(242 days)
Not Found
No
The description details a mechanical nebulizer powered by compressed air/oxygen, with no mention of AI or ML capabilities.
Yes
The device is described as a nebulizer intended to aerosolize liquid medication for patient breathing, which is a therapeutic action.
No
The device is a nebulizer intended to aerosolize liquid medication for delivery to a patient for breathing, which is a therapeutic function, not diagnostic.
No
The device description explicitly states it consists of physical components like a nebulizer, patient interface (mouthpiece or mask), and is powered by an external compressed air or oxygen source. This indicates it is a hardware device, not software-only.
Based on the provided information, the Hudson RCI® TurboMist™ Nebulizer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device is intended to aerosolize liquid medication for direct delivery to the patient for breathing. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a nebulizer system that creates and delivers aerosolized medication. It does not involve the examination of specimens derived from the human body for diagnostic purposes.
- Performance Studies: The performance studies focus on aspects like particle size, shelf life, cleaning, and biocompatibility, which are relevant to the device's function as a drug delivery system, not its ability to provide diagnostic information.
IVD devices are used to examine specimens (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Hudson RCI® TurboMist™ Nebulizer does not perform this function.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
CAF
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 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.
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
adult and pediatric (greater than 22 lbs or 10 kg)
Intended User / Care Setting
licensed healthcare professional / hospital or homecare environment.
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)
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:
- Particle Size characterization: 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. 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). Results for the TurboMist nebulizers and both patient interfaces met all pre-determined acceptance criteria and demonstrated that the device meets its product specifications. Results for all devices were considered comparable and within the clinically acceptable range.
- Shelf life: 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.
- Useful life: Performed on the subject device with both proposed patient interfaces (mouthpiece and aerosol mask) and determined to be 7 days or 50 cleaning cycles.
- Cleaning & Disinfection: Performed on the subject device with both proposed patient interfaces (mouthpiece and aerosol mask) based on FDA Guidance: "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", AAMI TIR12:2010, and AAMI TIR30:2011. All testing concluded that the nebulizer could be cleaned and disinfected effectively by use of the methods stated in the IFU.
- 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 were 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. Biological endpoints evaluated/tested included Carcinogenicity, Genotoxicity, Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Material Mediated Pyrogenicity, Acute Systemic Toxicity, Subacute Toxicity, Subchronic Toxicity, Chronic Toxicity, Implantation, Extractables/Leachables, and Chemical characterization of materials.
- 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. Endpoints assessed included Emissions of Particulate Matter (including PM2.5), Emissions of Volatile Organic Compounds (VOCs), and Evaluated Leachables In Condensate.
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.
Not Found
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
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"
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)
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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
Device | Secondary Predicate | Substantial
Equivalence
Discussion |
|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Hudson RCI®
TurboMist™ Nebulizer | AirLife Misty Fast
Small Volume
Nebulizer | 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 |
| Classification
Product Code | CAF | CAF | CAF | Identical |
| Regulatory Class | Class II | Class II | Class II | Identical |
| Intended Use | 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. | This AirLife Small Volume
Nebulizer is intended to
be used to aerosolize
liquid medication into
gases that are delivered
directly to the patient for
breathing.
The patient population
includes adults, pediatrics,
and infants that are
spontaneously breathing | This MC300 Nebulizer is
intended to be used to
aerosolize liquid
medication into gases
that are delivered directly
to the patient for
breathing. | Identical |
| Characteristic | Subject Device | Primary Predicate
Device | Secondary Predicate | Substantial
Equivalence
Discussion |
| Device Name | Hudson RCI®
TurboMist™ Nebulizer | AirLife Misty Fast
Small Volume
Nebulizer | MC 300* | |
| 510(k) Number | K230602 | K123527 | K173367 | |
| Indications for use | 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 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. | This device is intended to
be used to aerosolize liquid
medication
into gases that are
delivered directly to the
patient far breathing.
The patient population
includes adults, pediatrics,
and infants that
are spontaneously
breathing. The product is a
prescriptive device
intended to be used in
hospital setting. | The nebulizer is intended
to be used with pediatric
(ages 2 years and above)
and adult patients, who are
under the care of a
licensed healthcare
provider or physician.
