(240 days)
Not Found
No
The device description and performance studies focus on mechanical and physical properties of a disposable humidifier, with no mention of AI or ML technologies.
Yes
The device is designed to add moisture to breathing gases for patients, aiming to make the gases more comfortable to breathe. This directly addresses a physiological need (moisture for respiratory gases) and provides a therapeutic effect.
No
The device is described as a humidifier that adds moisture to breathing gases; its function is therapeutic (to make gases more comfortable to breathe), not diagnostic.
No
The device description clearly describes a physical, hardware-based humidifier with components like a bottle, pressure relief valve, and audible alarm. It does not mention any software as the primary or sole function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to add moisture to breathing gases for administration to patients. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description details how the device humidifies gases by channeling air through water. This process is related to gas conditioning for breathing, not analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.), detect markers of disease, or provide any form of diagnostic information about the patient's health status.
- Performance Studies: The performance studies focus on safety and performance related to humidification, flow rate, alarms, and physical integrity. These are typical tests for respiratory support devices, not IVDs.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Intended to add moisture to breathing gases for administration to pediatic through adult patients weighing > 10 kg >1 month in homecare, hospital, extended care and hospice.
Product codes (comma separated list FDA assigned to the subject device)
BTT
Device Description
There are two models of the Hudson RCI Disposable Humidifier. Both models have identical intended uses and modes of operation. One model has a 4 PSI pressure relief valve (referred to as model 3230) and the other has a 6 PSI pressure relief valve (referred to as model 3260). Regardless of device model, the disposable humidifier delivers humidified gases to the patient. Both models of the non-prefilled disposable humidity in water vapor form to respiratory gases delivered to patients to make the gases more comfortable to breathe. The disposable humidifier incorporates a pressure relief valve with an audible alarm at 4 psi or 6 psi. depending on the model selected.
In both models, air is channeled through the water-containing bottle where it becomes humidified before exiting the device and being administered to the patient.
The patient can influence the use of these devices by occluding or loosening secure connections. In cases where the patient is also the user, over or under filling the device and selection of incorrect oxygen percent concentration and gas input pressures may influence the use of the device.
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
pediatic through adult patients weighing ≥ 10 kg >1 month
Intended User / Care Setting
homecare, hospital, extended care and hospice.
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 tests were performed to demonstrate safety based on current industry standards:
- Biocompatibility
- Packaging ●
- Environmental Conditioning (high and low humidity) ●
- . Aging
- ISO 80601-2-74 Medical electrical equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
- 0 Humidification Output
- o Flow Rate
- o Alarm
- . Pull Test
- Useful life testing ●
The results of these tests indicate that the Hudson RCI Bubble Humidifiers are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 26, 2023
Medline Industries, Inc. % Joy Gutermuth Consultant Ram+ 2790 Mosside Blvd. Suite 800 Monroeville, Pennsylvania 15146
Re: K230559
Trade/Device Name: Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT Dated: September 27, 2023 Received: September 27, 2023
Dear Joy Gutermuth:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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.
1
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" (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 (OS) 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 QS 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
2
DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K230559
Device Name
Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve
Indications for Use (Describe)
Intended to add moisture to breathing gases for administration to pediatic through adult patients weighing > 10 kg >1 month in homecare, hospital, extended care and hospice.
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
510(k) Summary
DATE PREPARED
October 25, 2023
MANUFACTURER AND 510(k) OWNER
Medline Industries, Inc. 1 Three Lake Dr. Northfield, IL 60093 Phone: 724-640-9680
Contact Person: Nicole Schaffer, Manager Regulatory Affairs, Respiratory
REPRESENTATIVE/CONSULTANT
Joy Gutermuth, Regulatory Consultant RQM+ Telephone: +1 (412) 810-8172 Email: jgutermuth(@rqmplus.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | Hudson RCI® Disposable Humidifier with 4 PSI Pressure
Relief Valve (3230)
Hudson RCI® Disposable Humidifier with 6 PSI Pressure
Relief Valve (3260) |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bubble Humidifier |
| Regulation Number: | §868.5450 |
| Class: | II |
| Product Code: | BTT |
PREDICATE DEVICE IDENTIFICATION
The Hudson RCI Bubble Humidifiers are substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary
Predicate |
|---------------|--------------------------------------|----------------------|
| K161719 | Salter Labs Bubble Humidifier | ✓ |
The predicate devices have not been subject to a design related recall.
5
DEVICE DESCRIPTION
There are two models of the Hudson RCI Disposable Humidifier. Both models have identical intended uses and modes of operation. One model has a 4 PSI pressure relief valve (referred to as model 3230) and the other has a 6 PSI pressure relief valve (referred to as model 3260). Regardless of device model, the disposable humidifier delivers humidified gases to the patient. Both models of the non-prefilled disposable humidity in water vapor form to respiratory gases delivered to patients to make the gases more comfortable to breathe. The disposable humidifier incorporates a pressure relief valve with an audible alarm at 4 psi or 6 psi. depending on the model selected.
