(133 days)
The SUPRA SCAN™ Delivery System when connected to a compatible laser system is indicated for use in the treatment of ocular pathology of anterior segments including, retinal photocoagulation, pan retinal photocoagulation for 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
- · Macular edema
- · Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma.
SUPRA SCAN™ Delivery System is a scanning laser delivery system that enables the use of proprietary pattern scanning technology when coupling with laser platforms. This offers existing commercially available laser platform the ability to deliver a full spectrum of pattern scanning options.
The Quantel Medical SUPRA SCAN™ Delivery System consists of the following system components:
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- Scanning Laser Delivery System adapter with scanner controls that may be coupled to a slit lamp type Haag Streit or similar models, and connected to a currently cleared Quantel Medical 532nm retinal photocoagulator (SUPRA 532).
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- Scanner control module with LCD/Touch screen, power supply, electronics and electrical connections.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SUPRA SCAN™ Delivery System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the SUPRA SCAN™ Delivery System's equivalence to a predicate device rather than setting specific numerical acceptance criteria for performance in a clinical study. The "acceptance criteria" here are implicitly whether the device meets the specifications and safety standards of the predicate device, or relevant international and US standards. The "reported device performance" is essentially a comparison of its technical specifications to those of the predicate.
Given the nature of the submission (510(k) for substantial equivalence), the acceptance criteria are primarily that the device's technical characteristics, safety profile, and intended use are sufficiently similar to the predicate device.
| Characteristic / Acceptance Criteria (Implicit) | SUPRA SCAN™ Delivery System Performance | Predicate Device (PASCAL Synthesis™) Performance | Comparison / Outcome |
|---|---|---|---|
| Intended Use | Photocoagulation of anterior and posterior segments of the eye for various ocular pathologies. | Photocoagulation of anterior and posterior segments of the eye for various ocular pathologies. | Equivalent |
| Laser Energy Source | Frequency doubled Nd:YAG | Frequency doubled Nd:YAG | Equivalent |
| Laser Energy Delivery | Single spot & Multi spot | Single spot & Multi spot | Equivalent |
| Spot Placement | Centered on Guide Beam | Centered on Guide Beam | Equivalent |
| Laser energy Intensity | Selected by Physician | Selected by Physician | Equivalent |
| Pulsing System | Continuous | Continuous | Equivalent |
| Output Wavelength | 532 nm | 532 nm | Equivalent |
| Average Power (AP) | 2W (with SUPRA Scan) | 2 W | Equivalent |
| Laser Safety Class | 4/IV | 4/IV | Equivalent |
| Exposure Selections (t) | 0.007s to continuous | 0.01s to continuous | Slightly broader range for SUPRA SCAN, but considered equivalent/safe. |
| Cooling Method | Solid State Cooling with thermoelectric (Peltier) heat pump | Air cooled | Different, but considered safe and effective to meet performance. |
| Aiming Beam Type | Red diode | Red diode | Equivalent |
| Aiming Beam Wavelength | 635 nm | 635 nm | Equivalent |
| Aiming laser power |
§ 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.