(208 days)
The Med2000 SpA Nebulizer Compressors, Models P1 and P2, are AC-powered air compressors, with adapter, intended to provide a source of compressed air for medical purposes for use in home health care. These devices are provided with the Model A1/C (AndyFlow) pneumatic nebulizer and should only be used with this nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for inhalation by a patient for treatment of respiratory disorders such as allergies, asthma, cystic fibrosis. COPD. etc. It can be used with adult or pediatric patients.
The Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories, is a pneumatic nebulizer which, when driven by a compatible air compressor, nebulizes specific inhalable drugs for inhalation by a patient. It can be used with adult or pediatric patients.
Med2000 SpA Nebulizer Compressors, Models P1 and P2: The two models (P1 and P2) differ only in minor cosmetic aspects of their shape that have no effect on performance or safety. These piston compressors are housed in a compact, irregularly-shaped white-plastic housing. Dimensions are: 60" x 4.7" x 2.4" for both compressors, and weigh 1.1 lbs. Neither models contain microprocessors. A "power cube" transformer (Med2000 Class 2 power unit) plugs into a wall outlet (2-blade plug) and provides 16 VAC to the motor via a thin 2-conductor cord that plugs into the compressor. The compressors are supplied with compatible patient tubing (2 meters), and will be marketed with a compatible medication nebulizer and respective instruction manuals.
Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories: The Nebulizer, Model A1/C (AndyFlow), is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. This device operates on the Venturi principle and is refillable. It is manufactured using polypropylene plastics, injection molded and is intended for single patient use. The Nebulizer, Model A1/C (AndyFlow), has several attachments that are used with the nebulizer during the nebulization process. The attachments include a mouthpiece, a 2 meter connecting tube (which connects to the lower part of the nebulizer opposite the mouthpiece), a pediatric breathing mask and an adult breathing mask. These are standard accessories for nebulizer devices. The Nebulizer, Model A1/C (AndyFlow), is a hand-held pneumatically powered nebulizer that consists of a nebulizer top that is screwed into a nebulizer cup. The bottom of the cup has a fitting to accept a source of nebulizing gas. The device consists of a nebulizer portion (which forms and conveys an aerosol) and a reservoir portion (which contains non-aerosolized drug).
The provided text describes a 510(k) summary for Med2000 SpA Nebulizer Compressors and Nebulizer, aiming to demonstrate substantial equivalence to predicate devices, rather than establishing new acceptance criteria or conducting a study to prove performance against specific acceptance criteria.
The document discusses comparisons to predicate devices based on "similarities and differences" in characteristics and lists "performance testing" conducted. However, it does not define explicit acceptance criteria or report performance against such criteria in the way a study proving device meeting acceptance would. Furthermore, it explicitly states "Discussion of Clinical Tests Performed: Not Applicable".
Therefore, I cannot extract the requested information in the format of a table of acceptance criteria and reported device performance or details about study design elements like sample sizes, expert qualifications, or adjudication methods, as this information is not present in the provided text.
Based on the provided text, here's what can be stated about the device and its testing:
Device: Med2000 SpA Nebulizer Compressors, Models P1 and P2, with Nebulizer, and Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories.
Purpose of the Submission: To demonstrate substantial equivalence to legally marketed predicate devices, not to establish new performance criteria or prove performance against a new set of acceptance criteria.
"Acceptance Criteria" (Implicit from Substantial Equivalence and Performance Testing):
While not formally presented as "acceptance criteria," the submission implies that the device's performance should be comparable to or not raise new questions of safety or effectiveness relative to the predicate devices. The non-clinical tests performed serve to demonstrate this comparability.
"Reported Device Performance" (Implicit from Non-Clinical Tests and Comparison):
The document lists "performance testing" conducted, but it doesn't provide specific quantitative results for the Med2000 device or a direct comparison to acceptance criteria. Instead, it states that "bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."
Unable to Provide Due to Lack of Information in the Text:
- A table of acceptance criteria and the reported device performance: This document is a 510(k) summary for substantial equivalence, not a detailed performance study with explicit acceptance criteria. Performance data against specific criteria is not presented.
- Sample size used for the test set and the data provenance: Not applicable, as this was a non-clinical bench testing submission, not a study involving human subjects or data sets in the way a clinical study would.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method 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 device or a comparative effectiveness study involving human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-based device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as this was non-clinical bench testing against established engineering and safety standards, and comparison to predicate device characteristics.
- The sample size for the training set: Not applicable, as this is not a machine learning/AI device.
- How the ground truth for the training set was established: Not applicable.
Summary of Relevant Information from the Text:
- Non-Clinical Tests Performed (as a proxy for demonstrating equivalence/ "meeting implicit criteria"):
- EPA PM 10 Testing
- Nebulizer Particle Characterization Studies
- ISO 10993 Biocompatibility Testing
- Maximum pressure and flow under various conditions (temperatures, line voltage, storage)
- Fluid Spill Resistance
- Maximum Surface and Air Temperatures
- Sinusoidal Vibration
- Impact (drop) Resistance
- Leakage Current and Dielectric Withstand (Electrical Safety)
- EMC Testing
- Clinical Tests Performed: Not Applicable (explicitly stated)
- Conclusion: The bench testing demonstrated that any technological differences do not raise new questions of safety or effectiveness, leading to a finding of substantial equivalence to the predicate devices.
§ 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).