(239 days)
CARDIPIA800H and CARDIPIA400H are the portable recording device which is to acquire, display, record, and export 12-lead ECG signals and data defined as the electrical heart activity induced on patient skin. ECG are intended to use for adult and pediatic which is defined between 0 and 15 years old by a physician, trained or licensed professionals in a hospital, clinic, medical office, medical use facilities or a prescribed environment under the direction of a physician. CARDIPIA800H and CARDIPIA400H have the resting ECG,12/6-recording and displaying, 12-lead ECG measurement, and optional export ECG data for hospital information system. NOTE: ECG should not be used as the patient monitoring system for long term patient monitor.
The CARDIPIA800H and CARDIPIA400H consist of main body, power cable. Both devices are intended to be used with 3rd party lead electrodes supplied to a patient by a physician or a monitoring center. High quality FDA cleared lead electrodes should be used. TRISMED's CARDIPIA ECG (model: CARDIPIA800H, CARDIPIA400H) feature the resting ECG, 12/6recording and displaying, 12-lead ECG measurement, and optional export ECG data for hospital information system. CARDIPIA ECG is able to record the standard 12-lead resting ECG with 12, 6 or 3 channel format and any lead combinations of the 12 leads in automatic or manual mode. The preview mode allows to verify the content of the report on the display before printing it. This is useful to avoid printing reports with artifacts or unusable signal. CARDIPIA ECG is freely operated by main AC power without additional adjustment, or by the built-in rechargeable battery which can be used for a limited time in place of AC power. CARDIPIA ECG can save internal memory and export all patient data from USB memory stick or import from USB memory stick to on data management mode.
The provided text describes a 510(k) premarket notification for the CARDIPIA ECG (Models: CARDIPIA400H, CARDIPIA800H). This submission aims to demonstrate substantial equivalence to a legally marketed predicate device (MAC2000 ECG Analysis System, K133622) rather than proving the device meets specific performance acceptance criteria for a novel algorithm or AI.
The document states that the CARDIPIA ECG device is an electrocardiograph to acquire, display, record, and export 12-lead ECG signals. It is intended for use by medical professionals for adult and pediatric patients (0-15 years old).
Therefore, the information you've requested regarding acceptance criteria and performance studies in the context of an AI/algorithmic device (e.g., effect size of AI assistance, expert adjudication for ground truth) is not applicable or available in this document. The document specifically states, "CARDIPIA ECG does not require clinical studies to demonstrate substantial equivalence to the predicate devices."
Instead, the submission focuses on demonstrating substantial equivalence to the predicate device through a comparison of:
- Indications for Use
- Technological Characteristics
- Principles of Operation
- Performance Specifications (general performance characteristics, not clinical outcomes)
The performance data mentioned in the document refers to non-clinical performance testing to demonstrate compliance with international and FDA-recognized consensus standards and FDA guidance documents related to safety, essential performance, electromagnetic compatibility, usability engineering, software life-cycle processes, and cybersecurity.
Here's a breakdown of the available information based on your request, highlighting where information is not present:
1. Table of acceptance criteria and reported device performance:
The document does not provide a table of acceptance criteria in the sense of accuracy, sensitivity, or specificity for an algorithmic diagnosis. Instead, it presents a comparison table of technical specifications and performance characteristics between the subject device and the predicate device, implying that meeting or being comparable to these predicate characteristics demonstrates acceptable performance for an ECG device.
