BrainPort V100 Oral Electronic Vision Aid
by Wicab, Inc. United States 510(k)
510(k) K152851
Product code PIC
Overview
The BrainPort V100 is an Oral Electronic Vision Aid, classified under FDA regulation 886.5905. This non-surgical device uses sensory substitution technology to translate visual information from an integrated video camera into tactile stimulation on the tongue, enabling users to perceive orientation, mobility cues, object identification, and limited text recognition. Designed for individuals with blindness or severe visual impairment, it provides real-time sensory feedback to assist in daily activities.
The device is supplied as a reusable, non-sterile medical instrument intended for home or clinical use. It requires no surgical intervention and operates within MRI-safe parameters, though users should consult facility guidelines before MRI exposure. The BrainPort V100 received FDA 510(k) clearance under the Traditional review pathway, classified as a Class II device. Storage instructions and maintenance protocols are detailed in the accompanying user manual.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152851 | Date24 Dec 2015 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- BrainPort V100
- 510(k) Number
- FDA Product Code
- PIC
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5905
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Wicab, Inc.
Questions
How does the BrainPort V100 help users with visual impairment, and what types of activities can it assist with in daily life?
The BrainPort V100 uses sensory substitution technology to translate visual information from an integrated camera into tactile sensations on the tongue. This allows users with blindness or severe visual impairment to perceive orientation, mobility cues, identify objects, and even recognize limited text in real time. It’s designed to aid in daily activities like navigating spaces, recognizing faces or objects, and reading short text, though its primary function is enhancing spatial awareness and basic object recognition.
Is the BrainPort V100 reusable, and if so, what maintenance or care is required to keep it functioning properly?
Yes, the BrainPort V100 is a reusable device, not intended for single-use. Since it is non-sterile, proper care and maintenance are essential to ensure reliable performance. Users should follow the detailed storage and cleaning instructions provided in the included user manual to maintain hygiene and functionality. The manual also outlines maintenance protocols to extend the device’s lifespan.
Can the BrainPort V100 be used during an MRI scan, and what precautions should users take?
The BrainPort V100 is designed to operate within MRI-safe parameters, meaning it does not contain components that would interfere with MRI technology. However, users should always consult their MRI facility’s specific guidelines before using the device during an MRI scan, as protocols can vary by location. This ensures compatibility and safety during the procedure.
What regulatory pathway was followed for FDA clearance of the BrainPort V100, and how does this classification affect its use?
The BrainPort V100 received FDA clearance under the Traditional 510(k) review pathway and is classified as a Class II device. This classification means it is subject to general controls and special controls to ensure safety and effectiveness, but it does not require the same stringent premarket approval process as Class III devices. The clearance indicates it is considered substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for its intended use as an oral electronic vision aid.
What types of environments or settings can the BrainPort V100 be used in, and is it suitable for both home and clinical settings?
The BrainPort V100 is explicitly designed for use in both home and clinical environments. It is a non-surgical, portable device that requires no specialized infrastructure, making it versatile for everyday activities at home or for therapeutic use in clinical settings. Its non-sterile classification means it is not intended for invasive procedures but is suitable for assisting users in their daily routines or under professional supervision.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K152851