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 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.

AI/ML Overview

This is a 510(k) premarket notification for the "Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve" and "Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve". The document asserts substantial equivalence to the predicate device "Salter Labs Bubble Humidifier (K161719)".

However, the provided text does not contain a study that proves the device meets specific acceptance criteria in the format requested. Instead, it summarizes non-clinical testing performed to demonstrate safety based on industry standards and establish substantial equivalence to a predicate device.

The document lists various tests performed and standards utilized, but it does not provide:

A table of acceptance criteria with reported device performance values against those criteria.
Sample sizes used for test sets.
Information about ground truth establishment, experts, or adjudication methods.
Details about MRMC studies or effect sizes for AI assistance.
Information on standalone algorithm performance or training set details.

The document provides a "Summary of Non-Clinical Testing" and then lists specific types of tests, such as "Humidification Output," "Flow Rate," "Alarm," and "Pull Test." While it states that the results of these tests indicate substantial equivalence, it does not detail the acceptance criteria for each test or the specific reported performance values that met those criteria.

Therefore, I cannot populate the requested table or provide the detailed information about study design, ground truth, and sample sizes that would typically be found in a study demonstrating device performance against acceptance criteria.

The information that is available regarding acceptance criteria and performance is very high-level and can be inferred from the "Comparison of Technological Characteristics" table and the "SUMMARY OF NON-CLINICAL TESTING" section:

Inferred Information from the Document:

1. A table of acceptance criteria and the reported device performance:

Criteria	Acceptance Criteria	Reported Device Performance
Humidification Output	10mg/l (from comparison to predicate)	The document implies the proposed device meets 10mg/l as it states "Same" in the Assessment of Equivalence column for this feature.
Flow Rate (Model 3230)	N/A (Predicate specifies 6-15 LPM. Proposed 3230 is 2-12 LPM)	2-12 LPM (Stated as a characteristic; not explicitly stated to meet an acceptance criterion for substantial equivalence in a specific performance manner, but rather as a product characteristic that is similar enough.)
Flow Rate (Model 3260)	N/A (Predicate specifies 6-15 LPM. Proposed 3260 is 2-15 LPM)	2-15 LPM (Stated as a characteristic; not explicitly stated to meet an acceptance criterion for substantial equivalence in a specific performance manner, but rather as a product characteristic that is similar enough.)
Alarm (Model 3230)	N/A (Predicate specifies 6 PSI. Proposed 3230 is 4 PSI)	4 PSI (Stated as a characteristic; not explicitly stated to meet an acceptance criterion for substantial equivalence in a specific performance manner, but rather as a product characteristic that is similar enough.)
Alarm (Model 3260)	N/A (Predicate specifies 6 PSI. Proposed 3260 is 6 PSI)	6 PSI (Stated as a characteristic; not explicitly stated to meet an acceptance criterion for substantial equivalence in a specific performance manner, but rather as a product characteristic that is similar enough, matching the predicate for this model.)
Pull Test Specification	Minimum 5lbs at 7in/min (Stated for proposed device; predicate does not state value)	The document implies the device meets this specification, as "Pull Test" is listed under non-clinical testing performed to demonstrate safety.
Biocompatibility	Compliance with ISO 18562-1, ISO 18562-2, ISO 18562-3, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-18 (for the proposed device).	The document states "Testing has been conducted per a biological evaluation and the applicable endpoints are summarized below" and lists the tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic toxicity, Material Mediated Pyrogenicity, Particulate Matter, Volatile Organic Compounds). It concludes that the devices do not raise new issues of safety or effectiveness compared to the predicate, implying compliance with these standards and successful completion of the tests.
Packaging	Not specified explicitly, but implies compliance with relevant standards.	"Packaging" is listed as a performed test; results are implied to be satisfactory for substantial equivalence.
Environmental Conditioning (high and low humidity)	Not specified explicitly, but implies compliance with relevant standards.	"Environmental Conditioning (high and low humidity)" is listed as a performed test; results are implied to be satisfactory for substantial equivalence.
Aging	Not specified explicitly, but implies compliance with relevant standards.	"Aging" is listed as a performed test; results are implied to be satisfactory for substantial equivalence.
Useful life testing	Not specified explicitly, but implies compliance with relevant standards.	"Useful life testing" is listed as a performed test; results are implied to be satisfactory for substantial equivalence.
ISO 80601-2-74 (Basic Safety & Essential Performance of Respiratory Humidifying Equipment)	Compliance with the standard.	The document lists this standard as one to which testing was performed, implying successful compliance for "Humidification Output," "Flow Rate," and "Alarm."

The document does not provide information for the following points as they are typically associated with clinical studies or more detailed performance reports, which are not present here:

Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a device performance summary focusing on non-clinical engineering and biocompatibility tests, not diagnostic accuracy requiring expert ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as this is a device performance summary focusing on non-clinical engineering and biocompatibility tests. For these tests, the "ground truth" would be established by the defined test methods and measurement standards (e.g., a specific method to measure humidification output).
The sample size for the training set: Not applicable, as this is not a machine learning device.
How the ground truth for the training set was established: Not applicable, as this is not a machine learning device.

Conclusion from the document:
The document concludes that "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." This statement implies that all the non-clinical tests were successfully completed and the devices met the performance expectations for substantial equivalence.

Summary

{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 PressureRelief Valve (3230)Hudson RCI® Disposable Humidifier with 6 PSI PressureRelief 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	PrimaryPredicate
K161719	Salter Labs Bubble Humidifier	✓

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

{5}------------------------------------------------

DEVICE DESCRIPTION

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.

