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510(k) Data Aggregation
(24 days)
COR12 ECG
The COR12 ECG is intended for measuring the surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. The COR12 ECG can be used for applications in patients age 4 years and older and a weight of 20 kg or higher. The COR12 ECG is intended to be used for routine ECG collection, recording both under resting and stress conditions. The measurement is performed by trained healthcare professionals under the direction of a physician in healthcare facilities (e.g. the doctor's office or hospital).
The COR12 ECG is intended for the recording of 12-lead ECG data of a patient by trained staff, e.g., nurse, doctor's assistant or the doctor. This can be performed as a resting or a stress ECG. It transmits the ECG data in a specified format by Bluetooth transmission to a customer-defined host software running with its own display, which is not part of the COR12. There is no display of ECG waveforms on the COR12.
Here's a breakdown of the acceptance criteria and study information for the COR12 ECG device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The device is claiming substantial equivalence to its predicate (Vyntus ECG – K150810) by stating that they are identical in all aspects. Therefore, the "acceptance criteria" and "reported device performance" are assumed to be the same as the predicate device, as per the submission's claim of identicality.
| Feature / Acceptance Criteria | Reported Device Performance (COR12 ECG & Predicate) | Comment |
|---|---|---|
| Indications for Use | ||
| Measures Surface ECG | Yes | Identical |
| Records & Displays/Prints ECG | Yes | Identical |
| Patient Age | 4 years and older | Identical |
| Patient Weight | 20 kg or higher | Identical |
| Use Conditions | Routine ECG, resting and stress conditions | Identical |
| User | Trained healthcare professionals | Identical |
| Environment of Use | Healthcare facilities (doctor's office/hospital) | Identical |
| Technical Specifications | ||
| Records ECG only | Yes | Identical |
| Data output | Recorded and displayed on screen or printed | Identical |
| Records under | Resting and stress conditions | Identical |
| Dimensions (W x H x D) | 8.0 x 9.3 x 2.1 cm (3.3 x 3.7 x 0.8 in) | Identical |
| Weight (without battery) | 200 g (0.4 lbs) | Identical |
| 12-channel Surface ECG | Yes | Identical |
| Electrodes | Standard ECG electrodes | Identical |
| Electrode Connection | 4 mm snap, gilded | Identical |
| ECG signal Technology | Impedance measurement | Identical |
| Accuracy of ECG signal | 1.94 μV/bit resolution (at 500 Hz sampling) | Identical |
| Filter | Bandpass 0.05 Hz – 150 Hz, No line filter | Identical |
| Pacemaker detection | 4000 Hz | Identical |
| Operating Temperature | 10 – 37 °C | Identical |
| Ambient Pressure | 700 to 1060 hPa | Identical |
| Humidity | 5 – 95% RH (not condensing) | Identical |
| Power Supply | 1x AA Alkaline or rechargeable NiMH battery | Identical |
| Runtime (with AA battery) | > 5h | Identical |
| Runtime (with NiMH battery) | > 8h (2850 mAh) | Identical |
| Current Consumption | 230 mA (Operation) / 185 mA (Idle) | Identical |
| Protection Classification | Device with internal power supply, Type CF | Identical |
| Recovery Time (defibrillation) |
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(20 days)
COR12+
The Cor12+ Holter Recorder is intended to acquire, record and store ECG data of patients that have been connected to the Cor12+ recorder and are undergoing Holter monitoring. The Cor12+ acquires, digitizes and stores data to be analyzed on a computer with special software.
The Cor12+ is indicated for use:
in a clinical setting, by qualified medical professionals only, for recording ECG data of symptomatic patients requiring ambulatory (Holter) monitoring of up to 24 hours.
The Cor12+ performs no cardiac analysis by itself; it solely records the ECG signals. The patient population for this device is from 4 years on and a minimum weight of 10 kg.
The digital Holter ECG recorder Cor12+ is a portable battery operated ECG amplifier with build in data storage on memory card (Mini SD size):
- Single dual color (green/yellow) LED .
- Button control (one Button) to activate communication interface, event . recording
- Two standard size AA batteries .
- Speaker for voice output for alarm messages .
