(31 days)
Avologi ENEO is an over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
Avologi ENEO is a battery operated device that uses low power light spectrum at red and infrared LED, at wavelength of 633±5nm, 830±5nm emitting optical power in a uniform distribution with no hot spots. It is a hand held light emitting diode(LED) device for the treatment of periorbital wrinkles designed for home-use.
The provided text describes the 510(k) premarket notification for the Avologi ENEO device, which is an over-the-counter light-emitting diode (LED) device for the treatment of periorbital wrinkles. However, the submission explicitly states that "Clinical data was not including in this submission." This means there is no study presented in this document that proves the device meets specific acceptance criteria based on clinical performance.
Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices through non-clinical testing and comparison of technical specifications.
Here's a breakdown of the requested information based on the provided text, highlighting where information is absent due to the nature of this 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
Since no clinical study was conducted for this 510(k) submission to demonstrate performance against specific clinical acceptance criteria, such a table cannot be provided from this document. The "acceptance criteria" here refers to the device meeting various safety and technical standards for substantial equivalence.
| Acceptance Criteria (Non-Clinical Standards) | Reported Device Performance (Compliance) |
|---|---|
| Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (AAMI / ANSI ES60601-1:2005/(R) 2012 And A1:2012, C1:2009/(R) 2012 And A2:2010/(R)2012) | Complies |
| Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements and Test (IEC 60601-1-2 Edition 4.0 2014-02) | Complies |
| Medical Electrical Equipment - Part 1-11: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment (IEC 60601-1-11 Edition 2.0 2015-01) | Complies |
| Photobiological Safety of Lamps and Lamp Systems (IEC 62471 First Edition 2006-07) | Complies |
| Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) | Complies |
| Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity (ISO 10993-5:2009/(R)2014) | Complies |
| Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10 Third Edition 2010-08-01) | Complies |
Note: The performance reported is compliance with the listed standards, not clinical effectiveness for wrinkle reduction, as no clinical study was presented.
2. Sample size used for the test set and the data provenance
Not applicable. No clinical test set data from human subjects was used for this submission. The "test set" in this context refers to the device itself being tested against non-clinical standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical study with a "ground truth" established by experts was performed or included in this submission.
4. Adjudication method for the test set
Not applicable. No clinical study requiring adjudication was performed or included in this submission.
5. 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
Not applicable. This device is an LED therapy device, not an AI-assisted diagnostic or interpretive tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth was established as no clinical study was conducted. The "ground truth" for the non-clinical tests would be the specifications and requirements of the various international standards.
8. The sample size for the training set
Not applicable. This device does not use an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not use an algorithm that requires a training set.
Summary of the Document's Conclusion:
The 510(k) submission for Avologi ENEO establishes substantial equivalence based on:
- Non-clinical bench tests: Verifying the device met design specifications and complied with electrical safety, EMC, home healthcare, photobiological safety, and biocompatibility standards (ISO 10993 suite).
- Comparison to predicate devices: Demonstrating similar indications for use, product code, device class, technology (LED, wavelengths, energy density, temperature), materials, and use environment (OTC, handheld, for periorbital wrinkles).
The submission explicitly states that no clinical performance data was included. Therefore, the acceptance criteria and study proving performance in the traditional sense of clinical efficacy are not detailed in this document. The "proof" of meeting acceptance criteria is through compliance with recognized technical and safety standards and demonstration of substantial equivalence to existing legally marketed 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.