(151 days)
The CALYSTO Series IV is intended for complete physiologic/hemodynamic monitoring, data acquisition and analytical assessment within any invasive clinical environment such as cardiac catheterization, invasive radiology and electrophysiology laboratories. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit patient data via intranet or internet, for storage, analysis and viewing at distributed locations, or may function as a stand-alone device. Use of CALYSTO Series IV is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.
The CALYSTO Central Station and Patient Care Monitors are intended for complete physiologic monitoring, clinical data acquisition and analytical assessment within any healthcare environment. Its users, responsible to interpret the data made available, will be professional health care providers. The system provides the ability to enable alarms (both visual and audible), which alert the operator to potential patient distress and facilitate timely responses. Use of CALYSTO Central Station and Patient Care Monitors is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.
The CALYSTO Series IV ECG Management system is intended for receiving and storing resting, stress and holter ECG data from source devices. ECG data is stored, unaltered, in its original format, and made available for review and procedural report generation purposes. CALYSTO Series IV does not provide interpretive functions, but stores interpretive functions generated by the source device in an integrated and expandable database. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit ECG data via intranet or internet, for storage, and viewing at distributed locations, or may function as a stand-alone device.
The CALYSTO Series IV is intended for complete physiologic/hemodynamic monitoring, data acquisition and analytical assessment within any invasive clinical environment such as cardiac catheterization, invasive radiology and electrophysiology laboratories. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit patient data via intranet or internet, for storage, analysis and viewing at distributed locations, or may function as a stand-alone device. Use of CALYSTO Series IV is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.
The CALYSTO Central Station and Patient Care Monitors are intended for complete physiologic monitoring, clinical data acquisition and analytical assessment within any healthcare environment. Its users, responsible to interpret the data made available, will be professional health care providers. The system provides the ability to enable alarms (both visual and audible), which alert the operator to potential patient distress and facilitate timely responses. Use of CALYSTO Central Station and Patient Care Monitors is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.
The CALYSTO Series IV ECG Management system is intended for receiving and storing resting, stress and holter ECG data from source devices. ECG data is stored, unaltered, in its original format, and made available for review and procedural report generation purposes. CALYSTO Series IV does not provide interpretive functions, but stores interpretive functions generated by the source device in an integrated and expandable database. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit ECG data via intranet or internet, for storage, and viewing at distributed locations, or may function as a stand-alone device.
The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) clearance letter from the FDA for the Witt Biomedical Corporation's Calysto Series IV, Patient Care Monitors and Central Station, and ECG Management System. It primarily focuses on:
- Substantial Equivalence Determination: The FDA has determined the device is substantially equivalent to predicate devices.
- Regulatory Classification: The device is classified as Class II, under Regulation Number 21 CFR 870.2300 (Cardiac Monitor).
- General Controls and Additional Regulations: Information about applicable FDA regulations.
- Indications for Use: Detailed descriptions of how the device is intended to be used.
To answer your request, information regarding a specific study, acceptance criteria (e.g., sensitivity, specificity, accuracy targets), and the methodology used to demonstrate performance would need to be present. This type of information is typically found in the 510(k) submission itself (which includes performance data and clinical studies if applicable), but not usually in the FDA's clearance letter.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).