Search Results

The MED2000 SpA Nebulizer Compressors, Models P3, P4 and P5, with Nebulizer, are ACpowered air compressors 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.

These line powered piston compressors are housed in a plastic cabinet (case). The plastic cabinet is the only distinctive component between the three devices, that are identical for all other components, material and characteristics. Dimensions are 4.7 in. x 9.1 x 7.5 in. and weight 3.3 lbs. P3, P4 and P5 units contain no microprocessors or other electronic components. They operate from 115 VAC, 60 Hz. Each unit is supplied with an instruction manual and an accessory kit containing a nebulizer pediatric mask, a mouthpiece.

The provided document describes a 510(k) premarket notification for MED2000 SpA Nebulizer Compressors, Models P3, P4, and P5. This submission focuses on establishing substantial equivalence to a predicate device (Med2000 SpA Nebulizer Compressor, Models P1 and P2). The testing performed is primarily non-clinical, demonstrating safety and effectiveness in accordance with FDA guidance, rather than a study proving specific acceptance criteria related to disease diagnosis or treatment efficacy.

Therefore, many of the requested elements are not applicable to this type of regulatory submission. The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable."

Here's a breakdown of the information that can be extracted from the provided text, and where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Specific Tests Performed (acting as implicit acceptance criteria for safety and performance):

• EPA PM 2.5 Testing
• EMC testing
• Dielectric Withstand
• Current Dispersion Test or Leakage Current Test
• Surface Temperature Test
• Air Temperature Test
• Storage conditions Operating environment extremes
• Sinusoidal Vibration Test
• Impact Resistance - Drop Test
• Fluid Spill Resistance Test

2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in the context of a test set for clinical performance, as it primarily relies on non-clinical engineering and performance testing. The "device sample(s) tested" is mentioned, but the exact number isn't quantified. The data provenance is internal testing performed by the manufacturer, MED2000 SpA, or its contracted labs, for regulatory submission purposes, and is inherently "prospective" for the purpose of demonstrating equivalence. The country of origin of the manufacturer is Italy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a nebulizer compressor, and its performance is evaluated through engineering and safety tests rather than clinical outcomes requiring expert-established ground truth.

4. Adjudication method for the test set
Not applicable. The tests performed are objective engineering and safety measurements, not subjective evaluations 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
Not applicable. This is a medical device (nebulizer compressor), not an AI-powered diagnostic tool. There are no "human readers" or "AI assistance" in the context of its function.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this type of submission is defined by established engineering standards, regulatory guidance (e.g., FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND), and comparison to the predicate device's known performance for safety and basic operational characteristics. There is no clinical "ground truth" like pathology or outcomes data needed for this 510(k) submission.

8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established
Not applicable. See point 8.

Ask a specific question about this device

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.

The Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories, may be used with compatible compressors or an air gas source providing between 4 and 8 lpm.

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 provided text describes a 510(k) submission for a medical device, the Med2000 SpA Nebulizer, AndyFlow Model A1/C with accessories. This is a premarket notification to demonstrate that the device is substantially equivalent to a legally marketed predicate device, not a study proving the device meets specific acceptance criteria in the way clinical trials or performance evaluations typically do for AI/ML devices. Therefore, a direct answer to your request in the format provided is not fully applicable.

However, I can extract information related to the "acceptance criteria" and "study" as presented within the context of a 510(k) for this specific type of medical device (a nebulizer). For medical devices like nebulizers, "acceptance criteria" are typically related to performance specifications that ensure the device delivers medication effectively, and "studies" are often bench tests demonstrating these performance characteristics.

Here's the information broken down based on your request, with an explanation of why some sections are "Not Applicable" for this type of submission:

Acceptance Criteria and Device Performance for Med2000 SpA Nebulizer, AndyFlow Model A1/C

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: In a 510(k) process for a device like a nebulizer, the "acceptance criteria" are largely based on demonstrating substantial equivalence to a predicate device. This means showing that the new device performs as intended and is as safe and effective as the predicate. The "reported device performance" demonstrates that these criteria are met, primarily through bench testing in this case.

Detailed Information as Requested:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for the bench tests. For device performance tests like particle characterization, sample sizes typically refer to the number of devices tested or the number of particle measurements taken, but this level of detail is not provided.
• Data Provenance: Not explicitly stated, but the manufacturer is Med2000 SpA, located in Padenghe Sul Garda, Italy. The testing would likely have been conducted by or for the manufacturer. The data is prospective in the sense that the tests were performed specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. For a nebulizer's particle characterization and safety testing (bench tests), "ground truth" is established by validated measurement techniques and adherence to international standards (e.g., ISO 10993). It does not involve expert consensus on subjective observations like in image interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication methods are relevant for subjective evaluations typically found in clinical trials or studies involving human interpretation. Bench testing for device performance relies on objective measurements and established protocols.

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

• Not Applicable. This device is a nebulizer, not an AI/ML diagnostic or image analysis tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant to this submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not Applicable. This device is a mechanical nebulizer; it does not contain an "algorithm" or operate in a "standalone" computational capacity.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Ground Truth Type: For the performance tests (Nebulizer Particle Characterization), the "ground truth" is based on objective physical measurements and adherence to recognized standards (e.g., for particle size distribution or nebulization rate). For biocompatibility, it's compliance with ISO 10993 standards. For safety, it's compliance with EPA PM 2.5 standards (though the context here indicates it's related to the device itself and not environmental monitoring).

8. The sample size for the training set

• Not Applicable. This device relies on mechanical and physical principles, not a machine learning model. Therefore, there is no "training set."

9. How the ground truth for the training set was established

• Not Applicable. As there is no training set for a machine learning model, this question is not relevant.

Summary of the "Study" (Non-Clinical Tests):

The "study" performed to demonstrate substantial equivalence consisted of non-clinical bench testing:

• Nebulizer Particle Characterization Studies: Conducted at both 4 lpm and 8 lpm flow rates. The purpose was to verify that the nebulizer effectively produces aerosols with appropriate particle characteristics for drug delivery, especially given the new broadened flow range (4-8 lpm). The submission states these tests "revealed that no other parameters were affected," indicating satisfactory performance and equivalence.
• EPA PM 2.5 Testing: This test was previously performed for the predicate device and remained unchanged, implying its continued relevance and compliance.
• ISO 10993 Biocompatibility Testing: Similar to PM 2.5 testing, this was previously done for the predicate and remained unchanged, demonstrating the materials used in the device are biocompatible.

The overall "study" conducted for this 510(k) was focused on demonstrating that the slight labeling change (flow range) did not negatively impact the performance, safety, or effectiveness of the device compared to its predicate. No clinical studies were deemed necessary ("Not Applicable" for clinical tests).

Ask a specific question about this device

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:

1. 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.
2. 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.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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: Not applicable. This is not an AI device or a comparative effectiveness study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-based device.
7. 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.
8. The sample size for the training set: Not applicable, as this is not a machine learning/AI device.
9. 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.

Ask a specific question about this device