(255 days)
The SE-1202 12-lead electrocardiograph is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements is offered to clinicians on an advisory basis only.
CONTRAINDICATIONS:
SEMIP algorithm is not intended for interpretive statements of neonatal patients from birth to 28 days.
The SE-1202 electrocardiograph features a 10.1" LCD touch screen, an operation panel, user-programmable reports, and the ability to operate on either battery or AC power. It is capable of simultaneous acquisition, display, and print of 12-lead ECG. It uses algorithm to generate measurements, data presentations, graphical presentations and interpretative statements. The record can be saved in flash memory or send to PC.
The provided document is a 510(k) Premarket Notification from Edan Instruments, Inc. for their Electrocardiograph SE-1202. It establishes substantial equivalence to a predicate device (Edan Instruments, Inc, Electrocardiograph: SE-12, SE-12 Express, SE-1200, and SE-1200 Express, K171942).
The document does not contain details about a study addressing specific acceptance criteria for an AI/algorithm's performance as typically required for devices with interpretive or diagnostic AI functionalities. Instead, it focuses on the performance of the electrocardiograph hardware and its ability to meet general electrical safety, EMC, and basic functional standards (e.g., heart rate range, noise, filter specifications).
The device's software includes an algorithm (SEMIP or Glasgow) that generates measurements, data presentations, graphical presentations, and "interpretative statements." However, the document explicitly states that these interpretations are "offered to clinicians on an advisory basis only." Furthermore, it contraindicates the SEMIP algorithm for neonatal patients.
Given that the core of the request is about acceptance criteria and a study that proves the device meets specific acceptance criteria related to its performance, and the document explicitly states "Clinical data: Not applicable," it indicates there wasn't a clinical study designed to test the interpretive algorithm's performance against detailed criteria for accuracy, sensitivity, or specificity in a diagnostic context. The "Performance validation via EDAN proprietary database" is mentioned, but no specifics about this validation, its acceptance criteria, or its results are provided.
Therefore, many of the requested details cannot be extracted from this document, as it describes a device where the interpretive statements are advisory and clinical data showing performance of these interpretive features in a diagnostic capacity was not deemed necessary for this 510(k) clearance.
However, I will extract what is available and clearly state what information is not present.
Here's an analysis of the acceptance criteria and the study as described in the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating equivalence to a predicate device through technical specifications and compliance with general medical device standards, rather than defining and meeting specific analytical or clinical performance acceptance criteria for an AI/algorithm's diagnostic accuracy. The "acceptance criteria" here are more about meeting safety, EMC, and basic functional parameters of the ECG device itself, and showing the interpretive algorithm's presence but framing its output as advisory.
| Criteria Category / Parameter | Acceptance Criteria (from document, implicitly or explicitly) | Reported Device Performance (from document) |
|---|---|---|
| Electrical Safety | Conformity with ANSI AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009(R) 2012 and A2:2010/(R) 2012 | Found to comply. |
| Electromagnetic Compatibility (EMC) | Conformity with IEC 60601-1-2:2014 (Fourth Edition) | Found to comply. |
| Functional/Bench Performance | Conformity with IEC 60601-2-25 Edition 2.0 2011-10 | Bench testing results show that the subject device meets its accuracy specification and meets relevant consensus standards. Performance validated via EDAN proprietary database. (Specific "accuracy specification" details are not provided in this document excerpt). |
| Software Verification & Validation | As recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | Conducted and documentation provided. |
| Intended Use | Acquire ECG signals from adult and pediatric patients; used in healthcare facilities by doctors and trained professionals; cardiogram helps analyze/diagnose heart disease; interpreted ECG with measurements is advisory. | Same as the predicate device. |
| Contraindication | SEMIP algorithm not intended for interpretive statements of neonatal patients from birth to 28 days. | Explicitly stated as a contraindication. |
| Basic Performance Specs (Example) | HR Range: 30 BPM ~ 300 BPM, Noise: ≤12.5 µVp-p, Input Impedance: ≥100 MΩ (10 Hz) | Met, or comparable to predicate device. For example, HR Range: 30 BPM ~ 300 BPM, Noise: ≤12.5 µVp-p, Input Impedance: ≥100 MΩ (10 Hz). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for any performance testing related to the interpretive algorithm. The document mentions "Performance validation via EDAN proprietary database" but does not give details on the size or characteristics of this database.
- Data Provenance: Not specified (e.g., country of origin). The document indicates it's an "EDAN proprietary database," suggesting it's internal.
