(242 days)
The Hudson RCI® TurboMist™ Nebulizer is intended to be used to aerosolize liquid medication into gases that are delivered directly to the patient for breathing.Its use is indicated when a licensed healthcare professional prescribes or administers medical aerosol to a patient using a small volume nebulizer.
The patient population includes adult and pediative (greater than 22 lbs or 10 kg) patients that are spontaneously breathing.
The product is a single patient, multi-use, non-sterile, disposable, prescriptive device intended to be used in a hospital or homecare environment.
The Hudson RCI® TurboMist™ Nebulizer System (herein referred to as "TurboMist system" or "subject device") consists of the TurboMist small volume nebulizer and a patient interface, which may include a swivel mouthpiece ors an aerosol mask and elbow adaptor. The aerosol mask is available in adult and pediatric versions. The TurboMist small volume nebulizer is a hand-held, breath-enhanced jet nebulizer designed to aerosolize liquid medications as prescribed by a physician. The nebulizer is powered by an external compressed air or oxygen source, and the aerosol is created by an internal jet located inside the nebulizer jar. The nebulizer is designed to entrain additional room air upon patient inhalation, enhancing aerosol generation and resulting in a faster nebulization rate than traditional jet nebulizers.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the Hudson RCI® TurboMist™ Nebulizer System. It details the device's indications for use, technological characteristics, comparison to predicate devices, and a summary of non-clinical testing performed to demonstrate substantial equivalence.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Study/Characteristic | Acceptance Criteria (Implied/Stated) | Reported Device Performance/Conclusion |
|---|---|---|
| Particle Size Characterization | All pre-determined acceptance criteria for particle size and overall performance (not explicitly detailed, but implied to be within clinically acceptable range and comparable to predicate devices). Cascade Impactor vacuum flow rate of 15 LPM was utilized, per FDA's "Reviewer Guidance for Nebulizer, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH - 1993). | Particle size characterization results for the TurboMist nebulizers with both mouthpiece and mask, using 15 LPM impactor vacuum flow rate, met all pre-determined acceptance criteria and demonstrated that the device meets its product specifications. Results for the subject device, primary predicate (AirLife Misty Fast Small Volume Nebulizer), and secondary predicate (MC 300*) were considered comparable and within the clinically acceptable range. |
| Shelf Life | Demonstrated ability to maintain performance after the equivalent of five years aging. | Shelf life testing was performed on the subject device with both proposed patient interfaces (mouthpiece and aerosol mask) after the equivalent of five years aging. (Implies it met criteria, though not explicitly stated as "met"). Real-time aging studies have been initiated. |
| Useful Life | Determined to be 7 days or 50 cleaning cycles. | Useful life testing was performed on the subject device with both proposed patient interfaces (mouthpiece and aerosol mask) and determined to be 7 days or 50 cleaning cycles. (This is the determined value, implying it’s a qualified useful life). |
| Cleaning & Disinfection | Compliance with guidelines in FDA Guidance: "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", AAMI TIR12:2010, and AAMI TIR30:2011. The nebulizer should be cleanable and disinfectable effectively. | All testing concluded that the nebulizer could be cleaned and disinfected effectively by use of the methods stated in the IFU. |
| Biocompatibility | Evaluation and/or testing for specific biological endpoints based on nature and duration of contact (External communicating, Tissue/bone/dentin communicating, Surface Contact, Mucosal Membrane; Permanent duration of use > 30 days). Common aerosolized medications contacts were considered. Endpoints included: Carcinogenicity, Genotoxicity, Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Material Mediated Pyrogenicity, Acute Systemic Toxicity, Subacute Toxicity, Subchronic Toxicity, Chronic Toxicity, Implantation, Extractables/Leachables, Chemical characterization of materials (per ISO 10993 standards). | Biocompatibility evaluation and testing was performed on the subject device and associated patient interfaces. The materials were characterized as permanent contact. (Implies satisfactory results as no issues were reported and it supports substantial equivalence). |
| Gas Pathway | Evaluation and/or testing for emissions of particulate matter (including PM2.5), volatile organic compounds (VOCs), and leachables in condensate (per ISO 18562 standards). | Gas pathway evaluation and testing was performed on the subject device and associated patient interfaces per ISO 18562-1. Endpoints assessed included: Emissions of Particulate Matter (including PM2.5) (ISO 18562-2:2017), Emissions of Volatile Organic Compounds (VOCs) (ISO 18562-3:2017), Evaluated Leachables In Condensate (ISO 18562-4:2017). (Implies satisfactory results as no issues were reported and it supports substantial equivalence). |
| Overall Substantial Equivalence | The device must meet the requirements of its pre-defined acceptance criteria and intended use, demonstrating equivalence to predicate devices without raising new questions of safety and effectiveness. | Based on testing data, including biocompatibility tests and aerosol particle performance tests, the TurboMist™ Nebulizer System meets the requirements of its pre-defined acceptance criteria and intended use. Therefore, the subject device is substantially equivalent to the primary predicate device for hospital setting and secondary predicate device for homecare setting. |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Particle Size Characterization: Not explicitly stated, but testing was performed on "the subject device with both proposed patient interfaces (mouthpiece and aerosol mask)" and "the primary predicate with a mouthpiece and aerosol mask." This implies at least one sample of each configuration for each device. The data for the secondary predicate was a "review of published test data in the 510(k) summary table."