The device is designed to
aerosolize prescribed
medication for inhalation
by a patient in the hospital,
clinic or home care
environment. The nebulizer
is a single patient use
device. | Identical
Primary Predicate is used
for hospital environment
only
Secondary Predicate is
used for both hospital and
home care environment |
| Contraindications | None | None | None | Identical |
| Patient Population | Adult and pediatric greater
than 22 lbs or 10 kg )
patients | Adult, pediatric, and infant | Adult and pediatric (ages 2
years and above) patients | Equivalent:
Both the primary predicate
and the secondary
predicate are inclusive of
the subject device |
| Characteristic | Subject Device | Primary Predicate
Device | Secondary Predicate | Substantial
Equivalence
Discussion |
| Device Name | Hudson RCI®
TurboMist™ Nebulizer | AirLife Misty Fast
Small Volume
Nebulizer | MC 300* | |
| 510(k) Number | K230602 | K123527 | K173367 | populations (Adult and
Pediatric greater than 22
lb or 10 kg patients) |
| Patient interface | Mouthpiece and aerosol
mask with elbow adaptor | Mouthpiece and aerosol
mask | Mouthpiece and aerosol
mask | 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 patient
use for multiple treatments | Identical |
| Core Technology | Pneumatic jet nebulizer | Pneumatic jet nebulizer | Pneumatic jet nebulizer | Identical |
| Principle of
Operation | Venturi | Venturi | Venturi | Identical |
| Principle of
Operation | The nebulizer is connected
to an external compressed
air or oxygen source using
oxygen tubing. The air
passes through an internal
jet, and the solution inside
the jar is aerosolized.
Additional room air is
entrained through an air
entrainment port,
enhancing aerosol output. | The nebulizer is connected
to an external compressed
air or oxygen source using
oxygen tubing. The air
passes through an internal
jet, and the solution inside
the jar is aerosolized.
Additional room air is
entrained through an air
entrainment port,
enhancing aerosol output. | Compressed air is driven
through a converging
nozzle, where it
accelerates and emerges
at a high velocity, creating
a vacuum (venturi effect).
The vacuum draws a liquid
residing in a reservoir
up through a cylindrical
channel and into the
emerging airstream formed
by the nozzle, to mix with
air and impact upon a rigid
surface. This process uses
energy from the airstream
to convert
liquid into small droplets
called aerosol. Upon
reaching the user aerosol
is suitably refined to enter
the lungs effectively. | Equivalent
The subject device, the
primary predicate and the
secondary predicate use
the same core technology,
principle of operation and
type of gas source. |
| Characteristic | Subject Device | Primary Predicate
Device | Secondary Predicate | Substantial
Equivalence
Discussion |
| Device Name | Hudson RCI®
TurboMist™ Nebulizer | AirLife Misty Fast
Small Volume
Nebulizer | MC 300* | |
| 510(k) Number | K230602 | K123527 | K173367 | |
| Entrains additional
room air through an
air entrainment port
to enhance aerosol
output (breath-
enhanced) | Yes | Yes | Yes | Identical |
| Type of Gas source | Compressed air or oxygen | Compressed air or oxygen | Compressed air or oxygen | Identical |
| Nebulizer driving
gas flow rate (LPM) | 8 LPM | 8 ± 1 LPM | 8 LPM | Identical |
| Maximum Fill
Capacity | 10 mL | 10 mL | 6 mL | Equivalent |
| Patient Contact Type | External communicating
(Indirect gas pathway)
Tissue/bone/dentin
communicating
Duration of Use -
Permanent
(> 30 days due to potential
for cumulative use)
And
Surface Contact
Mucosal Membrane
Duration of Use -
Permanent
(> 30 days due to potential
for cumulative use) | External communicating
(Indirect gas pathway)
Tissue/bone/dentin
communicating
Duration of Use -
Permanent
(> 30 days due to potential
for cumulative use)
And
Surface Contact
Mucosal Membrane
Duration of Use -
Permanent
(> 30 days due to potential
for cumulative use) | External communicating
(Indirect gas pathway)
Tissue/bone/dentin
communicating
Duration of Use -
Permanent
(> 30 days due to potential
for cumulative use)
And
Surface Contact
Mucosal Membrane
Duration of Use -
Permanent
(> 30 days due to potential
for cumulative use) | Identical |
| Environment of Use | Hospital and Home care
setting | Hospital setting | Hospital and Home care
setting | Identical to Primary
predicate for Hospital use.