In both models, air is channeled through the water-containing bottle where it becomes humidified before exiting the device and being administered to the patient.
The patient can influence the use of these devices by occluding or loosening secure connections. In cases where the patient is also the user, over or under filling the device and selection of incorrect oxygen percent concentration and gas input pressures may influence the use of the device.
INDICATIONS FOR USE
Intended to add moisture to breathing gases for administration to pediatric through adult patients weighing ≥ 10 kg >1 month in homecare, hospital, extended care and hospice.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Medline Industries believes that the Hudson RCI Bubble Humidifiers are substantially equivalent to the predicate device based on the information summarized here:
The subject devices have a similar design and dimensions and use similar or identical materials as the device cleared in K161719. The subject devices have intended use and similar technological characteristics to the devices cleared in K161719. The devices have similar instrumentation to the device cleared in K161719. These technological characteristics have undergone testing to ensure the subject devices are substantially equivalent to the predicate.
| Product Features | Proposed
Bubble Humidifiers | Predicate
Salter Labs Bubble
Humidifier (K161719) | Assessment of
Equivalence |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Classification | Class II | Class II | Same |
| Product Code | BTT | BTT | Same |
| Regulation
Number | §868.5450 | §868.5450 | Same |
| Regulation Name | Respiratory gas humidifier | Respiratory gas humidifier | Same |
| Product Features | Proposed
Bubble Humidifiers | Predicate
Salter Labs Bubble
Humidifier (K161719) | Assessment of
Equivalence |
| Intended Use | Intended to add moisture to
breathing gases for
administration to pediatric
through adult patients
weighing $\ge$ 10 kg >1 month in
homecare, hospital, extended
care and hospice. | Intended to add moisture to
breathing gases for
administration to patients >1
month in homecare, hospital,
extended care and hospice. | Similar |
| Indications for
Use | Intended to add moisture to
breathing gases for
administration to pediatric
through adult patients
weighing $\ge$ 10 kg >1 month in
homecare, hospital, extended
care and hospice. | The bubble humidifier is
intended to add moisture to
breathing gases for
administration to patients >1
month in homecare,
hospital, extended care and
hospice.
The bubble humidifier is a
non-sterile device indicated
for single-patient usage. The
device is indicated for
patients who
require humidification of
high flow supplemental
breathing gases. | Similar |
| Representative
Image | | | Similar |
| Device Description | | | Similar |
| The Proposed Hudson RCI®
Disposable Humidifier with 4
PSI or 6PSI Pressure Relief
Valve is an empty, disposable,
non-sterile, not made with
natural rubber latex, device
intended to humidify
breathing gas prior to delivery
to a patient. It is provided in
two configurations with either
a 4 PSI or 6 PSI safety valve
and can operate within flow
rates of 2-12 LPM (model
3230) or 2-15 LPM (model
3260). The device is used with
various breathing gas sources
(i.e., oxygen concentrators,
gas cylinders, and wall
outlets) and provides
connection for delivery of
humidified breathing gas via
face masks or cannulas and
use of optional oxygen tubing
and water traps (sold
separately). This device is a
passive device and is not a
cascade humidifier, is not
heated, and is not prefilled. | humidify breathing gas prior
to delivery to a patient. The
Salter Labs Bubble
Humidifier (6-15 LPM) with
6 PSI (410mbars) safety
valve is provided with a 6
pounds per square inch (PSI)
safety valve and can operate
within flow rates of 6 to 15
liters per minute (LPM). The
device is used with various
breathing gas sources (i.e.,
oxygen concentrators, gas
cylinders and wall outlets)
and provides connection for
delivery of humidified
breathing gas via face masks
or cannulas, and use of
optional oxygen tubing and
water traps (face masks, 21
CFR 868.5580; nasal
cannulas, 21 CFR 868.5340;
oxygen tubing, 21 CFR
868.5860 and water traps, 21
CFR 868.5995 are 510(k)
exempt).
This device is a passive
device and is not a cascade
humidifier, is not heated and
is not prefilled. The device is
made of a humidifier bottle
which is used to hold water
during use, a lid which seals
the humidifier bottle, an
audible pressure relief
mechanism to notify the user
of a downstream occlusion
and a diffuser located at the
end of a PVC diffuser tube
inside the humidifier bottle.
