(53 days)
The intended use of PADECG is to acquire resting ECG signals from adult and pediatric patients through body surface ECG electrodes. It is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by PADECG can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. It is mainly used in ECG inpatient department of hospitals or healthcare facilities.
PADECG is iPad-Based ECG work station. PADECG System primarily composed of DX12(iOS) Transmitter and PADECG Analysis Software, the product is designed to collect and analyzes 12-Lead resting ECG. The DX12(iOS) Transmitter contains lead wires and sends the ECG data to PADECG Analysis Software through Bluetooth. The PADECG Analysis Software will be uploaded to the App Store, so that customers can download it to their own iPad and install it. The PADECG Analysis Software which is installed in the iPad can display the ECG data. The PADECG Analysis Software can analysis the ECG data, and provide an advisory diagnostic result.
The provided text describes the 510(k) premarket notification for the Edan Instruments, Inc. PC ECG, model PADECG. The information focuses on demonstrating substantial equivalence to a predicate device (Edan Instruments, Inc., SE-1515, K152427) rather than providing detailed acceptance criteria and a study proving the device meets those criteria for its interpretive statements.
However, based on the information available and common regulatory practices for ECG devices with interpretive capabilities, we can infer some details regarding the "ECG interpretation feature validation by database testing" mentioned.
Here's an attempt to answer your questions based on the provided text, and where information is not explicitly stated, common practice for similar devices is used as a reasonable inference:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state a table of acceptance criteria for the interpretive algorithm's performance (e.g., sensitivity, specificity for specific diagnoses). Instead, it mentions that "ECG interpretation features were also validated by database testing." The "Comparison between PADECG and Predicate Device SE-1515" table (pages 4-5) details technical specifications of the device itself and explicitly states:
| Item | PADECG | SE-1515 (Predicate) |
|---|---|---|
| Algorithm | Algorithm of the Smart ECG Measurement and Interpretation Programs (SEMIP), version 1.8 | Algorithm of the Smart ECG Measurement and Interpretation Programs (SEMIP), version 1.8 |
| Heart Rate Meter | 30 BPM ~300 BPM, ±1BPM | 30 BPM ~300 BPM, ±1BPM |
| Measuring the ECG | Amplitudes (mV), intervals (ms), and slopes (mV/s) can be ensured on all ECG waveforms | Amplitudes (mV), intervals (ms), and slopes (mV/s) can be ensured on all ECG waveforms |
| Reanalysis | Manually change the measurement marks of medians and the interpretation result | Manually change the measurement marks of medians and the interpretation result |
| Interpretation library | Has Interpretation library and can edit | Has Interpretation library and can edit |
| Resolution | 2.52uV/LSB | 2.52uV/LSB |
| 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 | ≥20MΩ (10Hz) | ≥20MΩ (10Hz) |
| System Noise | <15µVp-p | <15µVp-p |
| Dynamic Range | AC Differential ± 5mV, DC offset ±500mV | AC Differential ± 5mV, DC offset ±500mV |
| Common Mode Rejection | ≥100 dB | ≥100 dB |
| Pace Detect | ±2 to ±500 mV@0.1 to 2.0ms | ±2 to ±500 mV@0.1 to 2.0ms |
| ESD Sensitivity | ±6 kV contact, ±8 kV air | ±6 kV contact, ±8 kV air |
Implicit Acceptance Criteria for Interpretation (Inferred from common practice):
While not explicitly stated with quantitative targets in this document, for ECG interpretation algorithms, acceptance criteria typically involve:
- Agreement with a cardiologist's diagnosis: High percentage agreement (e.g., >85% or >90%) for various diagnostic categories (normal, abnormal, specific arrhythmias, ST-T changes, etc.).
- Agreement with measurements: High correlation (e.g., R-squared > 0.95) and minimal bias in automated measurements of intervals (PR, QRS, QT), amplitudes (P, QRS, T), and axes compared to expert measurements.
- Clinical Significance: Demonstrating that the advice provided by the algorithm does not lead to significant misdiagnosis or harm when used as an advisory tool.
