(60 days)
The Family of IR.IDEX® IQ Laser Systems (IQ 532 [532nm], IQ 630-670 [630mm-670m], IQ 810 [810nm] [IRIDEX Cyclo G6 Laser System]) and the hand pieces & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse TM or LongPulse TM mode. Intended for soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dematology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows:
810nm (IRIDEX Cyclo G6 Laser System)
Ophthalmology:
The IRIDEX® Cyclo G6 Laser System and Probe Delivery Devices (G-Probe & 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: Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes. Mode: uP
G-Probe: For the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory. Treatment: Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes. Mode: CW
The Iridex Cyclo G6 is 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-Probeand MicroPulse P3 probe Handpieces. Microscope Adapters, and Laser Indirect Ophthalmoscopes (these are not used with the Cyclo G6 but are available for use with the other members of the laser family).
- Optional Cart/Stand
This document is a 510(k) premarket notification for the Iridex Cyclo G6 laser system. It asserts substantial equivalence to a predicate device (K071687 Family of Iridex IQ Laser Systems), rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the context of a new diagnostic or AI-based device.
Therefore, many of the requested elements (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable or not present in this type of FDA submission.
However, I can extract information related to the device's technical specifications and the basis for its safety and effectiveness claims.
Acceptance Criteria and Reported Device Performance (Table)
Since this is a submission for substantial equivalence based on technological characteristics and indications for use being identical or very similar to a predicate device, specific performance metrics with acceptance criteria as typically seen for novel diagnostic devices are not provided. Instead, the "performance" here relates to the device's physical and functional attributes matching the predicate.
| Characteristic | Acceptance Criteria (Predicate's Performance/Specification) | Reported Device Performance (Iridex Cyclo G6) |
|---|---|---|
| Indications for Use | Same as K071687 | Exactly the same as K071687 (including 810nm Ophthalmology indications for Glaucoma treatment with MicroPulse P3 and G-Probe) |
| Wavelength | 810nm (for the relevant part of the predicate) | 810nm |
| Aiming beam | 630nm-650nm | 630nm-650nm |
| Power Watts | ≤ 5W | ≤ 5W |
| Pulse Duration (µsec) | 10µsec-60min | 10µsec-60min |
| Output Mode | CW (CW-Pulse, MicroPulse, Long Pulse) | CW (CW-Pulse, MicroPulse, Long Pulse) |
| Repetition rate | ≤ 1kHz | ≤ 1kHz |
| Laser media | Diode, Diode-pumped, frequency doubled, solid state | Diode, Diode-pumped, frequency doubled, solid state |
| User interface | Manual & Remote Controls | Manual & Remote Controls |
| Laser activation | footswitch | footswitch |
| Delivery devices, how supplied | Delivery Devices provided Sterile packaged & non-sterile | Delivery Devices provided Sterile packaged & non-sterile |
| Electrical requirements | 90-130 VAC, 50/60 Hz; 200-240 VAC, 50/60 Hz | 90-130 VAC, 50/60 Hz; 200-240 VAC, 50/60 Hz |
Study Information (Based on the provided document)
-
Sample size used for the test set and the data provenance:
- Not Applicable. This submission explicitly states: "No clinical data was needed for these indications. They are identical to those on K071687." Therefore, there was no separate "test set" of patient data used to evaluate the device's clinical performance as part of this 510(k). The evaluation relies on the known performance and safety of the predicate device and the new device's comparable technical specifications.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As no clinical data/test set was used for this submission, there was no need for experts to establish ground truth for a test set.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set was used.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a laser surgical instrument, not an AI-assisted diagnostic or image analysis tool. Therefore, an MRMC study related to human reader improvement with or without AI assistance is not relevant to this submission.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a hardware laser system, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. No new clinical ground truth was established for this submission. The "ground truth" for demonstrating substantial equivalence was the established safety and effectiveness of the existing predicate device, backed by its technical specifications and historical clinical use.
-
The sample size for the training set:
- Not Applicable. This is a laser hardware system, not a machine learning algorithm requiring a training set.
-
How the ground truth for the training set was established:
- Not Applicable. No training set was used.
Summary of the Study:
The "study" in this context is a bench testing and engineering comparison against the predicate device, K071687. The submission explicitly states:
- "No clinical data was needed for these indications. They are identical to those on K071687."
- "The technological characteristics of the Iridex Cyclo G6 laser are substantially equivalent to those of the predicate device."
- "The review of the indications for use and technical characteristics provided demonstrates that the Iridex Cyclo G6 Laser is substantially equivalent to the predicate device and is safe and effective for use for the various indications for use stated."
- "The software changes that are the subject of this 510(k) were verified and validated in accordance with the Iridex design control procedures."
The document relies on the inherent safety and efficacy already established for the predicate device due to the identical indications for use and substantially equivalent technical characteristics of the Iridex Cyclo G6. The "proof" is the detailed comparison of specifications, demonstrating that the new device performs identically to a legally marketed device.
§ 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.