(263 days)
The PerioLase Nd: YAG Pulsed Dental Laser System is intended for use in laser surgery procedures for ablation, incision, excision, vaporization, and coagulation of soft tissues in specialties such as general and cosmetic dentistry, oral, maxillofacial, and cosmetic surgery, otolaryngology / ENT surgery, arthroscopy, dermatology and plastic surgery, gastroenterology, general surgery, gynecology, neurosurgery, ophthalmology, podiatry, pulmonary surgery, and urology.
Orophayrngeal / Dental Surgery
- Abscess incision and drainage
- Aphthous ulcers treatment
- Biopsies, incisional and excisional
- Excision and ablation of benign lesions and conditions
- Excision and vaporization of herpes simplex I and II
- Exposure of unerupted / partially erupted teeth
- Facilitation of subgingival calculus removal
- Fibroma removal
- Frenectomy
- Frenotomy
- Gingival incision and excision
- Gingival troughing for crown impressions
- Gingivectomy
- Gingivoplasty
- Hemostasis
- Hemostatic assistance
- Implant recovery
- Incision of infection when used with antibiotic therapy
- Laser-assisted new attachment procedure (cementum-mediated periodontal ligament no the root surface in the absence of long junctional epithelium)
- Laser-assisted uvulopalatoplasty (LAUP)
- Lesion (tumor) removal
- Leukoplakia
- Modification of the dentin surface, including increasing the mineral and decreasing the organic composition of the dentin surface, reducing bacteria on the dentin surface, improving the shear bond strength of composite resin, reducing the adhesive failure of composite resin, and removing demineralized dentin surfaces
- Operculectomy
- Oral papillectomy
- Periodontal regeneration - true regeneration of the attachment apparatus (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface when used specifically in the LANAP® Protocol
- Pulpotomy
- Pulpotomy as an adjunct to root canal therapy
- Reduction of denture hyperplasia
- Reduction of gingival hypertrophy
- Removal of filling material such as gutta percha or resin as an adjunct treatment during root canal retreatment
- Removal of post-surgical granulations
- Selective ablation of enamel (first degree) caries removal
- Soft tissue crown lengthening
- Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level or loss, and tooth mobility
- Tissue retraction for impression
- Vestibuloplasty
General Surgery
Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, and coagulation of soft tissue). All soft tissue is included, striated and smooth tissue, meniscus, mucous membrane, lymph vessels and nodes, organs and glands
- Appendectomy
- Cholecystecomy
- Debridement of decubitus ulcers
- Hemorrhoidectomy
- Hepatectomy
- Herniorrhaphy
- Lymphadenectomy
- Mastectomy
- Pancreatectomy
- Parathyroidectomy
- Partial nephrectomy
- Pelvic adhesiolysis
- Pilonidal cystectomy
- Removal of fibromas
- Removal of lesions
- Removal of polyps
- Removal of tumors
- Resection of lipoma
- Splenectomy
- Thyroidectomy
- Tonsillectomy
- Tumor biopsy
Endonasal Surgery
Endonasal surgery (ablation, vaporization, incision, and coagulation of soft tissue) including:
- Adenoidectomy
- Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal tissues
- Tonsillectomy
Dermatology and Plastic Surgery
Dematology and plastic surgery (ablation, vaporization, excision, and coagulation of soft tissue) including:
- Debridement of decubitus ulcer
- Hemangiomas
- Lesions of skin and subcutaneous tissue
- Periungual and subungual warts
- Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemangiomae, warts, telangiectasiae, rosacea, venous lake, leg veins, and spider veins
- Plantar warts
- Port wine lesions
- Removal of tattoos
- Spider veins
- Telangiectasia
- Treatment of keloids
- Treatment of mild to moderate inflammatory acne vulgaris
- Treatment of wrinkles
- Venous lakes
Podiatry (ablation, vaporization, excision, and coagulation of soft tissue) including:
- Matrixectomy
- Periungual and subungual warts
- Plantar warts
- Radical nail excision
- Neuromas
The PerioLase® MVP-7™ is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
The laser head consists of a flashlamp-pulsed Nd:YAG rod in an optical resonant cavity. The energy and the width of each laser pulse are determined by the size and shape of the current pulse through the flashlamp. The current pulse through the flashlamp is controlled by the flashlamp switching circuit. This circuit is based on a solid-state switch that sets the current level and pulse width according to the microprocessor controller. The rate at which the laser pulses are produced, the repetition rate or the pulses/second, is also determined by the microprocessorcontrolled switching circuit. The output energy of each laser pulse is measured by the internal energy monitor. This value is compared to the energy setting by the microcontroller and adjustments are made if necessary. The laser beam emitted from the laser head is coupled into a fiber-optic cable at the fiber port. The presence of the fiber-optic cable is detected by a sensor such that the laser will not fire if the fiber-optic cable is not in place. The laser aperture is at the distal tip of the fiber. The laser head is cooled by circulating water whose excess heat is removed by an air-water heat exchanger. The operator controls the laser through the touch screen display. The microcontroller handles all of the logic required to set the energy levels, pulse widths, and repetition rates for the laser output, monitors the output pulses to assure proper output energy, monitors all of the interlocks and sensors, and checks for proper operation of the switches, power supplies, and cooling system. Proper operation of the microcontroller is checked by an independent watchdog microprocessor. The system is designed such that no single fault can result in a system failure. All of the requirements of the laser safety standards of the CDRH as well as of the IEC 60825-1 standard are incorporated, including the remote interlock connector, the laser stop button, the key control, and the safety and manufacturer's labels.
