(151 days)
- Dental Soft Tissue Indications
Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:
- Excisional and incisional biopsies .
- Exposure of unerupted teeth
- Fibroma removal
- Frenectomy
- Frenotomy
- Gingival troughing for crown impressions
- Gingivectomy
- Gingivoplasty
- Gingival incision and excision
- Hemostasis and coagulation
- Implant recovery
- Incision and drainage of abscess
- Leukoplakia
- Operculectomy
- Oral papillectomies
- Pulpotomy
- Pulpotomy as an adjunct to root canal therapy
- Reduction of gingival hypertrophy
- Soft tissue crown lengthening
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa.
- Vestibuloplasty
- Tissue retraction for impression
- Laser Periodontal Procedures
- Laser soft tissue curettage
- Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
- Sulcular debridement (removal of diseased, infected, 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 mobility.)
- Whitening
- Light activation for bleaching materials for teeth whitening
- Laser-assisted whitening/bleaching of teeth
- Pain Therapy
- Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
The EPIC™ 10 system uses an Indium Gallium Arsenide Phosphorous (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a hand piece that emits the energy to the target site. A visible light is emitted at the same time to visually identify the treatment location. The EPIC"" 10 Laser System is comprised of a Base Console, a detachable delivery system, tips, and a wireless footswitch. Various types of the single use tips are included for different applications and the device is activated by means of a wireless footswitch. The EPIC"" 10 Laser is a surgical and therapeutic device designed for a wide variety of oral soft tissue procedures and dental whitening, as well as for use in providing temporary relief of minor pain.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the EPIC™ 10 device, based only on the information given:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly define specific numerical or performance-based "acceptance criteria" for the EPIC™ 10 device. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. This means the acceptance criterion for regulatory clearance is that the EPIC™ 10 is as safe, as effective, and performs as well as the previously cleared predicate devices for the same indications for use.
Therefore, the "reported device performance" is primarily a statement of its equivalency to the predicate devices and the successful completion of a clinical test for Pain Therapy, rather than specific quantitative metrics for each indication.
| Acceptance Criterion (Implicit) | Reported Device Performance and Evidence Provided |
|---|---|
| Substantial Equivalence to Predicate Devices: | The submission states: "Substantial Equivalence for the EPIC™ 10 system has also been determined through comparison to the company's previous cleared devices. This Special 510(k) submission demonstrates that the EPIC™ 10 system is as safe, as effective, and performs as well as the predicate devices." |
The key evidence for this is:Technological Characteristics Comparison: A detailed table (Appendix 1, partially provided) comparing the EPIC™ 10's design, material, chemical composition, energy source, size, weight, power, wavelength, maximum power, modulation, frequency, pulse duration, and aiming beam to predicate devices (ezlase™ 10W and iLase™), showing substantial similarity.Indications for Use Comparison: A table (Appendix 1, partially provided) demonstrating that all indications for use for the EPIC™ 10 are identical to, or a combination of, the indications cleared for the predicate devices (K061898, K082938, K083595, K083069, and K093852). No new indications are added.Non-clinical Performance Data: "Non-clinical performance data is not presented." Instead, an "Evaluation Report including the references, literature and publications is included in the 510(k) submission for the demonstration of safety and effectiveness of this device and to support substantial equivalence to the company's owned legally marketed devices." |
| Safety and Effectiveness for Pain Relief Indication (Clinical): | "The clinical test for the therapeutic heating device indications (Pain Therapy) listed in Item 4 of the IFU have been conducted with human subjects and the performance data demonstrated that the device can perform the pain therapy as described in the indication for use safely and effectively." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For the Pain Therapy indication: "human subjects" were used. The specific number of subjects (sample size) is not provided in the text.
- For all other indications: No specific "test set" or sample size is mentioned, as substantial equivalence is claimed based on prior predicate device clearances and literature review, not new clinical testing for these indications.
- Data Provenance:
- For the Pain Therapy indication: "conducted with human subjects." The country of origin is not specified.
- It is a prospective study for the Pain Therapy indication, as it was conducted specifically for this device against those indications.
- For other indications, the data provenance relates to the predicate devices' clearances and literature, which is not detailed here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: This information is not provided for the "Pain Therapy" clinical test or for establishing ground truth for any other part of the submission.
- Qualifications of Experts: This information is not provided.
4. Adjudication Method (for the test set)
- The adjudication method for the Pain Therapy clinical test is not described in the provided text.
- For other aspects, the reliance on prior predicate clearances implies that the "adjudication" was through the regulatory review process for those original devices and subsequent literature review for this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- An MRMC comparative effectiveness study is not mentioned or described in the provided text.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- This device is a laser system, not an algorithm. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance) study" is not applicable. The device is designed for human operation.
7. Type of Ground Truth Used
- For the Pain Therapy indication's clinical test: The ground truth appears to be based on direct clinical assessment of patient responses to "Pain Therapy" (e.g., pain relief, symptom change), as implied by "performance data demonstrated that the device can perform the pain therapy as described in the indication for use safely and effectively." It is not explicitly stated as expert consensus, pathology, or specific outcomes data, but rather the observed clinical effect in human subjects.
- For other indications: The ground truth rests on the established safety and effectiveness of the predicate devices for their cleared indications, supported by literature review.
8. Sample Size for the Training Set
- This device is a hardware system, not an AI/ML algorithm that requires a "training set" in the conventional sense. Therefore, the concept of a "sample size for the training set" is not applicable.
9. How the Ground Truth for the Training Set Was Established
- As above, the concept of a "training set" and its ground truth establishment is not applicable to 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.