(448 days)
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.
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.
This document is a 510(k) Summary for the Hudson RCI Variable Concentration Large Volume Nebulizer, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance against specific acceptance criteria for a new and innovative AI-powered product.
Therefore, the requested information categories related to AI/algorithm performance, such as sample size for test sets and training sets, number of experts for ground truth, adjudication methods, MRMC studies, and standalone algorithm performance, are not applicable to this document. This document describes a traditional medical device, not an AI/ML-driven one.
Here's a response tailored to the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding reported device performance values in the manner typically seen for novel AI systems with quantitative metrics for accuracy, sensitivity, specificity, etc. Instead, it states that tests were performed to demonstrate safety based on current industry standards and concludes that the device is substantially equivalent to predicate devices. The "performance" here refers to meeting established safety and functional requirements rather than predictive accuracy.
Here's an interpretation based on the provided text, outlining the tests performed and the general "acceptance" that they indicate substantial equivalence:
| Test (Acceptance Criteria Implicitly Met) | Reported Device Performance (Implied) |
|---|---|
| Biocompatibility (ISO 10993-1, -5, -10, -11, -18) | Compliant with relevant ISO standards for external communicating, prolonged/permanent contact devices that indirectly contact tissue/bone/dentin, and indirect gas pathway. |
| Packaging | Satisfactory for maintaining device integrity and sterility/cleanliness. |
| Environmental Conditioning (high and low humidity) | Withstood environmental conditions without adverse impact on performance. |
| Aging | Demonstrated satisfactory performance over its useful life. |
| oxygen entrainment | Achieved specified oxygen concentrations (FIO2 28-98%) |
| Lift testing | Performed as intended during operation, likely referring to mechanical stability or water lift. |
| Humidity output | Produced adequate and consistent humidity output. |
| Useful life testing | Maintained performance throughout its intended useful life. |
| Cleaning process | Demonstrated appropriate cleanability or non-cleanability (given it's single-use). |
| Comparison to predicate devices (K041418, K141214) | Demonstrated similar design, dimensions, materials, intended use, and technological characteristics, leading to a conclusion of substantial equivalence. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is typically found in detailed study reports or clinical trial summaries, which are not part of this 510(k) Summary. The document describes pre-clinical (bench) testing, not human subject data. Therefore, concepts like "test set," "data provenance," "country of origin," and "retrospective/prospective" studies as they apply to clinical data are not present. The "tests were performed" implies an internal engineering and quality assurance process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. "Ground truth" in the context of expert consensus is relevant for diagnostic algorithms or subjective assessments. For a physical device like a nebulizer, the "ground truth" is typically established by objective measurements against engineering specifications and validated test methods overseen by qualified engineers and technicians. The document does not specify the number or qualifications of individuals involved in setting or verifying these engineering standards or conducting the tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in medical image analysis). For the physical and chemical testing of a nebulizer, the "adjudication" is through meeting predefined analytical standards and specifications, not through expert consensus on subjective findings.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. MRMC studies are specific to evaluating diagnostic technologies, often AI-driven, where human readers interpret cases. This document is for a physical medical device (nebulizer) and does not involve human "readers" or an AI component.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an algorithm and does not have a "standalone" or "human-in-the-loop" mode for performance evaluation in the context of AI. It is a mechanical device that delivers aerosolized humidity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" is based on:
- Engineering specifications and standards: Performance metrics like oxygen entrainment percentages, humidity output, and mechanical integrity are objectively measured against predefined engineering targets.
- Material compatibility standards: Biocompatibility is assessed against ISO 10993 series standards.
- Safety standards: General device safety is evaluated against recognized industry standards and regulatory requirements.
8. The sample size for the training set
Not applicable. There is no "training set" as this device is not an AI/ML model that undergoes a training process.
