(57 days)
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
- 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.
The RinoFlow Micronized E.N.T. Wash System provides aerosol irrigation with positive pressure. The device has two settings that facilitate a twophase 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 provided text describes the RinoFlow Micronized E.N.T. Wash System, a new device for nasal and sinus irrigation and humidification of the upper respiratory tract.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that:
"The safety and effectiveness of the RinoFlow Micronized E.N.T. Wash System were verified through performance-related testing that consisted of Electrical Safety, Electromagnetic Compatibility, Mechanical and Environmental Testing. The RinoFlow Micronized E.N.T. Wash System was tested and found compliant with the standards referenced in the "Draft FDA Reviewer Guidance for Premarket Notifications," November 1993."
This indicates that the acceptance criteria were based on compliance with specific standards outlined in the mentioned FDA guidance document. However, the exact quantitative acceptance criteria (e.g., specific thresholds for electrical safety, EMI levels, mechanical durability) are not detailed in this document.
Table 1: Acceptance Criteria and Reported Device Performance (Summary based on available information)
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety | Compliant with standards referenced in "Draft FDA Reviewer Guidance for Premarket Notifications," November 1993. |
| Electromagnetic Compatibility | Compliant with standards referenced in "Draft FDA Reviewer Guidance for Premarket Notifications," November 1993. |
| Mechanical | Verified through performance-related testing; compliant with standards referenced in "Draft FDA Reviewer Guidance for Premarket Notifications," November 1993. |
| Environmental | Verified through performance-related testing; compliant with standards referenced in "Draft FDA Reviewer Guidance for Premarket Notifications," November 1993. |
| Substantial Equivalence | Demonstrated to be substantially equivalent to the Ethicare Puls-ator Irrigator Lavage (K821481) based on performance-related testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Testing was performed to demonstrate that the performance of the RinoFlow Micronized E.N.T. Wash System in its intended environment is as safe and effective as that of the legally marketed predicate device."
No specific sample size for a test set is mentioned. The "testing" refers to technical performance evaluations (electrical, mechanical, environmental) rather than a clinical study with patient data. Therefore, there is no data provenance (e.g., country of origin, retrospective/prospective) in the context of clinical data for this type of device submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since the testing described is primarily technical performance testing of the device itself (electrical safety, mechanical, etc.) and not an assessment of clinical outcomes against a ground truth diagnosis or condition, there were no experts used to establish ground truth for a clinical test set. The "ground truth" for these types of tests are the specifications and standards themselves.
4. Adjudication Method for the Test Set
As there was no clinical test set requiring expert interpretation or diagnosis, no adjudication method was applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in this document. The submission focuses on technical performance and substantial equivalence to a predicate device, not on comparing performance with and without AI assistance (as AI is not mentioned in the context of this device).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device, the RinoFlow Micronized E.N.T. Wash System, is a physical medical device (a powered nasal irrigator), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not applicable to this submission. The device itself operates independently of human interpretation in terms of its function (e.g., aerosolizing solutions).
7. The Type of Ground Truth Used
The "ground truth" for the testing described in this submission is the established engineering standards and specifications for electrical safety, electromagnetic compatibility, mechanical performance, and environmental robustness, as outlined in the "Draft FDA Reviewer Guidance for Premarket Notifications, November 1993." The device was tested for compliance against these technical benchmarks. There is no biological or diagnostic "ground truth" in the typical sense (e.g., pathology, clinical outcomes) mentioned for the verification of this device.
8. The Sample Size for the Training Set
This submission pertains to a physical medical device, not a machine learning model or algorithm. Therefore, the concept of a "training set" and its sample size is not applicable.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no training set for this type of device.
§ 874.5550 Powered nasal irrigator.
(a)
Identification. A powered nasal irrigator is an AC-powered device intended to wash the nasal cavity by means of a pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.