||
| results of the physical | |||
| examination, the ECG tracings, | |||
| and other clinical findings. A | |||
| qualified physician is asked to | |||
| over read and validate (or change) | |||
| the computer generated ECG | |||
| interpretation. | |||
| Where the clinician decides to | |||
| evaluate the electrocardiogram of | |||
| adult and pediatric patients as part | |||
| of decisions regarding possible | |||
| diagnosis, potential treatment, | |||
| effectiveness of treatment or to | |||
| rule-out causes for symptoms. | Different | ||
| Lead Number | 12/15/16 | 12/16 | Different |
11
| Item | SE-1515 | Philips TC70 | Remark |
|---|---|---|---|
| 510(k) Number | Current Submission | K113144 | --- |
| 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 | |||
| Outpatient Department and | |||
| Physical Examination | |||
| Department. | To acquire multi-channel ECU | ||
| signals from adult and pediatric | |||
| patients from body surface ECG | |||
| electrodes and to record, display, | |||
| analyze and store these ECU | |||
| signals for review by the user. To | |||
| be used in healthcare facilities by | |||
| trained healthcare professionals. | |||
| Analysis of the ECU signals is | |||
| accomplished with algorithms that | |||
| provide measurements, data | |||
| presentations, graphical | |||
| presentations and interpretations | |||
| for review by the user. | |||
| The interpreted EGG with | |||
| measurements and interpretive | |||
| statements is offered to the | |||
| clinician on an advisory basis | |||
| only. It is to be used in | |||
| conjunction with the clinician's | |||
| knowledge of the patient, the | |||
| results of the physical | |||
| examination, the EGG tracings, | |||
| and other clinical findings. A | |||
| qualified physician is asked to | |||
| over read and validate (or change) | |||
| the computer generated ECG | |||
| interpretation. | 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
12
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.