(70 days)
Not Found
No
The device description and performance studies focus on mechanical and physical properties related to humidification, with no mention of AI or ML technologies.
Yes
The device is described as providing "therapeutic humidity output" and is intended to "control the drying and irritation of the respiratory mucosa," which are therapeutic effects.
No
This device is a humidifier designed to add humidity to a patient's breathing gases, which is a therapeutic function, not a diagnostic one. It does not measure, analyze, or interpret any physiological data to determine a medical condition.
No
The device description clearly outlines physical components such as reservoirs, adaptors, and a pressure relief valve, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "add humidity to a patient's breathing gases." This is a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on how the device adds water vapor to inhaled gas to prevent drying and irritation of the respiratory mucosa. This is a physical process applied to the patient's breathing, not a test performed on a sample from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis or monitoring of a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Hudson RCI® AquaPak® Prefilled Humidifier adds humidity to a patient's breathing gases.
Product codes (comma separated list FDA assigned to the subject device)
BTT
Device Description
Hudson RCI® AquaPak® Prefilled Humidifiers add water vapor (molecular H₂O) to a dry medical gas that is suspended in the gas to be inhaled by the patient.
The Hudson RCI® AquaPak® Prefilled Humidifiers are designed to add humidity to inspired gas, helping to control the drying and irritation of the respiratory mucosa. The humidifiers feature a micro-diffuser that produces smaller bubbles and greater surface agitation, allowing for a quiet operation and therapeutic humidity output.
Prefilled sterile reservoirs for AquaPak® Humidifiers come in four sizes; 190ml, 340ml, 540ml and 650ml. Each reservoir must be used with a suitable adaptor component, which connects the system to a flow-metered gas source and provides humidifier functionality.
Adaptor types provided with Hudson RC1® AquaPak® Prefilled Humidifiers feature an audible pressure relief valve, which indicates a restriction of gas flow to the user.
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
Not Found
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)
Bench testing has been performed to verify that the performance of the proposed Hudson RCI® AquaPak® Prefilled Humidifier is substantially equivalent to the predicate device, and that the Hudson RC1® AquaPak® Prefilled Humidifier will perform as intended.
Test Performed: Packaging Integrity Tests
Reference to Standard (if applicable): ISTA 2A
Principle of Test: Determines the integrity of the packaged device against known shipping tests
Test Performed: Ink Adherence Tests
Reference to Standard (if applicable): ASTM F2252
Principle of Test: Determines ink adherence properties of the printed film used in packaging the device
Test Performed: Cannula Pop-Off, Bottle Burst, Occlusion Test
Reference to Standard (if applicable): N/A
Principle of Test: Determines strength of the tubing connector, the reservoir does not burst when nares are occluded and the relieve valve performs as expected to relieve pressure
Test Performed: Spitting Test
Reference to Standard (if applicable): N/A
Principle of Test: Determines the expected outcome that the humidifier will not spit or flood the tubing at the maximum flow rate of 10 LPM
Test Performed: Humidification Output Test
Reference to Standard (if applicable): N/A
Principle of Test: Determines the rate of humidification at which the liquid is humidified and emitted in milligrams per liter
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 1, 2014
Teleflex Medical, Inc. Mr. James A. Cochie Sr. Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, NC 27709
Re: K141353
Trade/Device Name: Hudson RCI® AquaPak® Prefilled Humidifier Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory gas humidifier Regulatory Class: Class II Product Code: BTT Dated: June 30, 2014 Received: July 2, 2014
Dear Mr. Cochie:
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. 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
Page 2 - Mr. Cochie
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141353
Device Name Hudson RCI® AquaPak® Prefilled Humidifier
Indications for Use (Describe) The Hudson RCI® AquaPak® Prefilled Humidifier adds humidity to a patient's breathing gases.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Anya C. Harry -S 2014.07.31 12:36:04 -04'00'
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3
Section 24 - 510(k) Summary
510(k) SUMMARY
Hudson RCI® AquaPak® Prefilled Humidifiers
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-8083 919-433-4996 Fax:
B. Contact Person
James Cochie Sr. Regulatory Affairs Specialist
C. Date Prepared
July 31, 2014
D. Device Name
Trade Name: Hudson RCI® AquaPak® Prefilled Humidifier
Common Name: Humidifier
Classification Name: Humidifier, Respiratory Gas (Direct Patient Interface), CFR -868.5450, Class II
E. Device Description
Hudson RCI® AquaPak® Prefilled Humidifiers add water vapor (molecular H₂O) to a dry medical gas that is suspended in the gas to be inhaled by the patient.
The Hudson RCI® AquaPak® Prefilled Humidifiers are designed to add humidity to inspired gas, helping to control the drying and irritation of the respiratory mucosa. The humidifiers feature a micro-diffuser that produces smaller bubbles and greater surface agitation, allowing for a quiet operation and therapeutic humidity output.
Prefilled sterile reservoirs for AquaPak® Humidifiers come in four sizes; 190ml, 340ml, 540ml and 650ml. Each reservoir must be used with a suitable adaptor component, which connects the system to a flow-metered gas source and provides humidifier functionality.
4
Section 24 – 510(k) Summary
Adaptor types provided with Hudson RC1® AquaPak® Prefilled Humidifiers feature an audible pressure relief valve, which indicates a restriction of gas flow to the user.
