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K Number
K980085
Device Name
PHACO COMMANDER
Manufacturer
SCIERAN TECHNOLOGIES, INC.
Date Cleared
1998-02-24

(46 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

Emulsification and aspiration of cataract

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter for the PHACO COMMANDER system, dated February 24, 1998. It confirms the device is substantially equivalent to legally marketed predicate devices for the indication of "Emulsification and aspiration of cataract."

Unfortunately, this document does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. The letter is a regulatory approval, not a scientific study report.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study proving the device meets those criteria, as that information is not present in the provided text.

§ 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.