(220 days)
Not Found
No
The device description and intended use focus on the mechanical function of aerosolizing sterile water or saline. There is no mention of AI, ML, or any computational analysis of data.
No.
This device provides humidification and aerosol delivery for respiration, which is a supportive function rather than a direct therapeutic treatment of a disease or condition.
No
The device description states its purpose is to "add sterile water or saline solution in aerosol form to a patient's breathing gases" and "generate aerosol, a fine mist of liquid water (or sodium chloride solution) that is suspended in the gas to be inhaled by the patient." This describes a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components such as reservoirs, adaptors, and collars, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to add sterile water or saline solution in aerosol form to a patient's breathing gases for inhalation therapy. This is a therapeutic application, not a diagnostic one.
- Device Description: The device description focuses on generating aerosol for inhalation, not on analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples, detect markers, or provide any information for diagnosing a disease or condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform such a function.
N/A
Intended Use / Indications for Use
Hudson RCI® AquaPak® Prefilled Nebulizer adds sterile water or saline solution in aerosol form to a patient's breathing gases. It may be used with pediatric (ages 2 years and above) and adult patients.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
Hudson RCI® AquaPak® Prefilled Nebulizers provide sterile water or sterile saline for inhalation therapy. Nebulizers generate aerosol, a fine mist of liquid water (or sodium chloride solution) that is suspended in the gas to be inhaled by the patient.
The Hudson RCI® AquaPak® Prefilled Nebulizers are designed to aerosolize and provide a fine mist of sterile water or saline solution to inspired gas during aerosol therapy.
Prefilled sterile reservoirs for AquaPak® Nebulizers come in three sizes; 440ml, 760ml and 1070ml. Each reservoir must be used with a suitable adaptor component, which connects the system to a flow-metered gas source and provides nebulizer functionality.
Adaptor types available for the Hudson RCI® AquaPak® Prefilled Nebulizers include the 028 and the 033 Nebulizer Adaptors. Both the standard model with the yellow collar (type 028) and the quiet model with the blue collar (type 033) feature an adjustable air entrainment window, which provides a specific oxygen concentration by entraining room air into the oxygen 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
pediatric (ages 2 years and above) and adult patients.
Intended User / Care Setting
hospital, sub-acute facilities, long-term care facilities and in a home care environment.
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 Nebulizer is substantially equivalent to the predicate device, and that the Hudson RCI® AquaPak® Prefilled Nebulizer will perform as intended.
Test Performed: Lift Pressure; Principle of Test: Measures the amount of negative pressure required to pull liquid up for nebulization.
Test Performed: Oxygen Entrainment; Principle of Test: Measures the percentage of oxygen/air mixture when adjusted to preset oxygen percentage.
Test Performed: Nebulization Rate; Principle of Test: Determines the basic rate at which the liquid is aerosolized and emitted in mL/min.
Test Performed: Particle Size Distribution; Principle of Test: Determines the particle size (MMAD) and geometric standard deviation (GSD) of the aerosolized liquid.
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
§ 868.5630 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three profiles facing right, suggesting a sense of forward movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2014
Teleflex Medical Incorporated c/o Mr. Jim Cochie Sr. Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, NC 27709
Re: K141214
Trade/Device Name: Hudson RCI® AquaPak® Prefilled Nebulizers Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer (Direct Patient Interface) Regulatory Class: Class II Product Code: CAF Dated: November 14, 2014 Received: November 20, 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. 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) K141214
Device Name
Hudson RCI® AquaPak® Prefilled Nebulizer
Indications for Use (Describe)
Hudson RCI® AquaPak® Prefilled Nebulizer adds sterile water or saline solution in aerosol form to a patient's breathing gases. It may be used with pediatric (ages 2 years and above) and adult patients.
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)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
Section 29 - 510(k) Summary - Updated
510(k) SUMMARY
Hudson RCI® AquaPak® Prefilled Nebulizers
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
August 26, 2014
D. Device Name
Trade Name: Hudson RCI® AquaPak® Prefilled Nebulizers
Common Name: Nebulizer
Classification Name: Nebulizer (Direct Patient Interface), CFR - 868.5630, Class II
E. Device Description
Hudson RCI® AquaPak® Prefilled Nebulizers provide sterile water or sterile saline for inhalation therapy. Nebulizers generate aerosol, a fine mist of liquid water (or sodium chloride solution) that is suspended in the gas to be inhaled by the patient.
The Hudson RCI® AquaPak® Prefilled Nebulizers are designed to aerosolize and provide a fine mist of sterile water or saline solution to inspired gas during aerosol therapy.
