(48 days)
The Energist ULTRA™ VPL Intense Pulsed Light System is intended for permanent hair reduction and the treatment of mild to moderate inflammatory Acne Vulgaris. 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 mild to moderate inflammatory Acne Vulgaris.
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 longterm or permanent 1 hair reduction in skin types I - V through selective targeting of melanin in hair follicles.
1 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
The Energist ULTRA VPL™ System is a light based medical device that delivers a beam of pulsed non-ionising radiation in the region of 530nm. The system is designed to be compact and self contained and includes the following features:
- . Control console unit
- Display panel .
- Power supply ◆
- Cooling system .
- . Removable handpiece with integrated switch, lamp, filter and glass coupling block
Here's an analysis based on the provided text:
Based on the provided 510(k) summary, the Energist ULTRA Variable Pulsed Light (VPL™) System did not undergo a study to prove it met specific quantitative acceptance criteria in the manner described in your request. Instead, the submission relies on demonstrating substantial equivalence to previously legally marketed predicate devices.
The document states: "Performance data was provided to demonstrate that the system is capable of providing the outputs necessary to achieve its required treatment parameters." However, it does not detail the specific performance criteria or the results of such data.
Therefore, the requested tables and detailed study information for acceptance criteria cannot be fully extracted from the provided text, as this type of information is generally not required for a 510(k) submission when substantial equivalence is the primary pathway.
Here's what can be inferred or stated based on the text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as quantitative metrics (e.g., specific clinical outcomes, percentages of reduction, safety thresholds). The implicit acceptance criteria are that the device performs equivalently to the predicate devices in terms of intended use and technological characteristics, and that any modifications do not raise new questions of safety or efficacy.
- Reported Device Performance: The document only generally states: "Performance data was provided to demonstrate that the system is capable of providing the outputs necessary to achieve its required treatment parameters." No specific quantitative performance results are provided in this summary.
| Acceptance Criteria (Inferred from substantial equivalence approach) | Reported Device Performance (General Statement) |
|---|---|
| Equivalent intended use to predicate devices | Categorically stated as having "identical intended use" as the McCue predicate system. |
| Equivalent technological characteristics (or differences don't impact safety/efficacy) | Stated as having "identical technological characteristics except for modifications to the device software and high voltage component. These differences do not result in differences in performance or raise new questions of safety and efficacy." Also, "equivalent energy outputs" to the Cyden predicate. |
| Capable of providing outputs for required treatment parameters | "Performance data was provided to demonstrate that the system is capable of providing the outputs necessary to achieve its required treatment parameters." |
2. Sample Size Used for the Test Set and Data Provenance:
No information is provided about a specific clinical "test set" with a defined sample size for the device's performance. The submission relies on equivalence to predicate devices, which would have had their own clinical data for market clearance.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable, as a de novo clinical study with expert ground truth establishment for this specific device's clinical performance is not described.
4. Adjudication Method:
Not applicable, as a de novo clinical study with expert adjudication is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No mention of an MRMC study. This type of study is more common for diagnostic imaging AI systems comparing human readers with and without AI assistance, which is not the nature of this device.
6. Standalone Performance Study:
No mention of a standalone performance study in the context of clinical outcomes to establish effectiveness. The "performance data" mentioned is likely related to engineering and output parameters rather than clinical efficacy.
7. Type of Ground Truth Used:
Not applicable for this 510(k) summary, as it does not describe a new clinical study for this device where "ground truth" for clinical outcomes would be established for the purpose of a novel efficacy claim.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/Machine Learning device that utilizes a "training set" in the conventional sense.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as the device is not an AI/Machine Learning system with a "training set."
Summary of 510(k) Substantial Equivalence Approach:
The Energist ULTRA VPL™ System's clearance is based on demonstrating substantial equivalence to two predicate devices: McCue Energist ULTRA™ (K040659) and Cyden IFL Professional System (K050165).
- Identical Intended Use: The new device claims an "identical intended use" to the McCue predicate device.
- Identical Technological Characteristics (with minor differences): The new device claims "identical technological characteristics" to the McCue predicate, except for "modifications to the device software and high voltage component." The key assertion is that "These differences do not result in differences in performance or raise new questions of safety and efficacy."
- Equivalent Principles, Mode of Action, and Energy Outputs: For the treatment of Acne Vulgaris, the device is stated to have "the same principles of operation, mode of action and equivalent energy outputs" as the Cyden predicate device.
Therefore, the "study" proving the device met "acceptance criteria" was implicitly the comparison to the predicate devices and the argument that its minor modifications did not negatively impact safety or efficacy, supported by general "performance data" (likely engineering/bench testing) showing it could achieve output parameters.
§ 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.