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I/A - VFE System II

FDA 510(k)

Class II (US FDA 510(k))

510(k) K854868

by Mira, Inc.

Identifiers

510(k) Number
K854868 FDA 510(k)
FDA Product Code
HQE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.4150 FDA 510(k)
Regulation Number
886.4150 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The I/A - VFE System II is an Ac-Powered Vitreous Aspiration and Cutting Instrument, classified as a Class II ophthalmic device. It is designed for use in vitreoretinal surgery to aspirate and cut vitreous humor, facilitating procedures such as vitrectomy. The system combines aspiration and cutting functions to enhance precision during intraocular interventions.

This device is supplied as a reusable instrument and is intended for use in sterile surgical settings, adhering to ophthalmic surgical protocols. It is regulated under FDA 510(k) clearance (K854868) with a Substantially Equivalent determination, falling under product code HQE and regulation number 886.4150. No third-party review was involved in its clearance process.

Frequently asked questions

What is the I/A - VFE System II used for in vitreoretinal surgery?

The I/A - VFE System II is specifically designed for vitreoretinal surgery to aspirate and cut vitreous humor during procedures like vitrectomy. By combining aspiration and cutting functions in a single instrument, it improves precision and efficiency in removing the vitreous body, which is essential for treating conditions such as retinal detachment, macular holes, or diabetic retinopathy.

Is the I/A - VFE System II a single-use or reusable device?

The I/A - VFE System II is a reusable instrument. It is intended for use in sterile surgical settings, adhering to standard ophthalmic surgical protocols to ensure patient safety and device longevity. Reusability requires proper cleaning, sterilization, and maintenance as outlined in Mira, Inc.’s instructions for use.

How is the sterility of the I/A - VFE System II maintained?

Since the I/A - VFE System II is reusable, sterility is maintained through adherence to surgical protocols, including cleaning, disinfection, and sterilization procedures before each use. The device must be processed in accordance with established medical device reprocessing guidelines to prevent contamination and ensure safe clinical use.

What regulatory pathway was followed for the I/A - VFE System II?

The I/A - VFE System II received FDA clearance through the 510(k) process, specifically under the Traditional review pathway. It was determined to be Substantially Equivalent (SESE) to a legally marketed predicate device, with a clearance number of K854868. The device falls under product code HQE and regulation number 886.4150, with no third-party review involved in its clearance.

Are there multiple models or variations of the I/A - VFE System II?

The I/A - VFE System II is associated with multiple FEI (Facility Equipment Identifier) numbers, indicating it may be distributed across various facility configurations or versions. However, these identifiers do not imply distinct clinical models but rather tracking for inventory and regulatory purposes. For specific technical or functional variations, refer to Mira, Inc.’s documentation or contact their technical support.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Vfi/vfe System Ii 510 (k) K854872 - FDA.report, K260817 FDA 510 (k) - MIRA Surgical System | Virtual Incision, Home - Aveo Systems

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mira, Inc.

Sources (1)

  • FDA 510(k) K854868 24 fields · synced Oct 1, 2026