(259 days)
CritiView is indicated for in-vivo monitoring of changes in NADH redox state and microvascular perfusion in tissue. Changes in the measured parameters, blood flow change, blood volume change, and NADH concentration change provide information on tissue metabolic activity. The CritiView uses a pencil style probe which is in contact with the tissue(s) to be measured / monitored. The device may be used for up to eight (8) hours per twenty-four (24) hour period. Tissues which may be monitored are: brain, liver, kidney, intestine, testis, skin. Note that heart may not be used, as the heart beating motion may not provide a reliable probe contact surface. Environment of use include - hospital - OR, ICU, Emergency Departments, High Dependency Units Institutions
The CritiView device carries out certain in-vivo, spectroscopic measurements and displays them as a trend. The parameters measured are blood flow change, blood volume change, and NADH concentration change. It is a multi-parametric monitoring device intended for the measurement of tissue metabolic state. The CritiView device consists of NADH Fluorometer and Doppler Flowmeter. The CritiView device is a modification of the predicate, Tissue Spectroscope (K992529).
The provided text is a 510(k) summary for the CritiView device, which is a cardiovascular blood flowmeter intended for in-vivo monitoring of changes in NADH redox state and microvascular perfusion in tissue.
It does not provide information on acceptance criteria or the specific study that proves the device meets acceptance criteria.
The document primarily focuses on:
- Device Description: What the CritiView is and what it measures.
- Indications for Use: How the device is intended to be used.
- Patient Population: The types of patients for whom the device is intended.
- Summary of Specifications: Technical details and operational parameters.
- Predicate Device Comparison: Stating that there are no significant differences between CritiView and its predicate device (Tissue Spectroscope, K992529).
- FDA Clearance Letter: Confirmation of substantial equivalence to a legally marketed predicate device.
Since the document explicitly states "There are no significant differences between the CritiView and the predicate – Tissue Spectroscope, K992529", it implies that the basis for clearance is substantial equivalence to the predicate device, rather than a new standalone clinical performance study with predefined acceptance criteria for the CritiView itself.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for the CritiView device is not available in the provided text. The 510(k) summary relies on the substantial equivalence to a predicate device, meaning that the predicate device would have undergone testing and had its performance established.
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).