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510(k) Data Aggregation
(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: < 1.0 mm for both. Bench testing confirmed equal performance in frequency, amplitude, acceleration, force-displacement, temperature, and noise compared to the predicate device. |
| Safety Features: Maintain existing safety features and ensure any new features do not introduce new risks. | Improved/Additional Safety Features: Subject device has "Tip retraction (< 6.0 N)", "Vibration damping at 2 mm", "Disable device after 30 days of use", and "Prescription and user verification required prior to device activation". The prescription and user verification processes are additional safety features that do not raise different questions. |
| Materials / Biocompatibility: Any changes in patient-contacting materials should be biocompatible and not raise new safety concerns. | Material Reduction and Bio-compatibility: Patient-contacting materials reduced from plastic (ABS) and silicone to only plastic (ABS). The ABS is the same as the predicate. The power button is now ABS, removing the need for a silicone coating. Biocompatibility testing (Cytotoxicity, Sensitization, Irritation per ISO 10993-1, -5, -10) was performed and found acceptable for surface device with limited (≤ 24 hours) contact with intact skin. |
| Software Functional Equivalence and Safety: Software should perform intended functions safely, and any changes should not introduce new risks. | Added Secure Prescription Activation: The subject device includes a "Secure prescription activation" feature in its key software functions, which is considered an additional safety feature. Both devices utilize firmware for voltage control, on-off, data logging, power level indication, and disabling after 30 days. Software verification and validation (IEC 62304) was performed, and the software maintains a "moderate" level of concern, same as the predicate. |
| Electrical Safety and EMC: Compliance with relevant international standards. | Compliance: Testing performed per IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 62366-1, and ANSI C63.27 (the latter specifically for Bluetooth). These are the same tests as the predicate, with the addition of ANSI C63.27 for Bluetooth communication. |
| Life Testing: Demonstrate expected useful life. | Simulated Life: Life testing simulated 12 months of twice-daily, bilateral use. The stated use life is 6 months, same as the predicate. |
| Other Technical Differences (e.g., charging port, memory): Should not affect safety or effectiveness. | Different Charging Port and Memory: USB-C vs. Micro-USB charging port; EEPROM vs. SD Card for memory. These differences are deemed not to affect device safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench testing and biocompatibility testing, not a clinical test set on human subjects to prove effectiveness.
- Bench Testing: No sample size is indicated for the comparative mechanical output testing. This testing would be performed on manufactured devices.
- Biocompatibility Testing: The testing (Cytotoxicity, Sensitization, Irritation) is performed on materials, not human subjects. No sample size of devices/materials is specified.
- Software Verification & Validation: This refers to testing of the software itself.
- Life Testing: "Simulated 12 months of twice-daily, bilateral use." The number of devices tested is not specified.
The document does not provide information on the country of origin or whether any data was retrospective or prospective, as it does not describe clinical studies for performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the provided text. The submission focuses on demonstrating substantial equivalence through engineering and safety testing, not clinical studies requiring expert ground truth establishment for a diagnostic or therapeutic outcome.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to the provided text. No clinical test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable to the provided text. The device is a neurostimulator for tear production, not an AI-assisted diagnostic imaging system. No human reader studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical electromechanical nerve stimulator, not a standalone algorithm. While it has software, its performance is intertwined with the hardware and user application. The "performance data" presented relates to the hardware, software, and biocompatibility, not an isolated algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the engineering and safety tests performed:
- Bench Testing: The "ground truth" is typically objective measurements (e.g., using calibrated sensors) of physical outputs (frequency, amplitude, acceleration, etc.) compared against the predicate device's measured outputs or design specifications.
- Biocompatibility: The "ground truth" comes from established ISO standards (ISO 10993 series) and their respective pass/fail criteria.
- Electrical Safety and EMC: The "ground truth" comes from compliance with international standards (e.g., IEC 60601 series, ANSI C63.27) and their specified limits.
- Software Verification & Validation: The "ground truth" is the adherence to software requirements and IEC 62304 standards.
8. The sample size for the training set
This information is not applicable. This submission describes a hardware medical device with software, not a machine learning model that requires a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
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