(65 days)
The Er:YAG handpiece is designed specificial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coaqulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
The IPL Handpiece is indicated for use in skin types I-IV according to the Fitzpatrick Scale for the following indications:
Hair Removal (650nm filter) Permanent hair reduction (650nm filter) Treatment of vascular lesions (510nm filter) Treatment of benign pigmented lesions (510 nm filter) Mild to Moderate inflammatory acne (450nm filter)
The Apex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. There are 2 handpieces with the system. One is an Er: YAG laser which contains the laser cavity in the head of the handpiece. The second is an Intense Pulsed Light. These handpieces can be removed by the user and interchanged. The Er:YAG Laser energy produced within the device is delivered to the tissue in a wavelength of 2940nm. The Intense Pulsed Light wavelengths are 450nm - 1200nm The user activates laser and IPL emission by means of a footswitch.
The provided document is a 510(k) summary for the Apex Er:YAG / IPL System. This type of submission focuses on demonstrating substantial equivalence to pre-existing devices, rather than proving novel effectiveness through new clinical studies. As such, the document explicitly states there is no performance data and no results of a clinical study provided for the Apex Er:YAG / IPL System itself.
Therefore, the following information, typically found in a clinical study report for device acceptance, is not available in the provided document:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method for the test set
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
- Whether a standalone (algorithm only) performance study was done
- The type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
However, based on the provided text, here's what can be stated about the acceptance criteria and the study that "proves" the device meets them within the context of a 510(k) submission:
1. Acceptance Criteria and Device Performance:
For a 510(k) submission, the "acceptance criteria" are typically defined by demonstrating substantial equivalence to legally marketed predicate devices. The "device performance" is shown through a comparison of technological characteristics and intended uses.
- Acceptance Criteria (Implicit for 510(k)): The device must be substantially equivalent to predicate devices in terms of intended use, technological characteristics, and safety and effectiveness. This means the new device should not raise new questions of safety or effectiveness.
- Reported Device Performance (as demonstrated for 510(k) equivalence): The document provides a comparison of the Apex Er:YAG / IPL System with its predicate devices.
| Feature | Apex Er:YAG / IPL (IPL component) | Apollo Mini IPL System (Predicate) | Apex Er:YAG / IPL (Er:YAG component) | MLT Erbium:YAG Laser System (Predicate) |
|---|---|---|---|---|
| Light Source | Pulsed Incoherent Light | Pulsed Incoherent Light | N/A (Laser) | N/A (Laser) |
| Max Fluence | Up to 35 J/cm² | Up to 35 J/cm² | 5 J/cm² | 5 J/cm² |
| Wavelength | 450 - 1200 nm | 450 - 1200 nm | 2940 nm | 2940 nm |
| Spot Size | 35 x 15 mm² | 35 x 15 mm² | 1.5mm, 3mm, 6mm, 9mm | 1.5mm, 3mm, 6mm, 9mm |
| Pulse Width | Up to 200 ms | Up to 200 ms | 300 µs | 300 µs |
| Beam Delivery | Light Guide | Light Guide | N/A | N/A |
| Max Power | N/A | N/A | 2.4 W | 2.4 W |
| Repetition Rate | N/A | N/A | Up to 10 pulse per second | Up to 10 pulse per second |
2. Study that proves the device meets the acceptance criteria (Substantial Equivalence):
The "study" in this context is a comparison of technological characteristics and intended uses against legally marketed predicate devices, rather than a de novo clinical trial.
- Type of Study: Predicate device comparison for substantial equivalence.
- Data Provenance: The data is a comparison of technical specifications provided by the manufacturer against the specifications of the identified predicate devices. It is not derived from retrospective or prospective patient data from a specific country.
- Sample Size: Not applicable. This is not a study involving patient or image data. The comparison is feature-by-feature.
3. & 4. Experts and Adjudication:
- Number of Experts/Qualifications: Not applicable. The 510(k) process for this device did not involve expert review or adjudication of patient cases or images to establish a ground truth. The comparison relies on documented technical specifications.
- Adjudication Method: Not applicable.
5. Multi-reader Multi-case (MRMC) Comparative Effectiveness Study:
- MRMC Study Done: No. The document explicitly states "Results of Clinical Study: None."
6. Standalone (Algorithm Only) Performance:
- Standalone Study Done: No. This device is a physical laser/IPL system, not an algorithm. The document explicitly states "Performance Data: None."
7. Type of Ground Truth:
- Ground Truth Used: Not applicable in the traditional sense of a clinical study. The "ground truth" for a 510(k) is the established performance and safety of the predicate devices. The new device is accepted if it is shown to have similar characteristics and intended uses that do not raise new questions of safety or effectiveness.
8. & 9. Training Set and Ground Truth for Training Set:
- Sample Size for Training Set: Not applicable. This is not an AI/ML device requiring a training set.
- How Ground Truth for Training Set was Established: Not applicable.
§ 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.