(170 days)
Device is intended for the incision, excision, vaporization, ablation and coagulation of soft tissue in oral and dentistry and for the ablation and vaporization of hard tissue in dentistry.
Hard Tissue
General Indications*
· Class I, II, III, IV and V cavity preparation
· Caries removal
· Hard tissue surface roughening or etching
· Enameloplasty, excavation of pits and fissures for placement of sealants
- For use on adult and pediatric patients
Root Canal Hard Tissue Indications
· Tooth preparation to obtain access to root canal
· Root canal preparation including enlargement
· Root canal debridement and cleaning
Bone Surgical Indications
· Cutting, shaving, contouring and resection of oral osseous tissues (bone)
· Osteotomy
Endodontic Surgery (Root Amputation) Indications
· Flap preparation - incision of soft tissue to prepare a flap and expose the bone.
· Cutting bone to prepare a window access to the apex (apices) of the root(s).
· Apicoectomy - amputation of the root end.
· Root end preparation for retrofill amalgam or composite.
· Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex.
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
Laser Periodontal Procedures
· Full thickness flap
· Partial thickness flap
· Split thickness flap
· Laser soft tissue curettage
· Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
· Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium
· Removal of granulation tissue from bony defects
· Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
· Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours)
· Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.)
· Osseous crown lengthening
· Removal of subgingival calculus
Soft Tissue Indications including Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:
· Excisional and incisional biopsies
· Exposure of unerupted teeth
· Fibroma removal
· Flap preparation incision of soft tissue to prepare a flap and expose the bone.
· Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions)
· Frenectomy and frenotomy
· Gingival troughing for crown impressions
· Gingivectomy
· Gingivoplasty
· Gingival incision and excision
· Hemostasis and coagulation
· Implant recovery
· Incision and drainage of abscesses
· Incision and drainage of periapical abscesses
· Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery
· Leukoplakia
· Operculectomy
· Oral papillectomies
· Pulpotomy
· Pulp extirpation
· Pulpotomy as an adjunct to root canal therapy
· Reduction of gingival hypertrophy
· Removal of pathological tissues (i.e. cysts, neoplasm or abscess) and hyperplastic tissues (i.e. granulation tissue) from around the apex .
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
· Root canal debridement and cleaning
· Soft tissue crown lengthening
· Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
· Vestibuloplasty
- For use on adult and pediatric patients
Equipment is mobile Er: YAG Medical Treatment and Coagulation Laser of model MEY-1-A intended to be used for dental surgery in hospital environment. Er.YAG Laser emits an infrared beam with a wavelength 2.94 um which is readily absorbed by water contained by both hard and soft tissues of the human body. As a result, a energy of the laser beam instantly vaporized the water molecules in hard tissues of the tooth causing the tissues to crumble away or resection of the soft tissues of gingival.
This document is a 510(k) summary for the AdvErL EVO Er: YAG Laser for Dentistry (Model: MEY-1-A). It focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria in the typical sense for diagnostic accuracy.
The performance of the MEY-1-A is examined by using international standards for medical electrical equipment and laser products to ensure safety and essential performance. The document does not describe a clinical study comparing the device's efficacy against specific acceptance criteria for a diagnostic or therapeutic outcome. Instead, it relies on demonstrating that the device has the "substantially same equivalent technical specifications" and "intended use and Indications of use" as its predicate devices, implying that if the predicates met their performance criteria, this device would as well.
Here's an breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Standards: | |
| IEC 60601-1:2005 (General requirements for basic safety and essential performance) | The device's performance was examined using this standard. (Implied compliance for substantial equivalence) |
| IEC 60601-2-22 (Particular requirements for safety of diagnostic and therapeutic laser equipment) | The device's performance was examined using this standard. (Implied compliance for substantial equivalence) |
| IEC 60825-1 (Safety of laser products-Part 1: Equipment classification and requirements) | The device's performance was examined using this standard. (Implied compliance for substantial equivalence) |
| IEC 60601-1-2:2007 (Electromagnetic compatibility - equipments and tests Edition 3) | The device's performance was examined using this standard. (Implied compliance for substantial equivalence) |
| Intended Use & Indications: | |
| Identical intended use and indications of use as predicate device I ("VERSAWAVE DENTAL ER: YAG LASER SYSTEM (K#041710)") | The MEY-1-A has the same "intended use and Indications of use" as predicate device I, except for "Removal of subgingival calculus." |
| Substantially similar intended use and indications of use as predicate device II ("WATERLASE MD TURBO PLUS MODEL 7200XXX (K#101658)") | The MEY-1-A has substantially similar "intended use and Indications of use" as predicate device II, but lacks the indication of "Root canal indications / Laser root canal disinfection after endodontic." |
| Technical Specifications: | |
| Substantially same "equivalent technical specifications" as predicate device I and II | The MEY-1-A has "substantially same 'equivalent technical specifications'" compared with both predicate devices. Minor differences in display, power calibration, and software are considered not to cause substantial impacts to effectiveness or safety. |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical performance study with a test set of data in the context of diagnostic or therapeutic accuracy, but rather compliance with safety and electrical standards. Therefore, information on sample size and data provenance for a test set is not applicable here. The "test set" in this context refers to the device itself undergoing engineering and safety testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert-established ground truth for a diagnostic or imaging performance metric.
4. Adjudication method for the test set
Not applicable. No clinical adjudication method is described.
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
Not applicable. This is a laser device, not an AI-assisted diagnostic or imaging device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm, but a physical medical device (laser).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is based on adherence to recognized international safety and performance standards (IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2) and a demonstration of substantial equivalence in intended use and technical specifications to previously cleared predicate devices.
8. The sample size for the training set
Not applicable. This device does not use an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.