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Intranasal Electrostimulation Device

Page Type
Product Code
Definition
This device type is intended to temporarily increase tear production using neurostimulation in adult patients.
Physical State
The intranasal tear neurostimulator is a handheld device with two electroconductive tips that are inserted into the nasal cavity during neurostimulation. The disposable tips are made of rigid biocompatible USP Class VI plastic and the conductive tips are made of silicone hydrogel. Additional hardware components include a reusable base, charging station, and cover. The base has two buttons that allow the user to select the stimulation level (device is locked from use after a predetermined amount of stimulation has been triggered).The device is powered by a rechargeable battery. Once the tips are removed, the base can be inverted and placed in the charger to replenish the battery.
Technical Method
The device activates tear production through stimulation of the nasolacrimal reflex. Stimulation activates the primary sensory afferent fibers in the ophthalmic and maxillary branches of the trigeminal nerve (CNV1 and CNV2). The device design limits the insertion length of the intranasal tips to ensure the probes do not physically reach the olfactory nerve fibers of nasal mucosa. The pulses delivered by the Intranasal Tear Neurostimulator induce action potentials in the surrounding nerve tissue by creating transient voltage depolarization in activated neurons. This neural activation initiates the nasolacrimal reflex, resulting in tear secretion.
Target Area
Nose.
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.5300
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.5300 Tear electrostimulation device

§ 886.5300 Tear electrostimulation device.

(a) Identification. A tear electrostimulation device is a non-implantable, electrostimulation device intended to increase tear production.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Non-clinical performance testing must assess the following electrical output specifications: waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density.

(2) Patient-contacting components of the device must be demonstrated to be biocompatible.

(3) Performance testing must demonstrate the electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment.

(4) Software verification, validation, and hazard analysis must be performed.

(5) Physician and patient labeling must include:

(i) Summaries of electrical stimulation parameters;

(ii) Instructions on how to correctly use and maintain the device;

(iii) Instructions and explanations of all user-interface components;

(iv) Information related to electromagnetic compatibility classification; and

(v) Instructions on how to clean the device.

[82 FR 60116, Dec. 19, 2017]

Intranasal Electrostimulation Device

Page Type
Product Code
Definition
This device type is intended to temporarily increase tear production using neurostimulation in adult patients.
Physical State
The intranasal tear neurostimulator is a handheld device with two electroconductive tips that are inserted into the nasal cavity during neurostimulation. The disposable tips are made of rigid biocompatible USP Class VI plastic and the conductive tips are made of silicone hydrogel. Additional hardware components include a reusable base, charging station, and cover. The base has two buttons that allow the user to select the stimulation level (device is locked from use after a predetermined amount of stimulation has been triggered).The device is powered by a rechargeable battery. Once the tips are removed, the base can be inverted and placed in the charger to replenish the battery.
Technical Method
The device activates tear production through stimulation of the nasolacrimal reflex. Stimulation activates the primary sensory afferent fibers in the ophthalmic and maxillary branches of the trigeminal nerve (CNV1 and CNV2). The device design limits the insertion length of the intranasal tips to ensure the probes do not physically reach the olfactory nerve fibers of nasal mucosa. The pulses delivered by the Intranasal Tear Neurostimulator induce action potentials in the surrounding nerve tissue by creating transient voltage depolarization in activated neurons. This neural activation initiates the nasolacrimal reflex, resulting in tear secretion.
Target Area
Nose.
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.5300
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.5300 Tear electrostimulation device

§ 886.5300 Tear electrostimulation device.

(a) Identification. A tear electrostimulation device is a non-implantable, electrostimulation device intended to increase tear production.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Non-clinical performance testing must assess the following electrical output specifications: waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density.

(2) Patient-contacting components of the device must be demonstrated to be biocompatible.

(3) Performance testing must demonstrate the electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment.

(4) Software verification, validation, and hazard analysis must be performed.

(5) Physician and patient labeling must include:

(i) Summaries of electrical stimulation parameters;

(ii) Instructions on how to correctly use and maintain the device;

(iii) Instructions and explanations of all user-interface components;

(iv) Information related to electromagnetic compatibility classification; and

(v) Instructions on how to clean the device.

[82 FR 60116, Dec. 19, 2017]