(270 days)
Not Found
No
The device description and performance studies focus on heating and aerosolization of sterile solution, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as providing "continuous heated aerosol for respiratory applications" and working with a nebulizer to deliver "heated solution...aerosolized into the patient gas stream," indicating its use in treating respiratory conditions.
No
This device is designed to heat sterile solution for aerosolization in respiratory applications, not to diagnose medical conditions.
No
The device description clearly describes a physical heater with a stainless-steel puncture pin, indicating it is a hardware device, not software-only.
Based on the provided information, the Hudson RCI AQUATHERM® III Plus External Adjustable Electronic Heater is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide continuous heated aerosol for respiratory applications, which is a therapeutic/supportive function for the patient's respiratory tract.
- Device Description: The device heats a sterile solution that is then aerosolized and delivered to the patient. It does not analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic purposes, or any of the typical components or functions of an IVD device (reagents, assays, measurement of biomarkers, etc.).
Therefore, the device falls under the category of a medical device used for respiratory therapy, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
CAF
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.
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
Not Found
Intended User / Care Setting
Hospital
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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
1
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)
Device Name
Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
Indications for Use (Describe)
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.
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.
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."
3
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 Dental |
| Devices (OHT1) | |
| Review Panel: | Anesthesiology |
PREDICATE DEVICE IDENTIFICATION
The AquaTherm Heater is substantially equivalent to the following predicates:
| 510(k)
Number | Predicate Device Name / Manufacturer | Primary
Predicate |
|------------------|-------------------------------------------------------------|----------------------|
| K880473 | Aero-Mist Nebulizer Heater/ Pegasus Research
Corporation | ✓ |
The predicate devices have not been subject to a design related recall.
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.
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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 | Proposed
Hudson RCI AquaTherm III Plus
External Adjustable Electronic
Heater | Predicate
Pegasus Research Corporation
Aero-Mist Nebulizer Heater |
|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The heater warms and evaporates
particles impinging on the heater
disc which is disposed below the
nebulizer. Return water drains
through the center tube into the
sterile water supply container
below the heater. The water is
drawn up from the sterile water
supply by a draw tube which is part
of the nebulizer itself. The draw
tube passes through the center
tube of the heater in use. |
| Intended Use | To provide continuous heated
aerosol for respiratory
applications. | "… to provide warm aerosol of
water particles into the respiratory
tract."*
Intended use not clearly stated in
510(k) summary |
| Indications for Use | The Hudson RCI AquaTherm III
Plus External Adjustable
Electronic Heater is designed for | "Respiratory therapy, in hospital, to
provide warm aerosol of water
particles into the respiratory tract." |
| Product Features | Proposed
Hudson RCI AquaTherm III Plus
External Adjustable Electronic
Heater | Predicate
Pegasus Research Corporation
Aero-Mist Nebulizer Heater |
| | use with the Hudson RCI
Nebulizer Adaptor and the
AquaPak system to provide
continuous heated aerosol for
respiratory applications. | Indications for use not clearly
stated in 510(k) summary |
| Representative
Image
*images feature
nebulizer adaptors
and tubing which
are not included
within this
submission. | 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 |
| Regulation
Number | §868.5630 | §868.5630 |
| Regulation Name | Nebulizer | Nebulizer |
| Accessories | Aquapak Nebulizer adapter Aquapak prefilled nebulizer reservoir Sold separately and not part of
this submission | Nebulizer adapter Prefilled nebulizer reservoir Sold separately |
| Environment | Hospital | Hospital |
| Sterilization
Method | Non-sterile | Non-sterile |
| Patient Contacting
Materials | Indirect patient contact only:
Stainless steel | Unknown- 510(k) does not
describe patient-contacting
materials |
| Product Features | Proposed
Hudson RCI AquaTherm III Plus
External Adjustable Electronic
Heater | Predicate
Pegasus Research Corporation
Aero-Mist Nebulizer Heater |
| Principles of
Operation | Adjustable temperature. The
AquaTherm Heater is placed
between a nebulizer adaptor (not
included) and a reservoir of sterile
solution (not included). 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. Rainout is returned to the
reservoir via the nebulizer adapter
return tube (rainout return tube is
part of the nebulizer adapter, not
the subject device). | Adjustable temperature. Warms
and evaporates particles on the
heater disc below the nebulizer.
Return water drains through the
center tube into the container
below the heater. The water is
drawn up from the water supply by
a draw tube; the nebulizer draw
tube passes through the center
tube 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 and
Transportation
Environment | Temperature: -20 °C to 50 °C
Relative Humidity: 0% to 94%
(non-condensing) | Temperature: -40 °C to 70 °C
Relative Humidity: 10% to 100%
(including condensate) |
| Output
Temperature
Range | 25°C -37°C | 25°C -40°C |
| Heat up Time | 25 minutes (about 20 minutes
after each subsequent
temperature adjustment) | Approximately 20 minutes |
| Operating
Environment | • 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 | Proposed
Hudson RCI AquaTherm III Plus
External Adjustable Electronic
Heater | Predicate
Pegasus Research Corporation
Aero-Mist Nebulizer Heater |
| Biocompatibility | External communicating, limited contact device that indirectly contacts tissue/bone/dentin. Indirect gas pathway | Unknown- 510(k) does not
describe any biocompatibility. |
| Standards Utilized | ISO 10993-1
ISO 10993-5
ISO 10993-10
ISO 10993-11
ISO 18562-1
ISO 18562-2
ISO 18562-3
IEC 60601-1-2
IEC 60601-1-11 | UL544 |
| Non-Clinical
Testing | Packaging
Cleaning process
EMC testing | Unknown- 510(k) does not state
testing. |
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6
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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.