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Intranasal Electrostimulation Device For Dry Eye Symptoms

Page Type
Product Code
Definition
This device type is intended to temporarily increase tear production using neurostimulation to improve dry eye symptoms. For prescription use only.
Physical State
The intranasal electrostimulation device for dry eye symptoms 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.
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 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
886.5310
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.5310 Intranasal electrostimulation device for dry eye symptoms

§ 886.5310 Intranasal electrostimulation device for dry eye symptoms.

(a) Identification. An intranasal electrostimulation device for dry eye symptoms is a prescription non-implantable, electrostimulation device intended to increase tear production for improvement in dry eye symptoms.

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

(1) Clinical performance testing must evaluate improvement of dry eye symptoms under anticipated conditions of use.

(2) 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.

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

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

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

(6) Training for the proper use of the device must be provided.

(7) 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;

(v) Instructions on how to clean the device; and

(vi) Summaries of clinical performance testing demonstrating safety and effectiveness.

[83 FR 52975, Oct. 19, 2018]

Intranasal Electrostimulation Device For Dry Eye Symptoms

Page Type
Product Code
Definition
This device type is intended to temporarily increase tear production using neurostimulation to improve dry eye symptoms. For prescription use only.
Physical State
The intranasal electrostimulation device for dry eye symptoms 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.
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 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
886.5310
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.5310 Intranasal electrostimulation device for dry eye symptoms

§ 886.5310 Intranasal electrostimulation device for dry eye symptoms.

(a) Identification. An intranasal electrostimulation device for dry eye symptoms is a prescription non-implantable, electrostimulation device intended to increase tear production for improvement in dry eye symptoms.

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

(1) Clinical performance testing must evaluate improvement of dry eye symptoms under anticipated conditions of use.

(2) 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.

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

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

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

(6) Training for the proper use of the device must be provided.

(7) 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;

(v) Instructions on how to clean the device; and

(vi) Summaries of clinical performance testing demonstrating safety and effectiveness.

[83 FR 52975, Oct. 19, 2018]