Hudson RCI® TurboMist™ Nebulizer System

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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" {1}------------------------------------------------ (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 {2}------------------------------------------------ OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ## 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 {5}------------------------------------------------ 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. {6}------------------------------------------------ | Characteristic | Subject Device | Primary Predicate<br>Device | Secondary Predicate | Substantial<br>Equivalence<br>Discussion | |--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Hudson RCI®<br>TurboMist™ Nebulizer | AirLife Misty Fast<br>Small Volume<br>Nebulizer | MC 300* | | | 510(k) Number | K230602 | K123527 | K173367 | | | Classification Name | Nebulizer<br>(Direct Patient Interface) | Nebulizer<br>(Direct Patient Interface) | Nebulizer<br>(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 | | Classification<br>Product Code | CAF | CAF | CAF | Identical | | Regulatory Class | Class II | Class II | Class II | Identical | | Intended Use | The Hudson RCI®<br>TurboMist™ Nebulizer is<br>intended to be used to<br>aerosolize liquid<br>medication into gases<br>that are delivered directly<br>to the patient for<br>breathing. | This AirLife Small Volume<br>Nebulizer is intended to<br>be used to aerosolize<br>liquid medication into<br>gases that are delivered<br>directly to the patient for<br>breathing.<br>The patient population<br>includes adults, pediatrics,<br>and infants that are<br>spontaneously breathing | This MC300 Nebulizer is<br>intended to be used to<br>aerosolize liquid<br>medication into gases<br>that are delivered directly<br>to the patient for<br>breathing. | Identical | | Characteristic | Subject Device | Primary Predicate<br>Device | Secondary Predicate | Substantial<br>Equivalence<br>Discussion | | Device Name | Hudson RCI®<br>TurboMist™ Nebulizer | AirLife Misty Fast<br>Small Volume<br>Nebulizer | MC 300* | | | 510(k) Number | K230602 | K123527 | K173367 | | | Indications for use | The Hudson RCI®<br>TurboMist™ Nebulizer is<br>intended to be used to<br>aerosolize liquid<br>medication into gases that<br>are delivered directly to the<br>patient for breathing. Its<br>use is indicated when a<br>licensed healthcare<br>professional prescribes or<br>administers medical<br>aerosol to a patient using a<br>small volume nebulizer.<br>The patient population<br>includes adult and pediatric<br>(greater than 22 lbs or 10<br>kg) patients that are<br>spontaneously breathing.<br>The product is a single<br>patient, multi-use, non-<br>sterile, disposable,<br>prescriptive device<br>intended to be used in a<br>hospital or homecare<br>environment. | This device is intended to<br>be used to aerosolize liquid<br>medication<br>into gases that are<br>delivered directly to the<br>patient far breathing.<br>The patient population<br>includes adults, pediatrics,<br>and infants that<br>are spontaneously<br>breathing. The product is a<br>prescriptive device<br>intended to be used in<br>hospital setting. | The nebulizer is intended<br>to be used with pediatric<br>(ages 2 years and above)<br>and adult patients, who are<br>under the care of a<br>licensed healthcare<br>provider or physician.<br>The device is designed to<br>aerosolize prescribed<br>medication for inhalation<br>by a patient in the hospital,<br>clinic or home care<br>environment. The nebulizer<br>is a single patient use<br>device. | Identical<br>Primary Predicate is used<br>for hospital environment<br>only<br>Secondary Predicate is<br>used for both hospital and<br>home care environment | | Contraindications | None | None | None | Identical | | Patient Population | Adult and pediatric greater<br>than 22 lbs or 10 kg )<br>patients | Adult, pediatric, and infant | Adult and pediatric (ages 2<br>years and above) patients | Equivalent:<br>Both the primary predicate<br>and the secondary<br>predicate are inclusive of<br>the subject device | | Characteristic | Subject Device | Primary Predicate<br>Device | Secondary Predicate | Substantial<br>Equivalence<br>Discussion | | Device Name | Hudson RCI®<br>TurboMist™ Nebulizer | AirLife Misty Fast<br>Small Volume<br>Nebulizer | MC 300* | | | 510(k) Number | K230602 | K123527 | K173367 | populations (Adult and<br>Pediatric greater than 22<br>lb or 10 kg patients) | | Patient interface | Mouthpiece and aerosol<br>mask with elbow adaptor | Mouthpiece and aerosol<br>mask | Mouthpiece and aerosol<br>mask | Identical | | Type of device | Disposable, hand-held,<br>non-sterile, single patient,<br>multi-use | Disposable, hand-held,<br>non-sterile, single patient,<br>multi-use | Disposable, handheld,<br>non-sterile, single patient<br>use for multiple treatments | Identical | | Core Technology | Pneumatic jet nebulizer | Pneumatic jet nebulizer | Pneumatic jet nebulizer | Identical | | Principle of<br>Operation | Venturi | Venturi | Venturi | Identical | | Principle of<br>Operation | The nebulizer is connected<br>to an external compressed<br>air or oxygen source using<br>oxygen tubing. The air<br>passes through an internal<br>jet, and the solution inside<br>the jar is aerosolized.<br>Additional room air is<br>entrained through an air<br>entrainment port,<br>enhancing aerosol output. | The nebulizer is connected<br>to an external compressed<br>air or oxygen source using<br>oxygen tubing. The air<br>passes through an internal<br>jet, and the solution inside<br>the jar is aerosolized.<br>Additional room air is<br>entrained through an air<br>entrainment port,<br>enhancing aerosol output. | Compressed air is driven<br>through a converging<br>nozzle, where it<br>accelerates and emerges<br>at a high velocity, creating<br>a vacuum (venturi effect).<br>The vacuum draws a liquid<br>residing in a reservoir<br>up through a cylindrical<br>channel and into the<br>emerging airstream formed<br>by the nozzle, to mix with<br>air and impact upon a rigid<br>surface. This process uses<br>energy from the airstream<br>to convert<br>liquid into small droplets<br>called aerosol. Upon<br>reaching the user aerosol<br>is suitably refined to enter<br>the lungs effectively. | Equivalent<br>The subject device, the<br>primary predicate and the<br>secondary predicate use<br>the same core technology,<br>principle of operation and<br>type of gas source. | | Characteristic | Subject Device | Primary Predicate<br>Device | Secondary Predicate | Substantial<br>Equivalence<br>Discussion | | Device Name | Hudson RCI®<br>TurboMist™ Nebulizer | AirLife Misty Fast<br>Small Volume<br>Nebulizer | MC 300* | | | 510(k) Number | K230602 | K123527 | K173367…