F. Indications for Use
The Hudson RCI® AquaPak® Prefilled Humidifier adds humidity to a patient's breathing gases.
G. Target Population
This device is intended for use on any patient connected to ventilation devices
H. Environments of Use
This device is intended for hospital, sub-acute facilities, long-term care facilities and in a home care environment.
This product is single use only.
I. Contraindications
There are no known contraindications.
J. Comparative Characteristics
The proposed Hudson RCI® AquaPak® Prefilled Humidifier is substantially equivalent to the predicate device:
| Comparative
Characteristics | Proposed Device:
Hudson RCI®
AquaPak® Prefilled
Humidifier | Predicate Device:
Hudson RCI®
AquaPak® Prefilled
Humidifier | Predicate Device:
CareFusion Airlife®
Prefilled Humidifier |
|--------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Teleflex Medical,
Inc. | Teleflex Medical,
Inc. | CareFusion |
| 510(k) Number | TBD | K780562 – Prefilled
Humidifier
K833974 –
Humidifier Adaptor | K853146 |
| Indications for Use | The Hudson RCI®
AquaPak® Prefilled
Humidifier adds
humidity to a
patient's breathing
gases. | The Hudson RCI®
AquaPak® Prefilled
Humidifier adds
humidity to a
patient's breathing
gases. | The CareFusion
Airlife® Prefilled
Humidifiers provide
a cost-effective
solution for sterile
water inhalation. |
| | | | (www.caefusion.com) |
| Principle of Operation | Gas bubbles through built-in diffuser in reservoir | Gas bubbles through built-in diffuser in reservoir | Gas bubbles through reservoir |
| Gas source | 50 Psi oxygen regulated via a flow meter | 50 Psi oxygen regulated via a flow meter | 50 Psi oxygen regulated via a flow meter |
| Technology and Features | Flow rate: 1.5 – 10 LPM
Audible notification of occlusion: 5 – 30 psi
Humidity output: At least 10mg H2O/L | Flow rate: 1.5 – 10 LPM
Audible notification of occlusion: 5 – 30 psi
Humidity output: At least 10mg H2O/L | Flow rate: 4 LPM for audible notification
Audible notification of occlusion: Not specified
Humidity output: Not specified |
| Sterilization | Adaptor – Non-sterile
Sterile Water/Saline Reservoirs - Reverse osmosis, distillation, and aseptic fill | Adaptor – Gamma Irradiation
Sterile Water/Saline Reservoirs - Reverse osmosis, distillation, and aseptic fill | Adaptor – Non-sterile
Sterile Water/Saline Reservoirs – Steam or dry heat |
| Single Use | Yes | Yes | Adaptor - Single Patient Use
Sterile Water/Saline Reservoirs – Single Use |
| Shelf Life | Adaptors – N/A Sterile Water/Saline – 2 years from date of manufacture | Adaptors – 5 years from date of manufacture
Sterile Water/Saline – 2 years from date of manufacture | Adaptors - N/A Sterile Water/Saline – 2 years from date of manufacture |
| Packaging | Adaptor Top web: Coated High Density Polyethylene (HDPE)
Adaptor Bottom web: Surlyn Amcor C-060 | Adaptor Top web: Tyvek
Adaptor Bottom film: Surlyn Amcor C-060
Bottle – Sealed | Adaptor - Heat sealed polybag
Bottle - Sealed polypropylene |
| | Bottle - Sealed
polypropylene | polypropylene | |
Teleflex Medical, Inc.
5
Section 24 – 510(k) Summary
6
Section 24 - 510(k) Summary
K. Non-clinical Comparative Performance Testing
Bench testing has been performed to verify that the performance of the proposed Hudson RCI® AquaPak® Prefilled Humidifier is substantially equivalent to the predicate device, and that the Hudson RC1® AquaPak® Prefilled Humidifier will perform as intended.
| Test
Performed | Reference to Standard (if
applicable) | Principle of Test |
|---------------------------------------------------------|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Packaging
Integrity Tests | ISTA 2A | Determines the integrity of the packaged
device against known shipping tests |
| Ink Adherence
Tests | ASTM F2252 | Determines ink adherence properties of
the printed film used in packaging the
device |
| Cannula Pop-
Off, Bottle
Burst,
Occlusion Test | N/A | Determines strength of the tubing
connector, the reservoir does not burst
when nares are occluded and the relieve
valve performs as expected to relieve
pressure |
| Spitting Test | N/A | Determines the expected outcome that
the humidifier will not spit or flood the
tubing at the maximum flow rate of 10
LPM |
| Humidification
Output Test | N/A | Determines the rate of humidification at
which the liquid is humidified and
emitted in milligrams per liter |
L. Substantial Equivalence
The proposed Hudson RCI® AquaPak® Prefilled Humidifier is substantially equivalent in intended use, design, performance and principles of operation to the identified predicate devices cleared under 510(k) K780562 and K833974. The differences between the proposed Hudson RCI® AquaPak® Prefilled Humidifier and the predicate devices are minor (sterile to non-sterile packaging) and raise no new issues of safety and efficacy. The proposed Hudson RCI® AquaPak® Prefilled Humidifier is substantially equivalent to the currently marketed predicate devices.