(128 days)
The Solea system is indicated for the following:
- Ablation of hard tissue for caries removal and cavity preparation
- Incision, Excision, Vaporization, Coagulation and Hemostasis of soft tissue in the oral cavity
- Cutting, shaving, contouring and resection of oral osseous tissue (bone)
The Solea system is a dental laser device previously cleared by the FDA for soft tissue dental indications (K123494) and hard tissue indications (K130420). The only changes from the previously cleared device are the addition of the osseous tissue indications. There have been no software changes or graphic changes to the Solea system. The osseous tissue settings are the same as the previously cleared device (K130420). The osseous settings have substantially equivalent fluence and irradiation as the hard tissue predicate devices. There are no other hardware or software changes to the Solea system device pending herein when compared to the device cleared under K123494 and K130420.
The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy to cut and ablate hard tissue and to cut soft tissue in the oral cavity. The Solea system utilizes advanced CO2 laser technology with a wavelength of 9.25μm to safely and effectively perform ablation, incision, excision, vaporization, coagulation and hemostasis procedures.
The provided text does not contain detailed acceptance criteria or a study that directly proves the device meets specific acceptance criteria in a quantitative manner as typically expected for assessing diagnostic accuracy (e.g., sensitivity, specificity).
However, it outlines a series of non-clinical tests that demonstrate the device's substantial equivalence to predicate devices in terms of safety and performance, indirectly serving as "acceptance criteria" for regulatory clearance. Since no clinical testing was performed or required due to substantial equivalence, metrics like sensitivity, specificity, or reader improvement with AI assistance are not applicable in this context.
Here's an interpretation of the non-clinical testing and how it relates to acceptance criteria fulfillment:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrical Safety (compliance with IEC 60601-1) | The system passed electrical safety testing in accordance with requirements for IEC 60601-1. |
| Electromagnetic Compatibility (EMC) (compliance with IEC 60601-1-2) | The system passed electromagnetic compatibility (EMC) testing to meet requirements for IEC 60601-1-2. |
| Laser Safety (compliance with IEC 60601-2-22 and IEC 60825-1) | The system passed particular requirements for IEC 60601-2-22 and IEC 60825-1 for the safety of diagnostic and therapeutic laser equipment. |
| Cleaning and Sterilization (Sterility Assurance Level (SAL) of at least 10^-6, conventional autoclave cycles qualified to ANSI/AAMI ST79) | The handpieces of the Solea system passed cleaning and sterilization validations for reusable medical devices based on the overkill approach to demonstrate sterilization cycle lethality as described in AAMI TIR12 to achieve a Sterility Assurance Level (SAL) of at least 10^-6 |
§ 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.