(136 days)
The clue medical and clue medical BASIC are handheld, battery operated single channel electrocardiographs intended for recording and transmitting ECG data by patients who are concerned about their heart rhythm. The clue medical and clue medical BASIC allow the patient to record their ECG data into the device memory and transmit it for display by healthcare professionals.
Specifically, the clue medical and clue medical BASIC are intended for patients that are concerned about their heart rhythm or have experienced the following symptoms that are suggestive of abnormal heart rhythm:
Skipped beats
Pounding heart (palpitations)
History of arrhythmia
The clue medical and cluc medical BASIC ECG data is intended to be used by a licensed health care practitioner. These measurements are not intended for any specific clinical diagnosis. The clinical significance must be determined by the physician.
The clue medical is an handheld battery operated single-channel ECG recorder featuring four fixed electrodes on the back of the device, an ECG lead connector, an IrDA and a Bluetooth interface and one single button to record and store up to ten ECG recordings with 30 seconds or two minutes duration. The stored ECG tests are processed into a printable Portable Document Format (PDF) that can be transmitted two ways. The PDF can be transmitted via IrDA or Bluetooth to an IrDa or Bluetooth capable local PC or printer. If the receiving device is not IrDa or Bluetooth capable, an optional IrDA USB stick is provided with the clue medical. The PDF file can then be saved, sent, displayed or printed. Alternatively, the PDF can be transmitted via a Bluetooth capable cell phone directly to the Telovital server for storage.
The device requires that a user is mentally and physically capable of reading and understanding the Patient Operating Instructions. The patient must also be physically capable of pressing the record button and holding the device to his/her chest for an adequate reading.
The clue medical BASIC is identical to the clue medical in design. The only difference is that the clue medical BASIC does not provide the added capability of sending the ECG data via cell phone directly to the Telovital server, it is only capable of transmission to a local PC or printer. The purpose of this Special 510(k) is to modify the method of wireless data transmission for both the clue medical and clue medical BASIC to include Bluetooth technology.
This 510(k) submission (K083630) is for a modification to an already cleared device, the Telovital clue medical and clue medical BASIC. The modification specifically concerns the addition of Bluetooth technology for wireless data transmission. As such, the submission focuses on demonstrating that this change does not affect the device's fundamental safety, effectiveness, or intended use compared to the previously cleared version (K082013).
Therefore, this document does not contain specific acceptance criteria for diagnostic performance or a detailed study proving the device meets new acceptance criteria for diagnostic accuracy. Instead, the "study" demonstrating acceptance is the testing performed against established safety and performance standards, asserting that the modification does not negatively impact these.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
As this submission is for a modification to an existing device, there are no specific diagnostic performance acceptance criteria or corresponding reported performance data for parameters like sensitivity, specificity, or AUC related to diagnostic accuracy. The acceptance criteria referenced are compliance with widely recognized medical device safety and performance standards. The reported "performance" for this submission is that the device continues to meet these standards after the modification.
| Acceptance Criteria (Standards) | Reported Device Performance (Compliance) |
|---|---|
| IEC 60601-1: General Requirements for Safety | Compliant |
| IEC 60601-1-1: Safety Requirements for Medical Electrical Systems | Compliant (Previously, reaffirmed) |
| IEC 60601-1-2: Electromagnetic compatibility - Requirements and tests | Compliant |
| IEC 60601-2-25: Particular Requirements for the Safety of Electrocardiographs | Compliant |
| IEC 60601-2-47: Particular requirements for safety, including performance, for ambulatory electrocardiographic systems | Compliant |
| IEC 60601-1, subclause 56.3(c): Electrode leadwires (for K082013) | Compliant |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for diagnostic performance as this submission is for a modification of an already cleared device, not a new diagnostic claim or performance study. The testing referenced relates to engineering and safety standards. Details on sample sizes for these engineering tests are not provided. The data provenance is implied to be from laboratory testing performed by the manufacturer to ensure compliance with the listed standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth as typically understood for diagnostic device evaluation (e.g., expert labels for medical images) is not relevant here. The ground truth for the engineering standards is the specifications and requirements defined within those standards.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study or any study involving human readers comparing AI-assisted vs. non-AI-assisted performance was not conducted or reported in this submission. The device is an ECG recorder, not an AI-driven interpretation system.
6. Standalone (Algorithm Only) Performance Study
No. This device is a hardware ECG recorder. While it captures ECG data, it doesn't perform automated diagnostic interpretation or rely on a standalone algorithm in the sense of an AI diagnostic tool.
7. Type of Ground Truth Used
The "ground truth" for this submission is conformity to established international medical device safety and performance standards (IEC 60601 series). These standards define technical requirements, electromagnetic compatibility, and safety criteria for medical electrical equipment, specifically for electrocardiographs.
8. Sample Size for the Training Set
Not applicable. This device is a hardware ECG recorder and does not describe an AI training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).