(69 days)
The SoftLase G2 - Surgical Diode Laser System is to provide the ability to perform intraoral soft tissue dental, general, oral maxillo-facial and cosmetic surgery. The SoftLase G2 is intended for ablating, incising, excising, vaporization and coagulation intraoral soft tissues using a contact fiber optic delivery system. The system is also intended for use in teeth whitening procedures.
The device will be used in the following areas: general and cosmetic dentistry otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery. The following are the indications for use for which the device will be marketed:
-Excision and Incision Biopsies
-Hemostatic assistance
-Treatment of Apthous Ulcers
-Frenectomy
-Frenotomy
-Gingival Incision and Excision
-Gingivectomy
-Gingivoplasty
-Incising and Draining of Abscesses
-Operculectomy
-Oral Papillectomy
-Removal of Fibromas
-Exposure of interrupted teeth
-Soft Tissue Crown Lengthening
-Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
-Tissue retraction for Impression
-Vestibuloplasty
-Light activation of bleaching materials for teeth whitening
-Laser-assisted bleaching / whitening of teeth
The laser diode assembly with fiber bundle, which contains 3 single diode lasers, each of 1.6 watt output power (Class IV lasers) lasing at about 808 nm. Each diode laser is coupled directly into a 200 um core optical fiber using a special positioner. The assembly also contains a 5-mw power - 650 nm pilot laser diode, which is coupled into the three core fibers. In the second version of the device, a single 5 Watt laser diode is used. A special optical system is implemented to focus its laser diode radiation into a delivery fiber. It allows an effective use of 300 um and 200 um fibers. In both versions, a visible light of pilot laser is used for aiming the tip of the delivering fiber onto the tissue.
The laser diode power supply, with two controller PCBs supplies power to the diodes in DC or pulsed mode.
The delivery fiber cables, consist of multi-mode, single core optical fibers available in 200, 300, 400 and 600 um diameters. The standard SMA 905 fiber connector terminates one end of the delivery fiber, which is attached to the SMA union at the rear panel of the laser box. The other end of the fiber is stripped of its protective jacket and is cleaved to provide laser radiation output.
The foot-switch, is a standard (UL-approved) commercial foot-switch/pedal that provides handsfree ON/OFF capabilities. This controls initiation/termination of laser power from the distal end of the delivery fiber. Each SoftLase G2 laser system is provided with two safety goggles, one fiber stripper and one sapphire wedge scribe for fiber cleaving.
The provided document is a 510(k) premarket notification for the SoftLase G2 - Surgical Diode Laser System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through novel clinical studies.
Therefore, the document does not contain information on:
- Acceptance criteria in the traditional sense (e.g., specific sensitivity, specificity, accuracy thresholds for a medical device's performance).
- A study that proves the device meets acceptance criteria with detailed methodologies, sample sizes, expert involvement, or statistical analysis.
- Sample sizes used for a test set and data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone (algorithm only) performance studies.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the submission relies on demonstrating substantial equivalence to predicate devices (SOFTLASE K003440, AURORA HL K992374, and TWILITE K003385) by comparing:
- Intended Use and Indications for Use: Stating that they were previously cleared by FDA for the predicate devices.
- Technical Characteristics: Showing similarity in device type (Diode laser), wavelength, maximum output power, operation mode, and delivery system.
- Laser Output Values: Stating they are "well within previously cleared values" of the predicate dental laser systems.
- Proven Safety and Effectiveness: Relying on the established safety and effectiveness of the predicate devices for the claimed indications.
- Safety and Performance Testing: This is mentioned generally, but no specific details of this testing (e.g., what was tested, methods, results, acceptance criteria) are provided in the document. It likely refers to internal engineering and functional tests to ensure the device operates as designed and meets electrical safety standards, rather than a clinical performance study.
Table of Acceptance Criteria and Reported Device Performance (as demonstrated by substantial equivalence):
| Feature/Criteria (Implied by Substantial Equivalence) | SoftLase G2 Reported Performance | Predicate Devices (SoftLase, Aurora HL, Twilite) Corresponding Performance | Meets Equivalence? |
|---|---|---|---|
| Type of laser | Diode laser | Diode laser | YES |
| Wavelength | 808 ± 5 nm | 808 ± 5 nm; 810 nm (+170 nm, -30 nm); 815 ± 15 nm | YES |
| Max output power | 3.5 Watt | 3.5 Watt; 1.5 Watt; 7 Watt | YES |
| Operation mode | Continuous wave and pulsed | Continuous wave and pulsed | YES |
| Delivery system | Multi-mode 400/600 um core quartz fiber | Multi-mode 400/600 um core quartz fiber | YES |
| Fiber aiming beam | 5 mw diode laser, 650 nm | 5 mw diode laser, 650 nm | YES |
| Activation means | Foot-switch | Foot-switch | YES |
| Intended Use and Indications for Use | -Excision and Incision Biopsies, -Hemostatic assistance, | ||
| ... (list of 20 indications including teeth whitening) | Same | YES | |
| Laser Output Values | "Well within previously cleared values" | - (Implied similar performance to predicate devices) | YES |
| Safety and Effectiveness | Substantially equivalent | Proven with predicate devices | YES |
In summary, the SoftLase G2's acceptance criteria are implicitly met by demonstrating that its design, performance characteristics, and intended use are "substantially equivalent" to already legally marketed devices, as outlined in the 510(k) process. No specific new clinical study data to demonstrate novel acceptance criteria are presented in 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.