Equivalent to Secondary
predicate for home care
Use |
| Characteristic | Subject Device | Primary Predicate
Device | Secondary Predicate | Substantial
Equivalence
Discussion |
| Device Name | Hudson RCI®
TurboMist™ Nebulizer | AirLife Misty Fast
Small Volume
Nebulizer | MC 300* | |
| 510(k) Number | K230602 | K123527 | K173367 | |
| Shelf Life | 5 years | 5 years | Not Available Publicly | Identical |
| Useful life | 7 days (assumes a
maximum of 6 cleaning
cycles per day plus a
safety factor) or 50
cleaning cycles | Cumulative duration of use
not to exceed 24 hours or
50 cleaning cycles | The nebulizer is a single
patient, disposable device
for use up to 7 days | Equivalent |
| Cleaning and
Disinfection
Instructions | Disassemble the nebulizer
by removing the oxygen
tubing and all accessory
components. Unscrew the
cap and remove the jet
from the jar.
Wash the nebulizer and
accessory components by
submerging in a warm
water and liquid dish soap
solution and wipe with a
cloth for 1 minute. Rinse
with warm water.
Inspect device for visible
soil and repeat cleaning
procedure if necessary.
Disinfect the nebulizer and
accessory components by
submerging in 70%
isopropyl alcohol for 10
minutes.
Air dry completely before
reassembling. | Unscrew the nebulizer cap
and bottle. Remove the
one-piece jet by pulling
and twisting the jet off the
jet stem. Wash all
components in warm
soapy water and rinse well.
Sterile water may also be
used in place of soapy
water. Shake out/off
excess water or sterile
water and air dry for 30
minutes. Alternatively,
shake out/off excess water
or sterile water and wipe
the device with a clean lint
free cloth until dry. To aid
in the drying process, you
may also use the
compressed air supply to
clear the orifice. Reseat
the jet by placing the jet
over the jet stem and snap
into place. Reattach the
nebulizer cap and bottle. | For home, hospital or clinic
• The exterior surfaces of
the nebulizer may be
wiped with a gauze lightly
moistened with either
distilled water or 70%
isopropyl alcohol (solvent)
• Remove the tubing from
the bottom of the device,
and disassemble the
nebulizer into its parts
(mouthpiece, corrugated
tube (if supplied), green
nozzle cover, top and cup).
Corrugated tubing should
be fully extended for
cleaning and until dry.
• Cleaning of the nebulizer
is recommended after each
aerosol treatment
Any of the following four
methods may be used:
A Sterile Water: Rinse the
disassembled nebulizer
parts thoroughly in sterile
water. Shake to remove
excess water. | Equivalent
The primary predicate and
the secondary predicate
have cleaning and
disinfection steps |
| Characteristic | Subject Device | Primary Predicate
Device | Secondary Predicate | Substantial
Equivalence
Discussion |
| Device Name | Hudson RCI®
TurboMist™ Nebulizer | AirLife Misty Fast
Small Volume
Nebulizer | MC 300* | |
| 510(k) Number | K230602 | K123527 | K173367 | |
| | | | B 70% Isopropyl Alcohol:
Wipe the outside of the
nebulizer with a tissue
dipped in 70% isopropyl
alcohol. Submerge the four
parts in 70% isopropyl
alcohol for 1 minute. Shake
to remove any excess
isopropyl alcohol.
C Air Dry: Disassemble the
nebulizer and shake out
any excess drug.
D Hand Washing: Wash
the disassembled parts in
a warm water and liquid
dish soap solution. Rinse
in clean warm water.
• After cleaning, inspect the
device to ensure it is clean.
If any residual soil is
detected, repeat the
selected cleaning step.
• For all methods, always
allow to air dry completely
(or dry with a lint free cloth)
before reassembling. It is
recommended the
nebulizer bottom be briefly
reconnected to the air
supply to clear the air
pathway. | |
Table 004-1 Comparison of Subject Device to Primary Predicate and Secondary Predicate
7
8
9
10
11
12
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 | |
|---|---|---|---|---|
| Valid | ||||
| Predicate | ||||
| Device | Well | |||
| established | ||||
| methods | Meets or | |||
| exceeds expected | ||||
| predicate | ||||
| performance | Unmitigated | |||
| use-related or | ||||
| design-related | ||||
| safety issues | Associated | |||
| design- | ||||
| related | ||||
| recall | ||||
| Primary Predicate Device |
AirLife Misty Fast Small
Volume Nebulizer
(K123527) | Used relevant
methods that
were
published
in the public
domain | Expected
frequency
of reported
adverse
events | No known
unmitigated use
related or
design-related
safety issues | No design
related recall
identified |
| Secondary Predicate
Device
MC 300* Nebulizer
(K173367) | Used relevant
methods that
were
published
in the public
domain | Expected
frequency
of reported
adverse
events | No known
unmitigated use
related or
design-related
safety issues | No design
related recall
identified |
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.
13
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
14
| 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.