(92 days)
NaturaLase PiQo4 - The NaturaLase Nd: Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module -is indicated for use in aesthetic applications 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.
1064 nm - Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat tattoo colors: black, brown, green, blue and purple.
The NaturaLase PiQo4 laser is a Nd:YAG 1064 Q-Switched laser with 532 KTP Optics and Pulse Slicing Module. The 532 KTP Optics is available to convert the basic 1064 nm wavelength to 532 nm and the pulse slicing electro-optics allows diverting the leading and trailing portions of the laser pulse away from the delivery system for the purpose of shortening the pulse duration without reducing the peak power.
The NaturaLase PiO04 laser offers fast and efficient treatment of tattoos and benign pigmented lesions removal through a variety of spot sizes, fluences and repetition rates. The laser energy is delivered via an articulated arm with interchangeable hand-pieces. A liquid crystal display (LCD) provides visual feedback of control settings and operating parameters. The mechanism of action for tattoo or pigmented lesion removal lies in delivering laser energy at very high peak power.
The provided text is a 510(k) summary for a medical device (NaturaLase PiQo4 laser). It details the device's characteristics and its equivalence to a predicate device but does not describe a clinical study or acceptance criteria related to device performance in a clinical setting.
Instead, the "Testing Performance" section refers to engineering and safety performance testing. Therefore, I cannot extract the information required for the requested table and study details.
Here's how to interpret the available information:
- Acceptance Criteria and Reported Device Performance: This section would typically involve clinical metrics like success rates, adverse event rates, or specific measurements related to the intended clinical effect. The document does not provide this. The "Testing Performance" section mentions compliance with safety and electrical standards (IEC 60601-1, IEC 62366, 60601-1-6, 60601-2-22, IEC 60825-1) and biocompatibility (ISO 10993), as well as software verification and validation. These are engineering/safety criteria, not clinical performance criteria.
Therefore, most of your requested points cannot be answered from the provided text.
Here's a breakdown of what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Clinical) | Reported Device Performance (Clinical) |
|---|---|
| Not specified in the document | Not specified in the document |
| Acceptance Criteria (Engineering/Safety) | Reported Device Performance (Engineering/Safety) |
| Compliance with IEC 60601-1 (medical electrical equipment, basic safety & essential performance) | Determined to be in conformance with IEC 60601-1 |
| Compliance with IEC 62366 (usability) | Determined to be in conformance with IEC 62366 |
| Compliance with IEC 60601-1-6 (usability) | Determined to be in conformance with IEC 60601-1-6 |
| Compliance with IEC 60601-2-22 (surgical lasers) | Determined to be in conformance with IEC 60601-2-22 |
| Compliance with IEC 60825-1 (laser safety of products) | Determined to be in conformance with IEC 60825-1 |
| Biocompatibility consistent with ISO 10993 | Biocompatibility is consistent with ISO 10993 |
| Acceptable software verification and validation | Software verification and validation results are acceptable for software release |
| Functional performance according to specifications | Performs according to specifications and functions as intended |
Study Details:
The provided text does not describe a clinical study to prove the device meets clinical acceptance criteria. The "Testing Performance" section refers to engineering and safety testing, not clinical efficacy or effectiveness.
Therefore, the following cannot be answered from the provided document:
- Sample size used for the test set and the data provenance: N/A (No clinical test set described)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A
- Adjudication method for the test set: N/A
- 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: N/A (This device is a laser, not an AI diagnostic tool involving human readers)
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an algorithm)
- The type of ground truth used: N/A
- The sample size for the training set: N/A
- How the ground truth for the training set was established: N/A
Conclusion:
The document focuses on demonstrating substantial equivalence to an existing legally marketed device (PicoWay Laser System, K142372) based on similar intended use, indications for use, technological characteristics, and safety testing. It explicitly states that "differences between the NaturaLase PiQ04 laser and predicate device in specific maximum energy levels and fluence delivered do not raise any new safety or effectiveness issues because the NaturaLase PiQo4 laser parameters fall within the range of parameters delivered by the predicate device."
This type of 510(k) submission typically relies on non-clinical performance data (like electrical safety, EMC, biocompatibility, and functional testing) and a comparison to a predicate device's established safety and effectiveness, rather than requiring a dedicated clinical study from the applicant to prove 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.