(98 days)
Used as a supplement to Holter Monitoring to document infrequent/transient symptoms such as lightheadedness, chest discomfort, palpitations, pre-syncope and syncope events.
Heartrak Smart AT/ Heartrak Smart ² is a patient-activated transtelephonic ECG loop memory monitor which records cardiac patients' symptoms. The patient calls the receiving center, hospital or physician's office from the patient's home. Heartrak Smart AT/Heartrak Smart² converts signals into audio tones which are transmitted over telephone lines. Heartrak Smart AT/Heartrak Smart" is a hand held, portable, externally applied device which is intended for transtelephonic use. Heartrak Smart AT/Heartrak Smart² does not deliver any energy, administer any drugs, or control a patient's life. Heartrak Smart AT/Heartrak Smart² is not a diagnostic tool and performs no diagnostic functions.
The provided text is a 510(k) summary for the Heartrak Smart AT/Heartrak Smart2 device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics.
Therefore, the requested information regarding an acceptance criteria table, detailed study design, sample sizes, expert qualifications, and specific performance results like sensitivity, specificity, or MRMC outcomes is not present in the provided document.
Instead, the document highlights:
- Predicate Device: Heartrak XL (K960499)
- Basis for Substantial Equivalence: Identical intended use, materials, packaging, labeling, method of operation, and manufacturing methods as the predicate device. It also states that the safety and effectiveness are substantially equivalent, and the technological characteristics are equivalent to the predicate and other event recorders.
- Intended Use: As a supplement to Holter Monitoring to document infrequent/transient symptoms such as lightheadedness, chest discomfort, palpitations, pre-syncope, and syncope events.
- Device Function: Patient-activated transtelephonic ECG loop memory monitor which converts signals into audio tones for transmission over telephone lines. It explicitly states it is not a diagnostic tool and performs no diagnostic functions.
In summary, this 510(k) relies on demonstrating similarity to an already approved device rather than providing a new clinical study with the detailed performance metrics requested. Consequently, sections like "Acceptance Criteria," "Reported Device Performance," "Sample Size for Test Set," "Number of Experts," "Adjudication Method," "MRMC Study," "Standalone Performance," "Type of Ground Truth," and "Training Set Information" cannot be filled from the given text.
§ 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).