21 CFR 886.5300 — Intranasal Electrostimulation Device
Ophthalmic (OP) · Part 886 Subpart F—Therapeutic Devices · § 886.5300
Identification
A tear electrostimulation device is a non-implantable, electrostimulation device intended to increase tear production.
Classification Rationale
Class II (special controls). The special controls for this device are:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| PQJ | Intranasal Electrostimulation Device | 2 | 1 |
Special Controls
PQJ — Intranasal Electrostimulation Device
In combination with the general controls of the FD&C Act, the Tear Electrostimulation Device is subject to the following special controls:
De Novo Order DEN160030
PQJ — Intranasal Electrostimulation Device
*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.
eCFR
PQJ — Intranasal Electrostimulation Device
(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.
Ecfr Llm
