(139 days)
The TitanPico Laser Workstation is indicated for the following at the specified wavelength:
532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
The TitanPico Laser Workstation is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
TitanPico Laser Workstation is a laser system that delivers energy in the 532nm and 1064nm wavelength. The combination of wavelength, pulse duration and energy fluence are disrupting the tattoo dye or pigment particles under the skin without harming the surrounding tissue. The fragmented dye or pigment particles eventually surface and fade as the epidermal layer of the skin is renewed.
This document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics for the new device. Therefore, much of the requested information regarding specific acceptance criteria, study design, and performance metrics for the proposed device is not explicitly stated in the provided text.
However, based on the document, I can extract information related to the comparison with the predicate devices and the non-clinical tests performed to demonstrate substantial equivalence.
Here's a breakdown of the information available and what is not explicitly stated in this FDA submission:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define "acceptance criteria" in the sense of quantitative performance targets for the new device itself. Instead, it aims to show substantial equivalence to predicate devices by comparing technical specifications. The "reported device performance" is mainly shown through the comparison table to the predicates and the assertion that non-clinical tests met standards.
| Feature | Acceptance Criteria (Implied: Similar to Predicate) | Reported Device Performance (TitanPico Laser Workstation) |
|---|---|---|
| Product Code | GEX | GEX |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Class | Class II | Class II |
| Indications for Use | Same as Predicate K153527 (tattoo removal at 532nm for Fitzpatrick I-III & 1064nm for I-VI, benign pigmented lesions removal for Fitzpatrick I-IV) | Matches Predicate K1535527 (see full description below) |
| Type of Use | Prescription Use | Prescription Use |
| Wavelength | 1064/532 nm | 1064/532 nm |
| Maximum Energy (1064nm) | 450mJ (PicoWay Laser System, K153527) | 400mJ |
| Maximum Energy (532nm) | 220mJ (PicoWay Laser System, K153527) | 200mJ |
| Aiming Beam | 635nm | 635nm |
| Repetition Rate | 1-10Hz | 1-10Hz |
| Spot size | Φ 2mm-10mm | Φ 2-10mm |
| Maximum Average Fluence | 6.25 J/cm² (PicoWay Laser System, K220853) | 6.25 J/cm² |
| Pulse Duration | 240-750ps (K153527) / 240-500ps (K220853) | 375-450ps |
| Laser Type | Nd: YAG | Nd: YAG |
| Activation | Foot-switch | Foot-switch |
| User Interface | Touchscreen with GUI | Touchscreen with GUI |
| Warm Up Time | 2 minutes | 2 minutes |
| Cooling method | Water cooling | Water cooling |
| Electrical Power | 100-240 VAC, 50/60 Hz (K153527) | ~110V, 60Hz |
| Delivery System | Articulated arm with 2 wavelength Zoom handpiece (K153527) | Articulated arm with wavelength Zoom handpiece |
| System dimension | 42" H x 18" W x 27" D / 107 cm H x 46 cm W x 69 cm D (K153527) | 1035mm×805mm×380mm |
| Software | Yes | Yes |
| Delivery Devices (supplied) | Non-Sterile, reusable, cleanable | Non-Sterile, reusable, cleanable |
| EMC/Electrical Safety Compliance | IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22 | Meets these standards |
| Biocompatibility | ISO10993-1, ISO10993-10, ISO10993-23, ISO10993-5 | Meets these standards |
Indications for Use (TitanPico Laser Workstation):
- 532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat red, yellow, and orange tattoo colors.
- 1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat black, brown, green, blue, and purple tattoo colors.
- Also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document states that no clinical tests were performed for the proposed device. The company "believes that the proposed device TitanPico Laser Workstation products does not need to carry out clinical tests, and the clinical study data that have been the legally marketed device can be used for reference."
- Therefore, there is no explicit test set sample size or data provenance provided for the proposed device in this submission. The "test set" in this context refers to non-clinical bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable, as no clinical tests were performed for the proposed device and therefore no ground truth was established by experts for a test set. Non-clinical tests typically rely on established engineering and safety standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable, as no clinical tests or expert interpretation of results for a test set were conducted. Non-clinical tests are evaluated against predefined physical and engineering standards.
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 a laser workstation, not an AI-assisted diagnostic or interpretation system. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a hardware laser system. The "software verification and validation" mentioned refers to the device's control software, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests, the "ground truth" is adherence to established international and national standards for medical electrical equipment, laser safety, and biocompatibility (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, ISO 10993 series). Performance was assessed against the specifications of these standards and the equivalence to the predicate devices.
- For the clinical effectiveness implied by substantial equivalence, the ground truth would have been established through the clinical studies conducted for the predicate devices, which are not detailed in this submission.
8. The sample size for the training set
- Not applicable, as this is a hardware device and not an AI/machine learning system that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of 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.