(28 days)
The intended use of electrocardiograph is 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. The proposed device has analysis feature, however the ECC with measurements and interpretive statements is offered to clinician on an advisory basis only.
The proposed digital electrocardiograph, iE 101 and iE 300, are designed based on the cleared digital electrocardiographs K141946 (iE 3). The proposed device has same intended use, functional modules design, working modes, analysis function and accessories. the proposed devices are different than the predicate device in that they has new printing channel for iE 101); new layout of user-machine interface; three different physical specification, such as screen size, device dimension, device weight; three different specification, such as battery capacity, noise level and CMRR; and a modified software which is modified to applicable to the proposed devices.
The proposed electrocardiographs, iE 101 and iE 300, follow the same design principle, main components, accessories and software; they acquire ECG electrical signals from patient body surface by ECG electrodes. After been amplified, filtered and transferred, the ECG signal waveforms are displayed on the LCD and recorded on the paper through thermal printer.
They consist of four modules, which are power supply module, signal collection module, amplification module, and control module.
They can acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal via one channel (iE 101) or three channel (iE 300).
The provided text describes a 510(k) submission for a Digital Electrocardiograph, models iE101 and iE300. The submission argues for substantial equivalence to a predicate device (K141946).
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on establishing substantial equivalence to a predicate device, rather than defining specific performance acceptance criteria for diagnostic accuracy. The "acceptance criteria" here are essentially the compliance with relevant safety and performance standards and the demonstration that the proposed device performs similarly to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1:2005 + A1: 2012 (General safety) | Complies with IEC 60601-1:2005 + A1: 2012 |
| Compliance with IEC 60601-1-2: 2007 (EMC) | Complies with IEC 60601-1-2: 2007 |
| Compliance with IEC 60601-2-25:2011 (Electrocardiographs particular requirements) | Complies with IEC 60601-2-25:2011 |
| Biocompatibility (ISO 10993) | Complies with ISO 10993 |
| Intended Use | Same as predicate device |
| Intended Population | Same as predicate device (Adult and pediatric patients) |
| Intended Environment | Same as predicate device (Hospital, clinics) |
| Configuration | Same as predicate device |
| Lead | Same as predicate device (Standard 12-lead) |
| Acquisition mode | Same as predicate device (Simultaneous 12-lead acquisition) |
| Recording format | Same as predicate device (Automatic / Manual / Rhythm) |
| Analysis mode | Yes (Same as predicate, advisory basis only) |
| Physical/Technical Specifications (e.g., screen size, channels, battery capacity, noise level, CMRR) | Differences noted but deemed not to affect substantial equivalence (e.g., iE101: 5.0" screen, 1 channel; iE300: 5.0" screen, 3 channel vs. predicate's 6.0" screen, 3 channel). Software modified to be applicable to proposed devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no test set in the context of clinical performance evaluation based on patient data. The "tests" conducted were non-clinical, likely bench testing and engineering verification to demonstrate compliance with standards.
- Sample Size for Test Set: Not applicable as no clinical test set was used.
- Data Provenance: Not applicable as no clinical data was used for a test set. The non-clinical tests were conducted by the manufacturer (Shenzhen Biocare Bio-medical Equipment Co., Ltd.) in China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable, as no clinical study or test set requiring expert-established ground truth was performed for this submission. The device's "analysis feature" is offered on an advisory basis only, meaning its interpretive statements are not intended as definitive diagnoses.
4. Adjudication Method for the Test Set
Not applicable, as no clinical study or test set requiring adjudication was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The submission explicitly states "No clinical study is included in this submission." Therefore, no MRMC study was conducted, and no effect size calculation for human readers with or without AI assistance is available.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device has an "analysis feature," the submission does not include any standalone performance study of this algorithm. The analysis feature provides "measurements and interpretive statements" on an "advisory basis only," indicating it's not cleared for diagnostic standalone use.
7. The Type of Ground Truth Used
Not applicable, as no clinical performance study requiring ground truth was conducted. For non-clinical tests (electrical safety, EMC, etc.), the "ground truth" would be the specifications and requirements of the relevant IEC standards.
8. The Sample Size for the Training Set
Not applicable. This device is an electrocardiograph hardware with an accompanying analysis feature. The submission does not describe a machine learning algorithm that underwent training with a specific dataset. The analysis function is likely based on pre-programmed algorithms rather than a trained AI model in the modern sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no described training set or AI model training in the submission.
§ 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).