This document describes a 510(k) premarket notification for the PerioLase Nd:YAG Pulsed Dental Laser System. It is a submission for substantial equivalence to legally marketed predicate devices, meaning it is not a new device requiring extensive new trials but rather an expansion of indications or minor modification to an already cleared device.
Therefore, the typical acceptance criteria and study information for a de novo device are not directly reported in this document in the same way. This submission primarily relies on comparing the device to existing predicate devices and showing that it shares similar technological characteristics and has equivalent intended uses.
However, new indications for use were added, and for these, clinical and laboratory data were provided.
Here's an analysis of the provided information based on your request:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of performance metrics (sensitivity, specificity, accuracy) as would be seen for a diagnostic AI device. Instead, the acceptance criteria for this 510(k) submission are based on demonstrating substantial equivalence to predicate devices in terms of:
- Technological Characteristics: Wavelength, pulse energy, pulse width, repetition rate, average power, laser classification, intended use, aiming beam, output mode, laser medium, user interface, laser activation, beam delivery, soft tissue cutting method, electrical requirements, system dimensions, system weight, and cooling.
- Safety and Performance Standards: Conformance to applicable regulations and safety standards, particularly 21 CFR 1010 and 21 CFR 1040 for electrical safety and output characteristics.
- Indications for Use: The new indications are supported by human and animal studies, demonstrating the device's ability to perform these specific actions.
Table of Device Characteristics (excerpt from document):
| Characteristic | Millennium PerioLase Nd:YAG Pulsed Dental Laser System (K182930) |
|---|---|
| Product Code | GEX, 21 CFR 878.4810 |
| **Regulation Medical | General & Plastic Surgery |
| Specialty** | |
| 510(k) Review Panel | General & Plastic Surgery |
| Device Class | II |
| Laser Class | IV (4) |
| Wavelength | 1064 nm |
| Aiming Beam | 630-680 nm (≤ 5.0 mW) |
| Power (Watts) | 6W maximum |
| Pulse Duration (µsec) | 100, 150, 250, 350, 450, 550, 650 |
| Energy per pulse (mJ) | 20-300 |
| Output Mode | Pulsed, multi-mode |
| Repetition Rate | 10-100 Hz |
| Laser Medium | Flashlamp-pumped, solid-state laser rod |
| User Interface | Touch screen control panel |
| Laser Activation | Footswitch |
| Beam Delivery | Fiber (300, 360, 400 μm) |
| **Soft Tissue Cutting | Contact |
| Method** | |
| **Electrical | 100-240 VAC, 50/60 Hz, 8 A/4 A |
| Requirements** | |
| System Dimensions | 11" W x 19" D x 25" H |
| System Weight | 45 lbs |
| Cooling | Air-cooled (internal water loop) |
New Indications for Use and Supporting Performance (from Section 7):
- Facilitation of subgingival calculus removal: Demonstrated by human and animal studies.
- Modification of the dentin surface: Demonstrated by human and animal studies, including:
- Increasing the mineral and decreasing the organic composition of the dentin surface.
- Reducing bacteria on the dentin surface.
- Improving the shear bond strength of composite resin.
- Reducing the adhesive failure of composite resin.
- Removing demineralized dentin surfaces.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Human and animal studies demonstrate the ability of a pulsed neodymium dental laser to remove subgingival calculus and modify the surface of dentin. The relevant clinical and laboratory reports are provided in Appendix B of this submission."
- Sample Size for Test Set: Not specified in the provided document. The exact number of human subjects or animals and detailed methodology for these studies are likely contained within "Appendix B," which is not available here.
- Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." The nature of "clinical and laboratory reports" suggests prospective studies for the new indications, but without Appendix B, this is an inference.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the excerpt. For laser device performance studies related to tissue manipulation, "ground truth" would typically refer to objective measurements, histological analysis, or clinical outcomes assessed by qualified dental or medical professionals, but the details are missing.
4. Adjudication Method for the Test Set
This information is not provided in the excerpt. Since the primary evidence cited for the new indications are "human and animal studies" and "laboratory reports," the concept of "adjudication method" (like 2+1 or 3+1 consensus) as typically applied to image-based AI diagnostics might not be directly applicable or detailed in this kind of submission. If expert assessment of clinical outcomes was used, an adjudication method might have been employed, but this is not stated.
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
This is not applicable to this device. The PerioLase Nd:YAG Pulsed Dental Laser System is a surgical laser, not an AI-powered diagnostic imaging system that assists human readers. Therefore, an MRMC study and effect size based on "human readers improve with AI vs without AI assistance" are not relevant for this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to this device. This is a physical laser device used by a human operator for surgical procedures, it is not an algorithm performing a task without human intervention.
7. The Type of Ground Truth Used
For the new indications (subgingival calculus removal, dentin surface modification), the ground truth would likely involve:
- Histology/Pathology: For assessing changes in dentin composition, bacterial reduction, and new attachment.
- Biomechanical Testing: For evaluating shear bond strength.
- Clinical Outcomes/Measurements: For confirming calculus removal, or other clinical improvements observed in human and animal studies.
The document refers to "human and animal studies" and "laboratory reports" (Section 7), implying that objective measurements and assessments were used to establish the efficacy for these new indications.
8. The Sample Size for the Training Set
This is not provided and is not applicable in the context of this device. The PerioLase laser system is not an AI/ML device that requires a "training set" in the computational sense. The "training" here refers to the development and optimization of the laser parameters and techniques, which is based on general scientific understanding, preclinical testing, and potentially iterative design improvements, not a machine learning training data set.
9. How the Ground Truth for the Training Set was Established
This is not applicable as the device is not an AI/ML product and thus does not have a "training set" 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.