(89 days)
The intended use of the 3-Channel 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 intended to be used only in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the 3-Channel Electrocardiograph can help users to analyze and diagnose heart disease. However, the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.
SE-3 Series (including SE-3, SE-300A, SE-300B, and SE-301) 3-channel electrocardiograph gathers ECG signals of 12 leads simultaneously. While all 12 leads are recorded and analyzed, printouts will only have 3 leads on a page, with 4 pages in series to output all 12 leads. It displays the operation menu, ECG parameters as well as electrocardiograms.
This document describes a 510(k) premarket notification for Electrocardiographs Models SE-3, SE-300A, SE-300B, and SE-301 by Edan Instruments, Inc. It seeks to demonstrate substantial equivalence to previously cleared predicate devices.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as quantitative targets in terms of diagnostic accuracy metrics. Instead, the document relies on demonstrating that the proposed devices (SE-3, SE-300A, SE-300B, and SE-301) perform comparably to the predicate devices (SE-3, SE-300A, SE-300B - K091513, and reference devices SE-601C - K131503, SE-12 Series - K160876). The comparison is primarily focused on technical specifications and safety standards.
The closest to "performance" in a diagnostic sense relates to the ECG interpretation features.
| Acceptance Criteria Category | Specific Criteria (Implicitly "comparable to predicate") | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate (acquire ECG from adult and pediatric patients, analyze and diagnose heart disease on an advisory basis). | Same |
| Safety Specifications | Compliance with relevant IEC standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25). | Complies with IEC 60601-1:2005/A1:2012, IEC 60601-1-2:2007 (for all models). SE-301 specifically mentions compliance to IEC 60601-1:2005/A1:2012 and EN 60601-1:2006/A1:2013, IEC 60601-1-2:2007, EN 60601-1-2:2007/AC:2010, IEC 60601-2-25:2011. |
| Biocompatibility | Compliance with ISO 10993-1 for surface-contacting devices (<24 hours). | Passes Cytotoxicity, Skin Sensitization, Skin Irritation tests. |
| Bench Testing | Pass tests per IEC 60601-2-25:2011. | All results show pass. |
| ECG Interpretation Features | Performance comparable to predicate devices' SEMIP algorithm (V1.6 and V1.7 versions). | V1.7 algorithms for SE-3 series were tested for pediatrics and results were comparable to V1.8. V1.8 in SE-301 is the same as SE-12 Series. Improvements in V1.7 for RVH, MI, T wave abnormal, and ventricular preexcitation measurement accuracy. |
| Software Verification & Validation | Compliance with FDA Guidance for "moderate" level of concern software. | Software verification and validation testing conducted, documentation provided, device considered "moderate" level of concern, demonstrating proper function. |
| Electrical Performance (e.g., HR Accuracy, Noise, CMRR) | Maintain or improve upon predicate specifications. | Many specifications are "Same" as predicate (e.g., HR range, accuracy, noise). Some are "Different" with improved values (e.g., A/D resolution, input circuit current, DC offset voltage, frequency response, CMRR, sampling frequency). |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "ECG interpretation features were also validated by database testing." However, no specific sample size for this test set is provided. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This detailed information is not provided in the document. It only mentions "ECG interpretation features were also validated by database testing" without elaborating on how the ground truth of that database was established or by whom.
4. Adjudication Method for the Test Set
The adjudication method for establishing ground truth from the test set is not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not mentioned. The submission focuses on demonstrating substantial equivalence based on technical specifications, safety, and a "database testing" for interpretation features, rather than human reader performance with and without AI assistance. Therefore, no effect size of human readers improving with AI assistance is reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The statement "ECG interpretation features were also validated by database testing" strongly suggests a standalone algorithm performance evaluation was conducted, where the algorithm's interpretations were compared against a database. However, details of this standalone study (metrics, specific results beyond "pass," sample size) are not provided.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document does not explicitly state the type of ground truth used for the "database testing" of the ECG interpretation features. It can be inferred that it would be against a known or expert-adjudicated database of ECG recordings, but the specific nature of that ground truth (e.g., expert consensus, comparison to gold standard diagnoses, or other clinical data) is not detailed.
8. The Sample Size for the Training Set
The document does not report the sample size for the training set used to develop or train the SEMIP algorithm versions.
