PROBE PTEYE
PTEYE - PTEYE-1
Device Description
A hand-held component of an intraoperative parathyroid detection system designed to aid surgeons in recognizing parathyroid tissue during open surgical thyroidectomies and parathyroidectomies using near-infrared (NIR) light and auto-fluorescence. The probe consists of a fibreoptic element that emits non-ionizing radiation in the near IR range (NIR), and another fibreoptic detector element for collection and transmission of the fluorescence emitted by the tissue to a photo detector. It is used with a dedicated control unit (not included). This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: QDF
Device Name: Parathyroid Autofluorescence Detection Device
Device Class: 2
Physical State: The device has a patient contacting fiber optic probe connected to a console with a coherent excitation light source in the near infrared spectrum. The device is used to capture autofluorescence signals of the target tissues. Imaging contrast agents are not required for autofluorescence detection.
Definition: An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.
Submission Type ID: 1
Review Panel: SU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: The device is a patient contacting device that quantifies the ratio of autofluorescence of parathyroid to thyroid tissue using a coherent excitation light source in the near infrared spectrum.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Parathyroid glands.
Regulation Number: 878.4550
Third Party Flag: N
Medical Specialty: SU
Device IdentifiersDevice Id: 00763000497057
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The information provided on this site includes data supplied by The GMDN Agency ("GMDN Content"), which is used under licence from The GMDN Agency. Any data/information suppliers who wish to extract GMDN Content from this site in order to use it as a basis for creating and supporting commercial services such as alternative categorisation, alternative GMDN Term assignment, mapping to other categorisations or ontologies, or for AI training purposes, must first obtain an appropriate licence from The GMDN Agency. No such activity is permitted without a licence. For more information on obtaining a licence, please contact The GMDN Agency (https://www.gmdnagency.org/contact-us/). None of the GMDN content constitutes any endorsement, advice, representation or warranty about any specific medical devices that may be described by such content; and no representation or warranty is made in relation to instructions for use, suitability for any application, treatment or condition, regulatory status, or any properties of a particular medical device.
GMDN ®. © GMDN Agency 2005-.