(257 days)
The Digital Electrocardiograph ME3 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 carded by the electrocardiograph can help users to analyze and diagnose heart disease. The proposed device has analysis feature, however the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
The ME6 is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Digital Electrocardiographs ME12P is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Digital Electrocardiograph ME15P is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall he used in healtheare facilities by doctors and/or trained healthcare professionals.
The Mediblu ME3 Digital Electrocardiograph is intended to acquire, display and record ECG signals from adult and pediatric patients through body surface ECG electrodes. ECG data result and patient information could be stored in the memory of the device. The obtained ECG records can help users to analyze and diagnose heart disease.
The Mediblu ME6P Digital Electrocardiograph is intended to acquire, display and record ECG signals from adult and pediatric patients through body surface ECG electrodes. ECG data result and patient information could be stored in the memory of the device. The obtained ECG records can help users to analyze and diagnose heart disease.
The Mediblu ME12P Digital Electrocardiograph is designed to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. After been amplified and filtered, the ECG signal waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data result and patient information could be stored in the memory of the device.
The Mediblu ME15P Digital Electrocardiograph is designed to acquire, display and record ECG signals from adult and pediatric patients through body surface ECG electrodes. After been amplified and filtered, the ECG signal waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data result and patient information could be stored in the memory of the device.
The provided document is a 510(k) Premarket Notification for the Mediblu ECG System Models ME3, ME6P, ME12P, ME15P. This type of submission aims to demonstrate substantial equivalence to a predicate device, rather than proving the safety and effectiveness of a device from scratch through clinical studies with specific acceptance criteria and performance metrics.
Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes for test/training sets, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.
Instead, the submission focuses on comparing the subject devices to existing predicate devices to demonstrate that their indications for use, technological characteristics, and performance are substantially equivalent, implying that they are as safe and effective as the legally marketed predicate devices.
The document states:
- "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..." (Page 0)
- "The non-clinical test data demonstrates that the Mediblu ECG system models are substantially equivalent to digital electrocardiograph systems cleared for marketing in the US." (Page 15)
- "There are no differences between the subject devices and the predicate devices." (Page 15)
The acceptance criteria here is "substantial equivalence" to a predicate device, which is demonstrated by presenting a side-by-side comparison of technical specifications and intended use. The "study" proving this largely involves non-clinical testing to ensure the device meets specified technical performance (e.g., input impedance, frequency response, noise level) and safety standards (e.g., IEC60601-1), and then detailing how these align with the predicate device.
Here's a summary of what is provided, framed in relation to your request, and why it doesn't fit the typical "acceptance criteria and study" for a de novo or PMA submission:
Mediblu ECG System Models (ME3, ME6P, ME12P, ME15P) 510(k) Premarket Notification
This submission is to demonstrate substantial equivalence to existing, legally marketed predicate devices, not to prove de novo safety and effectiveness through clinical trials against specific performance acceptance criteria. The "acceptance criteria" for a 510(k) is that the device is as safe and effective as a predicate device.
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (for 510(k)): Substantial equivalence to predicate devices, meaning the intended use and technological characteristics are the same, or if different, the differences do not raise new questions of safety or effectiveness.
- Reported Device Performance: Instead of a single "performance" score against an acceptance criterion, the document provides detailed technical specifications for each Mediblu model (ME3, ME6P, ME12P, ME15P) and directly compares them to their respective predicate devices. The "performance" is implicitly demonstrated by showing that all key technical specifications and features are "Same" as the predicate.
Example Table (Extracted from document for ME3 comparison):
| Characteristic | Mediblu ECG System Model ME3 (Subject Device) | Biocare Digital Electrocardiograph iE300 (Predicate Device K160092) | Comparison |
|---|---|---|---|
| Indications for Use | [Full definition, same as predicate] | [Full definition, same as subject] | Same |
| Dimensions | 281mm x 191mm x 59mm | 281mm x 191mm x 59mm | Same |
| Net Weight | 1.3 kg | 1.3 kg | Same |
| Lead | Standard 12-lead | Standard 12-lead | Same |
| Acquisition Mode | 1 × 12, 1 × 12+1R, 3 × 4, 3 × 4+1R, 3/2 | 1 × 12, 1 × 12+1R, 3 × 4, 3 × 4+1R, 3/2 | Same |
| Filters | AC Filter, Baseline Wander Filter, EMG Filter | AC Filter, Baseline Wander Filter, EMG Filter | Same |
| Input CIR Current |
§ 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).