(680 days)
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Not Found
No
The description focuses on direct image-to-electrotactile signal conversion based on luminance, without mentioning any learning, adaptation, or complex pattern recognition that would typically involve AI/ML.
No.
The device's description explicitly states it is "not used to diagnose or treat the underlying condition that leads to the user's visual impairment." It functions as an "adjunctive device" or "assistive aid" to help with orientation, mobility, and object recognition, rather than providing direct therapy.
No
The device description explicitly states, "The BrainPort V100 is not used to diagnose or treat the underlying condition that leads to the user's visual impairment." Instead, it is an aid for orientation, mobility, and object recognition.
No
The device description explicitly states that the BrainPort V100 consists of three hardware components: the headset, the controller, and the battery charger. This indicates it is not a software-only device.
Based on the provided information, the BrainPort V100 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- BrainPort V100 Function: The BrainPort V100 is an assistive device that translates visual information into electro-tactile stimulation on the tongue to aid profoundly blind individuals with orientation, mobility, and object recognition. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's an "oral electronic vision aid" to "aid profoundly blind patients in orientation, mobility, and object recognition." It explicitly states it is "not used to diagnose or treat the underlying condition that leads to the user's visual impairment."
Therefore, the BrainPort V100 falls under the category of an assistive medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BrainPort V100 is an oral electronic vision aid that provides electro-tactile stimulation to aid profoundly blind patients in orientation, mobility, and object recognition as an adjunctive device to other assistive methods such as the white cane or a guide dog.
Product codes
PIC
Device Description
The BrainPort V100 is an electronic assistive aid that translates images of objects captured by a digital camera into electro-tactile signals that are presented to the user's tongue. With training, users are able to use the electrotactile signals to perceive shape, size, location and motion of objects. The BrainPort V100 is intended to augment, rather than replace, other assistive technology such as the white cane or guide dog. The BrainPort V100 is not used to diagnose or treat the underlying condition that leads to the user's visual impairment. The BrainPort V100 is intended for prescription use only and for single patient use.
The BrainPort V 100 consists of three components: the headset, the controller (also known as the handset), and the battery charger as depicted in Figure 1. The headset is typically worn on the user's head and provides the image input and output functions of the device. The controller is generally handheld and provides the processing and power functions of the device. The battery charger is a commercial off-the-shelf unit used to charge the removable battery.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital camera
Anatomical Site
Tongue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professionals who have both credentials and practical experience working with the blind, such as: Certified Low Vision Specialists (CLVS), Certified Orientation and Mobility Specialist (COMS) and Teachers of the Visually Impaired (TVI). The device is for use by profoundly blind individuals and can be used in hospital and home-use environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The applicant conducted a one-year clinical study to demonstrate the safety and effectiveness of the BrainPort V100 device in assisting blind and visually impaired individuals in object recognition and orientation and mobility activities. This study was augmented by additional adverse event data collected outside the United States.
Study Design: The BrainPort V100 device was evaluated in a single arm, open label clinical study of 75 enrolled blind/profoundly blind subjects (visual acuity of light perception or worse) at 7 sites in the U.S. and Canada. Subjects underwent 2-3 days (10 hours) of training followed by in-home use over the span of 12 months.
The duration of each subject's participation was intended to be approximately 12 months. Total study duration was targeted to be approximately 18 months, or a sufficient time to enroll and evaluate 75 subjects with 12 months of device use.
The primary safety objective was to demonstrate an acceptable rate (
§ 886.5905 Oral electronic vision aid.
(a)
Identification. An oral electronic vision aid is a battery-powered prescription device that contains an electrode stimulation array to generate electrotactile stimulation patterns that are derived from digital object images captured by a camera. It is intended to aid profoundly blind patients in orientation, mobility, and object recognition as an adjunctive device to other assistive methods such as a white cane or a guide dog.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate an acceptable adverse event profile, including adverse events involving the mouth, tongue, and gums and demonstrate the effect of the stimulation to provide clinically meaningful outcomes. The clinical performance testing must also investigate the anticipated conditions of use, including potential use error, intended environment of use, and duration of use.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including simulated moisture ingress, device durability, and battery reliability.
(3) Software verification, validation, and hazard analysis must be performed.
(4) Analysis/testing must validate electromagnetic compatibility.
(5) Analysis/testing must validate electrical safety.
(6) Analysis/testing must assess and validate wireless coexistence concerns.
(7) Any elements of the device that contact the patient must be demonstrated to be biocompatible.
(8) Training must include elements to ensure that the healthcare provider and user can identify the safe environments for device use, use all safety features of the device, and operate the device in the intended environment of use.
(9) Labeling for the trainer and user must include a summary of the clinical testing including adverse events encountered under use conditions, summary of study outcomes and endpoints, and information pertinent to use of the device including the conditions under which the device was studied (
e.g., level of supervision or assistance, and environment of use).
