(478 days)
The Tissue Spectroscope is indicated for in-vivo monitoring of changes in NADH redox state and microvascular perfusion in tissue. Changes in these parameters provide information on tissue metabolic activity.
The Tissue Spectroscope is a device that carries out various in-vivo, spectroscopic measurements. It is a combination device consisting of an NADH Fluorometer and a Laser Doppler Flowmeter. The Tissue Spectroscope is used to transmit radiation at a known wavelength through tissue and to measure the fluorescence of NADH and the intensity of light reflected from the tissue, including the Doppler shift arising from the moving red blood cells. The Tissue Spectroscope measures the following three parameters: 1. Mitochondrial NADH fluorescence at 420 nm to 480 nm. 2. Doppler shifted laser light (325nm) reflected from moving blood cells. 3. Total backscattered light (325nm) reflected from the tissue. This parameter allows for correction of the NADH fluorescence measurement due to changes in tissue blood volume. These three parameters contain information, respectively, pertaining to the redox state of mitochondrial NAD/NADH of the tissue, microvascular blood flow in the tissue and total blood volume of the tissue. Changes in these values reflect changes in the balance between oxygen supply and oxygen demand.
The provided document is a 510(k) summary for the Vital Medical Ltd., Tissue Spectroscope, cleared on November 17, 2000. It details the device's description, indications for use, and a claim of substantial equivalence to predicate devices. However, this document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or any comparative effectiveness studies.
The document is a regulatory approval notice, not a clinical study report. It focuses on the substantial equivalence argument for regulatory clearance rather than providing detailed performance data from specific studies.
Therefore, I cannot populate the requested sections based on the provided text. The document states:
- Name of the Device: Tissue Spectroscope
- Indications for Use: The Tissue Spectroscope is indicated for in-vivo monitoring of changes in NADH redox state and microvascular perfusion in tissue. Changes in these parameters provide information on tissue metabolic activity.
- Predicate Devices: The Tissue Spectroscope is substantially equivalent to a combination of the Laserflow BPM2, the INVOS 3100A Cerebral Oximeter and the LKB-Wallac 1230 Arcus Fluorometer.
- Claim of Equivalence: "The differences between the systems raise no new issues of safety or effectiveness." and "We have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
To answer the prompt, information from a separate clinical study report or a more detailed section of the 510(k) application (which is not included here) would be required.
§ 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).