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cardiette microtei is a 12 lead ECG acquirer fitted with a display and keyboard. The electrical heart activity is detected by means of two or more electrocardiograph electrodes and the device can acquire and transmit an ECG trace in analogue (via sound coupling) or digital formal (USB port or via the wireless Bluetooth channel) to a remote PC.

The equipments are intended for use in routine ecg recording in physician practice and/or hospital. Intended use for non interpretive applications covers the full range of patient population with no limitations with respect to age, sex and race of the patient.

The equipment is intended to be used by trained medical personnel or physicians.

cardiette microtel does not include ecg interpretation tools and/or analysis programs. The device is intended to transmit ECG waveforms to a PC. Analysis program on a PC is a separate product not marketed with the Cardiette Microtel.

The hardware and the software of the equipment, except for the paper recorder routines and interpretation program, are the same of the predicated device.

Indication for use of cardiette microtel has not been changed, except for the ecg interpretation program not present on this device, with respect to the predicate device CARDIOLINE AR600, AR1200, AR2100 (ref. K051534 CARDIOLINE AR600, AR1200, AR2100).

cardiette microtel is an electrocardiograph providing the following characteristics:

• · standard and/or rechargeable internal AA batteries
• · simultaneous acquisition and storage of the 12 standard leads acquired from a 10 wire cable, or 7 leads (6 peripheral + 1 precordial) acquired from a 5 wire cable.
• · storege of 10 second ECG of acquired ECG signals (in 12 and 7 lead formats)
• · storage of up to 40 ecg recordings (optional)
• · digital filters for AC interference suppression and base-line drift
• · transmition of the ECG in an analogue format via sound coupling or in digital format (SCP format) via the USB port and also via the wireless Bluetooth channel
• · graphic LCD display for user interface and ECG visualisation (the ecg trace may be used only to evaluate the quality of the acquired ecq)
• · functional keyboard for patient identification input data (disabled in the basic product), ECG recording and ECG sending operations

The information provided is for a 510(k) premarket notification for the "cardiette microtel" electrocardiograph. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with specific acceptance criteria and performance metrics typically associated with novel devices.

Therefore, many of the requested sections below cannot be fully populated as this is not a study proving the device meets new acceptance criteria, but rather a demonstration that it is substantially equivalent to an existing device.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not present specific acceptance criteria in the typical format of a clinical study, as the submission focuses on substantial equivalence to a predicate device. Instead, performance characteristics of the "cardiette microtel" are compared directly to those of the predicate devices (CARDIOLINE AR 600, AR 1200, AR 2100) in Table 5.7.1. The "acceptance criteria" here is implicitly that the microtel's performance should be substantially similar to the predicate, with any differences not raising new questions of safety or effectiveness.

USB (optional)
Blue Tooth (only for microtel bt version). |
| DISPLAY | |
| Size: None/120 x 32 pixels (AR 600) | Backlit single-colour LCD 128x64 pixels |
| Nº of displayed channels: none (AR 600) | 1 |
| Traces speed: N/a (AR 600) | 12,5 mm/s |
| Sensitivity: N/a (AR 600) | 5 mm/mV |
| Keyboard | |
| Type i keys: Membrane 21 functional keys (AR 600) | Silicon rubber 20 functional keys |
| SW options | |
| ECG Interpretation: Interpretation Program HES EKG (AR 600) | No |

The main "performance" aspects derived from the comparison are that the microtel (the new device) lacks a thermal printer and ECG interpretation software, and has different interfaces (sound couple, USB, Bluetooth) and a display compared to the AR 600 predicate. These differences are described as not raising new questions of safety or effectiveness, as the intended use (acquisition and transmission of ECG signals) remains equivalent for non-interpretive applications.

2. Sample size used for the test set and the data provenance

The document describes no clinical test set in the traditional sense for evaluation of diagnostic accuracy or clinical performance. This is a 510(k) submission based on substantial equivalence to an existing device (CARDIOLINE AR 600, AR 1200, AR 2100). The "tests" mentioned are non-clinical: full safety tests and Electromagnetic Compatibility (EMC) tests according to various EN and IEC standards (EN60601-1, IEC 601-2-25, IEC 601-2-51, EN60601-1-2, ETSI EN 301 489-17, ETSI EN 300 328). The sample size for these engineering tests is not specified, but it would typically involve a small number of manufactured units of the device.

There is no mention of patient data (retrospective or prospective) from any country of origin in the context of performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical test set requiring expert ground truth establishment is described in this 510(k) submission.

4. Adjudication method for the test set

Not applicable. No clinical test set is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an electrocardiograph that acquires and transmits ECG signals, and explicitly does not include ECG interpretation tools or analysis programs. Therefore, no AI assistance or MRMC study involving human readers is relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device does not include an algorithm for interpretation or analysis. Its function is to acquire and transmit raw ECG signals.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No clinical performance testing against a ground truth is described. The relevant "ground truth" for this submission are the engineering standards (EN60601-1, IEC 601-2-25, IEC 601-2-51, EN60601-1-2, ETSI EN 301 489-17, ETSI EN 300 328) for safety and EMC, to which the device demonstrated compliance.

8. The sample size for the training set

Not applicable. The device does not employ any machine learning or AI algorithms that would require a "training set."

9. How the ground truth for the training set was established

Not applicable. No training set is described.

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