(92 days)
The Intended Use for Ellipse I2PL is:
Ellipse 12PL. is intended for use in dermatology.
- · Hair removal (permanent hair reduction).
- · Treatment of benign pigmented lesions (including, but not limited to solar lentigines, ephilides, mottled pigmentation) and benign vascular lesions (diffuse redness).
The Indications for Use for Ellipse I2PL are:
| Application | Treatment Variable | Fitzpatrick Skin Type | |||||
|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 6 | ||
| Hair Removal | |||||||
| HR Applicator | |||||||
| HR-S Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ⊖ |
| Hair Removal | |||||||
| HR-D Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Treatment of Benign Pigmented Lesions | |||||||
| And Benign Vascular Lesions | Pigmentation | ✓ | ✓ | ✓ | ✓ | ⊖ | ⊖ |
| Note: Patients with darker Fitzpatrick Skin Types (4 or above) or who are suntanned should always be treated with extra care and | |||||||
| attention. | |||||||
| Key: ✓ Allowed; ⊖ Not Allowed |
Ellipse If PL is an Intense Pulsed Light (IPL) system used for long-term removal of unwanted hair and for treatment of sun-damaged skin, including uneven pigmentation, age spots, large pores and diffuse redness in the area of dermatology.
The system consists of a console containing power unit and control electronics with control and display panel including software.
Applicators/hand-pieces are connected to the system in order to generate light energy for treatment in the waveband 555 nm - 950 nm.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study information for the Danish Dermatologic Development A/S (DDD) Ellipse I2PL dermatologic IPL system:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results with specific acceptance criteria and performance metrics for the device itself. Therefore, many of the requested details about specific study designs, sample sizes, ground truth establishment, and expert involvement are not explicitly present in this type of document. 510(k) clearances are often based on performance testing to ensure safety and functionality, and comparison to legally marketed predicate devices, rather than large-scale clinical trials proving efficacy against predefined acceptance criteria in the same way a PMA would require.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission, the "acceptance criteria" are not framed as specific performance thresholds that the device had to meet in independent clinical trials. Instead, the acceptance criteria are implicitly that the device's technical specifications and intended uses are substantially equivalent to legally marketed predicate devices. The "reported device performance" is essentially the device's capabilities and parameters, which are then compared to those of the predicate devices.
| Feature / Criterion (Implicit) | Ellipse I2PL Performance (Reported) | Corresponding Predicate Performance (for comparison) |
|---|---|---|
| Intended Use | Hair removal (permanent reduction) and treatment of benign pigmented and vascular lesions. | Matches or is a subset of predicate device intended uses (e.g., IPL™ Quantum, Skin Station™, EsteLux™). |
| Technology | Intense Pulsed Light (IPL) / broad spectrum light / touch screen operation. | Matches predicate devices (IPL™ Quantum, Skin Station™, EsteLux™). |
| Energy Spectrum | 555-950 nm | Predicates varied: 515-1200 nm (IPL™ Quantum), 400-1200 nm (Skin Station™), 470-1400 nm (EsteLux™). Ellipse I2PL's range falls within or overlaps these. |
| Energy Output/Setting | 0-21 J/cm² | Predicates varied: 15-45 J/cm² (IPL™ Quantum), 3-10 J/cm² (Skin Station™), 12-40 J/cm² (EsteLux™). Ellipse I2PL's range overlaps. |
| Pulse Duration | 5-55 mS | Predicates varied: 2-16 mS (to 48 mS triple pulsed) (IPL™ Quantum), 10 and 35 mS (Skin Station™), 10-100 mS (EsteLux™). Ellipse I2PL's range overlaps. |
| Applicator/Hand-piece Spot Size | 10 x 48 mm | Predicates varied: 8 x 34 mm (IPL™ Quantum), 22 x 55 mm and 35 x 12 mm (Skin Station™), various from 10x15mm to 16x46mm (EsteLux™). Ellipse I2PL's spot size is comparable to predicate devices. |
| Charge Time/Repetition Rate | 1.5-2.0 Sec. | Predicates: 2 Sec. (IPL™ Quantum), N/A (Skin Station™), 1 Sec. (EsteLux™). Ellipse I2PL's rate is comparable. |
| Cooling Method | Cooling handpiece by circulating water. | Predicates varied: Skin cooling components integrated in hand piece (IPL™ Quantum), N/A (Skin Station™), Skin cooling possible with Cool Roller™ (EsteLux™). Ellipse I2PL cooling method is similar or equivalent. |
| Patient Skin Types (Hair Removal) | Fitzpatrick Skin Types 1-5 (HR/HR-S applicators), 1-6 (HR-D applicator). | Implicitly equivalent to predicate devices' safe operating parameters. |
| Patient Skin Types (Pigmented/Vascular Lesions) | Fitzpatrick Skin Types 1-4. | Implicitly equivalent to predicate devices' safe operating parameters. |
The "study" that proves the device meets the acceptance criteria is the 510(k) submission itself, which primarily relies on comparison and demonstration of substantial equivalence to predicate devices, rather than a de novo clinical trial with specific performance endpoints. The conclusion explicitly states: "Based on this analysis of the overall performance characteristics of the mentioned predicate devices Danish Dermatologic Development A/S believes that no significant differences exist. The Ellipse I-PL system should not raise new issues of safety and effectiveness and is judged to be substantially equivalent to the mentioned predicate devices."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. 510(k) submissions generally do not include detailed clinical study reports with patient sample sizes. The "test set" here refers to the parameters and specifications of the device being compared to predicates. Performance claims for the device would have been supported by internal testing and possibly limited clinical data, but the specifics are not in this summary.
- Data Provenance (country of origin, retrospective/prospective): Not specified in this 510(k) summary. Given the manufacturer is Danish, internal testing might have been done in Denmark or in collaboration with clinical sites.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- For a 510(k) based on substantial equivalence, ground truth for device performance is often established by engineering and medical professionals within the company and/or by referring to published literature and the established performance of the predicate devices. Clinical efficacy data, if used, would typically refer to assessments by qualified dermatologists or medical practitioners.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. This level of detail regarding clinical study methodology (like adjudication) is typically not found in a 510(k) summary unless a specific clinical study was a critical part of the equivalence claim, which is not the case here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, the provided 510(k) summary does not indicate that an MRMC comparative effectiveness study was performed. The evaluation focuses on the device's technical specifications and intended use in comparison to predicate devices, not on human reader performance with or without AI assistance.
- Effect size of AI improvement: Not applicable, as no MRMC study with AI assistance is mentioned.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Not explicitly stated in terms of a formal standalone clinical study report. The device itself (an IPL system) is a standalone technology, meaning it operates independently of "human-in-the-loop" performance in the context of an algorithm or AI. The performance of the device's energy output, pulse duration, and other physical parameters would have been characterized through engineering bench testing and system verification, which could be considered a form of standalone performance evaluation for the device's technical specifications.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for the device's claims of safety and effectiveness in a 510(k) context is primarily established by:
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices for similar indications.
- Technical Specifications: Engineering measurements and verification of the Ellipse I2PL's physical parameters (energy, wavelength, pulse duration) to ensure they are within safe and effective ranges comparable to predicates.
- Clinical Literature/Experience: General dermatologic understanding of IPL technology for hair removal and lesion treatment.
- If any minimal clinical data was included to support the claim, then patient outcomes (e.g., hair reduction, lesion clearance) would have been the ground truth, likely assessed by clinicians. However, no such data is detailed here.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is an IPL system, not an AI/ML algorithm that requires a "training set" in the conventional sense. Its functionality is based on established physics of light-tissue interaction.
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 this type of medical device.
§ 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.