Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)

K230559 · Medline Industries, Inc. · BTT · Oct 26, 2023 · Anesthesiology

Device Facts

• Record ID: K230559
• Device Name: Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)
• Applicant: Medline Industries, Inc.
• Product Code: BTT · Anesthesiology
• Decision Date: Oct 26, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Disposable, non-sterile, passive bubble humidifier; adds moisture to breathing gases (oxygen) for patient comfort. Input: breathing gas from oxygen concentrators, cylinders, or wall outlets. Operation: gas channeled through water-filled bottle via diffuser tube; humidified gas exits to patient via face mask or cannula. Models include 4 PSI or 6 PSI pressure relief valve with audible alarm for downstream occlusions. Used in hospital, home, extended care, hospice; operated by clinicians or patients. Output: humidified gas. Benefits: prevents airway dryness during supplemental oxygen therapy.

Clinical Evidence

Bench testing only. Performance validated per ISO 80601-2-74 (humidification output, flow rate, alarm function) and ISO 18562/ISO 10993 (biocompatibility, particulate matter, VOCs). Additional testing included pull tests, environmental conditioning, aging, and useful life testing.

Technological Characteristics

Passive, non-heated, non-prefilled bubble humidifier. Materials: polystyrene, polypropylene, PVC (DOHP). Dimensions/form: bottle with lid and diffuser tube. Flow rates: 2-12 LPM (3230) or 2-15 LPM (3260). Pressure relief: 4 PSI or 6 PSI. Standards: ISO 80601-2-74, ISO 18562-1/2/3, ISO 10993-1/5/10/11/18. Non-sterile, single-patient use.

Indications for Use

Indicated for pediatric through adult patients weighing ≥ 10 kg and >1 month old requiring humidification of breathing gases in homecare, hospital, extended care, and hospice settings.

Regulatory Classification

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.

Predicate Devices

• Salter Labs Bubble Humidifier (K161719)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Ethan L. Nyberg -S

Ethan Nyberg, Ph.D. Assistant Director

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DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) 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)

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# 510(k) Summary

### DATE PREPARED

October 25, 2023

# MANUFACTURER AND 510(k) OWNER

Medline Industries, Inc. 1 Three Lake Dr. Northfield, IL 60093 Phone: [phone]

Contact Person: Nicole Schaffer, Manager Regulatory Affairs, Respiratory

# REPRESENTATIVE/CONSULTANT

Joy Gutermuth, Regulatory Consultant RQM+ Telephone: [phone] Email: jgutermuth(@rqmplus.com

### DEVICE INFORMATION

| Proprietary Name/Trade Name: | Hudson RCI® Disposable Humidifier with 4 PSI Pressure<br>Relief Valve (3230)<br>Hudson RCI® Disposable Humidifier with 6 PSI Pressure<br>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<br>Predicate |
|---------------|--------------------------------------|----------------------|
| K161719 | Salter Labs Bubble Humidifier | ✓ |

The predicate devices have not been subject to a design related recall.