Given that the PADECG uses the "Algorithm of the Smart ECG Measurement and Interpretation Programs (SEMIP), version 1.8," which is the same algorithm as its predicate device (SE-1515), the primary evidence for meeting acceptance criteria for interpretation relies on the predicate device's prior validation and the demonstration that the PADECG implements this identical, validated algorithm correctly. The statement "ECG interpretation features were also validated by database testing" for the PADECG suggests that this algorithm's performance was confirmed on a test set, likely to ensure its faithful implementation on the new platform.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only states "database testing."
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This is a common omission in 510(k) summaries, which often focus on the type of testing rather than granular details of the dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. For ECG interpretation, ground truth is typically established by board-certified cardiologists or electrophysiologists, often with significant experience in ECG reading.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified. For ECG interpretation, consensus or adjudication by multiple expert readers is standard practice to establish ground truth.
5. 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
- MRMC Comparative Effectiveness Study: No, the document does not mention an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device's interpretation is clearly stated as "advisory basis only," indicating it's not a standalone diagnostic device but a tool that assists a professional.
- Effect Size of Improvement: Not applicable, as no such study was reported.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Standalone Performance: Yes, implicitly. The "ECG interpretation features were also validated by database testing" refers to the performance of the algorithm itself against a pre-established ground truth. While the device is not standalone in general clinical use (it advises clinicians), the algorithm's performance in interpreting ECGs from the database is a standalone evaluation of its output against ground truth. The device is cleared as an "advisory" tool, meaning its standalone diagnostic accuracy is assessed but not necessarily expected to be perfect or replace human judgment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not explicitly stated but heavily implied to be expert consensus or reference standard ECG interpretations derived from cardiologists. For ECG interpretation, this is the gold standard for validating algorithms. Pathology or outcomes data are generally not the direct ground truth for ECG interpretation algorithms, though they might be used in broader clinical studies of the overall diagnostic pathway.
8. The sample size for the training set
- Training Set Sample Size: Not specified. The document focuses on the validation of the interpretation features via "database testing" for the specific device being cleared. Details of the training set used for the original development of the "SEMIP, version 1.8" algorithm are not provided in this 510(k) summary.
9. How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Not specified in this document. For the original development of the SEMIP algorithm, it would likely have involved a large dataset of ECGs interpreted by multiple cardiologists, with discrepancies resolved through an adjudication process to establish the most accurate ground truth.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Edan Instruments. Inc. % Doug Worth Sr. Dir. US RA/QA Edan Medical 1200 Crossman Ave. Suite 200 Sunnyvale, California 94089
Re: K161302
Trade/Device Name: PC ECG, model PADECG Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: April 28, 2016 Received: May 9, 2016
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 vours.
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) K161302
Device Name PC ECG, model PADECG
Indications for Use (Describe)
The intended use of PADECG is to acquire resting ECG signals from adult and pediatric patients through body surface ECG electrodes. It is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by PADECG can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. It is mainly used in ECG inpatient department of hospitals or healthcare facilities.
| 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, 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: | Alice YangJune 29, 2016 |
| 2. Device name andclassification: | Device Name: PC ECG, model PADECGClassification 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 Instruments, Inc., SE-1515, K152427 |
| 5. Reason forSubmission | New Model. |
| 6. Pre-Submission,IDE | Not applicable, there is no Pre-Submission. |
| 7. Device Description: | PADECG is iPad-Based ECG work station. PADECG Systemprimarily composed of DX12(iOS) Transmitter and PADECGAnalysis Software, the product is designed to collect andanalyzes 12-Lead resting ECG. The DX12(iOS) Transmittercontains lead wires and sends the ECG data to PADECGAnalysis Software through Bluetooth.The PADECG Analysis Software will be uploaded to the AppStore, so that customers can download it to their own iPad andinstall it. The PADECG Analysis Software which is installed inthe iPad can display the ECG data. The PADECG AnalysisSoftware can analysis the ECG data, and provide an advisorydiagnostic result. |
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- Indications for Use: The intended use of PADECG is to acquire resting ECG signals from adult and pediatric patients through body surface ECG electrodes. It is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by PADECG can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. It is mainly used in ECG inpatient department of hospitals or healthcare facilities.
