(63 days)
The CARDIOTOUCH-3000 is intended to be used under the direct supervision of a licensed healthcare practitioner. The CARDIOTOUCH-3000 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes. The device is intended to acquire, analyze, display, and record electrocardiographic information from adult population. The device is not intended for home use. The device is not designated for intracardial use.
As an electrocardiograph with 12-channel, CARDIOTOUCH-3000 does not only provide parameters and diagnose a patient automatically for patient's electrocardiogram, but also it improves chart management by printing information on an operator as well as on the patient. Furthermore, for the convenience of operators, it is designed so that an operator needs to press a button once to let the machine measure and record patient's electrocardiogram, apply a filter, extract parameters, diagnose a patient automatically then print out a result on an A-4- size report. In addition, the built-in battery helps an operator carry and use CARDIOTOUCH-3000 easily and conveniently for a hospital on wheel and an emergency.
Acceptance Criteria and Device Performance for CARDIOTOUCH-3000
This submission for the CARDIOTOUCH-3000 is a "SPECIAL type" 510(k), claiming substantial equivalence to the predicate device, Bionet's EKG-2000 Cardio Care (K011328). The submission focuses on comparing technological characteristics rather than presenting new clinical study data with specific acceptance criteria. Therefore, the "acceptance criteria" are implicitly met by demonstrating identical or similar performance to the legally marketed predicate device.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic output. Instead, it relies on demonstrating technological equivalence to the predicate device. The "acceptance criteria" are therefore qualitative statements of similarity or identicality to the predicate device across various features and performance aspects.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (CARDIOTOUCH-3000) |
|---|---|
| Indications for Use: Identical to predicate device: detecting and measuring parameters to help doctors in determining patient's vital condition, including accurate heart rate, electrocardiograph wave, and printing current ECG waves and related numeric values. | Identical: "Both CardioCare-2000 and CardioTouch-3000 are detecting and measuring as below parameters to provide and help doctors for making figure out the patient's vital condition. • Accurate Heart Rate • Electrocardiograph wave • Printing the current ECG wave and related numeric values" |
| Target Population: Identical to predicate device: used by cardiologists and sports experts for monitoring heart patients. | Identical: "Predicate device and this device are used by cardiologist and sports expert etc. for watching heart patient condition." |
| Performance (Technical Specifications): Identical to predicate device for key ECG recording parameters. | Identical: |
| • ECG leads: Standard 12 leads | |
| • Sensitivity: 5,10,20, Auto | |
| • Input circuit: floating input, isolated and defibrillation protected. | |
| • Input impedance: ≥ 10MΩ | |
| • Input circuit current: ≤ ± 5mV | |
| • Calibration Voltage: 1mV±2% | |
| • Time Constant: 100dB or better | |
| • Frequency response: 0.05~150Hz within -3dB | |
| Design: Similar to predicate device, with variations in display type (e.g., LCD). | Similar: "CardioCare-2000 have 2line 16character LCD and CardioTouch-3000 have 320 X 200 dot with back lit LCD." |
| Materials: Identical to predicate device (ABS materials). | Identical: "CardioCare-2000 and CardioTouch-3000 are made of ABS materials." |
| Biocompatibility: Satisfied through use of disposable electrodes, identical to predicate device. | Identical: "Both of them are satisfied Biocompatibility through using disposable electrode." |
| Mechanical Safety: Identical to predicate device; coarse surfaces and sharp corners removed/covered to prevent patient damage. | Identical: "A coarse surface and a sharp corners of a device which has cause of patient damage of device are removed and covered." |
| Energy used and/or delivered: Identical to predicate device (rechargeable battery, 100V~240Vac 50/60 Hz). | Identical: "Both of them use the rechargeable battery (100V~240Vac 50/60 Hz and Built-in)." |
| Compatibility with environment and other devices: Identical to predicate device; suitable for EMI and EMC testing. | "CardioCare-2000 and CardioTouch-3000 are suitable for EMI and EMC test." |
| Where used: Identical to predicate device (Private Check, ER, Hospitals). | Identical: "Private Check, ER, Hospitals." |
| Standards met: Identical to predicate device. | Identical |
| Electrical safety: Identical to predicate device. | Identical |
| Thermal safety: Identical to predicate device. | Identical |
| Radiation safety: Identical to predicate device. | Identical |
| Automatic Diagnosis: Provides 25 diagnoses, an enhancement compared to the predicate's description but still within the scope of ECG analysis. (This is a feature rather than a direct comparison of diagnostic accuracy). | Available: "Twenty-five diagnoses are available through auto diagnosis" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific test set, sample size, or data provenance for evaluating the CARDIOTOUCH-3000's performance against clinical acceptance criteria. The submission relies on demonstrating substantial equivalence to a predicate device based on technological characteristics and shared intended use. This type of 510(k) (Special 510(k)) often focuses on design control changes and verification/validation activities to ensure the new device meets its own specifications, which are aligned with the predicate. There is no mention of a clinical performance study using patient data to prove diagnostic accuracy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As no specific test set or clinical performance study for diagnostic accuracy is described, there is no information regarding experts, ground truth establishment, or their qualifications.
4. Adjudication Method for the Test Set
Since no specific test set or clinical performance study is described, there is no information regarding an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done or at least not described in the provided summary. The submission focuses purely on demonstrating technological equivalence to a predicate device, not on comparing human reader performance with or without AI assistance. The device is a standalone ECG analysis system, not an AI-assisted interpretation tool for human readers in the context of this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself includes "automatic diagnosis" as a feature ("Twenty-five diagnoses are available through auto diagnosis"). However, the document does not describe a standalone performance study for this automatic diagnosis algorithm with explicit metrics (e.g., sensitivity, specificity, accuracy against a reference standard). The performance claims are limited to the technical specifications of ECG signal acquisition and analysis, stating they are "Identical" to the predicate.
7. The Type of Ground Truth Used
As no specific clinical performance study for diagnostic accuracy is described, there is no mention of the type of ground truth used. The "ground truth" for the submission is effectively the established performance and safety profile of the predicate device.
8. The Sample Size for the Training Set
The document does not mention a training set or its sample size. ECG analysis algorithms can be developed using large datasets, but this information is not part of this 510(k) summary, which focuses on hardware and basic functionality equivalence.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, there is no information on how its ground truth was established.
N/A