The iSE series 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. The electrocardiograph is capable of network communications and supports the informatized management of workflows in hospital and healthcare facilities.

Device Description

iSE-1210 and iSE-1810 Electrocardiograph can support ECG Data Sampling of maximum 12 leads and maximum 18 leads separately. iSE series electrocardiograph uses algorithm to generate measurements, data presentations, graphical presentations and interpretative statements. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals.

AI/ML Overview

The provided text is a 510(k) Premarket Notification summary for the Edan Instruments, Inc. Electrocardiograph (iSE series). It focuses on establishing substantial equivalence to previously cleared devices.

Based on the provided document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Key Takeaway: This 510(k) summary does not include a clinical study with real patient data to prove the device's diagnostic performance against a ground truth for conditions like heart disease. Instead, it relies heavily on non-clinical bench testing, electrical safety, EMC, human factors, and software verification/validation to demonstrate that the new device (iSE series) is as safe and effective as its predicate devices, primarily in its ability to acquire and process ECG signals according to established industry standards. The interpretation of ECGs with measurements and interpretive statements is explicitly stated as advisory only.

Therefore, the acceptance criteria and study described will pertain to the technical performance and safety of the ECG acquisition and processing rather than the diagnostic accuracy of an AI algorithm in interpreting ECGs for specific heart conditions.

Acceptance Criteria and Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance results in the format requested for diagnostic performance. Instead, it states that the device meets "accuracy specification" and "relevant consensus standards" through non-clinical bench testing.

Based on the "Performance Specifications" table (Table 1) and the "Performance testing-Bench" section, we can infer some performance aspects that were likely tested against standards.

Inferred Acceptance Criteria and Reported Device Performance (based on technical specifications and implied testing):

Acceptance Criteria Category	Specific Criterion (Inferred from standards/specs)	Reported Device Performance
Electrical Safety	Compliance with ANSI AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012	"assessed for conformity with the relevant requirements" (Pass)
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2:2014 (Fourth Edition)	"assessed for conformity with the relevant requirements" (Pass)
ECG Signal Accuracy / Performance	Compliance with IEC 60601-2-25 Edition 2.0 2011-10 (Particular requirements for electrocardiographs)	"meets its accuracy specification and meet relevant consensus standards" (Pass)
Heart Rate (HR) Recognition Range	HR Range for accurate recognition: 30 BPM - 300 BPM	30 BPM ~ 300 BPM (Same as predicate)
Analog-to-Digital Conversion	A/D Resolution: 24 bits	24 bits (Same as predicate)
Sampling Frequency (ECG Unit)	Sampling Frequency: 64,000 Hz (for general ECG unit)	64,000 Hz (Higher than predicate's 16,000 Hz, implying improved capability)
Frequency Response	Frequency Response: 0.01Hz ~ 350Hz (-3 dB)	0.01 Hz ~ 350 Hz (-3 dB) (Wider than predicate's 0.01Hz~300Hz, implying improved capability)
Filter Performance	Functionality of AC, DFT, EMG, and LOWPASS Filters	AC Filter: Same; DFT Filter: Same; EMG Filter: Same; LOWPASS Filter: Different (350Hz/300Hz/270Hz/150Hz/100Hz/75 Hz vs. 300Hz/270Hz/150Hz/100Hz/75Hz for predicate) (Implied Pass)
Pacemaker Detection Sampling Frequency	Pacemaker Detection Sampling Frequency (for specific models)	iSE-1810: 16,000Hz, Rhythm Lead; iSE-1210: 80,000Hz, Rhythm Lead (Different from predicate) (Implied Pass)
Human Factors/Usability	Compliance with "Applying Human Factors and Usability Engineering to Medical Devices" guidance and IEC 62366-1:2020	"safe and effective for the intended users, uses, and use environments" (Pass)
Software Verification & Validation	Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"	"conducted and documentation was provided" (Implied Pass)

