ML UNIVERSAL TUBING

• K Number: K983448
• Device Name: ML UNIVERSAL TUBING
• Manufacturer: MED-LOGICS, INC.
• Date Cleared: 1998-12-18 ( 79 days)
• Product Code: MSR
• Regulation Number: 886.4150
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: N/A

Intended Use

Irrigation and Aspiration of fluids during Ophthalmic phacoemulsification procedures.

Device Description

Med-Logics, Inc., Administration Set (UT 3004)
Med-Logics, Inc., Drainage Bag (UT 3002)
Med-Logics, Inc., Universal Tubing Set (UT 3000)

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA regarding Med-Logics, Inc.'s Administration Set, Drainage Bag, and Universal Tubing. This document is a regulatory letter approving a medical device based on its substantial equivalence to pre-existing devices. It does not contain information about acceptance criteria or study results in the context of device performance, algorithm evaluation, or clinical trials which are typically found in design validation reports or clinical study summaries.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on regulatory approval rather than technical performance data or study methodologies.

Regulation Number and Section

§ 886.4150 Vitreous aspiration and cutting instrument.

(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.