(120 days)
The iTEAR100 Neurostimulator is an electromechanical nerve stimulator device, indicated for temporary use (up to 30 days) to increase acute tear production during vibratory stimulation of the external nasal nerve in adults, under prescription of an eye care provider.
The iTEAR100 device is a prescription only, non-implantable, electromechanical stimulator intended to increase tear production acutely (over 30 days) through vibratory stimulation of the external nasal nerve in adult patients. The device's technological principle is the application of mechanical vibration to specific sensory neurons on the side of the nose. The device is battery-operated with a single vibratory tip. As the tip is pushed against the tissue, the beam deflects inward until it is deflected fully into the device consists of a handheld unit with a plastic shell, power button, charging port, and effector tip accessible from the exterior. The interior includes mechanical and electrical subsystems comprised of a motor, supercapacitor, printed circuit board assembly (PCBA) including driver board, control board and Bluetooth microprocessor, vibrating cantilever beam attached to the effector tip, and real-time clock. The iTEAR100 Neurostimulator connects via Bluetooth Low Energy to a mobile application downloaded onto the user's mobile device (compatible with iOS or Android operating system). The mobile application is necessary to activate the device for initial use and collects device usage data which the user may upload to a cloud database at the user's discretion.
The Olympic Ophthalmics iTEAR100 Neurostimulator is a medical device for temporarily increasing tear production. The provided text, a 510(k) Summary, focuses on demonstrating substantial equivalence to a previously cleared predicate device (iTEAR100 Neurostimulator, DEN190026), rather than presenting a study designed to prove the device meets specific clinical acceptance criteria for effectiveness in human subjects.
The core of the acceptance criteria described in the document is the claim of "substantial equivalence" to the predicate device. This is primarily demonstrated through comparative performance testing of mechanical outputs and other technical specifications, alongside adherence to relevant safety standards.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly define "acceptance criteria" in terms of specific clinical outcomes for tear production for this submission. Instead, the acceptance criteria are implicitly that the subject device's performance regarding safety and technical characteristics is comparable to, or improved from, the predicate device, and that these changes do not raise new questions of safety or effectiveness. The reported device "performance" is primarily a demonstration of this equivalence across various technical aspects.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance and Comparison to Predicate |
|---|---|
| Intended Use / Indications for Use: Maintain the same clinical purpose and target population as the predicate. | Same: The iTEAR100 Neurostimulator is indicated for temporary use (up to 30 days) to increase acute tear production during vibratory stimulation of the external nasal nerve in adults, under prescription of an eye care provider. |
| Key Technological Characteristics: Changes should not raise different questions of safety or effectiveness. | Change from wired to Bluetooth communication: The subject device uses Bluetooth Low Energy for wireless communication, a mobile app, and a cloud database, while the predicate used wired (USB) communication. This change is deemed not to raise different questions of safety or effectiveness. Other core components (cantilever, weighted motor, PCBA, etc.) remain the same. |
| Physical Dimensions: Be similar to the predicate. | Similar: Subject device: 80 mm x 58 mm x 25 mm. Predicate device: 80 mm x 58 mm x 23.5 mm. Tip Protrusion: Subject device 5.1 mm, Predicate 5.0 mm. |
| Effector Tip Thickness: Remain the same. | Same: 2.9 mm for both. |
| Power Source: Remain the same. | Same: 3.7 V rechargeable battery for both. |
| Frequency and Amplitude of Vibration: Remain within specified ranges and be comparable to the predicate. | Same: Frequency: 200 - 300 Hz (270 unloaded) for both. Amplitude: |
§ 886.5305 Electromechanical tear stimulator.
(a)
Identification. An electromechanical tear stimulator is a non-implantable device intended to increase tear production via mechanical stimulation.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing under anticipated conditions of use must evaluate tear production and all adverse events, including tissue damage, pain, headache, and discomfort.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be conducted:
(i) An assessment of mechanical output specifications, including vibration amplitude and frequency, pressure and force, and acoustic (noise level) properties;
(ii) Mechanical safety testing to validate safeguards related to the pressure aspects of the device; and
(iii) Use life testing.
(3) Performance data must demonstrate the electrical safety, thermal safety, and electromagnetic compatibility (EMC) of all electrical components of the device.
(4) All patient-contacting components of the device must be demonstrated to be biocompatible.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Physician and patient labeling must include:
(i) A detailed summary of the device's technical parameters;
(ii) Instructions for use, including an explanation of all user-interface components and information regarding proper device placement;
(iii) Information related to electromagnetic compatibility classification;
(iv) Instructions on how to clean and maintain the device;
(v) A summary of the clinical performance testing conducted with the device;
(vi) Language to direct end users to contact the device manufacturer and MedWatch if they experience any adverse events with this device; and
(vii) Information on how the device operates and the typical sensations experienced during treatment.