- Shelf Life: Not explicitly stated how many samples were aged, but it was "the subject device with both proposed patient interfaces (mouthpiece and aerosol mask)."
- Useful Life: Not explicitly stated how many samples were tested, but it was "the subject device with both proposed patient interfaces (mouthpiece and aerosol mask)."
- Cleaning & Disinfection: Not explicitly stated how many samples were tested, but it was "the subject device with both proposed patient interfaces (mouthpiece and aerosol mask)."
- Biocompatibility: Not explicitly stated, but testing was performed on "the subject device as well as both proposed patient interfaces (mouthpiece and aerosol mask)."
- Gas Pathway: Not explicitly stated how many samples were tested, but it was "the subject device as well as both proposed patient interfaces (mouthpiece and aerosol mask)."
Data Provenance: The studies appear to be prospective testing conducted specifically for this 510(k) submission, with the exception of the secondary predicate's particle size data which was a retrospective review of published data. The document does not specify the country of origin for the data generation, but it is for a US FDA submission by Medline Industries LP (headquartered in Northfield, Illinois, USA), suggesting the testing was performed, overseen, or compiled for a US regulatory context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This document describes non-clinical performance and safety testing of a medical device (nebulizer). It does not involve human subject data or diagnostic performance where "ground truth" would be established by experts or adjudicated. The "ground truth" for these tests is defined by established engineering and scientific standards (e.g., ISO, AAMI, FDA guidance) for physical and chemical properties, functionality, and biological safety. Therefore, this section is not applicable in the context of this 510(k) summary.
4. Adjudication Method for the Test Set:
Not applicable, as this is a non-clinical device performance and safety study, not a diagnostic study requiring expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. This document describes the substantial equivalence of a physical medical device (nebulizer) through non-clinical performance and safety testing, not the comparative diagnostic effectiveness of a reader-dependent system or AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used:
As noted in section 3, the "ground truth" for the non-clinical tests is represented by the established scientific and engineering standards, guidance documents (e.g., FDA guidance, ISO standards, AAMI standards), and the pre-defined product specifications/acceptance criteria that the device must meet to demonstrate safe and effective performance and substantial equivalence to predicate devices. These are objective measures rather than expert consensus on a diagnostic outcome or pathology.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This is not an AI/machine learning device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 31, 2023
Medline Industries LP Lakshmi Kanuri Sr. Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K230602
Trade/Device Name: Hudson RCI® TurboMist™ Nebulizer System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: October 5, 2023 Received: October 5, 2023
Dear Lakshmi Kanuri:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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.
Ethan L. Nyberg -S
Ethan Nyberg. Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices
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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) K230602
Device Name Hudson RCI® TurboMist™ Nebulizer System
Indications for Use (Describe)
The Hudson RCI® TurboMist™ Nebulizer is intended to be used to aerosolize liquid medication into gases that are delivered directly to the patient for breathing.Its use is indicated when a licensed healthcare professional prescribes or administers medical aerosol to a patient using a small volume nebulizer.
The patient population includes adult and pediative (greater than 22 lbs or 10 kg) patients that are spontaneously breathing.
