(14 days)
The Styla MicroLaser™/StylaOrtho™ is to provide the ability to perform intraoral soft tissue dental, general, oral maxilla-facial and cosmetic surgery. The Styla MicroLaser™/StylaOrtho™ is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a contact fiber optic delivery system.
The device will be used in the following areas: general and cosmetic dentistry otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, genecology, urology, opthamology and pulmonary surgery. The following are the oralpharingeal 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
-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 Styla MicroLaser™/StylaOrtho™ are the first soft-tissue laser developed as a handheld unit. It is wireless, lightweight, easy to set up, simple to use, requires less power, and cost efficient.
With the Styla MicroLaser™/StylaOrtho™ Zap Lasers introduces a miniature X-Y adjusting module for coupling a diode laser with a disposable fiber. Fiber accuracy is better than 5 um and the alignment is extremely stable. A module with a specific lens was developed by Zap Lasers in order to achieve such precision and alignment. Such a design greatly simplifies the fiber management and setup of operatory time as the fiber is attached into the tip allowing this item to be disposable and simple to be used. No fiber scoring is needed as the disposable tip is provided already scored to decrease setup tip and user's error.
The Laser and Control Box comprise the following major modules:
The laser diode assembly contains one single emitter laser diode of 2.0 watt output power (Class IV laser) lasing at 808 nm. The diode laser is directly coupled to a lens and aligned to the fiber optic inside the removable tips, using (patent pending) a 2 axis laser alignment system. It also contains a 5 m W power, 650 nm laser diode coupled to the same fiber optic. The laser's visible light is designed to aid the user to aim the tip of the delivery fiber onto the tissue.
The Styla Microlaser™/StylaOrtho™ is designed to dissipate heat during normal operation and may feel warm to the touch after prolonged use. The laser module is mounted towards the tip of the unit, which acts as a heat sink during normal operation. The temperature is monitored by a sensor that prevents overheating.
Laser power controller provides electric power to the diodes in continuous wave and pulsed mode. It supplies about 2 VDC and current up to 4A to the diodes. The controller contains a high efficiency DC to DC converter that converts the battery voltage to the precise voltage needed for laser operation. This ensures that the majority of the energy is used for light and not converted into heat.
The delivery tips with fiber built in consist of 400 micron core multi-mode optical fiber, and a precise alignment mechanism. The fiber is factory installed into the tip and requires no installation by the end user.
The foot-switch is a standard (UL-approved) commercial foot-switch that provides hands-free ON/OFF capabilities. This switch controls initiation/termination of laser power from the distal end of the delivery fiber wirelessly.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Styla MicroLaser™/StylaOrtho™ device:
This 510(k) summary is for a Class II surgical laser device, and the primary method for demonstrating safety and effectiveness is through establishing substantial equivalence to existing predicate devices, rather than conducting new, de novo clinical trials with specific acceptance criteria and performance metrics in the way one might expect for a novel AI/software device.
Therefore, many of the requested categories (like sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this type of submission. The 'study' in this context refers to the comparison against predicate devices and adherence to regulatory standards.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Intended Use & Indications | Must be substantially equivalent to predicate devices. | Styla MicroLaser™/StylaOrtho™ has intended use and indications for use previously cleared by FDA for predicate devices. |
| Technical Characteristics | Must be similar to those of cleared predicate devices. | Technical characteristics are similar to those of the cleared Odyssey Navigator and EZLase. |
| Laser Output Values | Must be within previously cleared values of predicate dental laser systems. | Laser output values are well within previously cleared values of the predicate dental laser system. |
| Safety and Effectiveness | Must demonstrate proven safety and effectiveness for claimed indications, similar to predicate devices. | Predicate devices and other cleared laser systems with similar power outputs have proven safety and effectiveness in the treatment of the claimed indications. |
| Performance Standards | Compliance with specific FDA (21 CFR 1010 & 1020, Laser Notice 50) and international standards (IEC60601-1, IEC60601-2-22, IEC60825-1). | The device complies with 21 CFR 1010 & 1020, with permissible deviations relative to Laser Notice 50. It also complies with IEC60601-1:1995+A1+A2, IEC60601-2-22:1995, and IEC60825-1:1993+A1+A2. |
| Manufacturing & Quality | Compliance with general controls and voluntary standards (SOPs, vendor/process cert, QSR, ISO materials, eGMP, ISO 9000 series). | Zap Lasers, LLC intends to comply fully with general controls. Various voluntary performance standards are utilized. |
| Heat Dissipation | Designed to dissipate heat during normal operation and prevent overheating. | The device is designed to dissipate heat and has a sensor to prevent overheating. |
| Fiber Accuracy/Alignment | Precision in fiber coupling and alignment. | Fiber accuracy is better than 5 µm and alignment is extremely stable. (A module with a specific lens was developed to achieve this precision and alignment). |
| Sterilization & Packaging | Appropriate sterilization, packaging, and storage procedures. | Device is supplied non-sterile; disposable tips are non-sterile and to be discarded. Packaging is typical medical grade. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. This submission relies on substantial equivalence to predicate devices, not a test set of data from human or phantom subjects.
- Data Provenance: Not applicable in the context of a "test set." The "data" primarily comes from the regulatory clearance of predicate devices and adherence to manufacturing/performance standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. No ground truth was established by experts for a test set in the context of this 510(k) submission.
4. Adjudication Method for the Test Set:
- Not applicable. There was no test set requiring adjudication in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study is not relevant for demonstrating substantial equivalence for a Class II surgical laser device where technical performance and equivalence to predicates are the key elements.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This is a physical medical device (a surgical laser), not an algorithm or AI system.
7. The Type of Ground Truth Used:
- Not applicable in the typical sense of a clinical trial. The "ground truth" for this submission is implicitly derived from the established safety and effectiveness of the predicate devices as previously cleared by the FDA, and the device's adherence to relevant performance and safety standards. The assessment is about whether the new device performs effectively and safely like already-approved devices, not about its ability to diagnose or measure against a gold standard in a new context.
8. The Sample Size for the Training Set:
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, this is not an AI/ML device, so there is no training set or ground truth established in that context.
§ 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.