| Characteristics | Subject Device – CARDIPIA ECG (CARDIPIA400H, CARDIPIA800H) | Predicate Device - MAC2000 ECG Analysis System |
|---|---|---|
| Indication for Use | CARDIPIA800H and CARDIPIA400H are the portable recording device which is to acquire, display, record, and export 12-lead ECG signals and data defined as the electrical heart activity induced on patient skin. ECG are intended to use for adult and pediatric which is defined between 0 and 15 years old by a physician, trained or licensed professionals in a hospital, clinic, medical office, medical use facilities or a prescribed environment under the direction of a physician. CARDIPIA800H and CARDIPIA400H have the resting ECG,12/6-recording and displaying, 12-lead ECG measurement, and optional export ECG data for hospital information system. NOTE: ECG should not be used as the patient monitoring system for long term patient monitor. | The MACTM2000 ECG Analysis System is a portable device intended to be used by or under the direct supervision of a licensed healthcare practitioner using surface electrodes to acquire, analyze, display, and record information for adult and pediatric populations in a hospital, medical professional's facility, clinics, physician's office or outreach centers. NOTE: Pediatric populations are defined as patients between the ages of 0 and 15 years. The MACTM2000 ECG Analysis System provides the following modes of operation: • Resting ECG mode • Arrhythmia mode • Exercise mode for exercise stress testing (optional) • RR analysis mode for RR interval analysis (optional) |
| The basic system prints 6 or 12 leads of ECG and is upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis. Arrhythmia detection is provided for the convenience of automatic documentation. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional. | ||
| Product Code | DPS | DPS, DQK, DXH |
| Operating Principle | Electrocardiographs | Electrocardiographs (DPS) |
| Target Population | Pediatric patient (0 ~ 15 years) and adult | Pediatric patients (0~15 years) and adult |
| ECG Acquisition | 12-lead ECG with simultaneous 10-lead | 12-lead simultaneous acquisition |
| Lead | 12 Standard Leads : I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 | 12-lead analysis |
| Safety | EN 60601-1 (IEC 60601-1) Medical electrical equipment – Part 1: General Requirements for Safety Class I (Degree of protection against electrical shock) Defibrillation proof (5000VDC) based on type CF applied part Complied IEC60601-1 | EN 60601-1 (IEC 60601-1) Medical electrical equipment – Part 1: General Requirements for Safety IEC60601-1 protection class I Type CF defibrillation-proof applied part |
| EMC | IEC 60601-1-2 General Requirements for Safety Electromagnetic Compatibility CISPR 11, Class A / IEC60601-1-2 | CISPR11, Group 1, Class B |
| Performance | IEC 60601-2-25 Safety of Electrocardiographs | IEC 60601-2-25 Safety of Electrocardiographs |
| Sensitivity | 1.25, 2.5, 5, 10, 20, 40mm/mV, Auto | 2.5, 5, 10, 20, 40 mm/mV with ±5% accuracy |
| Recording Speed | 5, 10, 12.5, 25, 50, 100 mm/s | 5, 12.5, 25, and 50 mm/s |
| QRS Beat Display & Sound | 30 ~ 240 bpm on real time. | Heart Rate meter: 30 to 300 BPM QRS Detection: available |
| Sampling Rate | 1000 samples/sec/channel | 500 or 1000 samples/second/channel |
| Filters | Muscle Filter: 25 / 35 Hz Drift filter(baseline): 0.1/0.15 /0.25/ 0.32 / 0.5 Hz AC filter : 50 / 60 Hz High frequency filter: 75 / 100 / 150 / 200 Hz | Muscle: 20 Hz, 40 Hz, 100 Hz, 150 Hz Automatic Baseline correction: User-selectable Hight cutoff Frequency: configurable at 20 Hz, 40 Hz, 100 Hz, 150 Hz |
| Display Type | Color TFT 7" LCD (Viewing area: 154.08mm x 85.92mm), Dots: 800 x 480 | 7-inch (177.8 mm) color TFT graphics display with support of minimum 32K colors Resolution WVGA – 800 x 480 pixels |
| Patient Data | Patient Name, ID, Code(barcode), Sex, Ethnic, Birthday, Age, Weight, Height, Drugs, Smoker, Systolic, Diastolic, Physician, hospital name | Patient information entry: Patient ID, Secondary Patient ID, Height, Weight, Gender, Race, Pacemaker Patient, Systolic BP, Diastolic BP, Location#, Room, Order Number, Phone Number, Medication, Ordering Physician, Referring Physician, Attending Physician, Technician, Test indication, four user-definable fields. |
| Key Operation | Alphanumeric key by membrane and LCD touch screen | Membrane keyboard with tactile feedback – Soft function keys, alphanumeric keys (Qwerty key set), |
| Weight | CARDIPIA 400H : 2.8 Kg with battery CARDIPIA 800H : 3.5 Kg with battery | approx. 5 kg (11.0 lb) (including battery, without paper) |
| Dimensions | CARDIPIA400H : 313 (L) x 252 (W) x 107 (H) CARDIPIA800H : 332 (L) x 308 (W) x 107 (H) | 390 x 330 x 200 mm Width x Depth x Height |
| Operation Power | 100 - 240VAC ±10 % 50/60 Hz free voltage | 100 to 240 VAC ±10% |
| Input Impedance | Greater than 100 MΩ per 10 Hz | >10MΩ @ 10 Hz |
| Leakage Current | Less than 10μΑ |
§ 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).