(57 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical aspects of an irrigation system, with no mention of AI or ML technologies.
Yes
The device is intended to treat conditions and disorders of the upper respiratory tract such as rhinitis and sinusitis, which explicitly indicates a therapeutic purpose.
No
The description indicates the device is used to treat conditions and disorders of the upper respiratory tract by aerosolizing solutions for irrigation and humidification, not to diagnose them.
No
The device description explicitly details hardware components like a Micronizer-Chamber, tubing, and a piston compressor, and the performance studies include electrical safety, electromagnetic compatibility, mechanical, and environmental testing, all indicative of a physical device.
Based on the provided text, the RinoFlow Micronized E.N.T. Wash System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- RinoFlow's Function: The RinoFlow system is used to deliver a solution (physiological saline) to the nasal and sinus passages for irrigation and humidification. It is a therapeutic device used to treat symptoms and conditions directly within the body.
- Lack of Specimen Analysis: The description does not mention the device analyzing any biological specimens. Its purpose is to physically wash and humidify the respiratory tract.
Therefore, the RinoFlow Micronized E.N.T. Wash System falls under the category of a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
21 CFR 874.5550, 77 ETP
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal cavity, nasopharynx, paranasal sinuses, upper respiratory tract
Indicated Patient Age Range
Adults and pediatrics (age ≥3).
Intended User / Care Setting
Hospital, clinic, physician's office, or home by prescription.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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.
2
General Technical Description
Intended Use/Indications for Use
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.
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.
3
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
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. Internal functions of the RinoFlow are diagrammed in Figure 12-2.
4
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.
5
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
6
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.