Hudson RCI Variable concentration Large Volume Nebulizer (1770)
Device Facts
| Record ID | K220955 |
|---|---|
| Device Name | Hudson RCI Variable concentration Large Volume Nebulizer (1770) |
| Applicant | Medline Industires, Inc. |
| Product Code | CAF · Anesthesiology |
| Decision Date | Jun 23, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5630 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
The non-prefilled nebulizer is indicated for use when humidity needs to the air flow going to a patient in the form of an aerosol. The large volume nebulizer also allows for the provision of humidified oxygen at select oxygen concentrations from 28% to 98%. This product is for single patient use and is designed to be used in hospital, nursing homes, extended care facilities, outpatient clinics as prescribed by a healthcare professional.
Device Story
Non-prefilled reservoir nebulizer; supplies humidity for inhalation therapy. Input: medical gas source (flow-metered). Operation: internal venturi nozzle draws solution from 500mL jar via pickup tube into gas stream; rotating collar adjusts air entrainment for oxygen concentration (28-98%); aerosol delivered via 22mm tubing. Used in hospitals, nursing homes, extended care facilities, outpatient clinics; operated by healthcare professionals. Output: humidified aerosol mist. Benefit: provides humidity and oxygen to patient airways; supports respiratory therapy.
Clinical Evidence
Bench testing only. Performance evaluation included biocompatibility (ISO 10993-1, -5, -10, -11, -18; ISO 18562-1, -2, -3), packaging, environmental conditioning, aging, oxygen entrainment, lift testing, humidity output, useful life, and cleaning process validation.
Technological Characteristics
Jet nebulizer; 500mL reservoir; polypropylene, polyethylene, LDPE, polystyrene, acrylic construction. Adjustable venturi nozzle for 28-98% FIO2. 22mm bull-nose output connector. Non-sterile. Standards: ISO 10993 (biocompatibility), ISO 18562 (gas pathway).
Indications for Use
Indicated for pediatric (ages 2+) and adult patients requiring humidified air or oxygen (28-98% concentration) via aerosol therapy in clinical or home settings.
Regulatory Classification
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.
Predicate Devices
- AirLife Misty Finity Large Volume Continuous Nebulizer (K041418)
Reference Devices
- Hudson RCI® AquaPak® Prefilled Nebulizer (K141214)
Submission Summary (Full Text)
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June 23, 2023
Medline Industires, Inc. % Joy Gutermuth Senior Specialist (Consultant) Ram+ 2790 Mosside Blvd. Suite 800 Monroeville, Pennsylvania 15146
Re: K220955
Trade/Device Name: Hudson RCI Variable concentration Large Volume Nebulizer (1770) Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: May 26, 2023 Received: May 26, 2023
Dear Joy Gutermuth:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Ting Song -S
# For
Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K220955
Device Name Hudson RCI Large Volume Nebulizer
#### Indications for Use (Describe)
The non-prefilled nebulizer is indicated for use when humidity needs to the air flow going to a patient in the form of an aerosol. The large volume nebulizer also allows for the provision of humidified oxygen at select oxygen concentrations from 28% to 98%. This product is for single patient use and is designed to be used in hospital, nursing homes, extended care facilities, outpatient clinics as prescribed by a healthcare professional.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-----------------------------------------------|
| <div> </div> | |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 510(k) SUMMARY
## DATE PREPARED
June 23, 2023
# MANUFACTURER AND 510(k) OWNER
Medline Industries, Inc. 1 Three Lake Dr. Northfield, IL 60093 Phone: 724-640-9680
Contact Person: Nicole Schaffer, Manager Regulatory Affairs, Respiratory
# REPRESENTATIVE/CONSULTANT
Joy Gutermuth, Regulatory Consultant RQM+ Telephone: +1 (412) 810-8172 Email: jgutermuth@rqmplus.com
## DEVICE INFORMATION
| Proprietary Name/Trade Name: | Hudson RCI Variable Concentration Large Volume<br>Nebulizer |
|------------------------------|-------------------------------------------------------------|
| Common Name: | Large Volume Nebulizer |
| Regulation Number: | §868.5630 |
| Class: | II |
| Product Code: | CAF |
# PREDICATE DEVICE IDENTIFICATION
The Hudson RCI Variable Concentration Large Volume Nebulizer is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary<br>Predicate |
|---------------|-----------------------------------------------------------|----------------------|
| K041418 | AirLife Misty Finity Large Volume Continuous<br>Neublizer | ✓ |
| K141214 | Hudson RCI® AquaPak® Prefilled Nebulizer | Reference Device |
The predicate devices have not been subject to a design related recall.
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# DEVICE DESCRIPTION
The large volume nebulizer is a non-prefilled reservoir nebulizer for supplying humidity for inhalation therapy. The device features a wing nut style connector that fits standard flow metered medical gas sources and includes a 500mL capacity jar with minimum and maximum fill lines. Large volume nebulize an internal venturi nozzle to draw the solution up from the jar through a small plastic pickup tube and into the gas stream to be aerosolized. A rotating collar sets the delivered oxygen concentration by controlling the size of the room air opening around the venturi. A bull-nose style output connector is used to connect 22mm aerosol tubing for delivery to the patient.