- Retrospective or Prospective: Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided in the document. Given that the interpretive statements are "advisory" and no clinical data was submitted, detailed ground truth establishment by experts for evaluative purposes is not described.
4. Adjudication Method for the Test Set
- This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. The document explicitly states "Clinical data: Not applicable." Therefore, an MRMC study was not performed or submitted for this 510(k). As a result, no effect size of human readers improving with AI vs. without AI assistance is reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- The document mentions "Performance validation via EDAN proprietary database" for the algorithm. However, specific details of this "standalone" performance (e.g., metrics like sensitivity, specificity, accuracy for specific arrhythmias or findings) are not provided, nor are the acceptance criteria for these metrics. The focus of the submission is on substantial equivalence of the overall device, not on analytical performance of the interpretive algorithm in isolation for diagnostic claims.
7. The Type of Ground Truth Used
- For the "Performance validation via EDAN proprietary database," the type of ground truth is not specified. Given the nature of ECG interpretation, it would typically involve cardiologist consensus or perhaps correlation with other diagnostic modalities for specific findings, but this document does not describe it.
8. The Sample Size for the Training Set
- This information is not provided. The document notes the use of "SEMIP or Glasgow" algorithms. These tend to be well-established, rule-based or statistical algorithms, rather than deep learning models that would have a distinct "training set" in the modern sense. If newer machine learning components were integrated, their training data size is not disclosed.
9. How the Ground Truth for the Training Set was Established
- This information is not provided. For established algorithms like SEMIP or Glasgow, their development likely involved expert consensus and large ECG databases over time, but the specific method for their training data's ground truth is not detailed here.
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October 1, 2021
Edan Instruments, Inc Ying Dai Regulatory Engineer #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, Guangdong 518122 China
Re: K210140
Trade/Device Name: Electrocardiograph: SE-1202 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, DYC Dated: July 15, 2021 Received: July 20, 2021
Dear Ying Dai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210140
Device Name Electrocardiograph(SE-1202)
Indications for Use (Describe)
The SE-1202 12-lead electrocardiograph is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements is offered to clinicians on an advisory basis only.
CONTRAINDICATIONS:
SEMIP algorithm is not intended for interpretive statements of neonatal patients from birth to 28 days.
Type of Use (Select one or both, as applicable)X 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.Tel: +86(0755) 26858736Fax: +86(0755) 26882223 | ||||||
|---|---|---|---|---|---|---|---|
| Contact person: | Ying DAI | ||||||
| Preparing date: | January 15, 2021 | ||||||
| 2. Device name and classification: | Trade Name: Electrocardiograph, model: SE-1202 | ||||||
| Common/Usual Name: Electrocardiograph | |||||||
| Classification NameProduct code21 CFR 870.2340 ElectrocardiographDPS21 CFR 870.2400 VectorcardiographDYC | Classification Name | Product code | 21 CFR 870.2340 Electrocardiograph | DPS | 21 CFR 870.2400 Vectorcardiograph | DYC | |
| Classification Name | Product code | ||||||
| 21 CFR 870.2340 Electrocardiograph | DPS | ||||||
| 21 CFR 870.2400 Vectorcardiograph | DYC | ||||||
| Regulatory Class: Class II | |||||||
| 3. Predicate Device(s): | Edan Instruments, Inc, Electrocardiograph: SE-12, SE-12 Express, SE-1200, and SE-1200 Express, K171942. | ||||||
| 4. Device Description: | The SE-1202 electrocardiograph features a 10.1" LCD touch screen, an operation panel, user-programmable reports, and the ability to operate on either battery or AC power. It is capable of simultaneous acquisition, display, and print of 12-lead ECG. It uses algorithm to generate measurements, data presentations, graphical presentations and interpretative statements. The record can be saved in flash memory or send to PC. | ||||||
| 5. Indication for Use | The SE-1202 12-lead electrocardiograph is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. | ||||||
| CONTRAINDICATIONS: | |||||||
| SEMIP algorithm is not intended for interpretive statements of neonatal patients |
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from birth to 28 days.
