VISULAS YAG III

• K Number: K042139
• Device Name: VISULAS YAG III
• Manufacturer: CARL ZEISS MEDITEC AG
• Date Cleared: 2004-09-09 ( 31 days)
• Product Code: GEX
• Regulation Number: 878.4810
• Type: Special
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

This device will be used in ophthalmic applications, including posterior capsulotomy and peripheral iridotomy. This device is intended for use primarily by physicians and health care workers and may only be used under the supervision of a physician. This device will not be sold to the general public.

Device Description

The VISULAS YAG III™is a Neodymium : Yttrium : Garnet (Nd: YAG) laser for ophthalmic applications, including posterior capsulotomy and peripheral iridotomy. The device operates at a wavelength of 1064 nm. The beam diameter is 10 um with a pulse length of

AI/ML Overview

This 510(k) submission for the Carl Zeiss Meditec AG VISULAS YAG III™ is for a medical device (a laser) and not a diagnostic AI/ML device. Therefore, the typical acceptance criteria and study design elements requested in the prompt, which are geared towards evaluating the performance of AI algorithms, are not applicable.

The submission focuses on demonstrating substantial equivalence to a predicate device (VISULAS YAG IIplus™) based on traditional medical device regulatory requirements.

Here's why the requested information cannot be provided from this document:

• No AI/ML Component: The VISULAS YAG III™ is a physical laser instrument used for ophthalmic procedures. It does not incorporate any AI or machine learning algorithms for diagnosis, prediction, or image analysis.
• Performance Metrics Differ: Acceptance criteria for a laser device typically relate to its physical specifications (e.g., wavelength, pulse duration, energy output, beam diameter, safety features) and its ability to perform its intended physiological functions safely and effectively. These are not reported in terms of diagnostic metrics like sensitivity, specificity, or AUC.
• Study Design Differs: The "study" referenced in this 510(k) is an internal comparison to a predicate device, focusing on functional equivalence and safety testing, not clinical performance studies with human readers or ground truth established by experts in an AI context.

Summary of available information as per the prompt's categories (with clarifications on why AI-specific aspects are not present):

1. A table of acceptance criteria and the reported device performance:
   • Acceptance Criteria for a Laser: These would typically involve engineering specifications (e.g., maximum energy output per pulse, beam diameter, pulse length, wavelength) and safety standards compliance. These are established internally by the manufacturer and are not explicitly listed as "acceptance criteria" in this summary.
   • Reported Device Performance: The document states:
     • Wavelength: 1064 nm
     • Beam diameter: 10 um
     • Pulse length:

Regulation Number and Section

§ 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.