## INDICATIONS FOR USE
The non-prefilled nebulizer is indicated for use when humidity needs to the air flow going to a patient in the form of an aerosol. The large volume nebulizer also allows for the provision of humidified oxygen at select oxygen concentrations from 28% to 98%. This product is for single patient use and is designed to be used in hospital, nursing homes, extended care facilities, outpatient clinics as prescribed by a healthcare professional.
## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Medline Industries believes that the large volume nebulizer is substantially equivalent to the predicate devices based on the information summarized here:
The subject device has a similar design and dimensions, and uses similar or identical materials as the devices cleared in K041418 and K141214. The subject device has the same intended use and similar technological characteristics to the devices cleared in both K041418 and K141214. The device has similar instrumentation to the device cleared in K041418 and K141214. These technological characteristics have undergone testing to ensure the device is as safe and effective as the predicates.
| Product Features | Proposed<br>Hudson RCI<br>Variable<br>Concentration<br>Large Volume<br>Nebulizer | Predicate<br>AirLife Misty Finity<br>Large Volume<br>Continuous<br>Nebulizer<br>(K041418) | Reference Device<br>Hudson RCI®<br>AquaPak® Prefilled<br>Nebulizer (K141214) |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II | Class II | Class II |
| Product Code | CAF | CAF | CAF |
| Regulation<br>Number | §868.5630 | §868.5630 | §868.5630 |
| Regulation Name | Nebulizer | Nebulizer | Nebulizer |
| Product Features | Proposed<br>Hudson RCI<br>Variable<br>Concentration<br>Large Volume<br>Nebulizer | Predicate<br>AirLife Misty Finity<br>Large Volume<br>Continuous<br>Nebulizer<br>(K041418) | Reference Device<br>Hudson RCI®<br>AquaPak® Prefilled<br>Nebulizer (K141214) |
| Intended Use | To add humidity in aerosol form to a patient's breathing gases. | This device is intended to be used to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. | To add humidity in aerosol form to a patient's breathing gases. |
| Indications for Use | The non-prefilled nebulizer is indicated for use when humidity needs to be added to the air flow going to a patient in the form of an aerosol. The large volume nebulizer also allows for the provision of humidified oxygen at select oxygen concentrations from 28% to 98%. This product is for single patient use and is designed to be used in hospital, nursing homes, extended care facilities, outpatient clinics as prescribed by a healthcare professional. | This device is intended to be used to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Continuous Large Volume Nebulizer. This product is a single patient use, non-sterile prescriptive device and is designed to be used under medical supervision in hospitals, nursing homes, extended care facilities or outpatient clinics. | The Hudson RCI® AquaPak® Prefilled Nebulizer adds sterile water or saline solution in aerosol form to a patient's breathing gases. |
| Product Features | Proposed<br>Hudson RCI<br>Variable<br>Concentration<br>Large Volume<br>Nebulizer | Predicate<br>AirLife Misty Finity<br>Large Volume<br>Continuous<br>Nebulizer<br>(K041418) | Reference Device<br>Hudson RCI®<br>AquaPak® Prefilled<br>Nebulizer (K141214) |
| Representative<br>Image | Image: Proposed Hudson RCI Variable Concentration Large Volume Nebulizer | Image: Predicate AirLife Misty Finity Large Volume Continuous Nebulizer (K041418) | Image: Reference Device Hudson RCI® AquaPak® Prefilled Nebulizer (K141214) |
| Product Features | Proposed<br>Hudson RCI<br>Variable<br>Concentration<br>Large Volume<br>Nebulizer | Predicate<br>AirLife Misty Finity<br>Large Volume<br>Continuous<br>Nebulizer<br>(K041418) | Reference Device<br>Hudson RCI®<br>AquaPak® Prefilled<br>Nebulizer (K141214) |
| Device | The large volume | The nebulizer is a | The Hudson RCI® |
| Description | nebulizer is a non-<br>prefilled reservoir | single patient use | AquaPak® Prefilled |
| | nebulizer for | device, which is filled<br>with a fluid, typically | Nebulizers provide<br>sterile water or sterile |
| | supplying humidity | respiratory | saline for inhalation |
| | for inhalation | medication and | therapy. Nebulizers |
| | therapy. The device | connected to an air | generate aerosol, a fine |
| | features a wing nut | source via flexible | mist of liquid water (or |
| | style connector that | tubing. The nebulizer | sodium chloride |
| | fits standard flow<br>metered medical gas | works by having the<br>fluid come into | solution) that is<br>suspended in the gas to |
| | sources and includes | contact with the | be inhaled by the |
| | a 500mL capacity jar | steam of gas. The gas | patient. The Hudson |
| | with minimum and | shatters the liquid | RCI® AquaPak® |
| | maximum fill lines. | into small particles. | Prefilled Nebulizers are |
| | Large volume | These particles then | designed to aerosolize |
