(49 days)
IRIS Pi Q switched Nd YAG laser system is indicated for the Incision, Excision, Ablation Vaporization of soft tissues for general dermatologic and general surgery procedures for Coagulation and Hemostasis
532nm wavelength
Tattoo removal light ink (red, tan, purple, orange, sky blue) Removal of benign epidermal pigmented lesions, Minor benign vascular lesions, Talangietasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses, Becker's Nevi, Freckles. Treatment of Post inflammatory Hyperpigmentation ( PIH)
1064nm wavelength
Tattoo removal dark ink (black, blue, green) Removal of Nevus of Ota, Removal or lightening of unwanted hair, Treatment of Common Nevi, Melasma Skin resurfacing procedures for treatment of Acne Scars, Wrinkle
The IRIS Pi O-Switched Nd:YAG laser system produces a two pulsed beam, 1064 nm Infrared and 532nm long pulse laser, and using two non-fractional handpieces (Zoom handpiece and 7mm collimated handpiece) is able to control various treatment fluence.
laser tube : placed in the mixed crystals of copper pipe to the heater and produces a laser beam, Resonator : amplifies the beam, through the Xe-gas contained lamp : Xe-gas contains high pressure lamp to increase specific laser beam lamp
This converted light energy creates the Nd: Y AG crystal and exhaust from the crystal is amplified into a specific wave length. Laser energy produced is delivered to the tissue by means of an articulated arm and a specially designed adjustable spot size Hand Piece.
The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using Foot Switch. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit.
This system also consist of
Optic main Bench assembly, Articulated Arm Hand pieces, LCD control panel, Cooling system, Foot Pedal Switch
This document is a 510(k) summary for the IRIS Pi Q-switched Nd:YAG laser, comparing it to a predicate device (K171648 BM.IRIS Nd:YAG). It does not describe acceptance criteria or a study proving the device meets said criteria in the way typically expected for an AI/CADe device. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device through technical specifications and adherence to general safety and performance standards for laser medical devices.
Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable to this type of submission, as it's not for a diagnostic AI/CADe device.
Here's an analysis based on the provided text, addressing the applicable points and explicitly stating when information is not present:
Summary of Acceptance Criteria and Device Performance (Not Applicable - Device is a laser, not AI/CADe)
This submission does not provide acceptance criteria in the typical sense for an AI/CADe or diagnostic device, nor does it report specific device performance metrics against such criteria. The device is a laser system, and its "performance" is assessed by comparing its technical specifications to those of a predicate device and by demonstrating adherence to international safety standards for laser products.
1. A table of acceptance criteria and the reported device performance
As this is a laser surgical instrument, the "acceptance criteria" are primarily related to safety and efficacy as demonstrated through substantial equivalence to a predicate device and compliance with relevant international standards. There are no specific performance metrics like sensitivity, specificity, or AUC mentioned in the context of diagnostic decision-making that would be typically found for an AI/CADe device.
Here's a table based on the comparison to the predicate device, highlighting differences that were reviewed for safety and effectiveness:
| Characteristic | Acceptance Criteria (Predicate Device K171648) | Reported Device Performance (K221789 IRIS Pi) | Comment |
|---|---|---|---|
| Laser Type | Nd YAG | Nd YAG | Same |
| Wavelength | 1064/532 nm | 1064/532 nm | Same |
| Operating Mode | Q-switched | Q-switched | Same |
| Mode Names | 1064, 532, SLP, BLUE Toning | 1064, 532, SLP, BLUE T | Same |
| Max Pulse Energy (mJ) | 1200 @ 1064 nm (Q) | 1600 @ 1064 nm (Q) | Different |
| 400 @ 532 nm (Q) | 500 @ 532 nm (Q) | Different | |
| 1500 @ 1064 nm (SLP) | 2000 @ 1064 nm (SLP) | Different | |
| 1000 @ 1064 nm (Blue Toning, PTP) | 1500 @ 1064 nm (BLUE T) | Different | |
| Spot Size (mm) | 2-10 @ 1064 nm | 2-10 @ 1064 nm | Same |
| 1.5-8 @ 532 nm | 2-10 @ 532 nm | Comparable | |
| Pulse Duration (ns) | 5-10 nm (all modes) | 5-10 nm (all modes) | Same |
| Repetition Rate (Hz) | 10-20 @ 1064/532 nm (Q) | 1-10 @ 1064/532 nm (Q) | Different |
| 10-20 @ 1064 nm (SLP) | 1-10 @ 1064 nm (SLP) | Different | |
| 10-20 @ 1064 nm (Blue Toning, PTP) | 1-15 @ 1064 nm (BLUE T) | Different | |
| Aiming Beam |
§ 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.