0
DE NOVO CLASSIFICATION REQUEST FOR BRAINPORT V100
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Oral electronic vision aid. An oral electronic vision aid is a battery-powered prescription device that contains an electrode stimulation array to generate electro-tactile stimulation patterns that are derived from digital object images captured by a camera. It is intended to aid profoundly blind patients in orientation, mobility, and object recognition as an adjunctive device to other assistive methods such as the white cane or a guide dog.
NEW REGULATION NUMBER: 886.5905
CLASSIFICATION: CLASS II
PRODUCT CODE: PIC
BACKGROUND
DEVICE NAME: BRAINPORT V100
SUBMISSION NUMBER DEN130039
DATE OF DE NOVO: August 7, 2013
- CONTACT: Wicab Inc. 8313 Greenway Blvd. Suite 100 Middleton, WI 53562 608-829-4500
REQUESTER'S RECOMMENDED CLASSIFICATION: CLASS II
INDICATIONS FOR USE
The BrainPort V100 is an oral electronic vision aid that provides electro-tactile stimulation to aid profoundly blind patients in orientation, mobility, and object recognition as an adjunctive device to other assistive methods such as the white cane or a guide dog.
LIMITATIONS
BrainPort V100 is indicated for prescription use only.
Candidates for the device should be profoundly blind.
Contraindications:
- . Any neurological condition that causes impaired sensitivity to the tongue or loss of consciousness
1
Warnings:
- . Limited data are available on the long-term effects of electrical stimulation of the tongue. Long-term effects (beyond one year) have not been evaluated in clinical trials.
- The BrainPort V100 should be not used in patients experiencing numbness or lack of feeling of the tongue, or in patients with a history of injury to the tongue resulting in impaired sensation or use of the tongue.
- The BrainPort V100 should only be used after the user has completed training. Do not give the device to untrained individuals for use.
- Limited data are available on stimulation sensitivity for individuals with oral conditions such as oral ulcerations, herpes simplex, oral thrush, and geographic tongue. If use of the device causes discomfort, discontinue use.
- . The BrainPort V100 has not been thoroughly evaluated in the presence of dental implants. The safety of dental implants in BrainPort users is unknown. The use of this device potentially may cause heating of dental implants; chronic use of this device potentially may result in loosening and failure of dental implants.
- The BrainPort V100 is not used to diagnose or treat the underlying condition that leads to ● the user's visual impairment.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS. PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The BrainPort V100 is an electronic assistive aid that translates images of objects captured by a digital camera into electro-tactile signals that are presented to the user's tongue. With training, users are able to use the electrotactile signals to perceive shape, size, location and motion of objects. The BrainPort V100 is intended to augment, rather than replace, other assistive technology such as the white cane or guide dog. The BrainPort V100 is not used to diagnose or treat the underlying condition that leads to the user's visual impairment. The BrainPort V100 is intended for prescription use only and for single patient use
The BrainPort V 100 consists of three components: the headset, the controller (also known as the handset), and the battery charger as depicted in Figure 1. The headset is typically worn on the user's head and provides the image input and output functions of the device. The controller is generally handheld and provides the processing and power functions of the device. The battery charger is a commercial off-the-shelf unit used to charge the removable battery.
Image /page/1/Figure/11 description: The image shows a person wearing a headset and glasses with a device in their mouth. The headset is connected to the glasses and has a wire that runs down to the device in the person's mouth. The person is also holding a controller in their hand. The controller has several buttons and a screen.
Figure 1: Artist Rendition of BrainPort V100 components: Controller and Headset
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Headset
A digital video camera is mounted on a pair of sunglasses at the nose bridge. The field of view of the camera is user-controlled and varies from narrow to wide angle views. There are two cables permanently attached to the left ear piece: the IOD assembly and the headset cable.
Intra Oral Device (IOD)
The IOD (tongue electrode array) contains electrodes that act as "pixels" for the tongue. The flat side with the electrodes should be in contact with the front top surface of the tongue. The user should close their lips around the thin stem, maximizing tongue contact with the electrodes. The electrodes provide stimulation to the tongue based on information received from the camera. The electrodes provide electro-tactile information that varies based on the size, location and relative luminance of objects within a visual scene. There is one cable exiting the thin stem of the IOD that is permanently attached to the ear piece of the headset. Figure 2 below presents the IOD sub-assembly of the BrainPort V100.
Image /page/2/Picture/4 description: The image shows a polished finished IOD subassembly. The subassembly appears to be a tool with a rectangular head and a handle. The head is light-colored, possibly white or beige, and has a grid-like pattern on its surface. The handle is dark, likely brown or black, and is attached to the head.
Figure 2 - IOD Subassembly of the BrainPort V100
Controller
The Controller contains the battery as well as the user control features for the BrainPort V100. An antenna provides wireless connection capabilities. The Controller is generally handheld. A belt clip is provided for hands free operation.
Battery & Battery Charger
Rechargeable Lithium-Polymer batteries and a battery charger with factory instructions are included with each BrainPort V100. All batteries included with the system should be fully charged at 3.7VDC prior to initial use.
The general specifications for the BrainPort V100 are listed in Table 1:
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| Physical | Length 13.3 cm
width 5.6 cm
height 3.5 cm (excluding belt clip)
weight