(81 days)
The McCue Energist ULTRATM VPL Intense Pulsed Light System is intended for permanent hair reduction. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels and the treatment of benign pigmented lesions.
- Intense Pulsed light Energy / wavelengths (530 950nm) .
The 530-950nm intense pulsed wavelengths are indicated for :
The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae.
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins, facial veins and venous malformations.
- Intense Pulsed light Energy / wavelengths (610 950nm) .
The 610-950nm intense pulsed wavelengths are indicated for :
The removal of unwanted hair from all skin types, and to effect stable long-term or permanent " hair reduction in skin types I - V through selective targeting of melanin in hair follicles.
11 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
The McCue Energist ULTRA™ is a light-based medical device that delivers a beam of pulsed non-ionising radiation in the region of 530nm to 950nm. The system has been designed to be compact and self-contained that includes: Control console unit Display panel Power supply Cooling system Removable handpiece with integrated switch, lamp, filter and glass coupling block
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study information for the McCue Energist ULTRA™ Pulsed Light System.
It's important to note that the provided text is a 510(k) Summary, which is a high-level overview. For detailed study protocols, raw data, and comprehensive acceptance criteria, one would typically need to consult a full 510(k) submission or scientific publications.
Acceptance Criteria and Device Performance
The provided 510(k) Summary, K040659 for the McCue Energist ULTRA™ Pulsed Light System, does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics in a table format as might be found in a clinical study report.
Instead, the submission relies on the concept of substantial equivalence to predicate devices. The primary "performance data" statement is qualitative:
"The differences in specifications of the McCue Energist ULTRA™ and the predicate devices do not result in different performance or raise new questions of safety and efficacy."
This indicates that the device is deemed to meet acceptance criteria by demonstrating that its technical specifications and intended uses are similar enough to already legally marketed devices that it does not introduce new safety or efficacy concerns. Therefore, the "acceptance criteria" are implicitly met by being substantially equivalent to the predicates.
Given this, a table of explicit acceptance criteria and corresponding performance cannot be generated directly from the provided text.
Study Information
Based on the provided 510(k) Summary, there is no detailed human or animal clinical study data presented to "prove the device meets acceptance criteria." The submission relies on substantial equivalence to predicate devices, meaning it leverages the established safety and effectiveness of those previously cleared devices.
Here's a breakdown of the requested information, mostly indicating what is not explicitly provided in the summary:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantitative targets (e.g., "90% hair reduction," "lesion clearance in X% of patients"). The acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices.
- Reported Device Performance: Not detailed in quantitative terms for efficacy. The performance is indirectly supported by the statement that "differences in specifications... do not result in different performance or raise new questions of safety and efficacy" compared to the predicate devices.
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Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- No specific sample size for a test set is mentioned. No clinical study data is detailed in this summary.
- Data Provenance: Not applicable as specific study data is not presented.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable as no specific test set or ground truth establishment based on expert review is described. The assessment is based on comparison to predicate devices and their established safety/efficacy.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no specific test set requiring adjudication is described.
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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:
- No MRMC study was done or reported. This device is an Intense Pulsed Light System, not an AI-powered diagnostic tool, so an MRMC study with human readers and AI assistance would not be relevant in this context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical light-based treatment device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for a new clinical study. The "ground truth" for the device's safety and efficacy is implicitly derived from the existing clearances and performance history of the predicate devices.
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The sample size for the training set:
- Not applicable as this is a physical medical device, not a machine learning algorithm requiring a training set.
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How the ground truth for the training set was established:
- Not applicable as this is a physical medical device, not a machine learning algorithm.
Summary of Findings from K040659:
The 510(k) summary for the McCue Energist ULTRA™ Pulsed Light System primarily focuses on demonstrating substantial equivalence to a list of previously cleared predicate devices (Lumenis IPL Quantum, Radiancy SpaTouch/Skin Station, Palomar EsteLux, Alderm/MBC Prolite/Plasmalite).
The basis for this substantial equivalence is the claim that "The differences in specifications of the McCue Energist ULTRA™ and the predicate devices do not result in different performance or raise new questions of safety and efficacy."
Therefore, this submission does not present detailed clinical study data, sample sizes, expert ground truth establishment, or specific performance metrics from a new study of the McCue Energist ULTRA™ itself. Instead, its acceptance is based on the premise that it is sufficiently similar to devices already proven safe and effective.
§ 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.