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510(k) Data Aggregation
(251 days)
The Clever TD-7001 Nebulizer is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize physician-prescribed solution for inhalation by the patient, except for Pentamidine. The Clever TD-7001 Nebulizer is for use with children and adult patients in the homecare environment.
Clever TD-7001 Nebulizer is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize physician-prescribed solution for inhalation by the patient. It is for use with children and adult patients in the homecare environment. Clever TD-7001 Nebulizer consists of a Nebulizer unit, a medication cap and a Jand Medication cup are single medication cup. The Nebulizer unit, me patient re-usable. The Nebulizer unit trol circuitry and is powered by using 2 AA alkaline batteries organ A onnects to electrical outlets. The patient interface comprises a mouthpiê medication cap contains the metal alloy mesh. When the device is turne ultrasonic piezoelectric element vibrate to cause the mesh vibrate. ation solution tin the reservoir of medication cup is aerosolized by the vibrating the aerosols can be inhaled through the mouthpiece or mask.
Here's a breakdown of the acceptance criteria and study information for the Clever TD-7001 Nebulizer, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Aerosol Characterization Testing (Particle Size Distribution) | |
| Equivalent performance to predicate device (K062263) for 3 drugs (Ipratropium bromide, Ventolin, Cromolyn sodium) with no significant difference (p > 0.035). | The test "has shown Clever TD-7001 Nebulizer consistent in repeatabil for each three classes of drug, and demonstrated equivalent performance? ate device K062263 that no significant difference (p>0.035) in the Clever TD-7001 Nebulizerst as the ame performance characteristics as the predicate device and meets its product specification as well." |
| Airpath Testing (Gas Sample Analysis) | |
| Device does not emit potential toxic gases (carbon monoxide, carbon dioxide, ozone, volatile organic compounds). | "Gas sample analysis of Clever TD-7001 Nebulizer has performed and shown the device does not emit potential toxic gases that may cause harmful influences to human, including carbon monoxide, carbon dioxide, ozone, or volatile organic compounds (VOCs)." |
| Output of particulate matter conforms to EPA PM2.5 standard. | "The output of particulate matter conformed to EPA requirements of the PM2.5 standard." |
| Materials (Biocompatibility) | |
| Meet ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation), ISO 10993-10 (sensitization), ISO 10993-6 (implantation), and ISO 10993-3 (genotoxicity) for gas path contact materials. | "Biocompatibility evaluations of cytotoxicity (ISO 10993-5), irritation (ISO 10993-10), sensitization (ISO 10993-10), implantation (ISO 10993-6) and genotoxicity (ISO 10993-3) tests have been conducted for the gas path contact materials." (Implies meeting the standards.) |
| Safety and EMC (Electrical Safety and Electromagnetic Compatibility) | |
| Meet EN 60601-1:1988+A1:1991+A2:1995 and EN 60601-1-1-2:2001+A1:2006, CISPR 11:2003. | "The electromagnetic compatibility and electric safety of the proposed device are tested to meet the following standards: - EN 60601-1:1988+ A1:1991+ A2:1995 - EN 60601-1-1-2:2001+A1:2006, CISPR 11: 2003" (Implies meeting the standards.) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the specific sample sizes for the test sets in the performance characteristic studies. It mentions "three drugs (Ipratropium bromide, Ventolin, and Cromolyn sodium)" were used for the aerosol characterization testing, implying at least three distinct test cases.
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. It is, however, implied to be generated specifically for the submission of this device, suggesting prospective testing conducted by the manufacturer, TaiDoc Technology Corporation (Taiwan).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the given text. For device performance testing of a nebulizer, "ground truth" would typically refer to objective measurements obtained from controlled laboratory conditions, rather than expert interpretation of data.
4. Adjudication Method for the Test Set
This information is not applicable/provided in the context of the described performance testing. The studies are objective measurements (e.g., particle size distribution, gas analysis) rather than subjective assessments requiring adjudication.
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
An MRMC comparative effectiveness study was not conducted. This type of study is typically relevant for AI-powered diagnostic imaging devices, not for a medical device like a nebulizer.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as the device is a nebulizer and does not involve an algorithm or AI. The performance tests described (aerosol characterization, airpath, materials, safety/EMC) are inherently "standalone" in the sense that they measure the device's physical and functional properties directly.
7. The Type of Ground Truth Used
The ground truth used for these studies is based on:
- Objective Measurement Standards:
- For Aerosol Characterization: Comparison to the performance of a legally marketed predicate device (K062263) using established methods like Cascade Impactor, with statistical significance testing (p > 0.035).
- For Airpath Testing: Compliance with EPA requirements (PM2.5 standard) and general toxic gas emission limits.
- For Materials: Adherence to international biocompatibility standards (ISO 10993 series).
- For Safety and EMC: Compliance with international electrical safety and electromagnetic compatibility standards (EN 60601 series, CISPR 11).
8. The Sample Size for the Training Set
This information is not applicable as the device is not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is not an AI/ML algorithm requiring a training set.
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