(243 days)
The eRapid™ Nebulizer System is a handheld nebulizer that will be used with patients for whom doctors have prescribed medication for nebulization. It is intended for adult and pediatric patients, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments.
The eRapid Nebulizer System is a modified version of the predicate FDA-cleared eFlow (now Trio ) Electronic Nebulizer, cleared in 510k Nos. K033833 and Special 510K No. K072670, and the Altera® Nebulizer System, cleared in 510(k) No. K100380. Its performance characteristics, however, are comparable to the predicates LC Star, cleared in 510(k) No. K963924, and Micro Mist Nebulizer, cleared in 510(k) No. K930525.
Similarities are that both the eRapid and the predicate Trio and Altera devices are identical in purpose, function, core technology and method of operation. They are singlepatient use, reusable electronic nebulizers, using micro-perforated vibrating membrane technology to aerosolize liquid medications. They are for adult and pediatric inhalation therapy in a home care, nursing home, sub-acute institution, or hospital environment. The devices are hand-held and portable, consisting of a controller and a nebulizer handset, connected with a connection cord. Power input for both devices is provided by either four AA batteries, or a DC or AC adapter. Alternate power cords, plugs and adapters allow their use in any country.
The eRapid incorporates three design modifications in comparison with the predicate eFlow Technology devices: (1) a larger capacity reservoir, and a smaller volume aerosol chamber; (2) for patient convenience, an accessory that aids in the cleaning of the aerosol head, and; (3) also for patient convenience, added software user-interface functions that allow the device to pause in its operation, as well as to operate the cleaning aid.
Also. while the eRapid and the predicates Trio. LC Star and Micro Mist are for use with those medications prescribed by doctors for nebulization (i.e. general purpose) the Altera has a drug-specific application.
The provided text describes a 510(k) summary for the eRapid Nebulizer System, focusing on its substantial equivalence to predicate devices rather than a standalone study with acceptance criteria for device performance as typically understood for AI/ML devices. Therefore, much of the requested information (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone algorithm performance) is not applicable or cannot be extracted from this document, as it pertains to a different type of medical device submission (nebulizer hardware, not an AI/ML diagnostic or therapeutic system).
However, I can extract information related to the device's technical specifications and how its performance was compared to predicate devices, which can be framed as fulfilling "acceptance criteria" for substantial equivalence.
Here's a breakdown of the information that can be extracted and how it relates to your request:
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to its predicate devices in terms of purpose, function, core technology, method of operation, and performance characteristics. The document doesn't list explicit quantitative acceptance criteria as would be typical for an AI/ML performance study (e.g., "sensitivity must be > 90%"). Instead, it compares specific performance metrics to those of predicate devices.
| Criteria Category | Acceptance Criteria (Implied) | Reported Device Performance and Comparison |
|---|---|---|
| Intended Use | Must be identical or highly similar to predicate devices. | Identical: For adult and pediatric patients for whom doctors have prescribed medication for nebulization, usable in various care environments. |
| Technology | Must use a similar core technology or principle of operation to at least one predicate device for aerosolization. | Uses micro-perforated vibrating membrane technology, identical to predicate eFlow Technology devices (Trio, Altera). |
| Biocompatibility | No new safety concerns from new materials; materials must be biocompatible. | In Vitro Cytotoxicity Study showed the aerosol head did not release substances in cytotoxic concentrations. Additional testing concluded new materials are biocompatible with no new safety issues. |
| Software Performance | Software must perform within specifications and be safe for intended use. | Test results concluded software performs within specifications and is safe. The document notes a permanent hazard analysis in the development process and simple architecture contribute to sufficient verification. |
| Cleaning & Disinfection | Must be effectively cleaned and disinfected by methods stated in the IFU, comparable to predicate devices. | Validation tests for manual and chemical cleaning/disinfection methods from predicate eFlow Technology devices are still valid. Two non-chemical disinfection methods were also validated. All concluded effective cleaning and disinfection. |
| Simulated Lifetime (Device) | No deleterious effects from cleaning, disinfection, or normal use over lifetime, comparable to predicate devices. | Simulated lifetime testing (including for the Easycare cleaning aid) concluded no deleterious effects from cleaning/disinfection methods; previous validations from eFlow devices are considered valid for eRapid. |
| Simulated Lifetime (Aerosol Head) | Same component as predicate eFlow devices, therefore previous testing of that component is sufficient. | Aerosol Head was not re-tested for this submission as it's the same component previously tested with predicate eFlow Technology devices. |
| Aerosol Characterization (Particle Size Distribution) | Performance characteristics (MMAD, GSD, RM, TM) should be comparable to or within an acceptable range relative to predicate devices. | MMAD: Higher than or comparable to predicates eFlow, LC Star, and Micro Mist. |
| GSD: Comparable to eFlow, but lower than LC Star and Micro Mist. | ||
| RM & TM: Less than eFlow and LC Star, but higher than Micro Mist. (Overall, these comparisons aim to demonstrate acceptable aerosol delivery characteristics). | ||
| EMC and Electrical Safety | Conforms to applicable international standards. | Conforms to IEC 60601-1 and IEC 60601-1-2. |
Non-Applicable or Unobtainable Information (for this document type)
The following points are typically relevant for AI/ML performance studies but are not provided or relevant in this 510(k) summary for a physical nebulizer device:
- Sample size used for the test set and the data provenance: Not applicable. Performance refers to engineering tests (e.g., aerosol characterization, biocompatibility, durability) not analysis of patient data by an algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a nebulizer involves physical measurements and engineering standards, not expert medical interpretation of data.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): For engineering tests, ground truth is based on standardized measurement techniques (e.g., cascade impaction for aerosol characterization, specified microbial cultures for cleaning efficacy).
- The sample size for the training set: Not applicable. This isn't an AI/ML device that requires a "training set."
- How the ground truth for the training set was established: Not applicable.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).