(88 days)
The MeDioStar NeXT Family laser system is intended for surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery and dermatology.
The MeDioStar NeXT Family laser system is intended for the treatment of benign vascular lesions.
The MeDioStar NeXT Family laser system is intended for the treatment of benign pigmented lessons.
The MeDioStar NeXT Family laser system is intended for hair reduction defined as reduced hair growth with or without maintenance when measured at 6, 9 and 12 months.
The MeDioStar NeXT and the MeDioStar NeXTPRO (The MeDioStar NeXT Family) are pulsed diode lasers emitting a wavelength of 755 - 950 nm, that are operated with a handpiece in contact with the skin. The lasers are a modification to previously cleared MeDioStar NeXT K111851. All systems comprise a main console unit, a handpiece and are triggered by means of a footswitch. There are several handpieces, the user can chose from.
This document describes the MeDioStar NeXT Family laser system, which is intended for various dermatological applications.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., a specific percentage of hair reduction or lesion clearance required for market clearance). Instead, it makes a general statement of substantial equivalence to predicate devices. The "reported device performance" is the assertion of this substantial equivalence based on similar technological characteristics and intended uses.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device MeDioStar NeXT K111851 in principles of operation, parameters, and indications for use. | The MeDioStar NeXT Family laser system is substantially equivalent to the MeDioStar NeXT K111851 with the same principles of operation, with similar parameters and the same indications for use. The fundamental scientific technology of the device is unchanged from the legally marketed predicate. |
| Substantial equivalence to predicate device Alma Lasers 755 nm Diode Module K140009 in parameters and indications for use. | The MeDioStar NeXT Family laser with handpiece ALX (755 nm) system is substantially equivalent to the Alma Lasers 755 nm Diode Module K140009 with similar parameters and the same Indications for use. |
| Safety and Effectiveness for intended uses. | The MeDioStar NeXT Family laser system is another safe and effective device for the treatment of benign vascular lesions, for hair removal, permanent hair reduction and the treatment of benign pigmented lesions. |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "Clinical Performance Data: None". This indicates that no new clinical study (test set) was performed to demonstrate the device's performance for this specific 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Since no clinical performance data was provided from a specific test set, there is no information regarding experts used to establish ground truth.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical performance data from a test set was provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
Not applicable, as no clinical performance data from a test set was provided, and therefore no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This device is a physical laser system, not an algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable.
7. The Type of Ground Truth Used:
Since no new clinical data was provided, there was no ground truth directly established for this submission. The submission relies on the established safety and effectiveness of the predicate devices.
8. The Sample Size for the Training Set:
Not applicable. This document pertains to a physical medical device (laser system), not an AI algorithm that would typically have a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as this device is not an AI algorithm.
Summary of the Study (as described in the document):
The "study" presented here is a Special 510(k) submission that relies on the concept of substantial equivalence to previously cleared predicate devices.
- No new clinical data or performance studies were conducted for this specific submission to prove the device meets acceptance criteria derived from new testing.
- Instead, the manufacturer argues that the MeDioStar NeXT Family laser system is substantially equivalent to two predicate devices:
- MeDioStar NeXT (K111851): This predicate is used for comparison regarding general principles of operation, similar parameters, and the same indications for use. The fundamental scientific technology is claimed to be unchanged.
- Alma Lasers 755 nm Diode Module (K140009): This predicate is used for comparison specifically for the MeDioStar NeXT Family's ALX (755 nm) handpiece, citing similar parameters and the same indications for use.
- The argument for substantial equivalence is based on a comparison of technical characteristics (wavelength, pulse duration, repetition rate, spot sizes, max. fluence) and intended uses between the proposed device and the predicate devices, as detailed in the "Summary of Technical Characteristics" table.
- The conclusion is that, based on this comparison, the MeDioStar NeXT Family is "another safe and effective device" for its stated indications.
§ 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.