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 items, detailed comparison information can be found in the following tables.
| Item | PADECG | SE-1515 |
|---|---|---|
| (Edan Instruments, Inc) | (Edan Instruments, Inc) | |
| 510(k)Number | Current Submission | K152427 |
| IntendedUse | The intended use of PADECG is toacquire resting ECG signals from adultand pediatric patients through bodysurface ECG electrodes. It is onlyintended to be used in hospitals orhealthcare facilities by doctors andtrained healthcare professionals. Thecardiogram recorded by PADECG canhelp users to analyze and diagnose heartdisease. However, the interpreted ECGwith measurements and interpretivestatements is offered to clinicians on anadvisory basis only. It is mainly used inECG inpatient department of hospitalsor healthcare facilities. | SE-1515 PC ECG is intended to acquireprocess and store ECG signals fromadult and pediatric patients undergoingstress exercise test or resting test. TheSE-1515 PC ECG is intended to be usedonly in hospitals and healthcarefacilities by doctors and trainedhealthcare professionals. Thecardiogram recorded by the SE-1515PC ECG can help users to analyze anddiagnose heart diseases. However, theECG with measurements andinterpretive statements is offered toclinicians on an advisory basis only. Itis mainly used in the ECG OutpatientDepartment and Physical ExaminationDepartment. |
| LeadNumber | 12 | 12/15/16/18 |
| Analysistime | 10s | 10s |
| Measuringthe ECG | Amplitudes(mV),intervals(ms) andslopes(mV/s) can be ensured on all | Amplitudes(mV),intervals(ms) andslopes(mV/s) can be ensured on all |
| Item | PADECG | SE-1515 |
| (Edan Instruments, Inc) | (Edan Instruments, Inc) | |
| ECG waveforms | ECG waveforms | |
| Reanalysis | Manually change the measurementmarks of medians and the interpretationresult | Manually change the measurementmarks of medians and the interpretationresult |
| Vector loop | Do not support the Vector loop | Support the FRANK sampling andCalculating VCG. Can show theFRANK leads X,Y,Z wave and mediancomplexes of the orthogonal FRANKleads X,Y,Z as well as the vector loopsin three plans |
| Interpretation library | Has Interpretation library and can edit | Has Interpretation library and can edit |
| Algorithm | Algorithm of the Smart ECGMeasurement and InterpretationPrograms(SEMIP), version 1.8 | Algorithm of the Smart ECGMeasurement and InterpretationPrograms(SEMIP), version 1.8 |
| CPU | Apple A5 or above | Pentium P4, Celeron D 310 or above |
| SystemMemory(RAM) | / | 1G or above |
| Capacity/Hard Disk | 16GB or above | 128GB or above |
| Printer | / | ink jet printer of more than 300dpi orlaser printerRecommend HP2035, HP2010,CANON iP1980 |
| Display | iPad 4:9.7'1536×2048iPad Air 1: 9.7'1536×2048iPad Mini 2:7.9'1536×2048iPad Mini 1:7.9'1024×768 | 17" TFT (Resolution: 12801024,1366768), 19" TFT (resolution:1440×900), 21" TFT(1920*1080) |
| OperatingSystem | iOS 7,iOS 8, iOS 9 | Windows XP SP3 (32 bit), Windows 7SP1 (32/64 bit) or Windows 8 (32/64bit), Windows 8.1 (32/64 bit) |
| Operating | DX12 (iOS) Transmitter:+5 ~+40 | DX12 Transmitter:+5 ~+40 |
| Transport/Storage | DX12 (iOS) Transmitter:-20°C (-4°F)~+55°C | DX12 Transmitter:-20°C (-4°F)~+55°C |
| Operating | DX12 (iOS) Transmitter:15%~95%Non-Condensing | DX12 Transmitter:25% to 80% RH |
| Transport/Storage | DX12 (iOS) Transmitter:15%~95%Non Condensing | DX12 Transmitter:25% to 93% RH non-condensing |