The diffusor is designed to
uniformly disperse the gas
throughout the water. Both
the bottle and lid are
constructed to be easy to
grip and reduce the chance
of cross threading. The
bottle is permanently | | Similar |
| Product Features | Proposed
Bubble Humidifiers | Predicate
Salter Labs Bubble
Humidifier (K161719) | Assessment of
Equivalence |
| Environment of
Use | Hospital, hospice, or home
care setting. | Hospital or home care
setting. | Similar |
| Principle of
Operation | This device is a passive
device and is not a cascade
humidifier, is not heated and
is not prefilled. It is used with
oxygen concentrators or gas
sources. Air is channeled
through a water-contained jar.
The air then becomes
humidified before exiting to
the patient. | This device is a passive
device and is not a cascade
humidifier, is not heated and
is not prefilled. It is used
with oxygen concentrators
or gas sources. Air is
channeled through a water-
contained jar. The air then
becomes humidified before
exiting to the patient. | Same |
| Sterilization
Method | Non-sterile | Non-sterile - | Same |
| Patient Contacting
Materials | Polystyrene, polypropylene,
PVC (DOHP) | Polyethylene, polystyrene,
PVC (DHOP) | Same |
| Prescription | Prescription only | Prescription only | Same |
| Single Use | Single patient use | Single patient use | Same |
| Cleaning | No preparations required prior
to use; cleaning process only.
Cleaning instructions
validated per useful life of
device. | No preparations required
prior to use; cleaning
process only. Cleaning
instructions validated per
useful life of device. | Same |
| Power Source | None- passive device, non-
heated | None- passive device, non-
heated | Same |
| Accessories (not
included) | Face mask, nasal cannula,
oxygen tubing, water traps | Face mask, nasal cannula,
oxygen tubing, water traps | Same |
| Biocompatibility | • External communicating,
limited contact device that
indirectly contacts
tissue/bone/dentin.
• Indirect gas pathway | • "Device does not touch
the patient" | Similar |
| Product Features | Proposed
Bubble Humidifiers | Predicate
Salter Labs Bubble
Humidifier (K161719) | Assessment of
Equivalence |
| | ISO 18562-1
ISO 18562-2
ISO 18562-3
ISO 10993-1
ISO 10993-5
ISO 10993-10
ISO 10993-11
ISO 10993-18 | ISO 10993-1
ISO 10993-5
ISO 10993-10 | Similar |
| Humidification
Output
Specification | 10mg/l | 10mg/l | Same |
| Flow Rate | Finished Good 3230: 2-12
LPM
Finished Good 3260: 2-15
LPM | 6-15 LPM | Similar |
| Alarm | Finished Good 3230: 4 PSI
Finished Good 3260: 6 PSI | 6 PSI | Similar |
| Pull Test
Specification
(tubing assembly
to diffuser and
tubing to lid) | Minimum 5lbs at 7in/min | Not stated | Unknown as predicate
does not state value |
6
7
8
9
SUMMARY OF NON-CLINICAL TESTING
The following tests were performed to demonstrate safety based on current industry standards:
- Biocompatibility
- Packaging ●
- Environmental Conditioning (high and low humidity) ●
- . Aging
- ISO 80601-2-74 Medical electrical equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
- 0 Humidification Output
- o Flow Rate
- o Alarm
- . Pull Test
- Useful life testing ●
The results of these tests indicate that the Hudson RCI Bubble Humidifiers are substantially equivalent to the predicate devices.
10
BIOCOMPATIBILITY
Requirements for biological evaluation were based on the FDA Guidance Document "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," September 4, 2020, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The expected contact category, type and duration for the proposed Bubble Humidifiers is as follows:
The Bubble Humidifiers are considered external communicating, permanent devices that indirectly contact tissue/bone/dentin per ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."
Testing has been conducted per a biological evaluation and the applicable endpoints are summarized below.
- . Cytotoxicity
- . Sensitization
- . Intracutaneous Reactivity
- . Acute Systemic toxicity
- Material Mediated Pyrogenicity
- Particulate Matter
- . Volatile Organic Compounds
The following standards have been utilized:
- ISO 18562-1, Biocompatibility evaluation of breathing gas pathways in healthcare ● applications - Part 1: Evaluation and testing within a risk management process
- . ISO 18562-2, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
- . ISO 18562-3, Biocompatibility evaluation of breathing gas pathways in healthcare application - Part 3: Tests for emissions of volatile organic compounds
- . ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
- . 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- . ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- . ISO 10993-11. Biological evaluation of medical devices - Part 11: Tests for systemic toxicitv
- ISO 10993-18, Biological evaluation of medical devices Part 18: Chemical . characterization of medical device materials within a risk management process
11
CONCLUSION
Based on the testing performed, including humidification output and additional gas pathway biocompatibility testing according to ISO 18562, it can be concluded that the subject devices do not raise new issues of safety or effectiveness compared to the predicate device. The similar indications for use, technological characteristics, and performance characteristics for the proposed Hudson RCI Bubble Humidifiers are assessed to be substantially equivalent to the predicate devices.