(139 days)
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue; marginal and interdental gingival and epithelial lining of free gingiva; frenotomy; biopsy; operculectomy; Implant recovery; gingivectomy; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of deseased epithelial lining ; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions ; exposure of unerupted/ partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket; Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; Fibroma removal; Gingival incision; Treatment of canker sores; herpetic ulcers of the oral mucosa: Laser soft tissue curettage: Reduction of gingival hypertrophy:.
The semiconductor laser diode is excited by the generation power supply to generate the laser, which is effectively transmitted to the treatment site through the optical fiber tip. It is composed of laser host (including internal power system, laser drive system, optical path system, LCD screen, emergency stop button, laser) and optic fiber tip. The device mainframe not supplied sterile and do not require sterilization prior to use. The consumable component (Fiber optic tip) not supplied sterile but require sterilization prior to use.
This document describes the regulatory submission for the Shenzhen Soga Technology Co., Ltd. Dental Diode Laser (Model: ILaser I). It focuses on demonstrating substantial equivalence to a predicate device, SIROLaser Advance (Model: FonaLaser), rather than presenting a study to prove acceptance criteria with specific performance metrics.
Here's an analysis based on the provided text, addressing the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for the device. Instead, it relies on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and adherence to recognized safety and performance standards. The "performance" reported is primarily that the device meets these safety and performance standards.
| Acceptance Criteria Category | Specific Criteria (from predicate comparison & standards) | Reported Device Performance |
|---|---|---|
| Classification and Intended Use | Identical classification (Class II, 21 CFR 878.4810) and intended use as the predicate device (Intra- and extra-oral surgery for various soft tissue procedures). | The subject device (SOGALaser, Model: ILaser I) has identical classification (GEX, NVK, Class II, 21 CFR 878.4810) and intended use compared to the predicate device (SIROLaser Advance, K103753). |
| Technological Characteristics | Substantially similar technological characteristics to the predicate device, with differences not affecting core usage or bringing new safety/effectiveness concerns. Expected parameters include Wavelength, Output Power, Frequency, Aiming Beam, Laser Class, N.O.H.D. (Nominal Ocular Hazard Distance). | Close matching to predicate: |
- Wavelength: 980nm ±20nm (vs. 970nm ±15nm for predicate). The document states this difference was verified for safety (IEC 60825-1, IEC 60601-2-22) and that the subject device's efficiency is better based on literature.
- Frequency: 1Hz to 100Hz (same as predicate).
- Output Power: 4.0 W Max CW / 8.0 W Peak Power (Pulse Mode) (vs. 4.0 W Max CW / 7.0 W Peak Power for predicate).
- Aiming Beam: Laser diode, 5 mW, 680nm±20nm, Class 1 (vs. max 1 mW, 635-650nm, Class 1 for predicate).
- Laser Class: IV (4) (same as predicate).
- N.O.H.D.: 3.03 meters (vs. 1.5 meters for predicate). Other characteristics (Principle of Operation, Environment of Use, Software) are also compared and deemed substantially equivalent. |
| Safety and Performance Standards | Compliance with recognized international standards for medical electrical equipment safety, electromagnetic compatibility, and laser product safety. Expected standards include: - IEC 60601-1 (Electrical Safety)
- IEC 60601-1-2 (Electromagnetic Compatibility)
- IEC 60825-1 (Safety of laser products - Part 1)
- IEC 60601-2-22 (Particular requirements for basic safety and essential performance of surgical laser equipment) | The device has been Verified to comply with:
- IEC 60601-1 (Electrical Safety)
- IEC 60601-1-2 (Electromagnetic Compatibility)
- IEC 60825-1 (Performance Safety and Effectiveness)
- IEC 60601-2-22 (Performance Safety and Effectiveness) |
| Sterilization Conditions | Specific conditions for sterilization of consumable components. | Consumable component (Fiber optic tip) requires sterilization at 121℃ (250°F) for 30 minutes. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This submission is based on demonstrating substantial equivalence to a predicate device and adherence to recognized standards, not on a clinical trial with a "test set" of patients or data in the typical sense for performance evaluation (e.g., diagnostic accuracy).
- Data Provenance: The "data" provided relates to the technical specifications of the device and its predicate, and results from non-clinical testing performed in accordance with international standards. The country of origin for the subject device is China (Shenzhen, Guangdong).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. There was no "test set" with ground truth established by experts in the context of this 510(k) submission for this type of device. The evaluation relies on engineering, safety, and performance testing against established standards.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as there was no test set requiring expert adjudication.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not performed. This device is a laser surgical instrument, not an AI-assisted diagnostic tool for "human readers."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a hardware surgical instrument, not an algorithm. Its performance is evaluated through physical and electrical safety, and functional testing, not standalone algorithmic performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" in this context is the successful demonstration of compliance with established international safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22). This relies on objective measurement and testing against the requirements set by these standards, rather than expert consensus on diagnostic images or pathology.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This device is a physical instrument, not an AI model requiring a training set of data.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment: Not applicable, as there is no training set for this device.
§ 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.