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	ProposedBubble Humidifiers	PredicateSalter Labs BubbleHumidifier (K161719)	Assessment ofEquivalence
Classification	Class II	Class II	Same
Product Code	BTT	BTT	Same
RegulationNumber	§868.5450	§868.5450	Same
Regulation Name	Respiratory gas humidifier	Respiratory gas humidifier	Same
Product Features	ProposedBubble Humidifiers	PredicateSalter Labs BubbleHumidifier (K161719)	Assessment ofEquivalence
Intended Use	Intended to add moisture tobreathing gases foradministration to pediatricthrough adult patientsweighing $\ge$ 10 kg >1 month inhomecare, hospital, extendedcare and hospice.	Intended to add moisture tobreathing gases foradministration to patients >1month in homecare, hospital,extended care and hospice.	Similar
Indications forUse	Intended to add moisture tobreathing gases foradministration to pediatricthrough adult patientsweighing $\ge$ 10 kg >1 month inhomecare, hospital, extendedcare and hospice.	The bubble humidifier isintended to add moisture tobreathing gases foradministration to patients >1month in homecare,hospital, extended care andhospice.The bubble humidifier is anon-sterile device indicatedfor single-patient usage. Thedevice is indicated forpatients whorequire humidification ofhigh flow supplementalbreathing gases.	Similar
RepresentativeImage			Similar
Device Description			Similar
The Proposed Hudson RCI®Disposable Humidifier with 4PSI or 6PSI Pressure ReliefValve is an empty, disposable,non-sterile, not made withnatural rubber latex, deviceintended to humidifybreathing gas prior to deliveryto a patient. It is provided intwo configurations with eithera 4 PSI or 6 PSI safety valveand can operate within flowrates of 2-12 LPM (model3230) or 2-15 LPM (model3260). The device is used withvarious breathing gas sources(i.e., oxygen concentrators,gas cylinders, and walloutlets) and providesconnection for delivery ofhumidified breathing gas viaface masks or cannulas anduse of optional oxygen tubingand water traps (soldseparately). This device is apassive device and is not acascade humidifier, is notheated, and is not prefilled.	humidify breathing gas priorto delivery to a patient. TheSalter Labs BubbleHumidifier (6-15 LPM) with6 PSI (410mbars) safetyvalve is provided with a 6pounds per square inch (PSI)safety valve and can operatewithin flow rates of 6 to 15liters per minute (LPM). Thedevice is used with variousbreathing gas sources (i.e.,oxygen concentrators, gascylinders and wall outlets)and provides connection fordelivery of humidifiedbreathing gas via face masksor cannulas, and use ofoptional oxygen tubing andwater traps (face masks, 21CFR 868.5580; nasalcannulas, 21 CFR 868.5340;oxygen tubing, 21 CFR868.5860 and water traps, 21CFR 868.5995 are 510(k)exempt).This device is a passivedevice and is not a cascadehumidifier, is not heated andis not prefilled. The device ismade of a humidifier bottlewhich is used to hold waterduring use, a lid which sealsthe humidifier bottle, anaudible pressure reliefmechanism to notify the userof a downstream occlusionand a diffuser located at theend of a PVC diffuser tubeinside the humidifier bottle.The diffusor is designed touniformly disperse the gasthroughout the water. Boththe bottle and lid areconstructed to be easy togrip and reduce the chanceof cross threading. Thebottle is permanently		Similar
Product Features	ProposedBubble Humidifiers	PredicateSalter Labs BubbleHumidifier (K161719)	Assessment ofEquivalence
Environment ofUse	Hospital, hospice, or homecare setting.	Hospital or home caresetting.	Similar
Principle ofOperation	This device is a passivedevice and is not a cascadehumidifier, is not heated andis not prefilled. It is used withoxygen concentrators or gassources. Air is channeledthrough a water-contained jar.The air then becomeshumidified before exiting tothe patient.	This device is a passivedevice and is not a cascadehumidifier, is not heated andis not prefilled. It is usedwith oxygen concentratorsor gas sources. Air ischanneled through a water-contained jar. The air thenbecomes humidified beforeexiting to the patient.	Same
SterilizationMethod	Non-sterile	Non-sterile -	Same
Patient ContactingMaterials	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 priorto use; cleaning process only.Cleaning instructionsvalidated per useful life ofdevice.	No preparations requiredprior to use; cleaningprocess only. Cleaninginstructions validated peruseful life of device.	Same
Power Source	None- passive device, non-heated	None- passive device, non-heated	Same
Accessories (notincluded)	Face mask, nasal cannula,oxygen tubing, water traps	Face mask, nasal cannula,oxygen tubing, water traps	Same
Biocompatibility	• External communicating,limited contact device thatindirectly contactstissue/bone/dentin.• Indirect gas pathway	• "Device does not touchthe patient"	Similar
Product Features	ProposedBubble Humidifiers	PredicateSalter Labs BubbleHumidifier (K161719)	Assessment ofEquivalence
	ISO 18562-1ISO 18562-2ISO 18562-3ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-11ISO 10993-18	ISO 10993-1ISO 10993-5ISO 10993-10	Similar
HumidificationOutputSpecification	10mg/l	10mg/l	Same
Flow Rate	Finished Good 3230: 2-12LPMFinished Good 3260: 2-15LPM	6-15 LPM	Similar
Alarm	Finished Good 3230: 4 PSIFinished Good 3260: 6 PSI	6 PSI	Similar
Pull TestSpecification(tubing assemblyto diffuser andtubing to lid)	Minimum 5lbs at 7in/min	Not stated	Unknown as predicatedoes 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.

Regulation Number and Section

§ 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).