(28 days)
The THUNDER Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows.
1064 nm (pulsed)
Dermatology/Plastic Surgery:
Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis.
The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
The laser is also indicated for the treatment of facial wrinkles.
Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months affer the completion of a treatment regime.
It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The laser is also indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
It is indicated for use on all skin types (Fitzpatrick I-VI ) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.
755 nm (pulsed)
Indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
Skin Cooler
The intended use of the integrated cooling system in the Thunder family is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments.
This Special 510(k) of the modified device Thunder family is submitted due to Device Modifications of the already cleared device EVO family (K160368) due to hardware and software change, together with a broadening of the range of some laser emission parameters.
This document details a 510(k) premarket notification for the "Thunder" family of laser devices, focusing on modifications made to an already cleared device, the "EVO family" (K160368). The submission aims to demonstrate substantial equivalence to the predicate device despite hardware and software changes and a broadening of laser emission parameters.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states: "There are no mandatory performance standards for this device." This implies that specific quantitative acceptance criteria in terms of device accuracy, sensitivity, or specificity (as one might find for diagnostic AI models) are not applicable or provided within this submission.
Instead, the acceptance criteria are framed in terms of compliance with established safety and performance standards for medical electrical equipment and laser products. The reported "performance" is that the modified device "successfully passed" these tests.
| Acceptance Criteria Type | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Safety | IEC 60601-1: 2012 (General requirements for basic safety and essential performance) | Passed |
| IEC 60601-1-2:2014 (Electromagnetic disturbances - Requirements and tests) | Passed | |
| IEC 60601-2-22:2007+ A1:2012 (Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment) | Passed | |
| IEC 60825-1: 2014 (Safety of laser products -- Part 1: Equipment classification and requirements) | Passed | |
| Usability | EN 60601-1-6:2010 + A1:2013 (General requirements for basic safety and essential performance - Collateral Standard: Usability) | Passed |
| Functional/Hardware | Evidence that "hardware and software change, together with a broadening of the range of some laser emission parameters" does not alter the intended use or safety/effectiveness compared to the predicate device. This is implicitly tested by passing the safety/EMC tests. | Device maintains same intended use as unmodified device. |
| Software | Software verifications and validation (as per internal protocols and relevant standards, implicitly covered by IEC 60601 series) | Successfully passed |
2. Sample Size Used for the Test Set and Data Provenance:
No information is provided regarding a "test set" in the context of clinical data or patient samples. The testing described is against engineering and safety standards, not a clinical dataset. Therefore, there is no mention of sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). This device is a laser system for surgical/dermatological applications, not a diagnostic AI device requiring clinical ground truth for validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable. The "ground truth" for this device revolves around its compliance with safety and performance engineering standards, not medical diagnoses. Therefore, there's no mention of experts establishing a clinical ground truth for a test set.
4. Adjudication Method for the Test Set:
Not applicable, as there is no clinical test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
Not applicable. This device is a laser system for treatment, not a diagnostic tool that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable in the typical sense of an AI algorithm. The device, as a laser system, operates "standalone" in that its hardware and software functions are tested independently of a human operator making a diagnostic decision. However, its intended use is always with a human operator. The performance testing focuses on the device's adherence to engineering specifications and safety standards as an independent unit.
7. The Type of Ground Truth Used:
The ground truth used for this device is compliance with established international and harmonized engineering and safety standards (e.g., IEC 60601 series, IEC 60825-1). This is a technical "ground truth" as opposed to a clinical or pathological ground truth:
- Safety Standards: Adherence to defined limits for electrical safety, EMI/EMC, laser output, etc.
- Performance Standards: The device meets its specified technical parameters (e.g., laser wavelength, power, pulse duration) within acceptable tolerances, which is evaluated during performance testing.
- Usability Standards: The device's user interface and operational aspects meet usability requirements.
8. The Sample Size for the Training Set:
Not applicable. This is a physical device (laser system), not an AI model trained on a dataset. There is no concept of a "training set" for the device itself or its modifications as described in this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of 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.