(416 days)
The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]) and the hand pieces, delivery devices & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse™,or LongPulse™ 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:
532 nm
Dermatology
· Pigmented Skin Lesions
· Vascular Lesions
Ear. Nose, and Throat (ENT)/ Otolaryngology
Otosclerotic Hearing loss and/or diseases of the inner ear:
· Stapedectomy
· Stapedotomy
· Myringotomies
Lysis of Adhesions
· Control of Bleeding
· Removal of Acoustic Neuromas
" Soft tissue Adhesion in Micro/Macro Otologic Procedures
Ophthalmology
Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty including:
· Retinal photocoagulation (RPC) for the treatment of
Diabetic retinopathy, including:
Nonproliferative retinopathy
Macular edema
Proliferative retinopathy
Retinal tears and detachments
Lattice degeneration
Age-related macular degeneration (AMD)
Retinopathy of prematurity
Sub-retinal (choroidal) neovascularization
Central and branch retinal vein occlusion
· Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including
Primary open angle/Closed angle
577nm
Dermatology:
· Treatment of Vascular and pigmented lesions
Ophthalmology:
Indicated for use in photocoagulation of both anterior and posterior segments including:
Retinal photocoagulation, panretinal photocoagulation and intravitreal ● endophotocoagulation of vascular and structural abnormalities of the retina and choroids including :
proliferative and nonproliferative diabetic retinopathy;
choroidal neovascularization;
branch retinal vein occlusion;
age-related macular degeneration
retinal tears and detachments
retinopathy of prematurity
Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle . Glaucoma
630 - 670nm
Ophthalmology:
Indicated for use in photocoagulation of both anterior and posterior segments including:
Retinal photocoagulation, panretinal photocoagulation and intravitreal . endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
proliferative and nonproliferative diabetic retinopathy;
choroidal neovascularization;
branch retinal vein occlusion;
age-related macular degeneration
retinal tears and detachments
retinopathy of prematurity
Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open . angle glaucoma
810nm
Opthalmology:
Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following:
· Retinal photocoagulation for the treatment of:
Diabetic retinopathy including;
Nonproliferative retinopathy
Macular edema
Proliferative retinopathy
Retinal Tears, Detachments and Holes
Lattice degeneration
Age-related macular degeneration (AMD) with choroidal neovascularizations (CNV)
Retinopathy of prematurity
Sub-retinal (choroidal) neovascularization
Central and Branch Retinal Vein Occlusion
Laser Trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation (TSCPC) . for the treatment of glaucoma, including;
Primary open angle
Closed angle
Refractory Glaucoma (recalcitrant/uncontrolled)
The Family of IRIDEX IQ Laser Systems is comprised of the following main components:
Main console containing the major electrical components, including: .
A 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); A
A LIO illumination connection:
Smart key port for detecting/operating safety filters and/or accessory A identification:
A Emergency stop switch:
A Kev switch:
Connector ports for the footswitch, remote control, and power cord; A
A treatment Footswitch (either wired, wireless, or wireless with PowerAdjust); .
A Wired Remote Control that duplicates the control panel; .
Delivery Accessories including OtoProbe handpieces, EndoProbe handpieces, . G-Probe and DioPexy Probe Handpieces, Dermatology Handpieces, Microscope Adapters, and Laser Indirect Ophthalmoscopes.
. Optional Cart/Stand
The provided 510(k) summary for the Family of IRIDEX IQ Laser Systems (K071687) does not contain information related to acceptance criteria or a study demonstrating the device meets such criteria.
This document is a premarket notification for substantial equivalence, which primarily focuses on arguing that a new device is as safe and effective as a legally marketed predicate device. In such submissions, the manufacturer typically references existing performance standards and demonstrates that their device conforms to these rather than presenting a performance study with specific acceptance criteria.
The summary states:
- Performance Standards: "The Family of IRIDEX® IQ Laser Systems ... conforms with: Federal Regulations; the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems: and, International Harmonized Standards." (Page 3)
- Rationale for Substantial Equivalence: "The Family of IRIDEX IQ Laser Systems shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices." (Page 3)
- Safety and Effectiveness Information: "The review of the indications for use and technical characteristics provided demonstrates that the Family of IRIDEX IQ Laser Systems is substantially equivalent to the predicate devices." (Page 3)
These statements indicate that the device's conformity is established by adherence to existing regulations and standards, and by demonstrating similarity to previously cleared devices. There is no mention of a specific study conducted by IRIDEX Corporation with defined acceptance criteria to "prove" device performance in the way one might expect for a novel or significantly different device requiring clinical data.
Therefore, I cannot populate the requested table and answer the specific questions below, as the information is not present in the provided text. The document is a regulatory submission focused on substantial equivalence rather than a detailed report of a performance study with acceptance criteria.
§ 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.