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# 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<br>Bubble Humidifiers | Predicate<br>Salter Labs Bubble<br>Humidifier (K161719) | Assessment of<br>Equivalence |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Classification | Class II | Class II | Same |
| Product Code | BTT | BTT | Same |
| Regulation<br>Number | §868.5450 | §868.5450 | Same |
| Regulation Name | Respiratory gas humidifier | Respiratory gas humidifier | Same |
| Product Features | Proposed<br>Bubble Humidifiers | Predicate<br>Salter Labs Bubble<br>Humidifier (K161719) | Assessment of<br>Equivalence |
| Intended Use | Intended to add moisture to<br>breathing gases for<br>administration to pediatric<br>through adult patients<br>weighing $\ge$ 10 kg >1 month in<br>homecare, hospital, extended<br>care and hospice. | Intended to add moisture to<br>breathing gases for<br>administration to patients >1<br>month in homecare, hospital,<br>extended care and hospice. | Similar |
| Indications for<br>Use | Intended to add moisture to<br>breathing gases for<br>administration to pediatric<br>through adult patients<br>weighing $\ge$ 10 kg >1 month in<br>homecare, hospital, extended<br>care and hospice. | The bubble humidifier is<br>intended to add moisture to<br>breathing gases for<br>administration to patients >1<br>month in homecare,<br>hospital, extended care and<br>hospice.<br>The bubble humidifier is a<br>non-sterile device indicated<br>for single-patient usage. The<br>device is indicated for<br>patients who<br>require humidification of<br>high flow supplemental<br>breathing gases. | Similar |
| Representative<br>Image | | | Similar |
| Device Description | | | Similar |
| The Proposed Hudson RCI®<br>Disposable Humidifier with 4<br>PSI or 6PSI Pressure Relief<br>Valve is an empty, disposable,<br>non-sterile, not made with<br>natural rubber latex, device<br>intended to humidify<br>breathing gas prior to delivery<br>to a patient. It is provided in<br>two configurations with either<br>a 4 PSI or 6 PSI safety valve<br>and can operate within flow<br>rates of 2-12 LPM (model<br>3230) or 2-15 LPM (model<br>3260). The device is used with<br>various breathing gas sources<br>(i.e., oxygen concentrators,<br>gas cylinders, and wall<br>outlets) and provides<br>connection for delivery of<br>humidified breathing gas via<br>face masks or cannulas and<br>use of optional oxygen tubing<br>and water traps (sold<br>separately). This device is a<br>passive device and is not a<br>cascade humidifier, is not<br>heated, and is not prefilled. | humidify breathing gas prior<br>to delivery to a patient. The<br>Salter Labs Bubble<br>Humidifier (6-15 LPM) with<br>6 PSI (410mbars) safety<br>valve is provided with a 6<br>pounds per square inch (PSI)<br>safety valve and can operate<br>within flow rates of 6 to 15<br>liters per minute (LPM). The<br>device is used with various<br>breathing gas sources (i.e.,<br>oxygen concentrators, gas<br>cylinders and wall outlets)<br>and provides connection for<br>delivery of humidified<br>breathing gas via face masks<br>or cannulas, and use of<br>optional oxygen tubing and<br>water traps (face masks, 21<br>CFR 868.5580; nasal<br>cannulas, 21 CFR 868.5340;<br>oxygen tubing, 21 CFR<br>868.5860 and water traps, 21<br>CFR 868.5995 are 510(k)<br>exempt).<br>This device is a passive<br>device and is not a cascade<br>humidifier, is not heated and<br>is not prefilled. The device is<br>made of a humidifier bottle<br>which is used to hold water<br>during use, a lid which seals<br>the humidifier bottle, an<br>audible pressure relief<br>mechanism to notify the user<br>of a downstream occlusion<br>and a diffuser located at the<br>end of a PVC diffuser tube<br>inside the humidifier bottle.<br>The diffusor is designed to<br>uniformly disperse the gas<br>throughout the water. Both<br>the bottle and lid are<br>constructed to be easy to<br>grip and reduce the chance<br>of cross threading. The<br>bottle is permanently | | Similar |
| Product Features | Proposed<br>Bubble Humidifiers | Predicate<br>Salter Labs Bubble<br>Humidifier (K161719) | Assessment of<br>Equivalence |
| Environment of<br>Use | Hospital, hospice, or home<br>care setting. | Hospital or home care<br>setting. | Similar |
| Principle of<br>Operation | This device is a passive<br>device and is not a cascade<br>humidifier, is not heated and<br>is not prefilled. It is used with<br>oxygen concentrators or gas<br>sources. Air is channeled<br>through a water-contained jar.<br>The air then becomes<br>humidified before exiting to<br>the patient. | This device is a passive<br>device and is not a cascade<br>humidifier, is not heated and<br>is not prefilled. It is used<br>with oxygen concentrators<br>or gas sources. Air is<br>channeled through a water-<br>contained jar. The air then<br>becomes humidified before<br>exiting to the patient. | Same |
| Sterilization<br>Method | Non-sterile | Non-sterile - | Same |
| Patient Contacting<br>Materials | Polystyrene, polypropylene,<br>PVC (DOHP) | Polyethylene, polystyrene,<br>PVC (DHOP) | Same |
| Prescription | Prescription only | Prescription only | Same |
| Single Use | Single patient use | Single patient use | Same |
| Cleaning | No preparations required prior<br>to use; cleaning process only.<br>Cleaning instructions<br>validated per useful life of<br>device. | No preparations required<br>prior to use; cleaning<br>process only. Cleaning<br>instructions validated per<br>useful life of device. | Same |
| Power Source | None- passive device, non-<br>heated | None- passive device, non-<br>heated | Same |
| Accessories (not<br>included) | Face mask, nasal cannula,<br>oxygen tubing, water traps | Face mask, nasal cannula,<br>oxygen tubing, water traps | Same |
| Biocompatibility | • External communicating,<br>limited contact device that<br>indirectly contacts<br>tissue/bone/dentin.<br>• Indirect gas pathway | • "Device does not touch<br>the patient" | Similar |
| Product Features | Proposed<br>Bubble Humidifiers | Predicate<br>Salter Labs Bubble<br>Humidifier (K161719) | Assessment of<br>Equivalence |
| | ISO 18562-1<br>ISO 18562-2<br>ISO 18562-3<br>ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>ISO 10993-11<br>ISO 10993-18 | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10 | Similar |
| Humidification<br>Output<br>Specification…