The product is a single patient, multi-use, non-sterile, disposable, prescriptive device intended to be used in a hospital or homecare environment.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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1. Date Summary Prepared October 5, 2023
2. Name, Address, Phone and Fax Number of Applicant
Medline Industries, LP 3 Lakes Dr, Northfield, IL 60093 (847) 949-5500 Registration Number: 1417592
3. Contact Person
Lakshmi Kanuri Sr. Regulatory Affairs Specialist Email – Ikanuri@medline.com
4. Subject Device
| Trade Name: | Hudson RCI® TurboMistTM Nebulizer System |
|---|---|
| Common Name: | Nebulizer (Direct Patient Interface) |
| Product Code: | CAF |
| Regulation Number: | 868.5630 |
| Classification: | Class II |
| Classification Panel: | Anesthesiology |
5. Primary Predicate Device
| Trade Name: | AirLife Small Volume Nebulizer |
|---|---|
| Common Name: | Nebulizer (Direct Patient Interface) |
| Product Code: | CAF |
| Regulation Number: | 868.5630 |
| Classification: | Class II |
| Classification Panel: | Anesthesiology |
| 510(k) Number: | K123527 |
6. Secondary Predicate Device
| Trade Name: | MC 300* |
|---|---|
| Common Name: | Nebulizer (Direct Patient Interface) |
| Product Code: | CAF |
| Regulation Number: | 868.5630 |
| Classification: | Class II |
| Classification Panel: | Anesthesiology |
| 510(k) Number: | K173367 |
This submission demonstrates substantial equivalence to the AirLife Small Volume Nebulizer (K123527) and
MC 300* (K173367) is used as a secondary predicate device to support homecare use.
7. Device Description
The Hudson RCI® TurboMist™ Nebulizer System (herein referred to as "TurboMist system" or "subject device") consists of the TurboMist small volume nebulizer and a patient interface, which may include a swivel mouthpiece ors an aerosol mask and elbow adaptor. The aerosol mask is available in adult and pediatric versions. The TurboMist small volume
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nebulizer is a hand-held, breath-enhanced jet nebulizer designed to aerosolize liquid medications as prescribed by a physician. The nebulizer is powered by an external compressed air or oxygen source, and the aerosol is created by an internal jet located inside the nebulizer jar. The nebulizer is designed to entrain additional room air upon patient inhalation, enhancing aerosol generation and resulting in a faster nebulization rate than traditional jet nebulizers.
8. Indications for Use
The Hudson RCI® TurboMist™ Nebulizer System is intended to be used to aerosolize liguid medication into gases that are delivered directly to the patient for breathing. Its use is indicated when a licensed healthcare professional prescribes or administers medical aerosol to a patient using a small volume nebulizer.
The patient population includes adult and pediatric (greater than 22 lbs or 10 kg) patients that are spontaneously breathing.
The product is a single patient, multi-use, non-sterile, disposable, prescriptive device intended to be used in a hospital or homecare environment.
9. Contraindications
None.
10. Technological Characteristics
The TurboMist small volume nebulizer is a breath-enhanced, pneumatic jet nebulizer, and is composed of a jet, jar, and cap. It operates based on the Venturi effect, whereby an external source of compressed air or oxygen is directed through the stem of the jar and upwards towards a narrow restrictive point. This change in flow path creates a low-pressure zone that helps to draw liquid medication upwards from the jar into the space between the jet and the jar through capillary action. When the liquid medication encounters the flow of compressed air or oxygen, it becomes aerosolized into a stream of small droplets. The TurboMist small volume nebulizer cap features an air entrainment port, through which additional room air can be entrained, enhancing aerosol output. The aerosolized medication is delivered to the patient utilizing either a swivel mouthpiece or an aerosol mask and elbow adaptor.
11. Comparison to Primary Predicate and Secondary Predicate
The Subject Device (The TurboMist system), the Primary Predicate (The AirLife Small Volume Nebulizer (K123527)) and the Secondary Predicate, (The MC 300* Nebulizer (K173367)) are identical in intended use, core technology, and mode of operation. Only minor differences exist between the subject, the primary predicate and the secondary predicate, which do not introduce issues of safety and effectiveness.
Table 004-1 illustrates the similarities and differences between the subject and Primary Predicate and Secondary Predicate.