| Item | PADECG(Edan Instruments, Inc) | SE-1515(Edan Instruments, Inc) |
| SafetyStandards | IEC60601-1IEC60601-1-2IEC60601-2-25IEC60601-1-6EN ISO14971 | IEC60601-1IEC60601-1-2IEC60601-2-25IEC60601-1-6EN ISO14971 |
| DataTransmission | Wireless BluetoothTechnology(Version:2.0,Frequency:2402-2480Hz) | USB interface and Wireless BluetoothTechnology(Version:2.0,Frequency:2402-2480Hz) |
| Anti-electric-shocktype | Class II | Class II |
| Anti-electric-shockdegree | Type CF with defibrillation-proof | Type CF with defibrillation-proof |
| Leadnumber | 12-lead | 12-lead |
| Degree ofprotectionagainstharmfulingress ofwater | Enclosed equipment without protectionagainst ingress of water | Enclosed equipment without protectionagainst ingress of water |
| Degree ofsafety ofapplicationin thepresence offlammablegas | Not suitable for use in the presence of aflammable anesthetic mixture with airor with oxygen or nitrous oxide | Not suitable for use in the presence of aflammable anesthetic mixture with airor with oxygen or nitrous oxide |
| Workingmode | Continuous operation | Continuous operation |
| SamplingRate | 10,000/sec/channel(sampling) | 10,000 /sec/channel (sampling) |
| Resolution | 2.52uV/LSB | 2.52uV/LSB |
| TimeConstant | ≥3.2 s | ≥3.2 s |
| FrequencyResponse | 0.05 Hz ~ 150 Hz (-3 dB) | 0.05 Hz ~ 150 Hz (-3 dB) |
| InputImpedance | ≥20MΩ (10Hz) | ≥20MΩ (10Hz) |
| SystemNoise | <15µVp-p | <15µVp-p |
| Item | PADECG(Edan Instruments, Inc) | SE-1515(Edan Instruments, Inc) |
| DynamicRange | AC Differential ± 5mV, DC offset±500mV | AC Differential ± 5mV, DC offset±500mV |
| CommonModeRejection | ≥100 dB | ≥100 dB |
| Pace Detect | ±2 to ±500 mV@0.1 to 2.0ms | ±2 to ±500 mV@0.1 to 2.0ms |
| ESDSensitivity | ±6 kV contact±8 kV air | ±6 kV contact±8 kV air |
| Heart RateMeter | 30 BPM ~300 BPM , ±1BPM | 30 BPM ~300 BPM , ±1BPM |
| High/LowPass Filters | AC Filter: 50 Hz/60 Hz/OffDFT Filter: 0.32Hz/0.67Hz/0.05HzEMG Filter:25Hz/35Hz/45Hz/OffLowpass Filter:150Hz/100Hz/75Hz/Off | AC Filter: 50 Hz/60 Hz/OffDFT Filter: 0.01 Hz/0.05 Hz/0.32 Hz/0.67 HzEMG Filter:25 Hz/35 Hz/45 Hz/OffLow Pass Filter:300 Hz/270 Hz/150 Hz/100 Hz/75 Hz |
Comparison between PADECG and Predicate Device SE-1515
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All the differences don't affect the safety and effectiveness which is concluded after all the required testing, so no safety and effectiveness issues relating to the system come into conclusion.
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 PADECG 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. And the accessories of PADECG are all cleared.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the PADECG PC ECG device, consisting of all the accessories in the system. The system complies with the IEC 60601-1:2005/A1: 2012 standards for safety and the IEC 60601-1-2: 2007 for EMC.
Bench Testing
Bench testing was conducted on the PADECG PC ECG device, consisting of all the accessories in the system. The system complies with the IEC 60601-2-25: 2011 and IEC
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62366: 2007 standards.
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.
11. Conclusion
The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that PADECG 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 PADECG PC ECG 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).