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K Number
K984143
Device Name
FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM
Manufacturer
FIBRA SONICS, INC.
Date Cleared
1999-02-16

(90 days)

Product Code
HQC
Regulation Number
886.4670
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Vitreoretinal Procedures (Ultrasonic emulsification and removal of cataracts)

Device Description

Fibra-Sonics Phaco III and IIIP Fragmentation System

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device called "FIBRA-SONICS PHACO III or IIIP Fragmentation Systems". It states that the device is "substantially equivalent" to predicate devices, but it does not include details on specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert qualifications.

§ 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.