21 CFR 886.5310 — Intranasal Electrostimulation Device For Dry Eye Symptoms
Ophthalmic (OP) · Part 886 Subpart F—Therapeutic Devices · § 886.5310
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.
Classification Rationale
Class II (special controls). The special controls for this device are:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QBR | Intranasal Electrostimulation Device For Dry Eye Symptoms | 2 | 2 |
Special Controls
QBR — Intranasal Electrostimulation Device For Dry Eye Symptoms
In combination with the general controls of the FD&C Act, the intranasal electrostimulation device for dry eye symptoms is subject to the following special controls: - (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: - a. Summaries of electrical stimulation parameters. - b. Instructions on how to correctly use and maintain the device. - c. Instructions and explanations of all user-interface components. - d. Information related to electromagnetic compatibility classification. - Instructions on how to clean the device. e. - Summaries of clinical performance testing demonstrating safety and effectiveness. f.
De Novo Order DEN170086
QBR — Intranasal Electrostimulation Device For Dry Eye Symptoms
*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.
eCFR
QBR — Intranasal Electrostimulation Device For Dry Eye Symptoms
(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.
Ecfr Llm
