(247 days)
The Depilite EL-8b DERMO FLASH TM Model A system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction.
The Depilite EL-8b DERMO FLASH TM Model SX-513a system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction.
The Depilite EL-8b DERMO FLASH TM Model SX-513c system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction, and treatment of vascular and benign pigmented lesions and inflammatory acne.
The Depilite EL-8b DERMO FLASH TM Model C system is a microprocessor-controlled dual nonablative xenon flash lamp-based medical device designed for permanent hair reduction, and treatment of vascular and benign pigmented lesions and inflammatory acne.
The Depilite EL-8b Series DERMO FLASH™ devices are microprocessorcontrolled nonablative light-based medical devices which use pulsed xenon lamps to deliver a selectable range of polychromatic light outside the range of harmful ultraviolet wavelengths leaving only the visual and infrared light to be presented for photo thermolysis epilation and skin treatments. Pre-set and manual delivery parameters - such as the appropriate wavelength, energy, pulse rate and exposure time - and other system features are modulated from the display and control panel on the main unit. The corresponding fluence is delivered through an air-cooled double lamp hand piece without making contact with the treated area (Non Contact Pulsed Light or NCPL™). The complete system consists of the Depilite EL-8b DERMO FLASH™ machine, a photothermolysis handle with treatment head, keys for main switch, a foot switch, electric power cable, protective goggles, and instruction manual.
Here's an analysis of the provided 510(k) summary regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) documentation does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics from a clinical study. The submission instead focuses on demonstrating substantial equivalence to predicate devices for specific "Indications for Use."
The "performance" is implicitly deemed acceptable if the device is found substantially equivalent to predicate devices already on the market with established safety and efficacy for the stated indications.
Implicit Acceptance Criteria (based on "Indications for Use" and substantial equivalence):
| Acceptance Criteria Category | Specific Criteria (Implicit) | Reported Device Performance (Implicit via Substantial Equivalence to Predicate Devices) |
|---|---|---|
| Intended Use | The device should be safe and effective for: |
- Permanent hair reduction
- Treatment of vascular lesions
- Treatment of benign pigmented lesions
- Treatment of inflammatory acne
(Applicable models vary as per specific Indications for Use statements) | The Depilite EL-8b Series DERMO FLASH™ Systems are "substantially equivalent to other legally-marketed flash light-based medical devices in U.S. commercial distribution for the same dermatological applications." This implies similar performance to predicates for these indications. |
| Safety | The device should be non-ablative, use polychromatic light outside harmful UV wavelengths, and comply with mandatory special controls (21 C.F.R. Part 1040 – Performance Standards for Light-Emitting Products). The differences in specifications from predicate devices should not raise new questions of safety. | The device is described as "microprocessor-controlled nonablative light-based medical devices which use pulsed xenon lamps to deliver a selectable range of polychromatic light outside the range of harmful ultraviolet wavelengths." It also states compliance with 21 C.F.R. Part 1040. |
| Efficacy | The device should achieve the intended clinical effects for permanent hair reduction, and treatment of vascular/benign pigmented lesions and inflammatory acne. The differences in specifications from predicate devices should not result in different performances or raise new questions of efficacy. | Substantial equivalence to predicate devices is the sole basis for efficacy. The document does not provide direct efficacy data for the device itself. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a specific clinical study with a "test set" for the Depilite EL-8b Series DERMO FLASH™ Systems. The basis for clearance is Substantial Equivalence to predicate devices. Therefore, there is no sample size or data provenance provided for a test set of this specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
As no specific test set clinical study for the Depilite EL-8b Series DERMO FLASH™ Systems is described, there is no information provided on the number or qualifications of experts used to establish ground truth.
4. Adjudication Method for the Test Set
Since no specific test set clinical study is described, there is no adjudication method provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned or described in the provided documentation. The clearance is based on substantial equivalence to existing devices, not a direct comparison of human readers with significant AI assistance. The device is a direct treatment device, not an AI diagnostic aid for human readers.
6. Standalone Performance Study
The 510(k) submission does not describe a standalone performance study (i.e., algorithm only without human-in-the-loop) for the Depilite EL-8b Series DERMO FLASH™ Systems. This device is a direct energy delivery system, not a diagnostic or AI algorithm in the traditional sense that would have "standalone performance" in terms of accuracy metrics. Its performance is tied to its physical output and clinical effect.
7. Type of Ground Truth Used
The documentation does not specify a type of ground truth used for evaluating the Depilite EL-8b Series DERMO FLASH™ Systems, as it relies on substantial equivalence. For the predicate devices, it would have been clinical outcomes (e.g., hair reduction, lesion clearance) established through clinical trials.
8. Sample Size for the Training Set
The provided documentation does not describe any "training set" as this is a physical medical device and not an AI/machine learning algorithm requiring a training phase in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
As there is no described training set, there is no information on how ground truth for a training set was established.
Summary of Approach:
This 510(k) clearance for the Depilite EL-8b Series DERMO FLASH™ Systems relies entirely on the concept of Substantial Equivalence. This means the manufacturer demonstrated to the FDA that their device is as safe and effective as a legally marketed predicate device(s) that already exist on the market. They achieve this by comparing the technological characteristics, intended use, and indications for use of their device to those of the predicate devices. They then argue that any differences do not raise new questions of safety or efficacy. Therefore, the detailed clinical study data, acceptance criteria, and ground truth methodologies associated with this specific device are not presented as they typically would be for a novel device or a device undergoing a PMA. Instead, the "proof" is the established safety and efficacy of the predicate devices.
§ 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.