9. How the Ground Truth for the Training Set Was Established
The document does not describe how the ground truth for the training set was established. It mentions that "the criteria of some diseases are optimized to improve automatic diagnostic accuracy including RVH, MI, T wave abnormal and optimization of some terms and optimize ventricular preexcitation measure method to improve accuracy" for SEMIP V1.7, implying some form of optimization based on clinical data, but the method of ground truth establishment is not detailed.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or fabric.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 25, 2017
Edan Instruments, Inc. % Doug Worth Sr. Dir. US RA/QA 1200 Crossman Ave. Suite 200 Sunnyvale, California 94089
Re: K171943
Trade/Device Name: Electrocardiographs: SE-301. SE-300A. SE-300B. SE-3 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: June 19, 2017 Received: June 28, 2017
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 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 (DICE) 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 (DICE) 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.
M.R. Hilleman
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) K171943
Device Name
Electrocardiograph, models SE-3, SE-300A, SE-300B and SE-301
Indications for Use (Describe)
The intended use of the 3-Channel Electrocardiograph is to acquire ECG signals from adult and pediatric patients (beginning at birth through 21 years of age) through body surface ECG electrocardiograph is intended to be used only in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the 3-Channel Electrocardiograph can help users to analyze and diagnose heart disease. However, the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.
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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510(K) Summary
Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92
| 1. Submitter: | Edan Instruments, Inc#15 Jinhui Road,Jinsha Community,Kengzi Sub-District, Pingshan District,Shenzhen, 518122 P.R.China.518067 P.R. ChinaTel: +86(0755) 26858736Fax: +1 (408) 418-4059 |
|---|---|
| Contact person:Preparing date: | Alice YangJune 19, 2017 |
| 2. Device name andclassification: | Device Name: ElectrocardiographModel: SE-3, SE-300A, SE-300B and SE-301Classification Name/ Product code:870.2340 Electrocardiograph/DPSRegulatory Class: Class II |
| 3.PremarketNotification Class IIICertification andSummary | Not applicable, the subject device is Class II. |
| 4. Predicate Device(s): | 1) EDAN Instrument, Inc. SE-3, SE-300A,SE-300B, K0915132) EDAN Instrument, Inc. SE-601C, K131503 (reference)3) EDAN Instrument, Inc. SE-12 Series, K160876 (reference) |
| 5. Reason forSubmission | The SE-3, SE-300A and SE-300B Electrocardiograph receivedFDA 510(k) clearance on July 24, 2009(K091513); whileSE-301 is a newly designed system which is developed basedon SE-3 but with better designed hardware structure,appearance, display, battery adapter together with a Wi-Fimodule, and not cleared yet. The changes of SE-3, SE-300A,SE-300B in this submission compared to the last clearedversion are mainly in resolution, color of screen, lithium batterypack, DE12 ECG board and assemble of screen. |
| 6. Pre Submission | Not applicable, there is no prior submission. |
| 7. Device Description: | SE-3 Series (including SE-3, SE-300A, SE-300B, andSE-301) 3-channel electrocardiograph gathers ECG signalsof 12 leads simultaneously. While all 12 leads are recordedand analyzed, printouts will only have 3 leads on a page,with 4 pages in series to output all 12 leads. It displays theoperation menu, ECG parameters as well aselectrocardiograms. |
| 8. Intended Use: | The intended use of the 3-Channel Electrocardiograph is toacquire ECG signals from adult and pediatric patients(beginning at birth through 21 years of age) through bodysurface ECG electrodes. The electrocardiograph is intended tobe used only in hospitals or healthcare facilities by doctors andtrained healthcare professionals. The cardiogram recorded by |
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IDE
the 3-Channel Electrocardiograph can help users to analyze and diagnose heart disease. However, the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.
