(286 days)
No
The device description and performance studies focus on the physical components and their ability to generate aerosol, with no mention of AI or ML technologies. The submission is primarily for a change in sterility and packaging.
Yes
The device is used to add sterile water or saline solution in aerosol form to a patient's breathing gases for inhalation therapy, which is a therapeutic purpose.
No.
The device is a nebulizer, which adds sterile water or saline solution in aerosol form to a patient's breathing gases for inhalation therapy. Its function is to deliver medication or moisture, not to diagnose a condition.
No
The device description clearly outlines physical components (adaptor, reservoir) and their function in generating aerosol, indicating it is a hardware-based medical 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 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 generates an aerosol mist for inhalation. It does not perform any tests on biological samples (blood, urine, tissue, etc.) to diagnose a condition.
- Lack of Diagnostic Language: The text does not mention any diagnostic purpose, analysis of biological samples, or providing information for diagnosis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to deliver a substance for inhalation, which is a treatment or supportive therapy, not a diagnostic process.
N/A
Intended Use / Indications for Use
The Hudson RCI® AquaPak® Sterile 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
CAF
Device Description
Hudson RCI® AquaPak® Sterile 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 during aerosol therapy.
The Hudson RCI® AquaPak® Sterile Prefilled Nebulizers consist of two components, a sterile adaptor and a prefilled sterile reservoir. The adaptor may be type 028 or type 033. The standard model with a yellow collar (type 028) and the quiet model with a blue collar (type 033) feature an adjustable air entrainment window, which provides a specific oxygen concentration by entraining room air into the oxygen stream. Prefilled sterile reservoirs for the Hudson RCI® AquaPak® Sterile Prefilled Nebulizers come in three sizes; 440ml, 760ml and 1070ml, and may be sterile water or sterile sodium chloride solution. The sterile reservoirs are cleared under K141214, and are presented here for reference only. Each reservoir, when combined with an adaptor component, provides nebulizer functionality when connected to a gas source.
The primary purpose of this Traditional 510(k) submission is to change the nebulizer adaptor cleared in K141214 from non-sterile, and update the packaging materials and shelf life to maintain sterility.
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
This device is intended for 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® Sterile Prefilled Nebulizer is substantially equivalent to the predicate device, and that the Hudson RCI® AquaPak® Sterile Prefilled Nebulizer will perform as intended.
There are no new patient contacting materials, so no biocompatibility testing was required for this submission.
The 'Lift Pressure', 'Oxygen Entrainment', 'Nebulization Rate', and 'Particle Size Distribution' testing is identical to the testing performed in the predicate K141214. The results of this testing showed that the subject device met all of the acceptance criteria established by the predicate. The 'Packaging configuration / Shelf Life' and 'Sterility Testing' ensure the sterile packaging and sterility are maintained after sterilization and shelf life testing per the referenced standards. The packaging for the subject device met the acceptance criteria of the standards cited below.
| Test Performed | Reference to Standard (if applicable) | Principle of Test |
|---|---|---|
| Packaging Configuration / Shelf life Testing | ASTM F1980-07, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. | Establishes integrity of the package materials and sterile barrier after shelf life testing, visual inspections and nebulization function test. |
| ASTM F2096, Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) | The packaging passed all of the acceptance criteria for the tests. | |
| Sterility Testing | ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11137-2:2013 (third edition) Sterilization of health care products - Radiation Part 2: Establishing the sterilization dose | Validates the correct dose of gamma radiation to ensure a sterile product at the point of use when manufactured, stored, and handled according to the instructions for use. The packaging passed all of the acceptance criteria for the tests. |
| Lift Pressure | N/A | Measures the amount of negative pressure required to pull liquid up for nebulization. The device passed all of the acceptance criteria for the tests. |
| Oxygen Entrainment | N/A | Measures the percentage of oxygen/air mixture when adjusted to preset oxygen percentage. The device passed all of the acceptance criteria for the tests. |
| Nebulization Rate | N/A | Determines the basic rate at which the liquid is aerosolized and emitted in mL/min. The device passed all of the acceptance criteria for the tests. |
| Particle Size Distribution | N/A | 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)
Reference Device(s)
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 consists of a circular seal with the text "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
July 26, 2016
Teleflex Medical, Inc. Brian Gall Senior Regulatory Affairs Specialist 3015 Carrington Mill Blvd. Morrisville, North Carolina 27560
Re: K153010
Trade/Device Name: Hudson RCI® AquaPak® Sterile Prefilled Nebulizers Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer (Direct Patient Interface) Regulatory Class: Class II Product Code: CAF Dated: June 16, 2016 Received: June 17, 2016
Dear Mr. Brian Gall:
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.