6. Predicate Device Comparison
Comparison to the predicate devices, the subject device has the same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following tables:
| Item | Predicate device(SE-12, SE-12 Express, SE-1200,and SE-1200 Express) | Proposed device(SE-1202) | ComparisonResult |
|---|---|---|---|
| K# | K171942 | K210140 | — |
| Intended Use | The intended use of SE-12 serieselectrocardiograph is to acquireECG signals from adult andpediatric patients through bodysurface ECG electrodes. Theelectrocardiograph is onlyintended to be used in hospitals orhealthcare facilities by doctors andtrained healthcare professionals.The cardiogram recorded by theelectrocardiograph can help usersto analyze and diagnose heartdisease. However, the interpretedECG with measurements andinterpretive statements is offeredto clinicians on an advisory basisonly. | The SE-1202 12-leadelectrocardiograph is intended toacquire ECG signals from adultand pediatric patients throughbody surface ECG electrodes.The electrocardiograph is onlyintended to be used in hospitalsor healthcare facilities by doctorsand trained healthcareprofessionals. The cardiogramrecorded by theelectrocardiograph can help usersto analyze and diagnose heartdisease. However, the interpretedECG with measurements andinterpretive statements is offeredto clinicians on an advisory basisonly. | Same |
| ECG functionality | Resting ECG, Exercise ECG | Resting ECG | Different |
| Algorithm | SEMIP or Glasgow | SEMIP or Glasgow | Same |
| The number ofelectrodes | 10 | 10 | Same |
| Mains Supply: | Operating Voltage = 100V-240V~Operating frequency = 50 Hz / 60Hz | Operating Voltage = 100V-240V~Operating frequency = 50 Hz / 60Hz | Same |
| Input Current = 0.9-0.4AOr Input power = 96VA | Input Current = 0.9-0.4AOr Input power = 96VA | Same | |
| Rated voltage = 14.8 V | Rated voltage = 14.8 V | Same | |
| Built-in Lithium BatteryPack: | Rated capacity = 5000mAh or2500mAh | Rated capacity = 5000mAh or2500mAh | Same |
| Performance Specifications | |||
| Recorder: | Thermal dot-matrix recorder | Thermal dot-matrix recorder | Same |
| HR Range: | 30 BPM ~ 300 BPM | 30 BPM ~ 300 BPM | Same |
| ECG Unit | |||
| Leads: | Standard 12 leads | 9 or 12 standard leads | |
| Acquisition Mode: | Simultaneously 12 leads | 9 or 12 leads acquisitionsimultaneously | Different |
| Processor Board | 800 MHz CPU | 1GHz CPU | |
| Sampling Frequency | 16, 000 Hz | 64,000 Hz | Different |
| Input Impedance: | ≥100 MΩ(10 Hz) | ≥100 MΩ(10 Hz) | Same |
| DC Offset Voltage: | ±600 mV | ±900 mV | Different |
| Noise: | ≤12.5 µVp-p | ≤12.5 µVp-p | Same |
| Filter | AC Filter | AC Filter | Same |
| DFT Filter:0.01Hz/0.05Hz/0.15Hz/0.25Hz/0.32Hz/0.5Hz/0.67Hz | DFT Filter:0.01 Hz / 0.05 Hz / 0.32 Hz / 0.67 Hz | Different | |
| EMG Filter | EMG Filter | Same | |
| LOWPASS Filter:300Hz/270Hz/150Hz/100Hz/75Hz | LOWPASS Filter:350 Hz / 300 Hz / 270 Hz / 150 Hz / 100 Hz / 75 Hz | Different | |
| Pacemaker Detection | |||
| Sampling Frequency | 16,000/sec/channel | 80,000 /sec/channel, Rhythm Lead | Different |
| Connection | |||
| Wireless connection | Wi-Fi | Wi-Fi | same |
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As seen in the comparison tables, the subject and predicate devices have similar design features and performance specifications. The technological differences between the subject and predicate devices do not raise different questions of safety or effectiveness.
7. Performance Data:
Non-clinical data:
Electrical safety and electromagnetic compatibility (EMC)
The SE-1202 electrocardiograph were assessed for conformity with the relevant requirements of the following standards and found to comply:
- ANSI AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009(R) 2012 and A2:2010/(R) 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2:2014 (Fourth Edition) Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: electromagnetic disturbances - Requirements and tests.
Performance testing-Bench
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Edan has conducted functional and system level testing to validate the performance of the results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards.
- IEC 60601-2-25 Edition 2.0 2011-10 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
- Performance validation via EDAN proprietary database
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".
Clinical data: Not applicable.
Summary
The non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate device.
8. Conclusion
The bench testing data and software verification and validation demonstrate that Electrocardiograph SE-1202 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).