The Hudson RCI AQUATHERM® III Plus External Adjustable Electronic Heater is designed for use with the Hudson RCI Nebulizer Adaptor and the AQUAPAK® system to provide continuous heated aerosol for respiratory applications.

Device Description

The AquaTherm devices are adjustable output temperature heaters. The AquaTherm Heater is placed between a nebulizer adaptor and a reservoir of sterile solution. When a gas flow is initiated to the nebulizer, sterile solution is drawn up from the reservoir and through the stainless-steel puncture pin in the center of the AquaTherm Heater. The solution is heated as it flows through the pin. The heated solution is then drawn into the nebulizer adaptor where it is aerosolized into the patient gas stream.

AI/ML Overview

This document, K223100, is a 510(k) premarket notification for a medical device (Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater) and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than independently proving the device meets specific performance acceptance criteria through a clinical study or a similar robust evaluation of its diagnostic capabilities.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic performance (e.g., accuracy, sensitivity, specificity, expert reads, MRMC studies, ground truth establishment) is not applicable to this document.

This FDA submission is for a heating device used with nebulizers, classified as a Class II device (Nebulizer, product code CAF). The purpose of a 510(k) is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, primarily through non-clinical testing and comparison of technological characteristics.

Here's why the requested information is not present and what is provided:

No Diagnostic Acceptance Criteria or Performance Reporting: This is not a diagnostic AI device or a device that relies on interpreting data to provide a diagnosis. Its function is to heat sterile solution for aerosolization. Therefore, there are no metrics like sensitivity, specificity, AUC, or other diagnostic performance indicators to report in a table.
No Clinical Study on Efficacy/Accuracy: The submission demonstrates substantial equivalence through:
- Comparison of Technological Characteristics: Showing similar design, intended use, operating principles, and materials to the predicate.
- Non-Clinical Testing: This includes:
  - Biocompatibility: To ensure materials are safe for patient contact (even if indirect).
  - Packaging: To ensure the device remains sterile/intact until use.
  - Cleaning: To ensure proper reprocessing if applicable (though the device is non-sterile).
  - EMC Testing: To ensure electromagnetic compatibility and safety.
- Compliance with Standards: Adherence to relevant ISO and IEC standards (e.g., for safety, quality, and electrical compatibility).
This type of submission does not typically involve clinical trials or multi-reader studies to establish diagnostic accuracy or performance improvement for human readers.
No Test Set/Ground Truth Details: Since there's no diagnostic performance being evaluated, there are no test sets, data provenance, expert ground truth establishment, or adjudication methods described. "Ground truth" in this context refers more to established engineering and safety standards rather than medical diagnostic truth.

Summary of Relevant Information (from the document) despite the non-applicability of the full request:

Type of Device: Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (a nebulizer heater).
Purpose: To provide continuous heated aerosol for respiratory applications.
Regulatory Pathway: 510(k) Premarket Notification.
Predicate Device: Aero-Mist Nebulizer Heater/Pegasus Research Corporation (K880473).
Demonstration of Safety and Effectiveness: Through non-clinical testing (Biocompatibility, Packaging, Cleaning, EMC Testing) and compliance to industry standards (ISO 10993 series, IEC 60601 series).
Conclusion: The device is substantially equivalent to the predicate and does not raise new issues of safety or effectiveness.

In essence, the "acceptance criteria" for this device are its ability to meet the specified non-clinical performance and safety standards, and to be functionally and technologically similar to the legally marketed predicate device, rather than diagnostic accuracy metrics.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 27, 2023

Medline Industries, Inc % Joy Gutermuth Senior Specialist (Consultant) Ram+ 2790 Mosside Blvd. Suite 800 Monroeville, Pennsylvania 15146

Re: K223100

Trade/Device Name: Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: June 13, 2023 Received: June 13, 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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,

Image /page/1/Picture/5 description: The image shows the name "Ethan L. Nyberg -S" in a large, sans-serif font. The text is black against a white background. The letters are evenly spaced and clearly legible.

Ethan Nyberg, Ph.D Assistant Director 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K223100

Device Name

Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

DATE PREPARED

June 26, 2023

MANUFACTURER AND 510(k) OWNER

Medline Industries 1 Three Lakes Drive, Northfield, IL, 60093 Telephone: Official Contact: Nicole Schaffer,

REPRESENTATIVE/CONSULTANT

Joy Gutermuth RQM+ Telephone: Email: iqutermuth@rgmplus.com

DEVICE INFORMATION

Proprietary Name/Trade Name: Hudson RCI AquaTherm III Plus External Adjustable

	Electronic Heather ("AquaTherm Heater")
Common Name:	Nebulizer Heater
Regulation Number:	868.5630
Class:	II
Product Code:	CAF
Premarket Review:	Ophthalmic, Anesthesia, Respiratory, ENT and DentalDevices (OHT1)
Review Panel:	Anesthesiology

PREDICATE DEVICE IDENTIFICATION

The AquaTherm Heater is substantially equivalent to the following predicates:

510(k)Number	Predicate Device Name / Manufacturer	PrimaryPredicate
K880473	Aero-Mist Nebulizer Heater/ Pegasus ResearchCorporation	✓

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

DEVICE DESCRIPTION

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INDICATIONS FOR USE

The Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater is designed for use with the Hudson RCI Nebulizer Adaptor and the AquaPak system to provide continuous heated aerosol for respiratory applications.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Medline Industries believes that the AquaTherm Heater is substantially equivalent to the predicate devices based on the information summarized here:

The subject device has a similar design and dimensions, and uses similar or identical materials as the device cleared in K880473. The subject device has the same intended use and similar technological characteristics to the device cleared in K880473. These technological characteristics have undergone testing to ensure the device is as safe and effective as the predicate.

