(29 days)
The Rapid Acoustic Pulse Device (RAP) is indicated for use as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients.
The Soliton Rapid Acoustic Pulse Device (RAP) is designed as an accessory to laser treatments for tattoo removal. The RAP uses repeated, rapidly rising acoustic waves, releasing pigment particles from the pigment laden macrophage (PLM) and dissipating the laser-induced whitening. This allows multiple laser passes in a single session, resulting in fewer office visits.
The RAP is composed of three parts: the Console, the Hand Piece and the connecting Cable. The Console supplies saline to the Hand Piece to enable formation of the shock wave within the acoustic pulse chamber. The Hand Piece generates acoustic waves in the saline. The acoustic waves pass through the acoustically transparent Window and acoustic ultrasound gel or similar hydrogel pad, which when placed against the surface of the tattoo to be removed, penetrates the skin to the typical depth of tattoo ink.
The RAP is a modification to the company's Acoustic Wave Device (AWD) that has already been cleared for the same indications for use (K190542). Only minor hardware and software changes have been made. These changes do not alter the fundamental scientific technology of the modified device. Specifically, the shape, frequency and repetition rate of the acoustic waves are not changed.
This document describes the Rapid Acoustic Pulse Device (RAP), an accessory to specific lasers for black ink tattoo removal. However, it does not contain a detailed study proving the device meets acceptance criteria in the format of a clinical trial or performance study with specific outcome measures.
Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Soliton Acoustic Wave Device (K190542)).
Here's a breakdown of the information provided, and where information is missing for your request:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The submission focuses on comparing the modified device to its predicate, rather than establishing new performance criteria or reporting on a clinical study against such criteria.
2. Sample size used for the test set and data provenance
This information is not provided. The document mentions "Verification testing using the same methods as used for the predicate device" but does not detail the sample sizes, type of data, or provenance of any test sets used in this verification or for the predicate device.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
This information is not provided. As there's no described clinical performance study, there's no mention of experts or ground truth establishment.
4. Adjudication method for the test set
This information is not 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
This information is not provided, and an MRMC study is not relevant here as the device is not an AI-driven image analysis tool for human readers. It's a physical device accessory for tattoo removal.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided, and a "standalone" performance study in the context of an algorithm is not applicable here as the device is a physical medical device accessory.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided.
8. The sample size for the training set
This information is not provided. No "training set" in the context of an AI/ML algorithm is mentioned or relevant to this device's description.
9. How the ground truth for the training set was established
This information is not provided.
Summary of what is provided regarding demonstration of device performance and safety (focused on substantial equivalence):
The document states that the Rapid Acoustic Pulse Device (RAP) is a modification of a previously cleared device, the Soliton Acoustic Wave Device (AWD) (K190542). The core argument for safety and effectiveness relies on the claim that:
- Minor changes: "Only minor hardware and software changes have been made. These changes do not alter the fundamental scientific technology of the modified device."
- Identical intended use/indications: Both RAP and AWD are indicated for use as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients.
- Similar technological characteristics and principles of operation: The shape, frequency, and repetition rate of the acoustic waves are not changed.
- Verification testing: "Verification testing using the same methods as used for the predicate device demonstrates that the RAP functions as specified and is as safe and effective as its predicate device." (No details on these methods, sample sizes, or results are provided, only the statement that it was done and considered acceptable.)
- Electrical safety and EMC: Repeated for RAP device by an independent test laboratory in accordance with IEC 60601-1 and IEC 60601-1-2. (Results are stated as acceptable, but specific data is not given.)
- Biocompatibility: Established based on the evaluation of the AWD, with no new patient-contacting materials used.
- Software verification: Conducted and testing results were found acceptable for the software changes. (Again, details are not provided.)
In essence, the submission argues that because the RAP device is fundamentally similar to its cleared predicate with only minor changes, and these minor changes were verified through established testing protocols (though not detailed here), it is substantially equivalent and thus safe and effective for its stated indications. It does not present a de novo clinical study with specific acceptance criteria and performance metrics for the RAP device itself.
§ 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.