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| Characteristic | Subject Device | Primary PredicateDevice | Secondary Predicate | SubstantialEquivalenceDiscussion |
|---|---|---|---|---|
| Device Name | Hudson RCI®TurboMist™ Nebulizer | AirLife Misty FastSmall VolumeNebulizer | MC 300* | |
| 510(k) Number | K230602 | K123527 | K173367 | |
| Classification Name | Nebulizer(Direct Patient Interface) | Nebulizer(Direct Patient Interface) | Nebulizer(Direct Patient Interface) | Identical |
| Common Name | Small Volume Nebulizer | Small Volume Nebulizer | Small Volume Nebulizer | Identical |
| Regulation Number | 868.5630 | 868.5630 | 868.5630 | Identical |
| ClassificationProduct Code | CAF | CAF | CAF | Identical |
| Regulatory Class | Class II | Class II | Class II | Identical |
| Intended Use | The Hudson RCI®TurboMist™ Nebulizer isintended to be used toaerosolize liquidmedication into gasesthat are delivered directlyto the patient forbreathing. | This AirLife Small VolumeNebulizer is intended tobe used to aerosolizeliquid medication intogases that are delivereddirectly to the patient forbreathing.The patient populationincludes adults, pediatrics,and infants that arespontaneously breathing | This MC300 Nebulizer isintended to be used toaerosolize liquidmedication into gasesthat are delivered directlyto the patient forbreathing. | Identical |
| Characteristic | Subject Device | Primary PredicateDevice | Secondary Predicate | SubstantialEquivalenceDiscussion |
| Device Name | Hudson RCI®TurboMist™ Nebulizer | AirLife Misty FastSmall VolumeNebulizer | MC 300* | |
| 510(k) Number | K230602 | K123527 | K173367 | |
| Indications for use | The Hudson RCI®TurboMist™ Nebulizer isintended to be used toaerosolize liquidmedication into gases thatare delivered directly to thepatient for breathing. Itsuse is indicated when alicensed healthcareprofessional prescribes oradministers medicalaerosol to a patient using asmall volume nebulizer.The patient populationincludes adult and pediatric(greater than 22 lbs or 10kg) patients that arespontaneously breathing.The product is a singlepatient, multi-use, non-sterile, disposable,prescriptive deviceintended to be used in ahospital or homecareenvironment. | This device is intended tobe used to aerosolize liquidmedicationinto gases that aredelivered directly to thepatient far breathing.The patient populationincludes adults, pediatrics,and infants thatare spontaneouslybreathing. The product is aprescriptive deviceintended to be used inhospital setting. | The nebulizer is intendedto be used with pediatric(ages 2 years and above)and adult patients, who areunder the care of alicensed healthcareprovider or physician.The device is designed toaerosolize prescribedmedication for inhalationby a patient in the hospital,clinic or home careenvironment. The nebulizeris a single patient usedevice. | IdenticalPrimary Predicate is usedfor hospital environmentonlySecondary Predicate isused for both hospital andhome care environment |
| Contraindications | None | None | None | Identical |
| Patient Population | Adult and pediatric greaterthan 22 lbs or 10 kg )patients | Adult, pediatric, and infant | Adult and pediatric (ages 2years and above) patients | Equivalent:Both the primary predicateand the secondarypredicate are inclusive ofthe subject device |
| Characteristic | Subject Device | Primary PredicateDevice | Secondary Predicate | SubstantialEquivalenceDiscussion |
| Device Name | Hudson RCI®TurboMist™ Nebulizer | AirLife Misty FastSmall VolumeNebulizer | MC 300* | |
| 510(k) Number | K230602 | K123527 | K173367 | populations (Adult andPediatric greater than 22lb or 10 kg patients) |
| Patient interface | Mouthpiece and aerosolmask with elbow adaptor | Mouthpiece and aerosolmask | Mouthpiece and aerosolmask | Identical |
| Type of device | Disposable, hand-held,non-sterile, single patient,multi-use | Disposable, hand-held,non-sterile, single patient,multi-use | Disposable, handheld,non-sterile, single patientuse for multiple treatments | Identical |
| Core Technology | Pneumatic jet nebulizer | Pneumatic jet nebulizer | Pneumatic jet nebulizer | Identical |
| Principle ofOperation | Venturi | Venturi | Venturi | Identical |
