(119 days)
The BioPhotas Celluma3 is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full face wrinkles.
The Biophotas Celluma is a portable, therapeutic device whose purpose is to provide even, cool, narrow-band wavelengths of polychromatic light (blue, 465nm red, 640nm and Near infrared, 880nm) produced by super-luminous LEDs (light emitting diodes) to treat a variety of skin and musculoskeletal conditions. The Celluma' uses a combination of visible red light (640mm) in combination with near infrared light (880nm) and is intended to improve the appearance of full-face wrinkles. Near infra-red (880nm) is intended to provide topical heating tissue temperature: for the temporary relief of minor muscles and joint pain, arthritis and muscle spasm; relieving stiffness; promotion the relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum (465nm) is intended to reduce mild to moderate inflammatory acne vulgaris. The Biophotas Celluma' is intended for use on areas of the body such as the full face, back, chest, knees or other areas where the therapeutic light may be beneficial. The system comprises of a semi-rigid, shape-taking frame upon which is mounted an array of LEDs, this allows the device to be contoured to the treatment area. The LEDs are embedded within a biocompatible Poron® foam covering that holds a transparent polycarbonate cover recessed within it. The biocompatibility nature of Poron® allows the device to be placed in contact with the skin. Nevertheless, the design of the device provides for maintaining a small distance between the surface of the skin and the surface of the device. The flexible LED panel is permanently connected by a three-foot long cable attached to a control panel that contains the circuitry and software that controls the device. The control panel contains several push buttons beneath a sealed cover. A power button that switches the device ON/OFF, a mode button that allows the user to select from 3 preprogrammed treatment modes; "Acne", "Wrinkles", and "Aches and Pains", a pulse button which allows the user to switch between pulse (default setting) or non-Pulse and a Start button that activates the desired treatment mode. The control panel receives its power from a separate cable that connects via an AC adaptor for 110-220 Volts to a standard U.S. electrical power outlet. The control panel contains an automatic shut-off safety feature.
The provided text is a 510(k) summary for the Biophotas Celluma3, a device intended for the treatment of full face wrinkles. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with reported performance metrics.
Therefore, the following information regarding acceptance criteria and a study proving the device meets these criteria cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and if so, the effect size of how much human readers improve with AI vs without AI assistance
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The sample size for the training set
- How the ground truth for the training set was established
The document primarily relies on non-clinical performance testing and a comparison of technological characteristics to assert substantial equivalence. It explicitly states: "Biophotas Celluma' is technologically identical to the previously cleared Biophotas Cellumas device (K152280). In this application, only the indication for use has been revised to expand the treatment of periorbital wrinkles to include full face wrinkles, a logical extension given the fact that the subject device in both submission has a large panel covering the entire face. In addition, the mechanism of action of low level light therapy for the treatment of "wrinkles" is well known to be the same irrespective of area that is being treated."
The provided text details non-clinical performance testing to demonstrate safety and effectiveness for the Biophotas Celluma system, but this is distinct from a clinical study to prove efficacy in meeting acceptance criteria for wrinkle reduction.
Non-Clinical Performance Testing Summary:
The Biophotas Celluma3 underwent several non-clinical performance tests in line with recognized standards to demonstrate safety and effectiveness and substantial equivalence to predicate devices. These tests addressed general requirements, biocompatibility, electrical safety, and software.
- Electrical safety and safety standards: The device passed testing per:
- IEC 60601-1:2012 (Electrical safety)
- IEC 60601-1-2:2007 (EMC testing)
- Software verification and validation testing:
- The software was classified as Class A according to IEC 62304:2006 (Medical device Software - software life cycle process).
- The FDA level of concern matrix classified the device software as "Minor."
- Biocompatibility: Based on transient and limited contact with intact skin, Biophotas Inc believes the device is safe and compliant with ISO 10993 and the FDA - Blue Book Memorandum #G95-1, supported by ISO 10993-1:2009 annex B.
- Usability Study: Per IEC 62366.
The document argues that "Where there are slight differences in technological parameters, these fall within the range of the predicate devices and those devices cleared under the OHS device code, or have been negated by non-clinical performance testing." This indicates that the non-clinical tests were used to negate potential differences from predicate devices, rather than to establish new performance criteria for wrinkle reduction through a standalone clinical study.
§ 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.