xPORT Lens Fragmentation System

• K Number: K191024
• Device Name: xPORT Lens Fragmentation System
• Manufacturer: Carl Zeiss Meditec Cataract Technology Inc.
• Date Cleared: 2019-08-13 ( 117 days)
• Product Code: HQC , MLZ
• Regulation Number: 886.4670
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: N/A

Intended Use

The intended use of the xPORT System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for the xPORT Lens Fragmentation System. It indicates that the device has been found substantially equivalent to legally marketed predicate devices for the fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration.

However, the provided text DOES NOT contain any information about acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

This letter is a regulatory clearance document, not a clinical study report. To fulfill the request, information from the actual 510(k) submission (which is typically much more extensive than just the clearance letter) would be required. Without that underlying data, it's impossible to describe the acceptance criteria and the study proving the device meets them.

Regulation Number and Section

§ 886.4670 Phacofragmentation system.

(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.