| Principle ofOperation | The nebulizer is connectedto an external compressedair or oxygen source usingoxygen tubing. The airpasses through an internaljet, and the solution insidethe jar is aerosolized.Additional room air isentrained through an airentrainment port,enhancing aerosol output. | The nebulizer is connectedto an external compressedair or oxygen source usingoxygen tubing. The airpasses through an internaljet, and the solution insidethe jar is aerosolized.Additional room air isentrained through an airentrainment port,enhancing aerosol output. | Compressed air is driventhrough a convergingnozzle, where itaccelerates and emergesat a high velocity, creatinga vacuum (venturi effect).The vacuum draws a liquidresiding in a reservoirup through a cylindricalchannel and into theemerging airstream formedby the nozzle, to mix withair and impact upon a rigidsurface. This process usesenergy from the airstreamto convertliquid into small dropletscalled aerosol. Uponreaching the user aerosolis suitably refined to enterthe lungs effectively. | EquivalentThe subject device, theprimary predicate and thesecondary predicate usethe same core technology,principle of operation andtype of gas source. |
| Characteristic | Subject Device | Primary PredicateDevice | Secondary Predicate | SubstantialEquivalenceDiscussion |
| Device Name | Hudson RCI®TurboMist™ Nebulizer | AirLife Misty FastSmall VolumeNebulizer | MC 300* | |
| 510(k) Number | K230602 | K123527 | K173367 | |
| Entrains additionalroom air through anair entrainment portto enhance aerosoloutput (breath-enhanced) | Yes | Yes | Yes | Identical |
| Type of Gas source | Compressed air or oxygen | Compressed air or oxygen | Compressed air or oxygen | Identical |
| Nebulizer drivinggas flow rate (LPM) | 8 LPM | 8 ± 1 LPM | 8 LPM | Identical |
| Maximum FillCapacity | 10 mL | 10 mL | 6 mL | Equivalent |
| Patient Contact Type | External communicating(Indirect gas pathway)Tissue/bone/dentincommunicatingDuration of Use -Permanent(> 30 days due to potentialfor cumulative use)AndSurface ContactMucosal MembraneDuration of Use -Permanent(> 30 days due to potentialfor cumulative use) | External communicating(Indirect gas pathway)Tissue/bone/dentincommunicatingDuration of Use -Permanent(> 30 days due to potentialfor cumulative use)AndSurface ContactMucosal MembraneDuration of Use -Permanent(> 30 days due to potentialfor cumulative use) | External communicating(Indirect gas pathway)Tissue/bone/dentincommunicatingDuration of Use -Permanent(> 30 days due to potentialfor cumulative use)AndSurface ContactMucosal MembraneDuration of Use -Permanent(> 30 days due to potentialfor cumulative use) | Identical |
| Environment of Use | Hospital and Home caresetting | Hospital setting | Hospital and Home caresetting | Identical to Primarypredicate for Hospital use.Equivalent to Secondarypredicate for home careUse |
| Characteristic | Subject Device | Primary PredicateDevice | Secondary Predicate | SubstantialEquivalenceDiscussion |
| Device Name | Hudson RCI®TurboMist™ Nebulizer | AirLife Misty FastSmall VolumeNebulizer | MC 300* | |
| 510(k) Number | K230602 | K123527 | K173367 | |
| Shelf Life | 5 years | 5 years | Not Available Publicly | Identical |
| Useful life | 7 days (assumes amaximum of 6 cleaningcycles per day plus asafety factor) or 50cleaning cycles | Cumulative duration of usenot to exceed 24 hours or50 cleaning cycles | The nebulizer is a singlepatient, disposable devicefor use up to 7 days | Equivalent |
| Cleaning andDisinfectionInstructions | Disassemble the nebulizerby removing the oxygentubing and all accessorycomponents. Unscrew thecap and remove the jetfrom the jar.Wash the nebulizer andaccessory components bysubmerging in a warmwater and liquid dish soapsolution and wipe with acloth for 1 minute. Rinsewith warm water.Inspect device for visiblesoil and repeat cleaningprocedure if necessary.Disinfect the nebulizer andaccessory components bysubmerging in 70%isopropyl alcohol for 10minutes.Air dry completely beforereassembling. | Unscrew the nebulizer capand bottle. Remove theone-piece jet by pullingand twisting the jet off thejet stem. Wash allcomponents in warmsoapy water and rinse well.Sterile water may also beused in place of soapywater. Shake out/offexcess water or sterilewater and air dry for 30minutes. Alternatively,shake out/off excess wateror sterile water and wipethe device with a clean lintfree cloth until dry. To aidin the drying process, youmay also use thecompressed air supply toclear the orifice. Reseatthe jet by placing the jetover the jet stem and snapinto place. Reattach thenebulizer cap and bottle. | For home, hospital or clinic• The exterior surfaces ofthe nebulizer may bewiped with a gauze lightlymoistened with eitherdistilled water or 70%isopropyl alcohol (solvent)• Remove the tubing fromthe bottom of the device,and disassemble thenebulizer into its parts(mouthpiece, corrugatedtube (if supplied), greennozzle cover, top and cup).Corrugated tubing shouldbe fully extended forcleaning and until dry.