| | nebulizers utilize an | impact a baffle that | and provide a fine mist |
| | internal venturi | further reduces the | of sterile water or |
| | nozzle to draw the | size of the particles. | saline solution to |
| | solution up from the<br>jar through a small | The majority of the<br>larger particles settle | inspired gas during<br>aerosol therapy. |
| | plastic pickup tube | inside the nebulizer | Prefilled sterile |
| | and into the gas | as a result of gravity | reservoirs for |
| | stream to be | and inertia, returning | AquaPak® Nebulizers |
| | aerosolized. A | the mist to liquid to | come in three sizes: |
| | rotating collar sets | repeat the | 440ml, 760ml, and |
| | the delivered oxygen | nebulization process. | 1070ml. Each reservoir |
| | concentration by | The smaller particles | must be used with a |
| | controlling the size | are then administered | suitable adaptor |
| | of the room air<br>opening around the | as the patient inhales.<br>The treatment is | component, which<br>connects the system to |
| | venturi. A bull-nose | completed when the | a flow-metered gas |
| | style output | majority of fluid is | source and provides |
| | connector is used to | nebulized. | nebulizer functionality. |
| | connect 22mm | | |
| | aerosol tubing for | | |
| | delivery to the | | |
| | patient. | | |
| Product Features | Proposed<br>Hudson RCI<br>Variable<br>Concentration<br>Large Volume<br>Nebulizer | Predicate<br>AirLife Misty Finity<br>Large Volume<br>Continuous<br>Nebulizer<br>(K041418) | Reference Device<br>Hudson RCI®<br>AquaPak® Prefilled<br>Nebulizer (K141214) |
| Accessories | Masks (not<br>included), tubing<br>(not included) | Masks (not included),<br>tubing (not included) | Nebulizer Adaptors,<br>masks (no included),<br>tubing (not included) |
| Environment | Hospital or home<br>care setting. | Hospitals, nursing<br>homes, extended care<br>facilities or outpatient<br>clinics. | Hospital or home care<br>setting. |
| Patient<br>Population | Pediatric (ages 2<br>years and above) and<br>adults. | Infant, pediatric, and<br>adult | Pediatric (ages 2<br>years and above) and<br>adults. |
| Principle of<br>Operation | Jet nebulizer with<br>adjustable air<br>entrainment | Jet nebulizer with<br>adjustable air<br>entrainment | Jet nebulizer with<br>adjustable air<br>entrainment |
| Sterilization<br>Method | Non-sterile | Non-sterile | Sterile |
| Patient<br>Contacting<br>Materials | Polypropylene,<br>polyethylene, LDPE,<br>polystyrene, acrylic,<br>dye | Thermoplastics | Thermoplastics |
| Single Use | Single patient use,<br>disposable | Single patient use,<br>disposable | Single patient use,<br>disposable |
| Adjustable<br>Oxygen Settings | FIO2 28-98% | FIO2 28-98% | FIO2 28-98% |
| Biocompatibility | ● External<br>communicating,<br>prolonged/perman<br>ent contact device<br>that indirectly<br>contacts<br>tissue/bone/dentin<br>● Indirect gas<br>pathway | ● Unknown from<br>publicly available<br>summary what<br>biocompatibility<br>endpoints were<br>assessed. | ● External<br>communicating,<br>prolonged/permanent<br>contact device that<br>indirectly contacts<br>tissue/bone/dentin.<br>● Indirect gas pathway |
| Product Features | Proposed<br>Hudson RCI<br>Variable<br>Concentration<br>Large Volume<br>Nebulizer | Predicate<br>AirLife Misty Finity<br>Large Volume<br>Continuous<br>Nebulizer<br>(K041418) | Reference Device<br>Hudson RCI®<br>AquaPak® Prefilled<br>Nebulizer (K141214) |
| Standards<br>Utilized | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>ISO 10993-11<br>ISO 10993-18<br>ISO 18562-1<br>ISO 18562-2<br>ISO 18562-3 | ISO 10993-1 | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>ISO 10993-11<br>ISO 10993-18 |
| Non-Clinical<br>Testing | • Packaging<br>• Environmental<br>Conditioning<br>(high and low<br>humidity)<br>• Aging<br>• Oxygen<br>entrainment<br>• Lift testing<br>• Humidity output<br>• Useful life testing<br>• Cleaning process | "Performance<br>evaluation of the<br>proposed and<br>predicated devices<br>consisted of cascade<br>impaction and output<br>rate testing." | • Packaging<br>• Environmental<br>Conditioning (high<br>and low humidity)<br>• Aging |
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# SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the Hudson RCI Variable Concentration Large Volume Nebulizer. The following tests were performed to demonstrate safety based on current industry standards:
- Biocompatibility
- . Packaging
- Environmental Conditioning (high and low humidity) ●
- Aging
- Oxygen entrainment ●
- Lift testing .
- Humidity output ●
- Useful life testing ●
- Cleaning process .
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The results of these tests indicate that the Hudson RCI Variable Concentration Large Volume Nebulizer is substantially equivalent to the predicate devices.
## CONCLUSION
Based on the testing performed, including additional gas pathway biocompatibility according to ISO 18562, it can be concluded that the subject device does not raise…