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 devicerelated 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.
1
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/ResourcesforYou/Industry/default.htm. 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
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
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use |
| Form Approved: OMB No. 0910-0120 | |
|---|---|
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. |
| 510(k) Number (if known) | K153010 |
|---|---|
| Device Name | Hudson RCI® AquaPak® Sterile Prefilled Nebulizers |
| Indications for Use (Describe) | The Hudson RCI® AquaPak® Sterile 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) | |
|---|---|
| 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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| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
PSC Publishing Services (301) 443-6740 EF
,
s
1 1 1 1 1
3
Section 31 - Updated 510(k) Summary
510(k) SUMMARY
K153010 – Hudson RCI® AquaPak® Sterile Prefilled Nebulizers
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 3015 Carrington Mill Blvd. Morrisville, NC 27560 USA Phone: 919-228-4350 Fax: 919-361-3939
B. Contact Person
Brian Gall Senior Requlatory Affairs Specialist, Respiratory Division
C. Date Prepared
15 June 2016
D. Device Name
Trade Name: Hudson RCI® AquaPak® Sterile Prefilled Nebulizers
Common Name: Nebulizer
Classification Name: Nebulizer (Direct Patient Interface), CFR - 868.5630, Class II
E. Device Description
Hudson RCI® AquaPak® Sterile 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 during aerosol therapy.
The Hudson RCI® AquaPak® Sterile Prefilled Nebulizers consist of two components, a sterile adaptor and a prefilled sterile reservoir. The adaptor may be type 028 or type 033. The standard model with a yellow collar (type 028) and the quiet model with a blue collar (type 033) feature an adjustable air entrainment window, which provides a specific oxygen concentration by entraining room air into the oxygen stream. Prefilled sterile reservoirs for the Hudson RCI® AquaPak® Sterile Prefilled Nebulizers come in three sizes; 440ml, 760ml and 1070ml, and may be sterile water or sterile sodium chloride solution. The sterile reservoirs are cleared under K141214, and are presented here for reference only. Each reservoir, when combined with an adaptor component, provides nebulizer functionality when connected to a gas source.
The primary purpose of this Traditional 510(k) submission is to change the nebulizer adaptor cleared in K141214 from non-sterile, and update the packaging materials and shelf life to maintain sterility.
4
Section 31 - Updated 510(k) Summary
F. Indications for Use
The Hudson RCI® AquaPak® Sterile 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.
G. Target Population
The Hudson RCI® AquaPak® Sterile Prefilled Nebulizer may be used with pediatric (ages 2 years and above) and adult patients.
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.
l. Contraindications
There are no known contraindications.
J. Comparative Characteristics
The proposed Hudson RCI® AquaPak® Sterile Prefilled Nebulizer is substantially equivalent to the nebulizer in the predicate device:
| Comparative
Characteristics | Proposed Device:
Hudson RCI® AquaPak®
Sterile Prefilled Nebulizer | Predicate Device:
Hudson RCI® AquaPak®
Prefilled Nebulizer |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Manufacturer | Teleflex Medical, Inc. | Same |
| 510(k) Number | K153010 | K141214 |
| Indications for
Use | The Hudson RCI®
AquaPak® Sterile Prefilled
Nebulizer adds sterile
water or saline solution in
aerosol form to a
patient's breathing gases.
