(114 days)
The SCAR 3 scanner, when used with DEKA Smartxide family lasers (K180193), is indicated for ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery.
The SCAR 3 scanner, when used with DEKA Smartxide family lasers (K180193), is indicated for use in the performance of specific applications in dermatology and plastic surgery as follows:
-The ablation, vaporization, excision, incision, and coagulation of soft tissue in the performance of laser burn debridement
-Laser skin resurfacing (ablation and/or vaporization) for treatment of:
· Wrinkles, rhytids, and furrows (including fine lines and texture irregularities)
-Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
- Acne scars
- · Surgical scars
The SCAR 3 scanning unit is an optional scanner that can be connected to the Deka SmartXide family lasers (K180193).
The SCAR 3 is composed of the following components:
- HiScan SCAR 3 head
- HiScan SCAR 3 cable
Laser emission parameters are selected through the GUI of the DEKA laser device to whom the scanner is connected.
Shape and size of the scanning area may also be selected by using the three keys on the scanning head.
This document is a 510(k) summary for the SCAR 3 scanner, a medical laser scanning unit. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria. Therefore, many of the requested fields cannot be directly extracted from the provided text.
Here is the information that can be extracted, acknowledging the limitations of the document's purpose:
1. Table of acceptance criteria and the reported device performance
The document does not present specific quantitative acceptance criteria or detailed device performance metrics in a readily extractable table format for clinical efficacy. Instead, it relies on demonstrating substantial equivalence to a predicate device by comparing indications for use, principle of operation, and technological characteristics.
| Feature | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (SCAR 3) |
|---|---|---|
| Indications for Use | Ability to perform ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, including specific applications like laser burn debridement, laser skin resurfacing for wrinkles, rhytids, furrows, fine lines, texture irregularities, acne scars, and surgical scars. | The SCAR 3 scanner, when used with DEKA Smartxide family lasers, is indicated for ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery. It is also indicated for laser burn debridement, laser skin resurfacing for wrinkles, rhytids, furrows (including fine lines and texture irregularities), acne scars, and surgical scars. (Stated as a subset of the predicate's indications). |
| Laser Wavelength | 10600 nm | 10600 nm |
| Pulse Energy | 2.5-150 mJ | 2.5-150 mJ |
| Spot Sizes | 0.12 mm | 0.12 mm |
| Scanning Area | Max 10*10 mm | Max 10*10 mm |
| Density (spots per scan %) | 1%-25% | 1%-25% |
| Pulse Duration | Data not available for predicate device (Implied acceptable performance based on overall clinical safety/efficacy of predicate) | 0.1-2.5 ms |
| Frequency (Hz) | 150-400 Hz | 150-450 Hz (Described as "Similar. Minor differences in maximum frequencies do not affect safety and effectiveness of the device.") |
| Safety and Performance | Compliance with relevant medical device and laser safety standards (e.g., IEC 60601-1, IEC 60825-1). | The SCAR 3 was tested and found in compliance with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1. This ensures its basic safety and essential performance, and electromagnetic compatibility. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states "Clinical Performance Data: None." and discusses "Non-Clinical Performance Data." Therefore, there is no test set in the context of clinical performance data used for this submission. The non-clinical performance data consisted of testing against recognized standards (see point 1 and 8).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical performance study with a test set requiring expert-established ground truth was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical performance study with a test set requiring adjudication was conducted.
5. 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
Not applicable. This device is a laser scanning unit, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical laser scanning unit, not an algorithm. Performance was evaluated through non-clinical testing against standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance testing (compliance with standards), the "ground truth" was compliance with the specified requirements and criteria outlined in the standards (e.g., electrical safety limits, electromagnetic compatibility limits, laser safety classifications). This is determined by engineering measurements and tests.
8. The sample size for the training set
Not applicable, as no clinical performance or machine learning study involving a training set was conducted for this submission. The device is a physical medical instrument.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
§ 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.