Product Features	ProposedHudson RCI AquaTherm III PlusExternal Adjustable ElectronicHeater	PredicatePegasus Research CorporationAero-Mist Nebulizer Heater
Device Description	The AquaTherm devices areadjustable output temperatureheaters. The AquaTherm Heater isplaced between a nebulizeradaptor and a reservoir of sterilesolution. When a gas flow isinitiated to the nebulizer, sterilesolution is drawn up from thereservoir and through thestainless-steel puncture pin in thecenter of the AquaTherm Heater.The solution is heated as it flowsthrough the pin. The heatedsolution is then drawn into thenebulizer adaptor where it isaerosolized into the patient gasstream.	The heater warms and evaporatesparticles impinging on the heaterdisc which is disposed below thenebulizer. Return water drainsthrough the center tube into thesterile water supply containerbelow the heater. The water isdrawn up from the sterile watersupply by a draw tube which is partof the nebulizer itself. The drawtube passes through the centertube of the heater in use.
Intended Use	To provide continuous heatedaerosol for respiratoryapplications.	"… to provide warm aerosol ofwater particles into the respiratorytract."**Intended use not clearly stated in510(k) summary
Indications for Use	The Hudson RCI AquaTherm IIIPlus External AdjustableElectronic Heater is designed for	"Respiratory therapy, in hospital, toprovide warm aerosol of waterparticles into the respiratory tract."*
Product Features	ProposedHudson RCI AquaTherm III PlusExternal Adjustable ElectronicHeater	PredicatePegasus Research CorporationAero-Mist Nebulizer Heater
	use with the Hudson RCINebulizer Adaptor and theAquaPak system to providecontinuous heated aerosol forrespiratory applications.	*Indications for use not clearlystated in 510(k) summary
RepresentativeImage**images featurenebulizer adaptorsand tubing whichare not includedwithin thissubmission.	Image: Hudson RCI AquaTherm III Plus Nebulizer Heater	Image: Pegasus Research Corporation Aero-Mist Nebulizer Heater
Classification	Class II	Class II
Product Code	CAF	CAF
RegulationNumber	§868.5630	§868.5630
Regulation Name	Nebulizer	Nebulizer
Accessories	Aquapak Nebulizer adapter Aquapak prefilled nebulizer reservoir Sold separately and not part ofthis submission	Nebulizer adapter Prefilled nebulizer reservoir Sold separately
Environment	Hospital	Hospital
SterilizationMethod	Non-sterile	Non-sterile
Patient ContactingMaterials	Indirect patient contact only:Stainless steel	Unknown- 510(k) does notdescribe patient-contactingmaterials
Product Features	ProposedHudson RCI AquaTherm III PlusExternal Adjustable ElectronicHeater	PredicatePegasus Research CorporationAero-Mist Nebulizer Heater
Principles ofOperation	Adjustable temperature. TheAquaTherm Heater is placedbetween a nebulizer adaptor (notincluded) and a reservoir of sterilesolution (not included). When agas flow is initiated to thenebulizer, sterile solution is drawnup from the reservoir and throughthe stainless-steel puncture pin inthe center of the AquaThermHeater. The solution is heated asit flows through the pin. Theheated solution is then drawn intothe nebulizer adaptor where it isaerosolized into the patient gasstream. Rainout is returned to thereservoir via the nebulizer adapterreturn tube (rainout return tube ispart of the nebulizer adapter, notthe subject device).	Adjustable temperature. Warmsand evaporates particles on theheater disc below the nebulizer.Return water drains through thecenter tube into the containerbelow the heater. The water isdrawn up from the water supply bya draw tube; the nebulizer drawtube passes through the centertube of the heater.
Power Supply	Mains powered	Mains powered
Voltage and Power	115 VAC at 60Hz, 1.5 A	115 VAC (+/- 10 volts) 1.7 A
Storage andTransportationEnvironment	Temperature: -20 °C to 50 °CRelative Humidity: 0% to 94%(non-condensing)	Temperature: -40 °C to 70 °CRelative Humidity: 10% to 100%(including condensate)
OutputTemperatureRange	25°C -37°C	25°C -40°C
Heat up Time	25 minutes (about 20 minutesafter each subsequenttemperature adjustment)	Approximately 20 minutes
OperatingEnvironment	• Temperature: 18°C to 26°C• Relative Humidity: 30% to 75%(non-condensing)• Pressure: 700 to 1060 hPa	• Temperature: 10°C to 40°C• Relative Humidity: 30% to 75%(non-condensing)• Pressure: 700 to 1060 hPa
Product Features	ProposedHudson RCI AquaTherm III PlusExternal Adjustable ElectronicHeater	PredicatePegasus Research CorporationAero-Mist Nebulizer Heater
Biocompatibility	External communicating, limited contact device that indirectly contacts tissue/bone/dentin. Indirect gas pathway	Unknown- 510(k) does notdescribe any biocompatibility.
Standards Utilized	ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-11ISO 18562-1ISO 18562-2ISO 18562-3IEC 60601-1-2IEC 60601-1-11	UL544
Non-ClinicalTesting	PackagingCleaning processEMC testing	Unknown- 510(k) does not statetesting.

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SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for the AquaTherm Heater. The following tests were performed to demonstrate safety based on current industry standards:

Biocompatibility ●
Packaging ●
Cleaning
EMC Testing ●

The results of these tests indicate that the AquaTherm Heater is substantially equivalent to the predicate devices.

CONCLUSION

Based on the testing performed, including gas pathway biocompatibility testing, and compliance to the latest edition of IEC 60601-1-2, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed AquaTherm Heater are assessed to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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).