Study Details (Based on the provided document)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for any performance testing beyond "Functional and system level testing" and "usability testing." No specific number of patient ECGs are mentioned for any diagnostic validation.
- Data Provenance: The document does not specify the country of origin for any data (if patient data was used implicitly in some "accuracy specification" bench testing, which is unlikely given the context). The studies mentioned (Electrical safety, EMC, performance bench testing, human factors, software verification) are non-clinical bench and lab-based studies. There is no mention of prospective or retrospective patient data collection.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For non-clinical bench testing, the "ground truth" is typically defined by engineering specifications, calibration standards, and validated test equipment rather than expert human interpretation of medical data.
- The interpretative statement for the ECGs is offered "on an advisory basis only," indicating that the device's interpretation is not intended to replace a physician's diagnosis.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. The studies described are technical performance tests against standards, not human reader studies requiring adjudication of medical diagnoses.
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:
- No. An MRMC study was not conducted or reported. The device's interpreted ECGs are advisory, and there's no claim of AI assistance for human readers in the diagnostic process. The "algorithm" mentioned (SEMIP V1.92) generates measurements, data presentations, graphical presentations, and interpretative statements, but its performance is not assessed in a comparative effectiveness study with human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Partially Yes, for technical performance. The bench testing (e.g., meeting accuracy specifications, sampling frequency, frequency response) can be considered a standalone performance assessment of the device's ability to acquire and process ECG signals according to engineering and industry standards. However, this is distinct from a standalone diagnostic performance study typically seen for AI/CADe devices. The document explicitly states "Clinical data: Not applicable." This confirms that no standalone clinical diagnostic performance study was performed or needed for this 510(k) submission, as the device's interpretations are advisory.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Technical Specifications/Industry Standards. For the non-clinical tests, the "ground truth" for the device's performance is compliance with established electrical safety, EMC, and ECG technical performance standards (e.g., IEC 60601 series). There is no "ground truth" of patient diagnosis (e.g., pathology, outcomes, expert consensus on disease states) used as this device is broadly an ECG acquisition and processing device, with its interpretive statements being advisory.
The sample size for the training set:
- Not applicable / Not specified. The document makes no mention of AI model training or a training set. The "algorithm" (SEMIP V1.92) is mentioned as generating interpretive statements, but its development process (e.g., use of a training set, machine learning) is not described or evaluated in this 510(k) summary. Given the nature of a foundational ECG device and the "advisory basis only" statement for interpretations, it's highly likely this algorithm is rule-based or statistical rather than a deep learning model requiring a large training set of annotated ECGs for diagnostic purposes.
How the ground truth for the training set was established:
- Not applicable. As no training set is mentioned or evaluated in the provided document, the process for establishing its ground truth is not described.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 7, 2022

Edan Instruments, Inc. Ying Dai Regulatory Engineer #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, Guangdong 518122 China

Re: K212278

Trade/Device Name: Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: February 28, 2022 Received: March 7, 2022

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 mediation-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.

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)

Device Name Electrocardiograph

Indications for Use (Describe)

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 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) 84513592
Contact person:Preparing date:	Joan. WeiJune 25th, 2021
2. Device name andclassification:	ElectrocardiographClassification Name/ Product code:
	21 CFR 870.2340 Electrocardiograph, DPSRegulatory Class: Class II
3.Premarket NotificationClass III Certificationand Summary	Not applicable, the subject device is Class II.
4. Predicate Device(s):	1) Edan Instruments, SE-18 Electrocardiograph, cleared under K170995(Primary)2) Edan Instruments, SE-12, SE-12 Express, SE-1200, and SE-1200 ExpressElectrocardiograph, cleared under K171942(Reference)
5. Reason forSubmission	By submission of the Traditional 510(k), Edan Instruments is requestingclearance for new devices iSE-1210 and iSE-1810 Electrocardiograph.
6.Pre-Submission,IDE	Not applicable, there is no pre-submission.
7. Device Description:	iSE-1210 and iSE-1810 Electrocardiograph can support ECG Data Sampling ofmaximum 12 leads and maximum 18 leads separately. iSE serieselectrocardiograph uses algorithm to generate measurements, data presentations,graphical presentations and interpretative statements. The electrocardiograph isonly intended to be used in hospitals or healthcare facilities by doctors andtrained healthcare professionals.

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1. Indication for Use The iSE series 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. The electrocardiograph is capable of network communications and supports the informatized management of workflows in hospital and healthcare facilities.

