(280 days)
Lite Touch™ Er YAG Laser Treatment System is intended for the vaporization, excision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties:
- · Dermatology
- · Cosmetic surgery
- · Plastic and general surgery
- · Oral surgery
- · Gynecology
- · Otorhinolaryngology
- · Podiatry
The Lite Touch™ is an Er:YAG Laser Treatment System intended for use in the vaporization, incision, excision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties: Dermatology; Cosmetic surgery; Plastic and general surgery; Gynecology; Otorhinolaryngology; and Podiatry.
The Lite Touch™ was previously cleared under K974460 in October 1997. This submission contains an expansion of the previously cleared indications for use. The Lite Touch™ consists of a streamlined, maneuverable cabinet that contains the laser source, control system, power supply and internal cooling system. The laser beam has a light wavelength of 2940nm and is delivered through a counterbalanced articulated arm and hand piece. There is a two stage process of dissimilar actions required to activate the laser beam. The operation of the Lite Touch™ are completely under the physician's control.
This document is a 510(k) summary for the Lite Touch™ Er YAG Laser Treatment System. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies to prove device performance against specific acceptance criteria. Therefore, several of the requested sections (e.g., sample sizes, expert qualifications, MRMC studies) are not applicable or cannot be extracted from this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present specific quantitative acceptance criteria or detailed device performance metrics in the way one might expect for an AI/device performance study (e.g., sensitivity, specificity, or accuracy targets). Instead, it focuses on demonstrating compliance with recognized safety and performance standards, and substantial equivalence to a predicate device based on technological characteristics.
| Acceptance Criteria (Implied/Standard) | Reported Device Performance (Compliance/Characteristics) |
|---|---|
| Safety and Electrical Standards Compliance: | |
| 21 CFR 1040.10 - Performance Standards for Light-Emitting Products | In compliance |
| 21 CFR 1040.11 - Performance Standards for Light-Emitting Products, Specific purpose laser products | In compliance |
| IEC 60601-1 Ed.3.0: 2005 + Corr 1. 2006 + Corr 2. 2007 (Medical electrical equipment) | Tested for conformance |
| IEC 60601-1-2 2007, EN 60601-1-2: 2007; EN 60601-1-2 2007/AC 2010 (EMC) | Tested for conformance |
| IEC 60601-2-22 2007, EN 60601-2-22 2013 (Laser equipment specific) | Tested for conformance |
| IEC 60825-1: 2007. EN 60825-1: 2007 (Safety of laser products) | Tested for conformance |
| IEC 62366: 2007/A1:2014; EN 62366: 2008 (Usability engineering) | Tested for conformance |
| IEC 60601-1-6: 2010: EN 60601-1-6: 2010 (Usability) | Tested for conformance |
| Functional Equivalence to Predicate Device (K150140): | |
| Power Level | Lite Touch™: 24w; Predicate: 20w (considered substantially equivalent; difference noted not to create new unacceptable risk) |
| Energy Delivered (pulse and super pulse) | Lite Touch™: 35-3000 mJ; Predicate: 2500mj max (considered substantially equivalent; difference noted not to create new unacceptable risk) |
| Length of Pulse | Lite Touch™: 300-1000us; Predicate: 100-1000us (considered substantially equivalent) |
| Frequency of Pulse | Lite Touch™: Up to 16 Hz; Predicate: 20 Hz (considered substantially equivalent) |
| Spot size at target | Lite Touch™: 4, 6, 8, 10 mm; Predicate: 1 – 12mm (considered substantially equivalent) |
| Wavelength | Both: 2940 nm (identical) |
| Output Mode | Both: Pulsed (identical) |
| Beam Delivery | Both: Articulated Arm (identical) |
| Aiming Beam | Lite Touch™: 635 nm; Predicate: 650nm (considered substantially equivalent) |
| Laser Medium | Both: Flashlamp pumped solid state Er:YAG rod (identical) |
| Cooling Methods | Both: Water/air heat exchanger (identical) |
| Display/User Interface | Both: Graphic user interface touchscreen (substantially equivalent concept) |
| Power Calibration | Both: Internal (identical) |
| Anatomical sites applicable, warnings, contraindications, general population use | Substantially equivalent |
2. Sample size used for the test set and the data provenance
This document describes a medical device clearance process based on demonstrating substantial equivalence to a predicate device and compliance with standards, not a clinical study involving a "test set" of patient data. Therefore, this information is not applicable and not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is not a study requiring a ground truth established by experts on a test set of data.
4. Adjudication method for the test set
Not applicable.
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 an Er:YAG laser system for surgical procedures, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The Lite Touch™ is a surgical tool, operated by a physician.
7. The type of ground truth used
Not applicable in the context of clinical performance evaluation studies for AI/diagnostic devices. The "ground truth" here is the device's adherence to engineering specifications and safety standards, and its perceived equivalence to an existing device.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that would require a 'training set.'
9. How the ground truth for the training set was established
Not applicable.
§ 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.