- PC program to set-up recorder via blue-tooth communication interface 0
Here's a breakdown of the acceptance criteria and study information for the Cor12+ Holter Recorder based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly define specific numerical acceptance criteria for performance metrics. Instead, the device's performance is established through substantial equivalence to predicate devices, particularly the H12+ Holter Recorder. The "acceptance criteria" here are implied by meeting or exceeding the performance characteristics of the predicate device, or by demonstrating that differences do not raise new questions of safety or effectiveness.
Therefore, the table below highlights key performance characteristics compared to the primary predicate device, the H12+. Where performance is improved, it is noted.
| Performance Characteristic | Predicate Device (H12+) Performance | Cor12+ Holter Recorder Performance | Acceptance/Equivalence |
|---|---|---|---|
| Indications for Use | Ambulatory monitoring up to 48 hours. No cardiac analysis itself. | Ambulatory monitoring up to 24 hours. No cardiac analysis itself. Patient population: 4 years on, min 10kg. | Substantially Equivalent (with reduced monitoring duration and explicit patient population) |
| Patient Population | 4 years on and older | 4 years on and older. Minimum weight of 10kg. | Substantially Equivalent |
| Input Dynamic Range | +/- 300mV @ DC | +/- 1300mV @ DC | Improved (Allows recording with increased baseline drift) |
| Frequency Response/Bandwidth | 0.05 - 150 Hz (According to EC11 and IEC 60601-1) | Identical | Substantially Equivalent |
| A/D Conversion | 20 bit | 24 bit | Improved |
| Sampling Rate for Data Storage | 1000 Hz or 180 Hz | 1000 Hz or 250 Hz | Improved (Lower rate slightly higher, beneficial for accuracy) |
| Leads | 12 Standard - US color coding | Identical | Substantially Equivalent |
| Interface (Data Storage) | Compact Flash Memory Card | SD Memory Card | Different technology, but serves same function. Considered equivalent. |
| Interface (Programming) | Compact Flash Memory Card (or keypad/display) | Bluetooth (for programming only) | Different technology, but serves same function. Considered equivalent. |
| Energy Type | 1 x 1.5 V (AA size) | 2 x 1.5 V (AA size, Lithium) | Different, but considered equivalent regarding function. |
| Mode of Operation | Manual, Manual delayed, Automatic recording | Automatic recording | Different (fewer modes), but still considered equivalent for intended use. |
| Electrode Impedance | Not explicitly stated as a feature of H12+. | Impedance measurement for electrode contact quality (similar to MasterScope ECG). | Equivalent to MasterScope ECG. This is an added feature for quality. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a clinical study with a "test set" in the traditional sense for evaluating device performance against pre-defined clinical endpoints or ground truth.
Instead, the submission relies on:
- Bench testing: "Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards."
- Compliance with standards: "The EMC testing was performed according EN 60601-1-2 and EN 60601-2-47. Electrical Safety testing was performed according IEC 60601-1 and IEC 60601-2-47."
- Substantial equivalence arguments: Comparing technical specifications to predicate devices.
Therefore, there is no specific sample size for a clinical "test set" or information about data provenance (e.g., country of origin, retrospective/prospective) for a study directly proving the device meets performance claims through patient data. The evaluation methodology is primarily non-clinical.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since there was no clinical "test set" with ground truth established on patient data, this information is not applicable and not provided in the document. The evaluation focuses on engineering, safety, and performance characteristic comparison.
4. Adjudication Method for the Test Set
As no clinical "test set" requiring ground truth and expert adjudication was conducted, this information is not applicable and not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically assesses the impact of an AI algorithm on human reader performance, which doesn't apply here as the Cor12+ is a data acquisition device, not an analytical AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The Cor12+ is described as a "Holter Recorder" that "performs no cardiac analysis by itself; it solely records the ECG signals." Therefore, there is no standalone algorithm performance to evaluate. Its function is data acquisition, digitization, and storage, not diagnostic analysis.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on demonstrating compliance with recognized electrical safety and EMC standards and showing technical equivalence or improvement over predicate devices in terms of physical and performance specifications for ECG signal recording, rather than clinical outcomes or expert consensus on diagnostic accuracy.
8. The Sample Size for the Training Set
Since the device does not employ machine learning or AI algorithms requiring a training set for analysis, this information is not applicable and not provided.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML algorithm, this information is not applicable and not provided.
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