9. Predicate Device Comparison

Comparison to the predicate and reference 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-18)	Proposed device(iSE Series)	ComparisonResult
K#	K170995	K212278	—
Indications for Use/Intended Use	The SE-18 18-lead electrocardiograph isintended to acquire ECG signals fromadult and pediatric patients through bodysurface ECG electrodes. Theelectrocardiograph is only intended to beused in hospitals or healthcare facilitiesby doctors and trained healthcareprofessionals. The cardiogram recordedby the electrocardiograph can help usersto analyze and diagnose heart disease.However, the interpreted ECG withmeasurements and interpretive statementsis offered to clinicians on an advisorybasis only.	The iSE Series electrocardiograph isintended to acquire ECG signals fromadult and pediatric patients throughbody surface ECG electrodes. Theelectrocardiograph is only intended tobe used in hospitals or healthcarefacilities by doctors and trainedhealthcare professionals. Thecardiogram recorded by theelectrocardiograph can help users toanalyze and diagnose heart disease.However, the interpreted ECG withmeasurements and interpretivestatements is offered to clinicians on anadvisory basis only. Theelectrocardiograph is capable ofnetwork communications and supportsthe informatized management of	Different
		workflows in hospital and healthcarefacilities.
Algorithm	SEMIP V1.8	SEMIP V1.92	Different
The number ofelectrodes	16	iSE-1810: 16iSE-1210: 10	Different
Power Supply Specifications
Mains Supply:	Operating Voltage = 100V-240V~Operating Frequency = 50Hz/60HzInput Current = 0.9A ~ 0.4A	Operating Voltage = 100V-240V~Operating frequency=50Hz/60HzInput current=1.1 A	SameSameDifferent
Lithium Battery Pack:	Rated voltage = 14.8 VRated capacity = 5000mAh--	Rated voltage = 15.2 VRated capacity = 3550mAhWhen the battery is fully charged, iSE can work (without printing) continuously at least 8 hours.100% recharge time: ≤ 5 hours90% recharge time: < 4 hours	Different
Performance Specifications
Recording (Optional for iSE with thermal printer)
Recorder:	Thermal dot-matrix recorder	Thermal dot-matrix recorder	Same
HR Recognition	HR Range	30 BPM ~ 300 BPM	30 BPM ~ 300 BPM	Same
ECG Unit	Leads:	iSE-1810: 9, 12, 15, 16 or 18 standard leadsiSE-1210: 9 or 12 standard leads	Different
	A/D	24 bits	24 bits	Same
	Sampling Frequency	16, 000 Hz	64,000 Hz	Different
	FrequencyResponse:	0.01Hz~300Hz (-3 dB)	0.01 Hz ~ 350 Hz (-3 dB)	Different
Filter	AC Filter	AC Filter	Same
	DFT Filter	DFT Filter	Same
	EMG Filter	EMG Filter	Same
	LOWPASS Filter:300Hz/270Hz/150Hz/100Hz/75Hz	LOWPASS Filter:350Hz/300Hz/270Hz/150Hz/100Hz/75 Hz	Different
Pacemaker Detection
	Sampling Frequency	iSE-1810(DE18): 16,000Hz, Rhythm LeadiSE-1210(DE12): 80,000Hz, Rhythm Lead	Different
Connection
Wireless connection	WiFi	WiFi, Bluetooth, 4G, NFC	Different
Item	Reference device(SE-12, SE-12 Express, SE-1200, andSE-1200 Express)	Proposed device(iSE Series)	ComparisonResult
K#	K171942	K212278	—
Indications for Use/Intended Use	The intended use of SE-12 serieselectrocardiograph is to acquire ECGsignals from adult and pediatric patientsthrough body surface ECG electrodes.The electrocardiograph is only intended tobe used in hospitals or healthcare facilitiesby doctors and trained healthcareprofessionals. The cardiogram recordedby the electrocardiograph can help usersto analyze and diagnose heart disease.However, the interpreted ECG withmeasurements and interpretive statementsis offered to clinicians on an advisorybasis only.	The iSE Series electrocardiograph isintended to acquire ECG signals fromadult and pediatric patients throughbody surface ECG electrodes. Theelectrocardiograph is only intended tobe used in hospitals or healthcarefacilities by doctors and trainedhealthcare professionals. Thecardiogram recorded by theelectrocardiograph can help users toanalyze and diagnose heart disease.However, the interpreted ECG withmeasurements and interpretivestatements is offered to clinicians on anadvisory basis only. Theelectrocardiograph is capable ofnetwork communications and supportsthe informatized management ofworkflows in hospital and healthcarefacilities.	Different
The number ofelectrodes	10	iSE-1210: 10	Same
Leads:	Standard 12 leads	iSE-1210: 9 or 12 standard leads	Different

Table 1: Comparison between iSE Series and SE-18

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Table 2: Comparison between iSE Series and SE-12 Series

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As seen in the comparison tables, the subject and predicate devices have similar intended use, design features and performance specifications. The technological differences between the subject and predicate devices do not raise different questions of safety or effectiveness.

10. Performance Data:

Non-clinical data:

Electrical safety and electromagnetic compatibility (EMC)

The iSE series electrocardiograph were assessed for conformity with the relevant requirements of the following standards:

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.

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Performance testing-Bench

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

Human Factors Engineering Testing

Edan has conducted usability testing to validate the usability of the devices. The results of usability testing show that the subject device safe and effective for the intended users, uses, and use environments and meet the requirement of following FDA s are Guidance and consensus standard:

Applying Human Factors and Usability Engineering to Medical Devices, issued on February 3, 2016
IEC 62366-1:2020 Medical Devices-Part 1:Application of usability engineering to medical devices

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 predicate devices.

11. Conclusion

The non-clinical data, bench testing data, and software verification testing demonstrate that iSE series electrocardiograph are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).