(81 days)
Not Found
Not Found
No
The device description focuses on mechanical and electrical components, with a microprocessor for basic control and monitoring. There is no mention of AI, ML, or image processing, and the functionality described is a simple automated shutter based on foot pedal activation.
No
The device is a safety mechanism (eye protection filter) for laser systems, not a therapeutic device that treats or diagnoses a disease.
No
This device is a mechanical shutter designed to protect the user's eyes from laser beams during surgical procedures. Its function is to provide protection, not to diagnose medical conditions or analyze data for diagnostic purposes.
No
The device description explicitly states it is a "mechanical shutter" and is connected to the laser by an "electrical cable," indicating it is a hardware device with integrated software control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Laserscope Automatic Eye Protection Filter is a mechanical shutter designed to protect the user's eyes from a surgical laser beam during procedures. It is a physical device that interacts with a laser system and an endoscope/microscope, not with biological samples.
- Intended Use: The intended use is to provide eye protection during surgical laser procedures, not to diagnose or monitor a patient's health status through analysis of biological samples.
The device's function is entirely focused on safety during a surgical procedure, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The Laserscope Automatic Eve Protection Filter is intended to be used in coniunction with an endoscope or microscope for all cleared Laserscope indications for the Orion and Aura Surgical Laser Systems.
Product codes
Not Found
Device Description
The Laserscope Automatic Eye Protection Filter (AEPF) is a mechanical shutter that moves protective filter(s) into the line of view before the laser beam is emitted from the laser aperture. The AEPF is automatically activated when the laser foot pedal is pressed. The AEPF provides the user with an unobstructed view of the target when the laser is not activated. The AEPF is connected to the laser by an electrical cable which interfaces with the main control board. The drive/control electronics are monitored by the laser system's microprocessor. The software default is to ask the user if they want to disable the Automatic Eye Protection Filter. In order to activate the laser beam, the user must attach the Automatic Eye Protection Filter or disable the feature through the laser's control panel if they do not plan to utilize the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
To the best of our knowledge. Automatic Eve Protection Filters have not been specifically classified; however, the surgical lasers for which the are intended have been classified as Class II medical devices by the OB/GYN, General Plastic Surgery, and ENT Device Advisory Panels. The Laserscope Automatic Eye Protection Filter is substantially equivalent (identical) to the Automatic Eye Protection Filter which is an integral part of the Laserscope 800 Series Surgical Laser System.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
APR - 7 1997
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS LASERSCOPE AUTOMATIC EYE PROTECTION FILTER
REGULATORY AUTHORITY:
Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT:
Lisa McGrath Laserscope 3052 Orchard Drive San Jose, CA 95134-2011 Phone: 408 943-0636 FAX: 408 943-1454
DEVICE TRADE NAME:
Laserscope Automatic Eye Protection Filter
DEVICE COMMON NAME:
Automatic Eye Protection Filter
DEVICE DESCRIPTION:
The Laserscope Automatic Eye Protection Filter (AEPF) is a mechanical shutter that moves protective filter(s) into the line of view before the laser beam is emitted from the laser aperture. The AEPF is automatically activated when the laser foot pedal is pressed. The AEPF provides the user with an unobstructed view of the target when the laser is not activated. The AEPF is connected to the laser by an electrical cable which interfaces with the main control board. The drive/control electronics are monitored by the laser system's microprocessor. The software default is to ask the user if they want to disable the Automatic Eye Protection Filter. In order to activate the laser beam, the user must attach the Automatic Eye Protection Filter or disable the feature through the laser's control panel if they do not plan to utilize the device.
0000009
Laserscope Premarket Notification for Automatic Eye Protection Filter
1
SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 2
DEVICE CLASSIFICATION:
To the best of our knowledge. Automatic Eve Protection Filters have not been specifically classified; however, the surgical lasers for which the are intended have been classified as Class II medical devices by the OB/GYN, General Plastic Surgery, and ENT Device Advisory Panels.
PERFORMANCE STANDARDS:
The Laserscope Orion and Aura Surgical Laser Systems conform with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for for medical laser systems. Laserscope is unaware of any specific standards for Automatic Eye Protection Filters.
INDICATION FOR USE STATEMENT:
The Laserscope Automatic Eve Protection Filter is intended to be used in coniunction with an endoscope or microscope for all cleared Laserscope indications for the Orion and Aura Surgical Laser Systems.
COMPARISON WITH PREDICATE DEVICE:
The Laserscope Automatic Eye Protection Filter is substantially equivalent (identical) to the Automatic Eye Protection Filter which is an integral part of the Laserscope 800 Series Surgical Laser System.
The risks and benefits for the Laserscope Automatic Eye Protection Filter are comparable to the predicate device when used for similar clinical applications.
Since the Laserscope Automatic Eve Protection Filter is substantially equivalent with respect to indications for use, materials, method of operation and physical construction to the predicate device, we believe it clearly meets the requirements for substantial equivalence according to Section 510(k) quidelines. Safety and effectiveness are reasonably assured, therefore justifying 510(k) clearance for commercial sale.
Laserscope Premarket Notification for Automatic Eye Protection Filter