• Cleaning of the nebulizeris recommended after eachaerosol treatmentAny of the following fourmethods may be used:A Sterile Water: Rinse thedisassembled nebulizerparts thoroughly in sterilewater. Shake to removeexcess water. | EquivalentThe primary predicate andthe secondary predicatehave cleaning anddisinfection steps |
| Characteristic | Subject Device | Primary PredicateDevice | Secondary Predicate | SubstantialEquivalenceDiscussion |
| Device Name | Hudson RCI®TurboMist™ Nebulizer | AirLife Misty FastSmall VolumeNebulizer | MC 300* | |
| 510(k) Number | K230602 | K123527 | K173367 | |
| B 70% Isopropyl Alcohol:Wipe the outside of thenebulizer with a tissuedipped in 70% isopropylalcohol. Submerge the fourparts in 70% isopropylalcohol for 1 minute. Shaketo remove any excessisopropyl alcohol.C Air Dry: Disassemble thenebulizer and shake outany excess drug.D Hand Washing: Washthe disassembled parts ina warm water and liquiddish soap solution. Rinsein clean warm water.• After cleaning, inspect thedevice to ensure it is clean.If any residual soil isdetected, repeat theselected cleaning step.• For all methods, alwaysallow to air dry completely(or dry with a lint free cloth)before reassembling. It isrecommended thenebulizer bottom be brieflyreconnected to the airsupply to clear the airpathway. |
Table 004-1 Comparison of Subject Device to Primary Predicate and Secondary Predicate
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Further on, Medline also considered the FDA Draft Guidance "Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission" to identify valid Primary predicate and secondary predicate device. Publicly available 510(k) Summary and Indications for Use documents for each device being considered as a valid predicate device has been reviewed in addition to application of the best practices identified in Table 004-2 below to support the submission.
Table 004-2 Best Practices for Selecting Primary and Secondary Predicate Devices
| A | B | C | D | |
|---|---|---|---|---|
| ValidPredicateDevice | Wellestablishedmethods | Meets orexceeds expectedpredicateperformance | Unmitigateduse-related ordesign-relatedsafety issues | Associateddesign-relatedrecall |
| Primary Predicate DeviceAirLife Misty Fast SmallVolume Nebulizer(K123527) | Used relevantmethods thatwerepublishedin the publicdomain | Expectedfrequencyof reportedadverseevents | No knownunmitigated userelated ordesign-relatedsafety issues | No designrelated recallidentified |
| Secondary PredicateDeviceMC 300* Nebulizer(K173367) | Used relevantmethods thatwerepublishedin the publicdomain | Expectedfrequencyof reportedadverseevents | No knownunmitigated userelated ordesign-relatedsafety issues | No designrelated recallidentified |
12. Summary of Non-Clinical Testing
The following non-clinical tests were completed to demonstrate substantial equivalence of the subject device to primary predicate device and a review of key published performance test data in the 510k summary table of the secondary predicate.
12.1 Particle Size characterization
Particle characterization testing was performed on the subject device with both proposed patient interfaces (mouthpiece and aerosol mask), as well as on the primary predicate with a mouthpiece and aerosol mask and a review of published test data in the 510(k) summary table of the secondary predicate (K173367) was completed.
Cascade Impactor vacuum flow rate of 15 LPM was utilized for the testing subject and primary predicate devices and review of published data for secondary predicate device per FDA's "Reviewer Guidance for Nebulizer, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH - 1993).
