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K Number
K980480
Device Name
SYNTEC VITMAN
Manufacturer
SYNTEC, INC.
Date Cleared
1998-05-04

(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

The Syntec VitMan is indicated for use in support of the following ophthalmic surgical procedures:

Removal of vitreous in cases of:

Vitreous cloudiness Diabetic vitreal hemorrhaging Trauma, including contusions, penetrations, and intraocular foreign bodies; Opacity Inflammation Endophthalmitis Bacterial Fungal Uveitis

Removal of lens remnants after cataract surgery;

· Remove vitreous traction under the retina producing localized or complete retinal detachment;

Removal of samples of vitreous for diagnostic purposes, i.e. endophthalmitis;

Treatment of vitreous loss during cataract surgery;

Clean vitreous strands from the cataract wound;

Perform emulsification of cataractous lens and its removal by aspiration and irrigation;

Provide internal illumination for vitreous surgery;

Provide air pressure for maintaining intraocular pressure for retinal surgery.

Device Description

Not Found

AI/ML Overview

This is a regulatory letter from the FDA regarding the K980480 submission for the Syntec Vitman Vitrectomy System. It primarily addresses the substantial equivalence determination and regulatory compliance. It does not contain information about acceptance criteria or a study proving the device meets them.

Therefore, I cannot extract the requested information from the provided text. The document states:

  • It is a review of a Section 510(k) notification.
  • The device is found to be substantially equivalent to predicate devices.
  • It outlines regulatory requirements for marketing the device.
  • It lists the indications for use of the Syntec VitMan.

None of the provided text describes acceptance criteria, performance data, study design, sample sizes, expert qualifications, or ground truth establishment. This information would typically be found in a separate study report or a different section of a 510(k) submission, not in the FDA's decision letter itself.

§ 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.