(448 days)
No
The device description and intended use describe a purely mechanical nebulizer for humidifying air/oxygen. There is no mention of any computational or data-driven components that would suggest the use of AI or ML.
Yes
The device is used to provide humidified air/oxygen for inhalation therapy, which is a therapeutic purpose.
No
The device is a large volume nebulizer used to provide humidified air or oxygen for inhalation therapy, which is a treatment rather than a diagnostic process.
No
The device description clearly outlines a physical medical device (nebulizer) with hardware components like a reservoir jar, venturi nozzle, pickup tube, and connectors. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide humidified air or oxygen to a patient for inhalation therapy. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The description details a mechanical device for aerosolizing liquids for inhalation. It does not describe any components or processes related to analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting or measuring specific substances or markers for diagnostic purposes.
- Performance Studies: The performance studies focus on safety, functionality (oxygen entrainment, humidity output), and equivalence to predicate devices used for similar therapeutic purposes. They do not involve diagnostic accuracy metrics.
In summary, the device's function is to deliver a therapeutic aerosol, not to provide diagnostic information about a patient's condition.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CAF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Pediatric (ages 2 years and above) and adults.
Intended User / Care Setting
Hospital, nursing homes, extended care facilities, outpatient clinics as prescribed by a healthcare professional.
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)
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
The results of these tests indicate that the Hudson RCI Variable Concentration Large Volume Nebulizer is substantially equivalent to the predicate devices.
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.
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
§ 868.5630 Nebulizer.
(a)
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.(b)
Classification. Class II (performance standards).
0
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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.
1
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
2
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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
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
Predicate |
|---------------|-----------------------------------------------------------|----------------------|
| K041418 | AirLife Misty Finity Large Volume Continuous
Neublizer | ✓ |
| K141214 | Hudson RCI® AquaPak® Prefilled Nebulizer | Reference Device |
The predicate devices have not been subject to a design related recall.
4
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
Hudson RCI
Variable
Concentration
Large Volume
Nebulizer | Predicate
AirLife Misty Finity
Large Volume
Continuous
Nebulizer
(K041418) | Reference Device
Hudson RCI®
AquaPak® Prefilled
Nebulizer (K141214) |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II | Class II | Class II |
| Product Code | CAF | CAF | CAF |
| Regulation
Number | §868.5630 | §868.5630 | §868.5630 |
| Regulation Name | Nebulizer | Nebulizer | Nebulizer |
| Product Features | Proposed
Hudson RCI
Variable
Concentration
Large Volume
Nebulizer | Predicate
AirLife Misty Finity
Large Volume
Continuous
Nebulizer
(K041418) | Reference Device
Hudson RCI®
AquaPak® Prefilled
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
Hudson RCI
Variable
Concentration
Large Volume
Nebulizer | Predicate
AirLife Misty Finity
Large Volume
Continuous
Nebulizer
(K041418) | Reference Device
Hudson RCI®
AquaPak® Prefilled
Nebulizer (K141214) |
| Representative
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
Hudson RCI
Variable
Concentration
Large Volume
Nebulizer | Predicate
AirLife Misty Finity
Large Volume
Continuous
Nebulizer
(K041418) | Reference Device
Hudson RCI®
AquaPak® Prefilled
Nebulizer (K141214) |
| Device | The large volume | The nebulizer is a | The Hudson RCI® |
| Description | nebulizer is a non-
prefilled reservoir | single patient use | AquaPak® Prefilled |
| | nebulizer for | device, which is filled
with a fluid, typically | Nebulizers provide
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
metered medical gas | works by having the
fluid come into | solution) that is
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
jar through a small | The majority of the
larger particles settle | inspired gas during
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
opening around the | as the patient inhales.
The treatment is | component, which
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
Hudson RCI
Variable
Concentration
Large Volume
Nebulizer | Predicate
AirLife Misty Finity
Large Volume
Continuous
Nebulizer
(K041418) | Reference Device
Hudson RCI®
AquaPak® Prefilled
Nebulizer (K141214) |
| Accessories | Masks (not
included), tubing
(not included) | Masks (not included),
tubing (not included) | Nebulizer Adaptors,
masks (no included),
tubing (not included) |
| Environment | Hospital or home
care setting. | Hospitals, nursing
homes, extended care
facilities or outpatient
clinics. | Hospital or home care
setting. |
| Patient
Population | Pediatric (ages 2
years and above) and
adults. | Infant, pediatric, and
adult | Pediatric (ages 2
years and above) and
adults. |
| Principle of
Operation | Jet nebulizer with
adjustable air
entrainment | Jet nebulizer with
adjustable air
entrainment | Jet nebulizer with
adjustable air
entrainment |
| Sterilization
Method | Non-sterile | Non-sterile | Sterile |
| Patient
Contacting
Materials | Polypropylene,
polyethylene, LDPE,
polystyrene, acrylic,
dye | Thermoplastics | Thermoplastics |
| Single Use | Single patient use,
disposable | Single patient use,
disposable | Single patient use,
disposable |
| Adjustable
Oxygen Settings | FIO2 28-98% | FIO2 28-98% | FIO2 28-98% |
| Biocompatibility | ● External
communicating,
prolonged/perman
ent contact device
that indirectly
contacts
tissue/bone/dentin
● Indirect gas
pathway | ● Unknown from
publicly available
summary what
biocompatibility
endpoints were
assessed. | ● External
communicating,
prolonged/permanent
contact device that
indirectly contacts
tissue/bone/dentin.
● Indirect gas pathway |
| Product Features | Proposed
Hudson RCI
Variable
Concentration
Large Volume
Nebulizer | Predicate
AirLife Misty Finity
Large Volume
Continuous
Nebulizer
(K041418) | Reference Device
Hudson RCI®
AquaPak® Prefilled
Nebulizer (K141214) |
| Standards
Utilized | ISO 10993-1
ISO 10993-5
ISO 10993-10
ISO 10993-11
ISO 10993-18
ISO 18562-1
ISO 18562-2
ISO 18562-3 | ISO 10993-1 | ISO 10993-1
ISO 10993-5
ISO 10993-10
ISO 10993-11
ISO 10993-18 |
| Non-Clinical
Testing | • Packaging
• Environmental
Conditioning
(high and low
humidity)
• Aging
• Oxygen
entrainment
• Lift testing
• Humidity output
• Useful life testing
• Cleaning process | "Performance
evaluation of the
proposed and
predicated devices
consisted of cascade
impaction and output
rate testing." | • Packaging
• Environmental
Conditioning (high
and low humidity)
• Aging |
5
6
7
8
9
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 .
10
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 new issues of safety or effectiveness compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Hudson RCI Variable Concentration Large Volume Nebulizer are assessed to be substantially equivalent to the predicate devices.