(90 days)
The BioMedix, Inc. Flostat Vascular Lab is a device for the use in the diagnosis of the etiology and extent of vascular pathology primarily in the peripheral vasculature and, in a more restricted sense, in the central vasculature(periorbital region ONLY). These tasks are accomplished via three separate modalities, each of which can be use to test either the arterial or venous system. The three modalities are 1) Pneumoplethysmography (blood pressure cuff air inflation), 2) Photoplethysmography (change in infrared light reflectance on skin as a relection of larger branches) and 31 wave doppler ultrasound velocity waveform Simple continuous measurement. NONE of these testing modalities are intended for FETAL USE and the devices and instruction manuals are so labelled.
The air pump Pneumoplethysmograph and infrared Photoplethysmograph are for use in studying the PERIPHERAL VASCULATURE ONLY.
The 5 MHz. continuous wave doppler ultrasound velocity meter and the 8 MHz. continuous wave doppler ultrasound velocity meter are for use in studying the PERIPHERAL VASCULATURE ONLY.
There is a separate control setting labelled clearly on the FLOSTAT vascular LaB - 'Ophthalmic-8 MHz.' doppler which is intended for an 8 MHz. continuous wave doppler ultrasound velocity meter exactly the same as the 8 MHz. continuous wave doppler velocity meter except that the 'Ophthalmic-8 MHz.' doppler has substantially lower acoustic output which conforms to the safety standards For periorbital studies specified by the Food and Drug Administration (FDA) . Through medical studies performed by the scientists at the it has been determined that ultrasound acoustic levels EDA, rated by various figures of merit (eg. ISPTA; etc.) are safe for different areas of the body :
For this reason, DO NOT EVER PERFORM PERIORBITAL STUDIES WITH THE. DOPPLER IN ANY MODE OTHER THAN THE 'Ophthalmic-8 MIZ.' MODE . Labels will also be placed on the doppler transducer that they are NOT FOR FETAL USE and specifying the correct frequency(5 MHz or 8 MHz) -
The doppler section is intended to generate velocity waveforms and values for study and audio output for physician analysis of the arterial and venous system.
The Ultrasonic Doppler device at 5 MHz. and 8 MHz . applies ultrasound energy through the extremities of the subject to assess blood velocity, blood velocity waveform morphology, spectrum analysis, pressure, and patency of PERIPHERAL VESSELS.
The Ultrasonic Ophthalmic- 8 MHz. device applies ultrasound energy to the periorbital region to assess blood velocity, blood velocity waveform morphology, and spectrum analysis in this area.
The Pneumoplethysmograph is used to gauge the arterial system the recording studies recording studies and is used to gauge the venous system through maximum venous outflow studies.
The Photoplethysmograph is used to gauge the arterial system through pulse waveform analysis and is used to gauge the venous system through venous reflux time tests. Full clinical information is provided in the Operators Instruction Manual(enclosed herein).
The BioMedix, Inc. Flostat Vascular Lab is a device for the use in the diagnosis of the etiology and extent of vascular pathology primarily in the peripheral vasculature and, in a more restricted sense, in the central vasculature(periorbital region ONLY). These tasks are accomplished via three separate modalities, each of which can be use to test either the arterial or venous system. The three modalities are 1) Pneumoplethysmography (blood pressure cuff air inflation), 2) Photoplethysmography (change in infrared light reflectance on skin as a relection of larger branches) and 31 wave doppler ultrasound velocity waveform Simple continuous measurement.
The provided document is an FDA 510(k) clearance letter for the FLOSTAT VASCULAR LAB (Doppler Ultrasound/Plethysmograph) from 1997. This type of document declares substantial equivalence to a predicate device, allowing the manufacturer to market the device. It does not typically contain detailed information about the acceptance criteria or a specific study proving the device meets said criteria in the format requested.
The letter focuses on the regulatory clearance process, specifying the device's classification, applicable regulations, and conditions for continued marketing (e.g., submission of a post-clearance special report with acoustic output measurements). It also lists the transducers included in the clearance.
Therefore, the requested information, such as a table of acceptance criteria, device performance, sample sizes, expert qualifications, and details of specific studies (MRMC, standalone), cannot be extracted from this document. The document states that the determination of substantial equivalence assumes compliance with good manufacturing practices and refers to general controls provisions of the Act for regulatory requirements.
The "Indications For Use" section (page 3 and 4) describes how the device is intended to be used for diagnosis, outlining the modalities (Pneumoplethysmography, Photoplethysmography, continuous wave doppler ultrasound) and the body regions they are applied to (peripheral vasculature, periorbital region). It also mentions safety standards for periorbital studies regarding acoustic output. However, this is descriptive of intended use and safety considerations, not a report of specific validation study results against acceptance criteria.
§ 892.1540 Nonfetal ultrasonic monitor.
(a)
Identification. A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.