(241 days)
The CG-7100 Personal Electrocardiogram Telephone Transmitter is a patient activated cardiac event monitor for evaluation of transient symptoms. The CG-7100 allows a patient to record non-standard 12 leads electrocardiogram (ECG) in device memory and transmit the stored data to transtelephonic receiver located in physician office, hospital or cardiac monitoring center. This non-standard 12 leads electrocardiogram(ECG), which is measured with CG-7100, should not be used for diagnostics in comparison to the standard 12 lead ECG obtained at standard electrode placement.
The CG-7100 is suggested to record and transmit ECG's to physicians for use in monitoring gross cardiac morphology changes in ambulatory patients for whom physicians, in their judgment, believe cardiac monitoring is appropriate.
Card Guard Model CG-7100 Personal Electrocardiogram Transmitter.
Unfortunately, I cannot fulfill your request to describe the acceptance criteria and study proving the device meets them based on the provided document. Here's why:
The document is an FDA 510(k) clearance letter for the Card Guard Model CG-7100 Personal Electrocardiogram Transmitter. This letter approves the device for marketing based on a determination of substantial equivalence to a predicate device.
Key Point: An FDA 510(k) clearance letter typically does not contain the detailed acceptance criteria or the full study report that led to the substantial equivalence determination. Instead, it references the 510(k) submission (K964836 in this case) which would contain that information.
The document indicates that the device transmits "non-standard 12 leads electrocardiogram (ECG)" and explicitly states: "This non-standard 12 leads electrocardiogram(ECG), which is measured with CG-7100, should not be used for diagnostics in comparison to the standard 12 lead ECG obtained at standard electrode placement." This statement is a crucial part of its intended use and suggests its primary role is for monitoring changes rather than formal diagnostic interpretation based on standard ECG criteria.
Therefore, I cannot extract the specific information you requested without access to the actual 510(k) submission (K964836) itself.
What this document does provide is:
- Device Name: Card Guard Model CG-7100 Personal Electrocardiogram Transmitter.
- Regulatory Class: II
- Product Code: 74 DXH
- Indications For Use: A patient-activated cardiac event monitor for evaluation of transient symptoms. It allows recording and transmission of non-standard 12-lead ECGs to physicians for monitoring gross cardiac morphology changes in ambulatory patients. Crucially, it emphasizes that this non-standard ECG should not be used for diagnostics in comparison to a standard 12-lead ECG.
- Date of Clearance: July 28, 1997
To answer your specific questions, you would need to access the original 510(k) submission, K964836, which would contain the detailed technical specifications, validation studies, and performance data.
§ 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).