Particle size characterization results for the TurboMist nebulizers and both patient interfaces (mouthpiece & mask) using 15 LPM impactor vacuum flow rate met all pre-determined acceptance criteria and demonstrated that the device meets its product specifications.
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When comparing particle size characterization and overall performance of the TurboMist system, the primary predicate and secondary predicate device at 15 LPM Cascade Impactor vacuum flow rate, results for all devices are considered to be comparable and within the clinically acceptable range.
12.2 Shelf life
Shelf life testing was performed on the subject device with both proposed patient interfaces (mouthpiece and aerosol mask) after the equivalent of five years aging. Real time aging studies have been initiated.
12.3 Useful life
Useful life testing was performed on the subject device with both proposed patient interfaces (mouthpiece and aerosol mask) and determined to be 7 days or 50 cleaning cycles
12.4 Cleaning & Disinfection
Cleaning and Disinfection testing was performed on the subject device with both proposed patient interfaces (mouthpiece and aerosol mask).
The cleaning and disinfection validation tests were based on the guidelines set forth in the following references
- . FDA Guidance: "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling"
- AAMI TIR12:2010 "Designing, Testing And Labeling Reusable Medical Devices For Reprocessing In Health Care Facilities: A Guide For Medical Device Manufacturers"
- . AAMI TIR30:2011 "A Compendium Of Processes, Materials, Test Methods, And Acceptance Criteria For Cleaning Reusable Medical Devices"
All testing concluded that the nebulizer could be cleaned and disinfected effectively by use of the methods stated in the IFU.
12.5 Biocompatibilitv
Biocompatibility evaluation and testing was performed on the subject device as well as both proposed patient interfaces (mouthpiece and aerosol mask). The materials contacting the patient have been characterized as external communicating (indirect gas pathway), tissue/bone/dentin communicating with a potential for permanent contact due to cumulative use and surface contacting, mucosal membrane, with a potential for permanent contact due to cumulative use. Contact of device materials with commonly aerosolized medications was taken into consideration when designing the test studies.
Table 4 details the biological endpoints that were evaluated and/or /tested based on the nature and duration of contact.
| Standard | Biological Endpoints |
|---|---|
| ISO 10993-3:2014 | Carcinogenicity |
| ISO 10993-3:2014 | Genotoxicity |
| ISO 10993-5:2009 | Cytotoxicity |
| ISO 10993-10:2010 | Sensitization |
Table 4 Summary of Biological Endpoints Evaluated/tested
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| Standard | Biological Endpoints |
|---|---|
| ISO 10993-11:2017 | Irritation or Intracutaneous Reactivity |
| ISO 10993-11:2017 | Material Mediated Pyrogenicity |
| ISO 10993-11:2017 | Acute Systemic Toxicity |
| ISO 10993-11:2017 | Subacute Toxicity |
| ISO 10993-11:2017 | Subchronic Toxicity |
| ISO 10993-11:2017 | Chronic Toxicity |
| ISO 10993-6:2017 | Implantation |
| ISO 10993-17: 2002 | Extractables/Leachables |
| ISO 10993-18:2020 | Chemical characterization of materials |
12.6 Gas Pathway
Gas pathway evaluation and testing was performed on the subject device as well as both proposed patient interfaces (mouthpiece and aerosol mask) per ISO 18562-1.
Table 5 details the Gas Pathway endpoints evaluated and/or /tested
| Table 5 Summary of Gas Pathway evaluated/tested | ||
|---|---|---|
| -- | -- | ------------------------------------------------- |
| Standard | Endpoint Assessed |
|---|---|
| ISO 18562-2:2017 | Tests for Emissions of Particulate Matter (including PM2.5) |
| ISO 18562-3:2017 | Tests for Emissions of Volatile Organic Compounds (VOCs) |
| ISO 18562-4:2017 | Evaluated Leachables In Condensate |
13 Conclusions
Based on testing data, including biocompatibility tests and aerosol particle performance tests, the TurboMist™ Nebulizer System meets the requirements of its pre-defined acceptance criteria and intended use. Therefore, the subject device TurboMist™ Nebulizer System is substantially equivalent to the primary predicate device for hospital setting and secondary predicate device for homecare setting.
§ 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).