lt may be used with
pediatric (ages 2 years
and above) and adult
patients. | Same |
| Principle of
Operation | Jet nebulizer with
adjustable air
entrainment | Same |
| Gas source | 50 Psi oxygen regulated
via a flow meter | Same |
| Flow rate and | 028 Model: | Same |
5
Section 31 - Updated 510(k) Summary
| FiO2 Control
Capabilities | 28% at 5 LPM
35% at 8 LPM
40% - 98% at 10 LPM
033 Model:
33% - 35% at 8 LPM
40% - 98% at 10 LPM | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------|---------------------|
| Aerosol Particle
Size Delivery | 1.5 to 3 micron range | Same |
| Sterilization | Adaptor sterilized by
Gamma Sterilization | Non-sterile adaptor |
| Single Use | Single Use only device | Same |
| Shelf Life | Adaptor – 5 years from
date of manufacture | Adaptor – N/A |
| Packaging | Adaptors – 50/case, 10 or
20/case when packaged
with water/ saline | Same |
K. Non-clinical Comparative Performance Testing
Bench testing has been performed to verify that the performance of the proposed Hudson RCI® AquaPak® Sterile Prefilled Nebulizer is substantially equivalent to the predicate device, and that the Hudson RCI® AquaPak® Sterile Prefilled Nebulizer will perform as intended.
There are no new patient contacting materials, so no biocompatibility testing was required for this submission.
The 'Lift Pressure', 'Oxygen Entrainment', 'Nebulization Rate', and 'Particle Size Distribution' testing is identical to the testing performed in the predicate K141214. The results of this testing showed that the subject device met all of the acceptance criteria established by the predicate. The 'Packaging configuration / Shelf Life' and 'Sterility Testing' ensure the sterile packaging and sterility are maintained after sterilization and shelf life testing per the referenced standards. The packaging for the subject device met the acceptance criteria of the standards cited below.
| Test
Performed | Reference to Standard (if
applicable) | Principle of Test |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Packaging
Configuration
/ Shelf life
Testing | ASTM F1980-07, Standard Guide for
Accelerated Aging of Sterile Barrier
Systems for Medical Devices. | Establishes integrity of the package materials
and sterile barrier after shelf life testing, visual
inspections and nebulization function test. |
| | ASTM F2096, Standard Test Method
for Detecting Gross Leaks in
Packaging by Internal Pressurization
(Bubble Test) | The packaging passed all of the acceptance
criteria for the tests. |
| Sterility
Testing | ISO 11137-1:2006 Sterilization of
health care products Radiation Part
1: Requirements for development,
validation and routine control of a | Validates the correct dose of gamma radiation
to ensure a sterile product at the point of use
when manufactured, stored, and handled
according to the instructions for use. |
6
Section 31 – Updated 510(k) Summary
| | sterilization process for medical
devices
ISO 11137-2:2013 (third edition)
Sterilization of health care products -
Radiation Part 2: Establishing the
sterilization dose | The packaging passed all of the acceptance
criteria for the tests. |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Lift Pressure | N/A | Measures the amount of negative pressure
required to pull liquid up for nebulization.
The device passed all of the acceptance
criteria for the tests. |
| Oxygen
Entrainment | N/A | Measures the percentage of oxygen/air mixture
when adjusted to preset oxygen percentage.
The device passed all of the acceptance
criteria for the tests. |
| Nebulization
Rate | N/A | Determines the basic rate at which the liquid is
aerosolized and emitted in mL/min.
The device passed all of the acceptance
criteria for the tests. |
| Particle Size
Distribution | N/A | Determines the particle size (MMAD) and
geometric standard deviation (GSD) of the
aerosolized liquid. |
L. Substantial Equivalence
The proposed Hudson RCI® AquaPak® Sterile Prefilled Nebulizer is substantially equivalent in intended use, design, performance and principles of operation to the identified predicate device cleared under 510(k) K141214. The differences between the proposed Hudson RCI® AquaPak® Sterile Prefilled Nebulizer and the predicate device are minor and raise no new issues of safety and efficacy.