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.

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/2 description: The image shows the text "SECTION 12 SUMMARY OF SAFETY AND EFFECTIVENESS" in bold, sans-serif font. The text is located in the upper left corner of the image. The image also contains the text "K963550" in the lower right corner.

5668

October 21, 1996

Official Contact

Francis X. Dobscha Manager, Regulatory Affairs Respironics, Inc. 1001 Murry Ridge Drive Murrysville, PA 15668

Classification Name 21 CFR 874.5550, 77 ETP

Common/Usual Name Powered Nasal Irrigator

Proprietary Name RinoFlow Micronized E.N.T. Wash System

Predicate Devices

Puls-ator Irrigator Lavage - K821481 Ethicare P.O. Box 5027 Fort Lauderdale, FL 33310

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Reason for Submission

The RinoFlow Micronized E.N.T. Wash System is a new device.

Substantial Equivalence

This premarket notification section 510(k) submission demonstrates that the RinoFlow Micronized E.N.T. Wash System is substantially equivalent to the Ethicare Puls-ator Irrigator Lavage (K821481), which is used to irrigate the nasal and sinus passages and humidify the upper respiratory tract.

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. 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.

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General Technical Description

Intended Use/Indications for Use

. 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.

Contraindications

The following pre-existing conditions contraindicate the use of the RinoFlow System:

. Operations to the tympanum (eardrum), including plastic operations on the tympanum
. Other pathologies of the tympanic area
. Injuries or recent surgery that may have fractured or disturbed the cribriform plate

Patient Population

Adults and pediatrics (age ≥3).

Environment of Use

Hospital, clinic, physician's office, or home by prescription.

Manufacturer

The RinoFlow Micronized E.N.T. Wash System is manufactured by Mefar (Italy) and distributed in the United States by Respironics, Inc.

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Summary of the Device Description

The RinoFlow Micronized E.N.T. Wash System (Figure 12-1) 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.

Image /page/3/Picture/4 description: The image shows a medical suction device. The device consists of a rectangular box with a handle on top and a suction tube connected to the side. The suction tube is connected to a nozzle. The device is used to remove fluids from the body.

The RinoFlow Micronized E.N.T. Wash System Figure 12-1.

Technical Description

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Image /page/4/Figure/2 description: This image is a diagram of a circuit. The diagram includes labels such as "Power Switch", "AC Inlet Terminal", "Fuse", "Compressor", "Transformer", "Airflow", "To Patient Circuit", and "Inlet/Filter Holder". The diagram shows the connections between these components.

Figure 12-2. Schematic Drawing of Internal Functions

The Micronizer-Chamber (Figure 12-3), 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.

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Image /page/5/Figure/2 description: This image shows an exploded view of a device with several labeled parts. The parts, from top to bottom, are labeled as 'Outer Shell,' 'Inner Shell,' 'Baffle,' and 'Body.' The 'Outer Shell' has two settings labeled 'Position One Setting' and 'Position Two Setting,' indicating adjustable functionality.

Figure 12-3. Exploded View of Micronizer-Chamber

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.

Principles of Operation

The Micronizer-Chamber is set for irrigation of the nasal cavity by rotating the outer shell to the first setting as indicated. Liquid is placed into the inner chamber of the Micronizer-Chamber. The outlet of the outer shell is placed in the opening of one nostril and held in that position. When the power button is pressed on, the compressor pressurizes the liquid via the air injector, creating a large-particle aerosol stream that is delivered through the outlet into the nasal cavity and nasopharynx. The irrigation of the mucous membranes softens and thins the mucus, facilitating its drainage. The drainage enters the space between the very tops of the inner and outer shells and descends into the outer chamber. Any drainage that does not enter the opening between the inner and outer shells is guided into the rim at the top of the outer shell. From there, the drainage descends through the four rim holes into the outer chamber. Because of the delivery pressure of the micronized wash solution, the nasal drainage cannot

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enter the inner chamber and mix with the washing fluid (Figure 12-4). The pressure generated by the patient's exhalation is released through the four holes on the outer shell. The procedure is repeated with the other nostril.

Image /page/6/Figure/3 description: This image shows a diagram of a nasal washing system. The diagram shows the outer and inner shells of the system, as well as the drainage and washing fluid being delivered. The washing fluid is delivered through the inner shell and then drains out through the outer shell.

Figure 12-4. Nasal Drainage Enters Outer Chamber Only

Once the wash is complete and the Micronizer-Chamber has been rinsed, the Micronizer-Chamber can be set for irrigation of the paranasal sinuses by rotating the outer shell to the second setting as indicated. This setting increases the velocity of the aerosol stream to reach the paranasal sinuses. The outlet of the outer shell is placed lightly against the opening of one nostril and held in that position. During treatment, the patient closes the contralateral nostril and periodically swallows and holds his or her breath for a brief period. This process is akin to Politzer's method, which can cause inflation of the Eustachian tube and middle ear. Any drainage that leaks from the nostril will continue to enter the chamber via the four holes along its rim. The pressure generated by the patient's exhalation is released through the four holes on the outer shell. The procedure is repeated with the other nostril.

Regulation Number and Section

§ 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.