9. 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 | Predicate device(SE-3, SE-300A,SE-300B) | Proposed device(SE-3, SE-300A, SE-300B) | ComparisonResult |
|---|---|---|---|
| K# | K091513 | Current Submission | — |
| Intended Use | The intended use of SE-3is to acquire ECG signalsfrom adult and pediatricpatients through bodysurface ECG electrodes.The electrocardiograph isintended to be used only inhospitals or healthcare | The intended use of the3-ChannelElectrocardiograph is toacquire ECG signals fromadult and pediatric patients(beginning at birth through21 years of age) throughbody surface ECG | Same |
| facilities by doctors andtrained healthcareprofessionals. Thecardiogram recorded bySE-3 can help users toanalyze and diagnose heartdisease. However, theECG with measurementsand interpretive statementsis offered to clinicians onan advisory basis only. | electrodes. Theelectrocardiograph isintended to be used only inhospitals or healthcarefacilities by doctors andtrained healthcareprofessionals. Thecardiogram recorded bythe 3-ChannelElectrocardiograph canhelp users to analyze anddiagnose heart disease.However, the ECG withmeasurements andinterpretive statements isoffered to clinicians on anadvisory basis only. | ||
| Safety Specifications | |||
| Safety Standards | IEC 60601-1:1988+A1+A2,EN 60601-1:1990+A1+A2,IEC/EN 60601-1-2: 2001+A1,IEC/EN60601-2-25NSI/AAMI EC-11 | IEC 60601-1:2005EN 60601-1:2006EN 60601-1-2:2007IEC 60601-1-2:2007IEC/EN60601-2-25:2011 | Different |
| 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 harmful ingressof water: | Ordinary equipment (Sealedequipment without liquidproof) | Ordinary equipment (Sealedequipment without liquidproof) | Same |
| Disinfection/sterilizationmethod: | Refer to the user manual fordetails | Refer to the user manual fordetails | Same |
| Degree of safety ofapplication in thepresence of flammablegas: | Equipment not suitable for usein the presence of flammablegas | Equipment not suitable for usein the presence of flammablegas | Same |
| Working mode: | Continuous operation | Continuous operation | Same |
| EMC: | CISPR 11 Group 1, Class A | CISPR 11 Group 1, Class A | Same |
| Environment Specifications | |||
| Temperature | |||
| Transport | -20°C~50°C | -20°C ~ +55°C | Different |
| Storage | -10°C~40°C | -20°C ~ +55°C | Different |
| Working | 5 °C ~40 °C | +5°C ~ +40°C | Same |
| Relative Humidity: | |||
| Transport & Storage | 25% RH ~ 95% RHNon Condensing | 25% RH ~ 93% RHNon Condensing | Different |
| Working | 25% RH ~ 85% RHNon-Condensing | 25% RH ~ 80% RHNon-Condensing | Different |
| Atmospheric Pressure: | |||
| Transport & Storage | 700 hPa ~ 1060 hPa | 700 hPa ~ 1060 hPa | Same |
| Working | 800 hPa ~ 1060 hPa | 800 hPa ~ 1060 hPa | Same |
| Power Supply Specifications | |||
| Operating voltage =100 V-115V~/220 V-240 V~ | Operating voltage=100 V-115 V~/220 V-240 V~ | Same | |
| Mains Supply: | Operating frequency = 50 Hz /60 Hz | Operating frequency = 50 Hz /60 Hz | Same |
| input power = 35 VA | input power = 35 VA | Same | |
| Rated voltage = 14.4 V | Rated voltage = 14.8 V | ||
| Rated capacity =1600 mAh | Rated capacity = 2500 mAh | ||
| Built-in Lithium BatteryPack: | When the battery is fullycharged, SE-3 can worknormally 6 hours. | When the battery is fullycharged, the 3-channelelectrocardiograph can worknormally about 6.5 hours. Itcan continuously record about3 hours in Manual mode, andrecord 330 reports at most inthe AUTO mode. | Different |
| Cycle life ≥ 300 times | Cycle life ≥ 300 times | Same | |
| Performance Specifications | |||
| RecordingRecorder: | Thermal dot-matrix recorder | Thermal dot-matrix recorder | Same |
