(249 days)
Wavelength range 430-1064 Nanometer
In this wavelength range, SureScan is designed to assist in the partial or full coagulation or denaturization of a variety of benign epidermal vascular and pigmented lesions where precise dosimetry is required to minimize damage to adjacent or underlying tissue layers. SureScan use is restricted for adaptation to those lasers that have received FDA clearance for applications in cutaneous laser surgery for the treatment of benign superficial vascular and pigmented lesions such as port wine stains angiomas, telangiectasia, café-au-lait marks, age spots, lentigines, tattoos and similar conditions.
Wavelength range 1440-10640 Nanometer
In this wavelength range. SureScan is designed to assist in a variety of procedures that require the ablation of soft tissue, where precise removal is required to minimize damage to adjacent or underlying tissue layers. SureScan use is restricted for adaptation to those lasers that have received FDA clearance for soft tissue ablation, such as scars, keloids, warts, skin malformations and similar conditions.
SureScan adapts to laser systems with wavelengths in the visible spectrum from 430nm to 700nm ( blue, green, yellow and red ) and to lasers in the invisible spectrum from 755nm to 2940nm to deliver precise amounts of energy to tissue.
SureScan comes equipped with multiple treatment patterns in multiple sizes. SureScan is programmable to enable adjustment of scan speed across tissue to ensure uniform laser absorption or ablation which significantly reduces thermal damage and thus the potential for post operative scarring.
SureScan also has an adjustable spot overlap density and scanner dwell time feature which allows the surgeon to select individual treatment parameters most suitable for various tissue types and lesions.
SureScan employs a microprocessor controlled, mirror system for scanning the laser beam. SureScan juxtaposes laser beam spots with precisely controlled timing and predetermined amounts of space in between or with spatial overlap of these spots. Depending on the type of laser used and its wavelength, highly controlled tissue coagulation or ablation is achieved with minimal thermal injury.
SureScan's operation is controlled via an existing laser foot switch, to eliminate any adjustment of the internal electronics or workings of the laser. To ensure precise transmission of the laser beam through the SureScan device and subsequent safe delivery of laser energy to tissue, a user controlled adjustment feature allows for realignment of the laser beam due to a misaligned fiber or other delivery system as it is directed through the SureScan hand piece.
As a result, the operator is always assured of optimum beam quality without 'clipping', as the laser beam exits the SureScan hand piece.
Different sized squares, rectangles, triangles, hexagons, parallelograms and lines may be selected and are outlined by the laser systems pilot laser. These various patterns are then automatically covered by the therapeutic laser and coagulate, denaturize or ablate tissue in a single scan cycle. This results in a more predictable and controlled tissue effect to optimize treatment results.
The provided document (K964831) is a 510(k) summary for the SureScan device, a laser accessory. It describes the device, its indications for use, and a technical description. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria.
The document is a premarket notification for substantial equivalence, not a clinical study report or a validation study. It focuses on demonstrating that the SureScan device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information in the table or the subsequent points because the document does not contain details about:
- Acceptance criteria and reported device performance: This document doesn't define specific performance metrics or acceptance criteria for the SureScan device's operation, nor does it report any testing results against such criteria.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, or ground truth details for a test set.
- Training set sample size or ground truth establishment for a training set.
The document primarily focuses on:
- Device Description: Explaining what the SureScan does (adapts to laser systems for precise energy delivery, offers various treatment patterns, adjustable scan speed, spot overlap, and dwell time).
- Intended Use/Indications: Specifying the wavelengths supported and the types of benign epidermal vascular and pigmented lesions or soft tissue ablation procedures it assists with.
- Substantial Equivalence: Listing predicate devices to which it claims equivalence.
Without a clinical or technical performance study, the requested information cannot be extracted from this document.
§ 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.