(42 days)
The BEAMAX/ FORMAX Pulsed Light Device Family and optional Handpies family are intended for use in aesthetic and cosmetic applications and in selective treatments required in the medical specialties of dermatology.
The BEAMAX/ FORMAX Pulsed Light Device Family and optional Handpies family with 415 - 950 nm wavelengths (with and without contact-cooling) are indicated for:
- Hair removal in all skin types (I-VI) to the Fitzpatrick scale. Permanent Hair Reduction. - Recommended wavelengths in the range of 635-950 nm or 580-950 nm
- Treatment of Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale -Recommended wavelength in the range of 535-950 nm
- Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 535-950 nm
- Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 415-950 nm
The proposed BEAMAX/ FORMAX family system is a pulsed light energy device based on a filtered, Xenon flashlamp.
The total emission spectrum of a Xenon flashlamp is from around 300 nm in the UV to 1000 nm in the near IR. The light emitted from the lamp is collected by a reflector and focused into a rectangular, waveguide. Prior to entering the waveguide, the light is transmitted through a longpass optical filter which blocks all wavelengths below the "cut-off" wavelength of the filter. Thus when a 635nm filter is used, only light of wavelengths above 635 nm is emitted. Since the lamp is surrounded by a water cooling jacket, actual wavelength emission is up to about 950 nm, due to water absorption of longer wavelengths.
The BEAMAX/FORMAX family system is equipped with four different handpieces which can be attached for different clinical applications. These handpieces differ in the optical filter applied, hence in the optical spectrum emitted, as well as in the time duration of the pulses emitted. A microprocessor based system controller is used to monitor and direct all system functions and Man Machine Interface.
The provided document is a 510(k) summary for the BEAMAX/ FORMAX Pulsed Light Device Family. This document focuses on demonstrating substantial equivalence to predicate devices rather than conducting a new clinical study to establish acceptance criteria and device performance from scratch. Therefore, many of the typical elements of a study that prove a device meets acceptance criteria are not present.
However, based on the information provided, here's an attempt to answer the request by interpreting "acceptance criteria" as the criteria for substantial equivalence, and "study" as the comparison to predicate devices:
Acceptance Criteria and Device Performance Study for BEAMAX/FORMAX Pulsed Light Device Family
Overview
The BEAMAX/FORMAX Pulsed Light Device Family sought 510(k) clearance by demonstrating substantial equivalence to legally marketed predicate devices, as opposed to conducting a de novo clinical trial with new performance acceptance criteria. The "acceptance criteria" here therefore refer to the criteria for substantial equivalence, and the "reported device performance" is framed by its similarity to the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a substantial equivalence submission, the "acceptance criteria" are the conditions under which the device is considered substantially equivalent to already cleared devices. The "reported device performance" is essentially that it matches or is comparable to these predicate devices for the specified indications.
| Criteria Category | Acceptance Criteria (for Substantial Equivalence to Predicate Devices) | Reported Device Performance (as demonstrated by comparison) |
|---|---|---|
| Intended Use | Identical to legally marketed predicate devices. | The intended use and indications of the submitted BEAMAX/FORMAX family are identical to legally marketed devices: BEAMAX (K063249), Harmony XL™ (K072564), and Cutera (K050047). |
| Indications for Use | Identical or comparable to legally marketed predicate devices, without raising new questions of safety/effectiveness. | The proposed device family includes broader indications than a prior BEAMAX (K063249) but is similar to the broader IPL indications of Harmony XL™ (K072564) and Cutera (K050047). No new questions of safety or effectiveness are raised. |
| Technological Features | Similar technology, performance, and specifications to legally marketed predicate devices. | The device is a pulsed light energy device based on a filtered Xenon flashlamp, similar to the predicate devices. It operates with a total emission spectrum of 300 nm to 1000 nm, and uses longpass optical filters to block specific wavelengths. Specific handpieces cater to different applications, similar to predicate devices. |
| Risks and Benefits | Comparable to predicate devices. | Due to similarity in intended use, indications, and technological features, the risks and benefits are comparable to the predicate devices. |
| Safety & Effectiveness | No new questions of safety or effectiveness are raised. | The submission states that "there are no new questions of safety or effectiveness raised by the introduction of SharpLight's BEAMAX/FORMAX Fluorescent Pulsed Light Systems." |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not applicable in the context of a 510(k) substantial equivalence submission, as direct human clinical outcome data from a "test set" for the new device is not provided. The "test" here is the comparison against the characteristics and established safety/effectiveness of predicate devices already on the market.
- Data Provenance: The "data" for comparison comes from the regulatory filings and established performance of the identified predicate devices, which are already marketed in the US. There is no mention of country of origin for new clinical data, nor is there a distinction between retrospective or prospective data for a newly conducted study for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. Ground truth, in the context of a 510(k) for substantial equivalence, is established by the FDA's prior clearance of the predicate devices based on their safety and effectiveness. No new expert consensus panel was convened for this specific submission to establish a "ground truth" for a new test set.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Since there's no new test set with human subject data requiring expert review and adjudication for this submission, no adjudication method like 2+1 or 3+1 was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The documentation focuses on technological and indications-for-use equivalence rather than human reader performance with or without AI assistance. The device is a pulsed light system, not an AI diagnostic tool that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This device is an energy-based medical device (pulsed light system), not an algorithm or AI system. Its performance is inherent in its physical operation and energy delivery for therapeutic purposes.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The new device's characteristics, intended use, and indications are compared against these established "truths" to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. As there is no training set for an AI/ML algorithm for this device, there is no ground truth established for such a set.
§ 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.