(78 days)
The Picocare Family is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064nm
The 1064nm wavelength of the Picocare Family system is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI).
532nm
The 532nm wavelength of the Picocare Family system is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.
The Picocare Family is the solid state laser capable of delivering energy at wavelengths of 1,064 nm or 532 nm at short durations of 450 ps (picoseconds). The device system consists of a main unit, an articulated arm, a handpiece and a foot switch. The laser output is delivered to the skin through the articulated arm delivery system terminated by the handpiece. The fluence (energy density) and frequency are controlled from the LCD display/Touch Pad located on the front of the main unit. The LCD display is used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Picocare Family device:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not necessarily on presenting a detailed clinical study with acceptance criteria in the same way a de novo application might. Therefore, explicit "acceptance criteria" and "reported device performance" against those criteria for a clinical effectiveness study are not clearly defined in the text as they would be for a clinical trial establishing effectiveness from scratch. Instead, the document relies on comparing technical characteristics and existing safety/effectiveness profiles of predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, the document is a 510(k) submission for substantial equivalence. It doesn't present a clinical study with primary and secondary endpoints and corresponding acceptance criteria. Instead, it compares the proposed device's technical characteristics to predicate devices and asserts that the changes do not alter safety or efficacy. The "acceptance criteria" for this submission are essentially that the device's characteristics are within an accepted range or similar enough to predicate devices such that new safety/efficacy concerns are not raised.
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Same Intended Use (Tattoo removal) | Met: "has the same intended use of affecting Removal of tattoos as the predicate devices" |
| Same Indications for Use (Specific wavelengths for tattoo colors and skin types) | Met: "the same indications and the same specific indication of removal of tattoos in Fitzpatrick skin types I-III with 532nm and Fitzpatrick skin types I-VI with 1064nm." |
| Similar Safety Profile (Laser class, power, fluence within acceptable limits) | Met: "Safety profiles are the same: a laser module output within the limitation of a Class 4 laser (per IEC 60825-1), Q-Switched Nd:YAG Laser and the same laser Max Fluence (10J/cm2 at 1064nm and 2.5J/cm2 at 532nm) with Picocare" |
| Similar Technical Characteristics (Wavelength, spot size, repletion rate, delivery method, design) | Met: "the spot size is exactly same as both Picocare and Picoway (2 to 10mm), and the repletion rate is the same as well." "laser class, laser power, wavelength, laser delivery method, device design, repletion rate, aiming beam, delivery element and pulse energy." |
| Pulse Duration within acceptable range (justified by predicate) | Met: The Picocare Family's 450ps pulse duration is "as the range of the Picoway Laser System (K153527)'s pulse duration (240ps – 750ps)." |
| No significant change to risk profile | Met: "It was determined there was no significant change to risk and no new risks were identified with respect to the modifications to the Picocare Family. All residual risks were found to be acceptable." |
| Verification testing met acceptance criteria | Met: "All the testing met acceptance criteria." (Refers to non-clinical tests) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Data): The document explicitly states: "no animal or new clinical data was required to show safety, efficacy or substantial equivalence to the currently cleared model." Therefore, there was no clinical test set in the traditional sense for evaluating the modified device's performance through patient data.
- Data Provenance: Not applicable as no new clinical data was gathered.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable as no new clinical data requiring expert review for ground truth was gathered. The determination of "substantial equivalence" relies on regulatory review and comparison to existing devices.
4. Adjudication Method for the Test Set
- Not applicable as no clinical test set was used to establish ground truth.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. The document states that "no animal or new clinical data was required."
6. If a Standalone (algorithm only without human-in-the-loop performance) was Done
- Not applicable. This is a laser device, not an AI algorithm.
7. The Type of Ground Truth Used
- For the purpose of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence was primarily:
- Regulatory definitions and established safety/efficacy profiles of the predicate devices (Picocare K162755 and Picoway Laser System K153527).
- Engineering and performance specifications of the proposed device, verified through non-clinical testing.
- Risk analysis to confirm no new risks were introduced by the modification.
8. The Sample Size for the Training Set
- Not applicable. No AI algorithm is being trained here. This refers to a medical device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No AI algorithm and thus no training set.
§ 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.