| Folded thermal paper | Folded thermal paper, | ||
| Recorder Paper: | Rolled thermal paper | Rolled thermal paper, | Same |
| Effective Width: | 72 mm | 72 mm | Same |
| Paper Speed: | 5 mm/s, 10 mm/s, 12.5 mm/s,25 mm/s, 50 mm/s (±3%) | 5 mm/s, 6.25 mm/s, 10 mm/s,12.5 mm/s, 25 mm/s, 50 mm/s(±3%) | Different |
| Accuracy of data: | ±5% (x-axis), ±5% (y-axis) | ±5% (x-axis), ±5% (y-axis) | Same |
| 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 |
| ECG Unit | |||
| Leads: | Standard 12 leads | Standard 12 leads | Same |
| Acquisition Mode: | Simultaneously 12 leads | Simultaneously 12 leads | Same |
| A/D Resolution: | 12 bits | 12 bits or24 bits (optional, with DE12ECG board) | Different |
| 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) | ≥50 MΩ (10 Hz) | Same |
| Input Circuit Current: | ≤0.05 μA | ≤0.05 μA /≤0.01 μA (optional, with DE12 | Different |
| ECG board) | |||
| Input Voltage RangeCalibration Voltage: | $\leq$ ±5 mVpp1 mV±3% | $\leq$ ±5 mVpp1 mV±3% | Same |
| ±500 mV / | |||
| DC Offset Voltage: | ±500 mV | ±600 mV (optional, with DE12ECG board) | Different |
| Noise: | $\leq$ 12.5 $\mu$ Vp-p | $\leq$ 12.5 $\mu$ Vp-p | Same |
| Multi-channel Crosstalk | $\leq$ 0.5 mm | $\leq$ 0.5 mm | Same |
| AC Filter: On / Off | AC Filter: On / Off | Same | |
| DFT Filter: 0.05Hz / 0.15Hz / | |||
| DFT Filter: 0.05Hz / 0.15Hz /0.25Hz / 0.5Hz | 0.25Hz / 0.32Hz / 0.5Hz /0.67Hz | Different | |
| Filter | EMG Filter: 25Hz / 35Hz /OFF | EMG Filter: 25Hz / 35Hz /45Hz / OFF | Different |
| LOWPASS Filter:150Hz /100Hz / 75Hz | LOWPASS Filter:150Hz /100Hz / 75Hz | Same | |
| $\geq$ 110 dB | $\geq$ 110dB /$\geq$ 115dB (optional, with DE12ECG board) | Different | |
| CMRR | |||
| Sampling Frequency | 1000 Hz | 1000 Hz | Same |
| External Input/ Output | |||
| Input | $\geq$ 100 kΩ; Sensitivity 10mm/V±5%;Single ended | $\geq$ 100 kΩ; Sensitivity 10mm/V±5%;Single ended | Same |
| Output | $\leq$ 100Ω; Sensitivity 1 V/mV±5%;Single ended | $\leq$ 100Ω; Sensitivity 1 V/mV±5%;Single ended | Same |
Table 1: Comparison between predicate device SE-3, SE-300B (K091513) and proposed device SE-3, SE-300A, SE-300B
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Table 2: Comparison between predicate device SE-3, SE-300B (K091513) and proposed device SE-301
| Item | Predicate device(SE-3, SE-300A,SE-300B) | Proposed device(SE-301) | ComparisonResult |
|---|---|---|---|
| K# | K091513 | Current Submission | — |
| Intended Use | The intended use of SE-3 is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is intended to be used only in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-3 can help users to analyze and diagnose heart disease. However, the ECG | The intended use of the 3-Channel 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 intended to be used only in hospitals or healthcare facilities by doctors and trained healthcare professionals. The | Same |
| with measurements andinterpretive statements isoffered to clinicians on anadvisory basis only. | cardiogram recorded by the3-ChannelElectrocardiograph can helpusers to analyze anddiagnose heart disease.However, the ECG withmeasurements andinterpretive statements isoffered to clinicians on anadvisory basis only. | ||
| Electronic Safety | |||
| Comply with: | IEC 60601-1:1988+A1+A2,EN 60601-1:1990+A1+A2,IEC/EN 60601-1-2: 2001+A1,IEC/EN60601-2-25 NSI/AAMIEC-11 | IEC 60601-1:2005/A1:2012EN 60601-1:2006/A1:2013IEC 60601-1-2:2007EN 60601-1-2:2007/AC:2010IEC 60601-2-25:2011 | Different |
| Anti-electric-shock type: | Class I with internal powersupply | Class I with internal powersupply | Same |
| Anti-electric-shockdegree: | Type CF | Type CF | Same |
