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K Number
K990384
Device Name
EZFLOW CONTINUOUS NEBULIZER,MODEL 1005
Manufacturer
PIPER MEDICAL PRODUCTS
Date Cleared
1999-04-26

(77 days)

Product Code
CAF
Regulation Number
868.5630
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

To be used under proper medical supervision to deliver medicinal aerosol and diagnostic formulation.

Device Description

EZflow Continuous Nebulizer™ Model 1005

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA to Piper Medical Products regarding their EZflow Continuous Nebulizer™ Model 1005. This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

Crucially, this type of FDA correspondence for a 510(k) clearance does not contain acceptance criteria or study data for the device's performance. A 510(k) submission typically relies on demonstrating substantial equivalence to a predicate device, which might involve comparing technical characteristics and, in some cases, performance data. However, the FDA letter itself does not detail these studies or their results.

Therefore,Based on the provided document, the following information cannot be extracted:

  1. A table of acceptance criteria and the reported device performance: This document does not contain performance criteria or study results.
  2. Sample size used for the test set and the data provenance: This document does not describe any specific test set or its provenance.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This document does not mention the use of experts or ground truth establishment for a test set.
  4. Adjudication method for the test set: This document does not describe any adjudication method.
  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: This document is related to a nebulizer, which is a medical device, not an AI-assisted diagnostic tool. Therefore, an MRMC study with AI assistance is not applicable.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As mentioned above, this device is not an algorithm, so standalone performance is not relevant.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is discussed in relation to performance studies.
  8. The sample size for the training set: There is no mention of a training set as this is not an AI/ML device.
  9. How the ground truth for the training set was established: Not applicable.

This document serves as a regulatory clearance, indicating that the device is deemed substantially equivalent to a pre-existing device, allowing it to be marketed. Information about specific performance studies and their results would typically be contained within the 510(k) submission itself, not in the FDA's clearance letter.

§ 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).