(197 days)
The PICOPLUS Laser System is indicated for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery as follows:
The 1064 nm wavelength and 450 pico-second pulse width of the PICOPLUS system is indicated for:
· Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
· Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
The 532 nm wavelength and 450 pico-second pulse width of the PICOPLUS system is indicated for:
- · Removal of tattoos for Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
- · Treatment of benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
The 1064 nm wavelength and nanosecond pulse width of the PICOPLUS system is indicated for:
- · Treatment of benign pigmented lesions on Fitzpatrick skin type I-VI
- Removal of dark and multi-colored tattoos containing dark colored tattoo inks on Fitzpatrick skin types 1-VI
The 532 nm wavelength and nanosecond pulse width of the PICOPLUS system is indicated for:
- · Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV
- Removal of lighter colored tattoo inks, including red and yellow inks, on Fitzpatrick skin types I-III
The PICOPLUS Laser System is a surgical laser instrument. The PICOPLUS Laser System is designed and manufactured in accordance with 21 CFR 820 (with emphasis on 820.30) and 21 CFR 1040 for medical devices in order to insure user safety and durability of use.
The PICOPLUS Laser System is a laser system, delivering energy at wavelengths of 1064 nm and 532 nm, both at pulse durations of 450 picoseconds (ps) and 2 nanoseconds (ns). The laser system console, an articulated arm and attached handpieces.
The provided text describes a 510(k) premarket notification for the PICOPLUS Laser System and asserts its substantial equivalence to predicate devices. However, it explicitly states that no clinical performance data was provided for the PICOPLUS Laser System itself because it is considered equivalent to previously cleared predicate devices. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria for the PICOPLUS Laser System is largely unavailable in the provided document.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as specific, measurable criteria for the PICOPLUS Laser System. The acceptance is based on substantial equivalence to predicate devices.
- Reported Device Performance: No clinical performance data is reported for the PICOPLUS Laser System. The document states: "No performance data has been provided since the PICOPLUS Laser System is equivalent to the previously cleared predicate devices with no new issues regarding safety and effectiveness."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable, as no clinical performance data was provided for the PICOPLUS Laser System itself.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable, as no clinical performance data was provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no clinical performance data was provided.
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. The PICOPLUS Laser System is a laser surgical instrument, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable, as no clinical performance data was provided.
8. The sample size for the training set
- Not applicable, as no clinical performance data was provided, and the device is not an AI algorithm requiring a training set in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable.
Summary based on the provided text:
The PICOPLUS Laser System's acceptance is based on a claim of substantial equivalence to two legally marketed predicate devices: the Cutera Enlighten III Laser System (K172077) and the Quanta System S.P.A. Discovery Pico Family (K163222). The applicant argues that the PICOPLUS device shares the "same intended use and Indications for Use statement" and that technological differences are "minor."
The documentation states that the PICOPLUS Laser System passed bench testing for compliance with applicable standards, including ISO 13485:2003, ISO 60601-1 for electrical safety, and IEC 60601-1-2 for electromagnetic compatibility. However, no clinical performance data was submitted for the PICOPLUS Laser System itself. The FDA's determination of substantial equivalence implies that the agency found the device to be as safe and effective as the predicate devices without requiring new clinical studies for this specific 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.