PROBE PTEYE-1 FIBER OPTIC

PROBE PTEYE
PTEYE - PTEYE-1

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.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 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