(15 days)
The LC Sprint is a handheld nebulizer, designed to aerosolize medication approved for nebulization and prescribed by a physician. The LC Sprint is intended for adult and pediatric patients consistent with the indications for the aerosol medication.
The LC Sprint is a small, single patient use, reusable air-powered nebulizer for the inhalation treatment of aerosolized medications. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.
The provided text describes the LC Sprint Reusable Nebulizer, its indications for use, and a comparison to predicate devices, but it contains limited information regarding specific acceptance criteria and the detailed study proving the device meets accepted criteria.
Based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate device equivalence) | Reported Device Performance (LC Sprint) |
|---|---|---|
| Aerosolization Efficiency | Comparable MMAD (Mass Median Aerodynamic Diameter) to predicate devices (Airlife® Misty Max 10TM Nebulizer, PARI LC® Star Nebulizer) | MMAD is comparable to the predicate devices. |
| Residual Medication | Comparable RM (Residual Medication) to predicate devices | RM is comparable to the predicate devices. |
| Total Mass Delivery | Comparable Total Mass to predicate devices | Total Mass is comparable to the predicate devices. |
| Safety and Effectiveness | Meets performance requirements and raises no new issues of safety or effectiveness. | Meets performance requirements and raises no new issues of safety or effectiveness. |
| Technological Characteristics | Similar materials, breath-enhanced design, and 2-way valve system to predicate devices. | Employs similar materials, similar breath-enhanced design, and utilizes a 2-way valve system similar to the I.C Star (predicate). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance tests (MMAD, RM, Total Mass). It is only stated that the LC Sprint was "tested to compare performance to the predicate devices." The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable and not provided. The study focuses on objective performance metrics of the device compared to predicate devices, not on expert interpretations or diagnoses that would require ground truth established by experts.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. The study involves measuring physical device performance metrics, not subjective assessments requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The device is a nebulizer for medication delivery, and its performance is assessed through physical characteristics (MMAD, RM, Total Mass) rather than through diagnostic interpretation by human readers.
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 medical device, not an AI algorithm. Its performance is inherent in its design and operation.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by the independent measurement of the physical properties related to aerosolized medication delivery, specifically:
- MMAD (Mass Median Aerodynamic Diameter): A measure of the particle size of the aerosol.
- RM (Residual Medication): The amount of medication remaining in the nebulizer after use.
- Total Mass: The total quantity of medication delivered.
These metrics are considered objective and measurable, and their values are compared directly to those of legally marketed predicate devices to establish substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable. The LC Sprint is a physical medical device, not a machine learning algorithm, and therefore does not have a "training set" in the computational sense.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no "training set" for this type of device.
§ 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).