(321 days)
The AIP Intense Pulsed Light System is an intense pulsed light device intended for the following: the treatment of benign vascular and pigmented lesions, and permanent hair reduction.
The AIP Intense Pulsed Light System is intended for use on all skin types (Fitzpatrick skin types I-VI).
The AesThera AIP Intense Pulsed Light System is a 400—1200 nm intense pulsed light delivery system, powered by Photo-Pneumatic™ technology. It is a portable tabletop system with a hand piece connected by an umbilical to the main console. The hand piece incorporates an intelligent tip that is replaced with every patient treatment. A "sealed" intelligent tip is used to transmit light to the patient's skin. Light is emitted only through the tip and is always sealed with the patient's surrounding tissue during intense pulsed light emission. All emitted light is contained within the tip during treatment. The hand niece of the AIP Intense Pulsed Light System is uniquely designed to promote increased ergonomics with all user interface and controls located on the hand piece.
This 510(k) summary does not contain the information requested for acceptance criteria and a study proving the device meets those criteria.
This document is a regulatory submission for a new medical device (AesThera AIP™ Intense Pulsed Light System) seeking 510(k) clearance by claiming substantial equivalence to existing predicate devices.
Here's why the requested information is not present:
- Acceptance Criteria & Device Performance Table: This type of table, with specific performance metrics and acceptance thresholds, is typically found in a detailed clinical study report or a design verification and validation (V&V) report. The 510(k) summary focuses more on demonstrating equivalence to predicates in terms of intended use, technology, and safety features.
- Study Details (Sample Size, Data Provenance, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set): The document provided is the 510(k) summary itself, which is a high-level overview. While the approval letter mentions the device is "substantially equivalent...for the indications for use stated in the enclosure," it does not detail any specific clinical studies performed by the manufacturer of this new device to establish its performance against predefined acceptance criteria.
Key points from the provided document relevant to its clearance:
- Intended Use: Treatment of benign vascular and pigmented lesions, and permanent hair reduction on all skin types (Fitzpatrick I-VI).
- Mechanism: Intense Pulsed Light (IPL) system (400-1200 nm) with proprietary Photo-Pneumatic™ technology.
- Regulatory Approach: Substantial Equivalence to listed predicate devices (SkinStation™, StarLux™, MediLux™, EsteLux™, etc.). This means the manufacturer is asserting their device is as safe and effective as existing legally marketed devices, rather than submitting results from a de novo clinical trial with specific performance endpoints.
- No detailed performance data: The document does not describe the specific performance metrics (e.g., clearance rates, adverse event rates, scar formation rates for lesion treatment; hair reduction percentage for hair removal) that would typically be evaluated in a study with acceptance criteria.
To answer your request, if this were a document describing a clinical study (which it is not), I would be looking for:
- A specific section detailing clinical study results.
- Explicitly stated primary and secondary endpoints.
- Statistical analyses establishing the device's performance against pre-defined thresholds.
Since this is a 510(k) summary, the "acceptance criteria" are effectively that the device is substantially equivalent to established predicate devices, and the "study" is the comparison made to those predicates, along with a declaration of its intended use and technological characteristics. No specific performance study with a defined test set, ground truth, or expert consensus is described within this document for the new 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.