(30 days)
The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 630-670 [630nm-670mm], IQ 810 [810mm] [IRIDEX Cyclo G6 Laser System]) and the hand pieces & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse™ mode. Intended for soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows:
810nm (The IRIDEX Cyclo G6 Laser System)
Ophthalmology:
The IRIDEX® Cyclo G6™ Laser System and Probe Delivery Devices (G-Probe Illuminate, & MicroPulse® P3) are used to deliver laser energy in either CW-Pulse (CW) or MicroPulse (uP) treatment mode and indicated for the treatment of Glaucoma:
MicroPulse P3 Device: For the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory. Treatment (Intended Use): Transscleral Cyclophotocoagulation (TSCPC) of the ciliary processes. Mode: μP
G-Probe & G-Probe Illuminate: For the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory. Treatment (Intended Use): Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes. Mode: CW
The Iridex Cyclo G6 is an 810nm (diode) ophthalmic laser comprised of the following main components:
- Main console containing the major electrical components, including:
- Control Panel including control knobs (power, interval, duration or software assigned function), treat/standby button, and display;
- Two delivery device fiber-optic connector ports (only one active at a time);
- LIO illumination connection;
- Smart key port for detecting/operating safety filters and/or accessory identification;
- Emergency stop switch;
- Key switch;
- Connector ports for the footswitch, remote control, and power cord;
- A treatment Footswitch (either wired, wireless, or wireless with PowerAdjust);
- A Wired Remote Control that duplicates the control panel;
- Delivery Accessories including G-Probe and MicroPulse P3 probe Handpieces, and the G-Probe Illuminate
- Optional Cart/Stand
The laser system automatically enters the "Standby" mode after it is turned on and completes its internal "selftest". Laser emission is not possible until the user attaches the proper delivery device, selects the desired treatment settings, verifies eye safety filter status, places the system into "Ready", and depresses the footswitch.
The system has a primary display screen (power, interval, duration, pulse mode, aiming beam brightness, illumination brightness, treatment/standby toggle, counter reset) and additional screens for ancillary options (system volume, display contrast/brightness, preset selection (user defined/generated), aiming beam settings).
The user may adjust power, treatment duration, treatment interval, type of laser output mode (CW-pulse, MicroPulse), aiming beam brightness, illumination brightness, and reset the laser shot counter. Additionally, for some delivery devices the user may optionally select the on/off operation of the countdown timer on the display screen as well as the on/off function of the voice countdown.
The G-Probe Illuminate that is the subject of this 510(k) is a handheld fiber optic delivery device. It is intended to be used to perform transscleral cyclophotocoagulation of the ciliary processes. It is differentiated from the G-Probe described in earlier submissions by the incorporation of two additional optical fibers to provide white light transillumination of the optic globe. Such transillumination can aid probe placement by revealing the location of internal ocular structures such as the ciliary processes. The incorporation of this transillumination function into a multifunction probe offers the user similar functionality as a separate handheld transilluminator, with a more convenient setup that requires fewer hands or assistants to operate. It is provided as a sterile, single-use device.
The provided document is a 510(k) Premarket Notification for the Iridex Cyclo G6 Laser System and G-Probe Illuminate. This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the manner one might find for a novel AI/software medical device.
Therefore, the typical acceptance criteria and study design for "device performance" in terms of accuracy, sensitivity, or specificity against a ground truth (e.g., for an AI diagnostic algorithm) are not applicable or present in this document. Instead, the document discusses the equivalence of the proposed device to a legally marketed predicate device based on technical characteristics and safety testing.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
As this is a 510(k) demonstrating substantial equivalence for a physical laser system and its probe (with an added illumination feature), there are no "acceptance criteria" presented in the measurable performance metrics typical for an AI/diagnostic software. Instead, the "performance" is demonstrated through successful completion of various engineering, sterility, and biocompatibility tests, and the "acceptance criterion" is essentially demonstrating that the modified device (Iridex Cyclo G6 Laser System with G-Probe Illuminate) performs safely and effectively at least as well as the predicate device.
The study that "proves" the device meets acceptance criteria is the sum of the conformance to various standards and the comparison of technological characteristics to the predicate.
| Acceptance Criteria Category (implied from 510(k) submission) | Reported Device Performance (Summary) |
|---|---|
| Technological Characteristics Equivalence | The Iridex Cyclo G6 Laser System with G-Probe Illuminate has substantially equivalent technological characteristics to the predicate device (K143154 - Iridex Cyclo G6 Laser System). Key identical characteristics include: |
- Product Code: General & Plastic Surgery
- Regulation: GEX, 21 CFR 878.4810
- Intended Use: Treatment of Glaucoma (Primary Open-Angle, Closed-Angle, Refractory)
- Indications for Use: Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes
- Wavelength: 810nm - Infrared (IR) Diode
- Aiming Beam: 630-670 nm - red (nominal) – variable intensity from 0 to
§ 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.