(202 days)
The Signalife Fidelity 200 Cardiac Event Recorder is a battery operated, user-activated recorder and transmitter intended to record an ECG and transmit their ECG data to medical professionals via a communication device to a cardiac monitoring service. This allows users to record and transmit their ECG data to medical professionals who are concerned about their heart rhythm and have experienced the following symptoms that are suggestive of abnormal cardiac rhythms: Pounding heart (Palpitations), Heart racing or irregular pulse, Lightheadedness or Faintness, History of Arrhythmia.
The device acquires an ECG signal and produces a single lead ECG. Upon user activation, an ECG signal is acquired and digitized producing a 45-second ECG recording utilizing the company's signal processing technology. The Signalife Fidelity 200 Cardiac Event Recorder converts the signal stream into a specific data format where it is stored on a memory chip for transtelephonic transmission to and analysis by another device such as the PaceArt System K024278 manufactured by Medtronic, Inc. Recorded data is not real time but stored for further analysis. The Signalife Fidelity 200 Cardiac Event Recorder is not intended to evaluate the signal or alarm. The fundamental technology of the Signalife Fidelity 200 Cardiac Event Recorder is the same as that of the predicate devices. The Signalife Fidelity 200 Cardiac Event Recorder employs the company's signal processing technology to minimize noise in the ECG signal created by the ambulatory nature of the signal source.
The provided document K071228 is a 510(k) summary for the Signalife Fidelity 200 Cardiac Event Recorder. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain information about specific acceptance criteria or a study proving the device meets particular performance metrics beyond general claims of substantial equivalence.
The document primarily focuses on:
- Device Description: A battery-operated, single-lead ECG event recorder that acquires and digitizes a 45-second ECG event for transtelephonic transmission.
- Intended Use: For individuals desiring access to a cardiac monitoring service, capable of recording and transmitting ECG data to medical professionals for analysis and diagnosis.
- Predicate Devices: HeartCard® Telephone Electrocardiograph Transmitter and Receiver (K010945), Card Guard CG-2206 1-Lead ECG Event Recorder (K963725), and CG-2211 Self Check ECG Transmitter (K012223).
- Basis for Substantial Equivalence: Claims equivalence in intended use, target population, technical characteristics, performance, and compliance to consensus standards for recording and transtelephonic transmission of ECG data.
Since the provided text does not include a performance study with acceptance criteria, the following points will indicate that the information is "Not provided in the document."
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document | Not provided in the document |
2. Sample size used for the test set and the data provenance
- Sample size: Not provided in the document.
- Data provenance: Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not provided in the document.
4. Adjudication method for the test set
- Not provided in the document.
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
- No MRMC study was described. The device is a "Cardiac Event Recorder" which records and transmits ECG data for subsequent analysis by a medical professional. It does not incorporate AI assistance for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The document states, "The ECG recording is then transferred to another device, such as the PaceArt® System K024278 manufactured by Medtronic, Inc. for ECG analysis." and "The Signalife Fidelity 200 Cardiac Event Recorder is not intended to evaluate the signal or alarm." This indicates that the device itself is a data acquisition and transmission tool, and any "standalone" analysis would be performed by a separate, downstream system (like PaceArt®) which is not part of this 510(k) submission. Therefore, a standalone performance study for signal evaluation by the Fidelity 200 was not done, as it's not its intended function.
7. The type of ground truth used
- Not provided in the document.
8. The sample size for the training set
- Not provided in the document.
9. How the ground truth for the training set was established
- Not provided in the document.
§ 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).