(450 days)
The LightScalpel LS-4020 CO2 Laser Systems are intended for use in laser surgery procedures for incision, excision, vaporization, ablation, and/or coagulation of soft tissue in specialties such as: general surgery, dermatology, dentistry and oral surgery, otorhinolaryngology, plastic and reconstructive surgery, neurosurgery, podiatry, and urology.
The LightScalpel LS-4020 laser system, similar to the previously released LS-1005 and LS-2010 laser systems are mobile platforms that utilizes a radio frequency (RF) excited carbon dioxide (CO2) laser tube to produce an infrared beam at a nominal 10.6 um wavelength at powers adjustable from 2 - 40 Watts Continuous Wave (CW) and 2 to 20 Watts SuperPulse (SP). The systems differ only in the laser tubes used and pre-programmed values in the controlling software, which allow higher laser tube outputs for the LS-2010 and LS-4020 systems. Laser energy is conducted to the point of application by a flexible fiber waveguide and handpiece assembly. Laser system operation is controlled by operator input on a touchscreen display panel. The RF laser drive is modulated to provide additional pulsed and SuperPulse emission modes selected from the laser system control panel.
The provided document is a 510(k) summary for the LightScalpel LS-4020 CO2 Laser System. This type of submission is for demonstrating substantial equivalence to pre-existing legally marketed devices, rather than proving effectiveness through extensive clinical trials. Therefore, the information requested regarding acceptance criteria, extensive study details, and ground truth establishment, which are typical for novel devices requiring clinical validation, is largely not present in this document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the format of a table with specific pass/fail thresholds for clinical performance. Instead, the substantial equivalence is based on technological characteristics and intended use being comparable to predicate devices.
| Characteristic | Acceptance Criteria (Implied as Comparable to Predicate) | Reported Device Performance (LS-4020) |
|---|---|---|
| Laser Medium | CO2 | CO2 |
| Wavelength (μm) | 10.6 | 10.6 |
| Laser Drive Source | RF | RF |
| Output Power (W) | Comparable to predicate (2-60W range) | 2-40 |
| Pulsed Power (W) | Comparable to predicate (2-60W range) | 2-40 |
| Gated PW (ms) | Comparable to predicate (5-1000ms range) | 5-500 |
| Gated Rep. Rate (pps) | Comparable to predicate (1-100pps range) | 1-50 |
| Superpulse (W) | Comparable to predicate (1-20W range) | 2-20 |
| Superpulse Peak (W) | Comparable to predicate (50-240W range) | 100 |
| Superpulse Pulse Duration | Comparable to predicate (Up to 2ms) | Up to 0.8 ms |
| Beam Delivery System | Flexible Fiber Waveguide or Articulated Arm | Flexible Fiber Waveguide |
| System HxWxD (in) | Similar dimensions to predicate | 40x15x15 |
| System Weight (lb) | Similar weight to predicate | 66 |
| Mobility | 4 Wheels & Handle | 4 Wheels & Handle |
| Intended Use | Incision, Excision, Vaporization, Ablation, and/or Coagulation of Soft Tissue, across various specialties | Incision, Excision, Vaporization, Ablation, and/or Coagulation of Soft Tissue, across various specialties |
| Line Voltage - Nom. | 100-240 VAC | 100-240 VAC |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission. No clinical "test set" of patients or images was used for performance evaluation that is described in the document.
- Data Provenance: Not applicable. The document states "Non-clinical performance data: Each LS-4020 laser system is tested for electrical safety and output characteristics." This implies testing on the device itself, not patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. No ground truth establishment by experts is mentioned as this was not a clinical study requiring such a process.
4. Adjudication Method
Not applicable. No clinical study or expert review requiring adjudication is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "Clinical performance data: None. Clinical testing was determined to be unnecessary, as the performance parameters are consistent with predicate CO2 laser systems and technology." Therefore, no MRMC study or assessment of AI assistance was performed or reported.
6. Standalone Performance Study
Yes, in a sense, a standalone technical performance was assessed. The document states: "Each LS-4020 laser system is tested for electrical safety and output characteristics. Representative data is presented in the Bench Testing section of this report." This refers to the device's technical specifications and safety performance, not its clinical efficacy in a standalone "algorithm only" context.
7. Type of Ground Truth Used
Not applicable for clinical performance. The "ground truth" for the device's substantial equivalence is the technical and operational characteristics of the predicate devices, and the LS-4020's ability to meet those non-clinical specifications.
8. Sample Size for the Training Set
Not applicable. This device is a laser system, not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is a physical device, not an AI/ML algorithm trained on data.
Summary of the Study Proving Substantial Equivalence:
The study proving the device meets the acceptance criteria is a technical and comparative analysis against legally marketed predicate devices, specifically the LightScalpel LS-1005 / LS-2010 CO₂ Laser Systems (K141658) and the Lumenis Ultrapulse™ (K151331).
The core of the submission relies on demonstrating that the LightScalpel LS-4020 has substantially equivalent technological characteristics and intended uses to these predicate devices. The document highlights that:
- The LS-4020 uses the same laser medium (CO2), wavelength (10.6 μm), and laser drive source (RF) as the predicates.
- Its output power, pulse settings, and superpulse parameters fall within the range of the predicates, or are otherwise comparable.
- The beam delivery system (flexible fiber waveguide) and physical characteristics (size, weight, mobility) are also considered comparable.
- Crucially, the Indications for Use for the LS-4020 are directly aligned with and appear to be largely identical to those of the predicate devices across numerous surgical specialties (General Surgery, Dermatology, Dentistry/Oral Surgery, ENT, Plastic/Reconstructive Surgery, Neurosurgery, Podiatry, Urology, Gynecology).
The submission explicitly states that no clinical performance data was deemed necessary because of this consistency with predicate CO2 laser systems and technology. Instead, non-clinical bench testing confirmed the electrical safety and output characteristics of each LS-4020 laser system. This approach is standard for 510(k) clearances where a new device is shown to be similar enough to existing ones that new clinical effectiveness and safety studies are not required.
§ 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.