| Degree of protectionagainst harmful ingressof water: | Ordinary equipment (Sealedequipment without liquid proof) | Ordinary equipment (Sealedequipment without liquid proof) | Same |
| Disinfection/sterilizationmethod: | Refer to the user manual fordetails | Refer to the user manual fordetails | Same |
| Degree of safety ofapplication in thepresence of flammablegas: | Equipment not suitable for use inthe presence of flammable gas | Equipment not suitable for use inthe presence of flammable gas | Same |
| Working mode: | Continuous operation | Continuous operation | Same |
| EMC: | CISPR 11 Group 1, Class A | CISPR 11 Group 1, Class A | Same |
| Environment Specifications | |||
| Temperature | |||
| Transport | -20 $^{\circ}$ C ~ 50 $^{\circ}$ C | -20°C (-4°F) ~ +55°C (+131°F) | Different |
| Storage | -10 $^{\circ}$ C ~ 40 $^{\circ}$ C | -20°C (-4°F) ~ +55°C (+131°F) | Different |
| Working | +5 $^{\circ}$ C ~ +40 $^{\circ}$ C | +5°C (+41°F) ~ +40°C (+104°F) | Same |
| Relative Humidity: | |||
| Transport & Storage | 25% RH ~ 95% RHNon-Condensing | 15% RH ~ 95% RHNon-Condensing | Different |
| Working | 25% ~ 85% RHNon-Condensing | 15% RH ~ 95% RHNon-Condensing | Different |
| Atmospheric Pressure: | |||
| Transport & Storage | 70 kPa ~ 106 kPa | 70 kPa ~ 106 kPa | Same |
| Working | 80 kPa ~ 106 kPa | 70 kPa ~ 106 kPa | Different |
| Power Supply Specifications | |||
| Mains Supply: | Operating voltage = 100 V-115 V~ / 220 V-240 V~ | Operating voltage = 100 V-240 V~ | Different |
| 60 Hz | 60 Hz | ||
| Power adapter output voltage: 19V, 2 A | Different | ||
| input power = 35 VA | |||
| Rated voltage = 14.4 V | Rated voltage = 14.8 V | ||
| Rated capacity = 1600 mAh | Rated capacity = 2500m Ah | ||
| When the battery is fully | |||
| charged, the 3-channel | Different | ||
| When the battery is fullycharged, SE-3 can worknormally 6 hours. | electrocardiograph can worknormally about 8.5 hours. It can | ||
| Built-in Lithium BatteryPack: | continuously record about 5 | ||
| hours in Manual mode, and | |||
| record at least 500 reports at | |||
| most in the AUTO mode. | |||
| Cycle life ≥ 300 times | Cycle life ≥ 300 times | Same | |
| Performance Specifications | |||
| Recording | |||
| Recorder: | Thermal dot-matrix recorder | Thermal dot-matrix recorder | Same |
| Folded thermal paper, 80 mm ×70 mm × 200 pages | Folded thermal paper, 80 mm ×70 mm × 200 pages | ||
| Recorder Paper: | Same | ||
| Rolled thermal paper, 80 mm ×20 m | Rolled thermal paper, 80 mm ×20 m | ||
| Effective Width: | 72 mm | 72 mm | Same |
| 5 mm/s,10 mm/s, 12.5 mm/s, 25mm/s, 50 mm/s (±3%) | 5 mm/s, 6.25 mm/s, 10 mm/s,12.5 mm/s, 25 mm/s, 50 mm/s(±3%) | Different | |
| Paper Speed: | |||
| Accuracy of data: | ±5% (x-axis), ±5%(y-axis) | ±5% (x-axis), ±5%(y-axis) | Same |
| 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 |
| ECG Unit | |||
| Leads: | Standard 12 leads | Standard 12 leads | Same |
| Acquisition Mode: | Simultaneously 12 leads | Simultaneously 12 leads | Same |
| A/D: | 12 bits | 24 bits | Different |
| Time Constant: | ≥3.2 s | ≥3.2 s | Same |
| Frequency Response: | 0.05 Hz ~ 150 Hz (-3 dB) | 0.01 Hz ~ 300 Hz (-3 dB) | Different |
| Input Impedance: | ≥50 MΩ (10 Hz) | ≥50 MΩ (10 Hz) | Same |
| Input Circuit Current: | ≤0.05 µA | ≤0.01 µA | Different |
| Input Voltage Range | ≤±5 mVpp | ≤±5 mVpp | Same |
| Calibration Voltage: | 1 mV±3% | 1 mV±3% | Same |
| DC Offset Voltage: | ±500 mV | ±600 mV | Different |
| Noise: | ≤12.5 µVp-p | ≤12.5 µVp-p | Same |
| Multi-channel Crosstalk | ≤0.5 mm | ≤0.5 mm | Same |
| AC Filter: On/Off | AC Filter: On/Off | Same | |