Prefilled sterile reservoirs for AquaPak® Nebulizers come in three sizes; 440ml, 760ml and 1070ml. Each reservoir must be used with a suitable adaptor component, which connects the system to a flow-metered gas source and provides nebulizer functionality.
4
Section 29 - 510(k) Summary - Updated
Adaptor types available for the Hudson RCI® AquaPak® Prefilled Nebulizers include the 028 and the 033 Nebulizer Adaptors. Both the standard model with the yellow collar (type 028) and the quiet model with the blue collar (type 033) feature an adjustable air entrainment window, which provides a specific oxygen concentration by entraining room air into the oxygen stream.
F. Indications for Use
The Hudson RCI® AquaPak® Prefilled Nebulizer adds sterile water or saline solution in aerosol form to a patient's breathing gases.
G. Target Population
The Hudson RCI® AquaPak® Prefilled Nebulizer may be used with pediatric (ages 2 years and above) and adults.
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 Nebulizer is substantially equivalent to the predicate device:
| Comparative
Characteristics | Proposed Device:
Hudson RCI® AquaPak®
Prefilled Nebulizer | Predicate Device:
Smiths Medical Portex™M
Thera-Mist® Large Volume
Nebulizer |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Teleflex Medical, Inc. | Smiths Medical ASD, Inc. |
| 510(k) Number | TBD | K962534 |
| Indications for Use | The Hudson RCI®
AquaPak® Prefilled
Nebulizer adds sterile
water or saline solution in
aerosol form to a patient's
breathing gases. | The Smiths Medical
Portex™ Thera-Mist®
Large Volume Nebulizer
delivers particulate
humidity in the 3 to 5
micron range for chronic
secretion patients. |
5
| Section 29 - 510(k) Summary - Updated | ||||||
|---|---|---|---|---|---|---|
| --------------------------------------- | -- | -- | -- | -- | -- | -- |
| Principle of
Operation | Jet nebulizer with
adjustable air entrainment | Jet nebulizer with
adjustable air entrainment |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Gas source | 50 Psi oxygen regulated via
a flow meter | 50 Psi oxygen regulated via
a flow meter |
| Flow rate and FiO2
Control
Capabilities | 028 Model:
28% at 5 LPM
35% at 8 LPM
40% - 98% at 10 LPM
033 Model:
28% - 35% at 8 LPM
40% - 98% at 10 LPM | Normal Flow LVN:
28% - 60 %
High Flow LVN:
36% - 95% at 14 - 15 LPM |
| Aerosol Particle
Size Delivery | 1.5 to 3 micron range | 3 to 5 micron range |
| Sterilization | Adaptors - Non-sterile
Sterile Water/Saline
Reservoirs - Reverse
osmosis, distillation, and
aseptic fill | Adaptors - Non-sterile
Sterile Water/Saline
Reservoirs - Reverse
osmosis, distillation, and
aseptic fill |
| Single Use | Yes | Yes |
| Shelf Life | Adaptors - N/A
Sterile Water/Saline – 2
years from date of
manufacture | Adaptors - N/A
Sterile Water/Saline – 2
years from date of
manufacture |
| Packaging | Adaptors - 50/case, 10 or
20/case when packaged with
water/ saline
Sterile water/saline - 10 or
20/case | LVN Adaptors - 40/case,
12/case when packaged with
water
Sterile Water - 12/case
Saline - Made-to-Order |
K. Non-clinical Comparative Performance Testing
Bench testing has been performed to verify that the performance of the proposed Hudson RCI® AquaPak® Prefilled Nebulizer is substantially equivalent to the predicate device, and that the Hudson RCI® AquaPak® Prefilled Nebulizer will perform as intended.
6
| Test
Performed | Reference to Standard (if
applicable) | Principle of Test |
|-------------------------------|------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Lift Pressure | N/A | Measures the amount of negative
pressure required to pull liquid up for
nebulization |
| Oxygen
Entrainment | N/A | Measures the percentage of oxygen/air
mixture when adjusted to preset oxygen
percentage |
| Nebulization
Rate | N/A | Determines the basic rate at which the
liquid is aerosolized and emitted in
mL/min |
| Particle Size
Distribution | N/A | Determines the particle size (MMAD)
and geometric standard deviation (GSD)
of the aerosolized liquid |
Section 29 – 510(k) Summary - Updated
L. Substantial Equivalence
The proposed Hudson RCI® AquaPak® Prefilled Nebulizer is substantially equivalent in intended use, design, performance and principles of operation to the identified predicate device cleared under 510(k) K962534. The differences between the proposed Hudson RCI® AquaPak® Prefilled Nebulizer and the predicate device are minor and raise no new issues of safety and efficacy. The proposed Hudson RCI® AquaPak® Prefilled Nebulizer is substantially equivalent to the currently marketed predicate device.