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The RinoFlow Micronized E.N.T. Wash System aerosolizes solutions intended for nasal and sinus irrigation and humidification of the upper respiratory tract. RinoFlow is used to treat conditions and disorders of the upper respiratory tract where homeostasis of the nasal mucosa is disturbed, resulting in symptoms such as catarrh, and mucopurulent or crusty secretions. Such conditions and disorders include:

• Rhinitis (as a symptom of colds, allergies, etc.) .
• . Both Acute and Chronic Sinusitis

RinoFlow Micronized E.N.T. Wash System should be used with a physiological saline solution. "Tap" water is not recommended.

RinoFlow Micronized E.N.T. Wash System is intended to be used by adults and pediatrics (age ≥3) in the home or doctor's office, and is available over-the-counter.

The RinoFlow Micronized E.N.T. Wash System provides aerosol irrigation with positive pressure. The device has two settings that facilitate a two-phase procedure for nasal irrigation and upper respiratory tract humidification. Phase One washes the nasal cavity and nasopharynx by hydrating and softening the mucus with a stream of large-particle aerosol, causing drainage to occur. Phase Two applies the aerosol stream with higher velocity that reaches the paranasal sinuses.

The RinoFlow E.N.T. Wash System consists of a Micronizer-Chamber connected by a length of tubing to a lubricant-free, sealed piston compressor. The compressor incorporates a reciprocating power pump design.

The Micronizer-Chamber , made of synthetic, washable polycarbonate material, is in four essential parts: the body, the inner shell, the outer shell, and the baffle. Tubing is connected at the bottom of the body. At the top of the body is an air injector covered by a baffle. The bell-shaped inner shell surrounds the air injector and baffle and tapers to an outlet at the top for the aerosol stream to exit. The rim at the bottom of the shell fits in a groove at the top of the body. The space inside the inner shell forms the inner chamber, where the liquid is micronized. The outer shell fits over the body, surrounding the inner shell and its contents. The outer shell is cylindrical and tapers to an outlet at the top. The outer shell can be rotated to two different positions, gliding vertically over the body. In the first position, the outer shell's outlet is vertically aligned slightly above that of the inner shell. The space between the outer shell and the inner shell forms the outer chamber, where the drainage is collected. This chamber is sealed at the bottom by an O-ring. The space between the very tops of the inner and outer shells forms an opening for the drainage to descend into the outer chamber during Phase 1. Four holes around the rim at the top of the outer shell provide the primary means for excess nasal drainage to enter the outer chamber. These holes also provide an outlet for patient exhalation.

When rotated to the second position, the outer shell lowers so its outlet meets that of the inner shell, joining the holes to create a single outlet. This configuration increases the velocity of the aerosol stream. The outer chamber is unaffected by this change in shell configuration, and any residual drainage will continue to enter the chamber via the four holes along its rim.

The document provided is a 510(k) premarket notification for the "RinoFlow Micronized E.N.T. Wash System". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study with specific acceptance criteria and performance outcomes in the way a clinical trial for a novel device would.

Therefore, the information typically requested regarding acceptance criteria and a study proving a device meets them (as per the prompt's structured questions) is not directly available in this document. The safety and effectiveness of the RinoFlow system are primarily established through a comparison to a predicate device and performance-related testing to ensure it functions as intended.

Here's an analysis based on the provided text, addressing the prompt's points where applicable, and noting where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance: This document does not contain a table of acceptance criteria and reported device performance in the typical sense of a clinical outcomes study with quantitative metrics. The acceptance criteria for this 510(k) revolve around demonstrating substantial equivalence to the predicate device and compliance with relevant standards.

   The "reported device performance" is summarized conceptually as:

   • Substantial Equivalence: The RinoFlow Micronized E.N.T. Wash System is substantially equivalent to the Ethicare Puls-ator Irrigator Lavage (K821481).
   • Safety and Effectiveness: Verified through "performance-related testing that consisted of Electrical Safety, Electromagnetic Compatibility, Mechanical and Environmental Testing."
   • Compliance: "Tested and found compliant with the standards referenced in the 'Draft FDA Reviewer Guidance for Premarket Notifications,' November 1993."

2. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not applicable in the context of a clinical test set. The document refers to "performance-related testing" which typically involves engineering and bench testing, not patient-based data. No patient test set size is mentioned.
   • Data Provenance: Not applicable for a clinical test set. The testing performed was technical (Electrical Safety, EMC, Mechanical, Environmental), likely done in a laboratory setting by the manufacturer or a contracted lab.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications: This information is not provided and is generally not relevant for this type of technical performance testing. Ground truth, in a clinical context, would typically refer to a definitive diagnosis or outcome, which is not being assessed here.

4. Adjudication Method for the Test Set: This is not applicable as there is no human-reader-based test set or ground truth adjudication described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: No MRMC study was mentioned or performed. This type of study assesses human reader performance, usually in diagnostics, which is not the primary focus of this device (a therapeutic/irrigation system).

6. Standalone Performance (Algorithm Only without Human-in-the-Loop): This is not applicable. The RinoFlow system is a physical medical device, not an algorithm, and its performance is inherently tied to its use by a human.

7. Type of Ground Truth Used: The "ground truth" here is compliance with technical specifications and standards (e.g., electrical safety standards, electromagnetic compatibility standards) and functional performance demonstrating that the device operates as intended for its stated use. It's not based on expert consensus, pathology, or outcomes data from a clinical trial, but rather on engineering and performance testing against established benchmarks and the predicate device's function.

8. Sample Size for the Training Set: This is not applicable. The device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established: This is not applicable.

In summary, the 510(k) submission for the RinoFlow Micronized E.N.T. Wash System demonstrates substantial equivalence to a predicate device through engineering and performance testing. It does not present data from a clinical study with outcome-based acceptance criteria or a "test set" in the sense of patient data evaluated by experts, as would be expected for a diagnostic or higher-risk device seeking de novo clearance or PMA approval.

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