| DFT Filter: 0.05 Hz/0.15Hz/0.25 Hz/0.32 Hz/0.5 Hz/0.67Hz | DFT Filter: 0.01 Hz, 0.05 Hz,0.32 Hz, or 0.67 Hz | Different | |
| Filter | |||
| EMG Filter: 25 Hz/35 Hz/OFF | EMG Filter: 25 Hz/35 Hz/45 Hz/OFF | Different | |
| LOWPASS Filter: 150 Hz/100 Hz/75 Hz | LOWPASS Filter: 300 Hz/270 Hz/150 Hz/100 Hz/75 Hz | Different | |
| CMRR | ≥110 dB | ≥140 dB (AC: ON)≥110 dB (AC: Off) | Different |
| Sampling Frequency | 1000 Hz | 16000 Hz | Different |
| Algorithm | SEMIP | SEMIP | Same |
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Table 3: Comparison between reference device SE-601C (K131503) with WiFi and SE-301
| Item | Predicate device(SE-601C) | Proposed device(SE-301) | ComparisonResult |
|---|---|---|---|
| K# | K131503 | Current Submission | — |
| WIFI Specifications (Optional) | |||
| Transmitting Frequency | 2.4 GHz | 2.4 GHz | Same |
| Frequency Band | 2.400 - 2.500 GHz (2.4 GHz ISM band) | 2.400 - 2.500 GHz (2.4 GHz ISM band) | Same |
| Modulation Type | OFDM with BPSK, QPSK, 16-QAM, and 64-QAM802.11b with CCK and DSSS | OFDM with BPSK, QPSK, 16-QAM, and 64-QAM802.11b with CCK and DSSS | Same |
| Transmitting Power | 17 dBm for 802.11b DSSS17 dBm for 802.11b CCK15 dBm for 802.11g/n OFDM | 17 dBm for 802.11b DSSS17 dBm for 802.11b CCK15 dBm for 802.11g/n OFDM | Same |
Table 4: Comparison between reference device SE-601C (K131503) and SE-3 with DE12 ECG board
| Item | Predicate device(SE-601C) | Proposed device(SE-3) | ComparisonResult |
|---|---|---|---|
| K# | K131503 | Current Submission | — |
| Sensitivity: | 2.5, 5, 10, 20mm/mV, 10/5 mm/mV, AGC | 2.5, 5, 10, 20mm/mV, 10/5 mm/mV, AGC | Same |
| Pacemaker Detection | |||
| Amplitude | ±2 mV ~ ±700 mV | ±2 mV ~ ±700 mV | Same |
| Width | 0.1 ms ~ 2.0ms | 0.1 ms ~ 2.0 ms | Same |
| Sampling Frequency | 10,000 / sec / channel | 10,000 / sec / channel | Same |
The version of SEMIP used in SE-301 is V1.8, which is the same as SE-12 Series.(K160876). But the version of SEMIP used in SE-3 series is V1.7, which was upgraded based on V1.6, the SEMIP version used in SE-601C.(K131503). Comparing SEMIP V1.6, the improvements of V1.7 were that the criteria of some diseases are optimized to improve automatic diagnostic accuracy including RVH, MI, T wave abnormal and optimization of some terms and optimize ventricular preexcitation measure method to improve accuracy. The V1.7 algorithms were explicated tested for pediatrics (from starting from birth) and the results were comparable to the V1.8 version of SEMIP.
As seen in the comparison tables, the subject and predicate devices have similar design features and
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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-301, SE-300B and SE-3 Electrocardiograph.
10. Performance Data:
Non-clinical data:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for SE-301, SE-3001A, SE-300B, and SE-3
ELECTROCARDIOGRAPH 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-301, SE-300A, SE-300B and SE-3 ELECTROCARDIOGRAPH 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 and no changes conducted during the testing to comply with the standards.
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.
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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.
11. Conclusion
The non-clinical data support the safety of the device and software and software verification and validation demonstrate that SE-301, SE-300A, SE-300B and SE-3 ELECTROCARDIOGRAPH 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-301, SE-300A, SE-300B and SE-3 ELECTROCARDIOGRAPH device is substantially equivalent to the predicate devices.
§ 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).