(561 days)
The Epi-Star Surgical Laser System is for Plastic Surgery The and Dermatology, intended use for the treatment of vascular and pigmented lesions in dermatology, and for the removal of hair.
The Nidek Epi-Star Surgical Laser System consists of a moveable console containing power supplies, aiming and treatment lasers on a solid optical rail, and a cooling mechanism to dissipate the heat generated by the system. A touch key pad control panel with alphanumeric displays that enables the user to control the laser systems operating parameters. The Epi-Star Surgical Laser System is a "Long Pulse Diode Laser" which operates at a wavelength of 800 nm, using a Near Infrared Diode Laser Array lasing medium. The system uses a separate laser diode for its aiming beam (635 nm) and the system has a Fluence Range of up to 50 Joules/cm2, variable Frequency Range (Repeat Rate) up to 15 Hz, and variable Pulse Width (Pulse Duration) up to 100 msec.
The Nidek Epi-Star Diode Surgical Laser System is a medical device intended for plastic surgery and dermatology, specifically for the treatment of vascular and pigmented lesions and for hair removal.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Predicate Device Equivalence | The Epi-Star system must be substantially equivalent to currently marketed predicate devices in terms of indications for use, design, methods of operation, physical construction, and functional/performance features. | The Epi-Star system is stated to be exactly the same as the Nidek Dio-Light 60 Diode Surgical Laser System (K981447) except for the intended use for hair removal, and shares the same design, functional, and performance features. It is also compared to other legally marketed predicate devices and found to have the same or similar design, functional, and performance features. |
| Safety and Effectiveness | The device must be safe and effective for its indicated uses. | The submission states that safety and effectiveness are reasonably assured, especially for hair removal, based on the information provided, and through design control procedures. |
| Regulatory Compliance | Manufacturing and design must comply with 21 CFR 1040.10 and 1040.11 (FDA regulations for Medical Laser Products). | The device is manufactured and designed to comply with these requirements. |
2. Sample Size Used for the Test Set and Data Provenance
No test set was described. The submission explicitly states "Clinical Performance Data: None presented" (Section VII) and "Non-Clinical Performance Data: None presented" (Section VIII). The basis for clearance is substantial equivalence to predicate devices, not direct testing on a new dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. No test set was used, and therefore no experts were required to establish ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable. No test set was used.
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 device is a laser system, not an AI-powered diagnostic tool, and no MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a laser surgical system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of device performance testing. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices to which the Epi-Star system is being compared.
8. The sample size for the training set
Not applicable. As this is a physical medical device (laser system) and not an AI/algorithm, there is no "training set" in the conventional sense.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
Summary of the Study Proving Acceptance Criteria:
The Nidek Epi-Star Diode Surgical Laser System gained regulatory clearance through the 510(k) pathway based on a demonstration of substantial equivalence to already legally marketed predicate devices, rather than through new clinical or non-clinical performance studies.
The core of the "study" demonstrating that the device meets acceptance criteria is a comparison of the Epi-Star's specifications and features against those of several predicate devices.
- Rationale for Substantial Equivalence (Section IX): The submission argues that the Epi-Star is "exactly the same" as the Nidek Dio-Light 60 Diode Surgical Laser System (K981447) in methods of operation, physical construction, and design, functional, and performance features, with the only difference being the intended use for hair removal. It also asserts that the Epi-Star shares "the same or similar design, functional, and/or performance features" with other predicate devices (Coherent/Palomar LightSheer, Sharplan Lasers EpiTouch ALEX, Candela Corp. GentleLASE, Cynosure Inc. Photogencia LPIR).
- Documentation: The comparison details are expected to be provided in "Appendix B, Substantial Equivalence Comparison" (though Appendix B is not included in the provided text).
- Safety and Effectiveness Justification (Section X & XI): The safety and effectiveness are "reasonably assured" because the device is substantially equivalent to predicates that are already deemed safe and effective. Design control procedures (mentioned in Appendix E) and safety features (in Appendix D, "DEVICE DESCRIPTION") are also cited to ensure safe use.
In essence, the "study" is a document-based comparison that leverages the prior regulatory clearance and established safety/effectiveness profiles of similar devices already on the market. No new clinical trials or performance evaluations with human subjects or dedicated test datasets were conducted or presented for the Epi-Star device itself in this submission.
§ 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.