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K Number
K981989
Device Name
THE WAVE DIGITAL PHACO SYSTEM
Manufacturer
CIRCUIT TREE
Date Cleared
1998-08-25

(81 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

Phacoemulsification of cataracts in the human eye.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a specific study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document is a 510(k) clearance letter from the FDA to Circuit Tree Medical, Inc. for "The Wave Digital Phaco System." It states that the device is substantially equivalent to legally marketed predicate devices for the indication of "Phacoemulsification of cataracts in the human eye."

This type of FDA letter confirms market clearance but does not typically include detailed study results, performance metrics, or information on how ground truth was established, which are usually found in the 510(k) summary or the full submission.

§ 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.