9. How the ground truth for the training set was established
Not applicable. As there is no AI/ML model, there is no "training set" or ground truth established for it. The standards and specifications are established through medical device development processes and regulatory requirements.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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) | |
|---|---|
| ☑ 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 VolumeNebulizer |
|---|---|
| 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 | PrimaryPredicate |
|---|---|---|
| K041418 | AirLife Misty Finity Large Volume ContinuousNeublizer | ✓ |
| 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 | ProposedHudson RCIVariableConcentrationLarge VolumeNebulizer | PredicateAirLife Misty FinityLarge VolumeContinuousNebulizer(K041418) | Reference DeviceHudson RCI®AquaPak® PrefilledNebulizer (K141214) |
|---|---|---|---|
| Classification | Class II | Class II | Class II |
| Product Code | CAF | CAF | CAF |
| RegulationNumber | §868.5630 | §868.5630 | §868.5630 |
| Regulation Name | Nebulizer | Nebulizer | Nebulizer |
| Product Features | ProposedHudson RCIVariableConcentrationLarge VolumeNebulizer | PredicateAirLife Misty FinityLarge VolumeContinuousNebulizer(K041418) | Reference DeviceHudson RCI®AquaPak® PrefilledNebulizer (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 | ProposedHudson RCIVariableConcentrationLarge VolumeNebulizer | PredicateAirLife Misty FinityLarge VolumeContinuousNebulizer(K041418) | Reference DeviceHudson RCI®AquaPak® PrefilledNebulizer (K141214) |
| RepresentativeImage | 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 | ProposedHudson RCIVariableConcentrationLarge VolumeNebulizer | PredicateAirLife Misty FinityLarge VolumeContinuousNebulizer(K041418) | Reference DeviceHudson RCI®AquaPak® PrefilledNebulizer (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 filledwith a fluid, typically | Nebulizers providesterile 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 flowmetered medical gas | works by having thefluid come into | solution) that issuspended 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 thejar through a small | The majority of thelarger particles settle | inspired gas duringaerosol 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 airopening around the | as the patient inhales.The treatment is | component, whichconnects 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 | ProposedHudson RCIVariableConcentrationLarge VolumeNebulizer | PredicateAirLife Misty FinityLarge VolumeContinuousNebulizer(K041418) | Reference DeviceHudson RCI®AquaPak® PrefilledNebulizer (K141214) |
| Accessories | Masks (notincluded), tubing(not included) | Masks (not included),tubing (not included) | Nebulizer Adaptors,masks (no included),tubing (not included) |
| Environment | Hospital or homecare setting. | Hospitals, nursinghomes, extended carefacilities or outpatientclinics. | Hospital or home caresetting. |
| PatientPopulation | Pediatric (ages 2years and above) andadults. | Infant, pediatric, andadult | Pediatric (ages 2years and above) andadults. |
| Principle ofOperation | Jet nebulizer withadjustable airentrainment | Jet nebulizer withadjustable airentrainment | Jet nebulizer withadjustable airentrainment |
| SterilizationMethod | Non-sterile | Non-sterile | Sterile |
| PatientContactingMaterials | Polypropylene,polyethylene, LDPE,polystyrene, acrylic,dye | Thermoplastics | Thermoplastics |
| Single Use | Single patient use,disposable | Single patient use,disposable | Single patient use,disposable |
| AdjustableOxygen Settings | FIO2 28-98% | FIO2 28-98% | FIO2 28-98% |
| Biocompatibility | ● Externalcommunicating,prolonged/permanent contact devicethat indirectlycontactstissue/bone/dentin● Indirect gaspathway | ● Unknown frompublicly availablesummary whatbiocompatibilityendpoints wereassessed. | ● Externalcommunicating,prolonged/permanentcontact device thatindirectly contactstissue/bone/dentin.● Indirect gas pathway |
| Product Features | ProposedHudson RCIVariableConcentrationLarge VolumeNebulizer | PredicateAirLife Misty FinityLarge VolumeContinuousNebulizer(K041418) | Reference DeviceHudson RCI®AquaPak® PrefilledNebulizer (K141214) |
| StandardsUtilized | ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-11ISO 10993-18ISO 18562-1ISO 18562-2ISO 18562-3 | ISO 10993-1 | ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-11ISO 10993-18 |
| Non-ClinicalTesting | • Packaging• EnvironmentalConditioning(high and lowhumidity)• Aging• Oxygenentrainment• Lift testing• Humidity output• Useful life testing• Cleaning process | "Performanceevaluation of theproposed andpredicated devicesconsisted of cascadeimpaction and outputrate testing." | • Packaging• EnvironmentalConditioning (highand low humidity)• 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 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.
§ 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).