(84 days)
The PicoWay laser system is indicated for the following at the specified wavelength:
532 nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
730 nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.
785 nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.
1064 nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
The PicoWay laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.
The Resolve handpieces (532 nm HE, 532 nm, 1064 nm) are also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV
The Resolve Fusion handpiece (1064 nm) is indicated for the treatment of wrinkles as well as benign pigmented lessons in Fitzpatrick Skin Types I-IV
The Resolve Fusion handpiece (532 nm) is indicated for the treatment of benign pigmented lesions in Fitzpatrick Skin Types I-IV
The PicoWay System has been previously cleared (K170597, K162454, K160607, K150326, K142372 and K153527) for tattoo removal and treatment/removal of benign pigmented lesions as well as treatment of acne scars and wrinkles. There are minor modifications to the current system to add four (4) new handpieces, minor system specifications, and new wavelengths. The additional new handpieces will work in the same way as the currently cleared PicoWay handpieces as in they will operate in the same manner as the predicate devices.
The PicoWay Laser System is a solid-state laser capable of delivering energy at wavelengths of 1064 nm, 532 nm, 730 nm (new) or 785 nm at extremely short duration in the range of 240-500 ps. The laser system contains one 755 nm (Alexandrite) laser head which is used to 'pump' (create) the 1064 nm picosecond wavelength. The 1064 nm wavelength can be frequency-doubled to 532 nm as desired. The outputs of the two lasers are designed to be co-linear on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either the 532 nm or 1064 nm wavelengths. The current 785 nm and new 730 nm wavelength contain a Ti:Sapphire laser rod that is pumped with the 532 nm energy. All these energies are delivered through an articulated arm and corresponding handpiece. Currently there are two cleared Resolve handpieces (1064 nm and 532 nm), a 785 nm handpiece and a Zoom handpiece that works on two wavelengths (532 nm and 1064 nm).
The provided document is a 510(k) summary for the Candela PicoWay Laser System (K191685). It focuses on adding new handpieces and wavelengths to an already cleared device. This type of submission relies heavily on demonstrating substantial equivalence to a predicate device rather than presenting a de novo clinical study with specific acceptance criteria for a novel AI device.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, as one would expect for an AI/ML medical device. Specifically, it lacks:
- A table of acceptance criteria and reported device performance for an AI/ML algorithm. The document primarily addresses the safety and performance of laser hardware.
- Sample size and data provenance for a test set to evaluate an AI/ML algorithm.
- Details on experts used to establish ground truth or adjudication methods for an AI/ML test set.
- Information on MRMC comparative effectiveness studies or standalone AI performance.
- Details on training set sample size or ground truth establishment for an AI/ML algorithm.
The document primarily discusses:
- Device Description: The PicoWay Laser System and the new handpieces/wavelengths.
- Technological Characteristics: Highlighting their similarity to the predicate device.
- Performance Data (for hardware safety and function):
- Electrical Safety and Electromagnetic Compatibility
- Biocompatibility
- Software (V&V for updated functionality, not an AI algorithm)
- Bench Testing (for hardware specifications)
- Ship Testing (for packaging integrity)
- Clinical Data: Explicitly states, "The PicoWay Laser System did not require clinical performance data." This further confirms the absence of clinical studies evaluating performance against acceptance criteria for an AI solution.
In summary, the provided text describes a submission for a laser system where the substantial equivalence argument is based on hardware modifications and engineering verification/validation, not on the performance of a new AI algorithm against pre-defined clinical acceptance criteria.
§ 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.