Search Results
Found 1 results
510(k) Data Aggregation
K Number
DEN170056Device Name
Parathyroid Detection (Model PTeye) System
Manufacturer
Date Cleared
2018-11-02
(403 days)
Regulation Number
878.4550Why did this record match?
Applicant Name (Manufacturer) :
AiBiomed, Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AiBiomed Parathyroid Detection System (PTeye) is an adjunctive tool intended to aid in the identification of parathyroid tissue by confirming parathyroid tissue already visually located by the surgeon.
Device Description
The Parathyroid Detection (PTeye) System aids surgeons in differentiating parathyroid tissue during common surgical procedures. The handheld probe assembly includes one glass fiber-optic element that emits non-ionizing radiation at 785 nm in the near IR range (NIR) and one fiber optic detector element that collects and transmits the fluorescence emitted by the tissue to a photo detector. The Parathyroid Detection (PTeye) System consists of the following components: 1. A console that includes: An LED display that indicates if the laser is on. A display for visual feedback. A speaker for auditory feedback. 2. A handheld fiber-optic probe assembly that interfaces into the console unit using two unique connectors. One connector plugs into the laser output and the other plugs into the photo detector input (fluorescent signal). 3. A foot pedal attached by a cable to the rear of the unit, used to control power to the laser and initiate data collection. 4. An external power supply and power cord that plugs into the power supply. Tissue detection is based on the ratio of the fluorescent response of parathyroid to thyroid tissue; with the assumption that the fluorescence of thyroid tissue is much lower than parathyroid. During surgery, five thyroid data points are collected by touching thyroid tissue with the probe assembly. The system calculates a baseline median for the thyroid tissue based on those points. The baseline value establishes a reference point for distinguishing parathyroid tissue, which produces a higher level of fluorescence. Once the baseline thyroid value has been calculated, a new operational screen will display to support continuous parathyroid search mode. To operate in this mode, the foot switch must be pressed in order to activate the laser. When laser emission is taking place, the LASER ON LED at the front of the system will illuminate. Responses indicating parathyroid tissue are communicated to the user through a bar graph, a detection percentage, a detection ratio, and audio feedback.
Ask a Question
Ask a specific question about this device
Page 1 of 1