CONSOLE PTEYE
PTEYE - PTEYE-RF
Device Description
An electrically-powered 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. It consists of a console with display and controls. The NIR light is emitted, and the florescence measured, using a single-use invasive probe (not included).
Environmental Conditions
- 1060.00
- 500.00
- 85.00
- 15.00
- 60.00
- -29.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
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: 00763000497163
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