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.

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.

AI/ML Overview

The document describes a 510(k) summary for the Hudson RCI® AquaPak® Sterile Prefilled Nebulizers. This is a medical device submission, and the content provided outlines the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the provided text in the context of your request for acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

The document provides a table outlining the tests performed and a general statement about performance. Specific quantitative acceptance criteria are not explicitly listed in a separate column, but the "Principle of Test" column often hints at what was being measured. The reported device performance for these tests is generally stated as "The device passed all of the acceptance criteria for the tests" or "The packaging passed all of the acceptance criteria for the tests."

Test Performed	Implied Acceptance Criteria (from Principle of Test)	Reported Device Performance
Packaging Configuration / Shelf life Testing	Establish integrity of the package materials and sterile barrier after shelf life testing, visual inspections and nebulization function test. (ASTM F1980-07, ASTM F2096)	"The packaging passed all of the acceptance criteria for the tests."
Sterility Testing	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. (ISO 11137-1:2006, ISO 11137-2:2013)	"The packaging passed all of the acceptance criteria for the tests."
Lift Pressure	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	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	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	Determines the particle size (MMAD) and geometric standard deviation (GSD) of the aerosolized liquid.	"The device passed all of the acceptance criteria for the tests."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document states "Bench testing has been performed". However, it does not specify the sample size used for any of the tests (e.g., how many devices were tested for lift pressure, nebulization rate, etc.). It also does not mention the country of origin of the data or whether the data was retrospective or prospective. Given it's bench testing, it's typically prospective in nature, but this is not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This section is not applicable to the provided document. The document describes a technical device (nebulizer) performance assessment, not an AI or diagnostic device that requires expert-established ground truth for image or data interpretation. The ground truth for these tests would be objective measurements against established engineering and industry standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This section is not applicable for the same reasons as point 3. Adjudication methods are relevant for subjective interpretations, typically in diagnostic studies with multiple human readers.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The document describes the performance of a medical device (a nebulizer), not an AI algorithm designed to assist human readers or interpreters.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This section is not applicable. The document is about a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the type of testing described (packaging integrity, sterility, lift pressure, oxygen entrainment, nebulization rate, particle size distribution) would be objective measurements against predefined engineering specifications and regulatory standards. For example, sterility would be verified by microbiological testing against a defined sterility assurance level (SAL), and particle size distribution would be measured using validated instruments against a specified range. It's not expert consensus, pathology, or outcomes data in this context.

8. The sample size for the training set

This section is not applicable. The document describes the testing of a physical medical device. There is no mention of a "training set" as this term is typically used in the context of machine learning or AI development.

9. How the ground truth for the training set was established

This section is not applicable for the same reasons as point 8.

Summary

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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.

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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

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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)

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FORM FDA 3881 (8/14)	Page 1 of 1
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PSC Publishing Services (301) 443-6740 EF

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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

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Section 31 - Updated 510(k) Summary

F. Indications for Use

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:

ComparativeCharacteristics	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 forUse	The Hudson RCI®AquaPak® Sterile PrefilledNebulizer adds sterilewater or saline solution inaerosol form to apatient's breathing gases.lt may be used withpediatric (ages 2 yearsand above) and adultpatients.	Same
Principle ofOperation	Jet nebulizer withadjustable airentrainment	Same
Gas source	50 Psi oxygen regulatedvia a flow meter	Same
Flow rate and	028 Model:	Same

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Section 31 - Updated 510(k) Summary

FiO2 ControlCapabilities	28% at 5 LPM35% at 8 LPM40% - 98% at 10 LPM033 Model:33% - 35% at 8 LPM40% - 98% at 10 LPM
Aerosol ParticleSize Delivery	1.5 to 3 micron range	Same
Sterilization	Adaptor sterilized byGamma Sterilization	Non-sterile adaptor
Single Use	Single Use only device	Same
Shelf Life	Adaptor – 5 years fromdate of manufacture	Adaptor – N/A
Packaging	Adaptors – 50/case, 10 or20/case when packagedwith 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.

TestPerformed	Reference to Standard (ifapplicable)	Principle of Test
PackagingConfiguration/ Shelf lifeTesting	ASTM F1980-07, Standard Guide forAccelerated Aging of Sterile BarrierSystems for Medical Devices.	Establishes integrity of the package materialsand sterile barrier after shelf life testing, visualinspections and nebulization function test.
	ASTM F2096, Standard Test Methodfor Detecting Gross Leaks inPackaging by Internal Pressurization(Bubble Test)	The packaging passed all of the acceptancecriteria for the tests.
SterilityTesting	ISO 11137-1:2006 Sterilization ofhealth care products Radiation Part1: Requirements for development,validation and routine control of a	Validates the correct dose of gamma radiationto ensure a sterile product at the point of usewhen manufactured, stored, and handledaccording to the instructions for use.

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Section 31 – Updated 510(k) Summary

	sterilization process for medicaldevicesISO 11137-2:2013 (third edition)Sterilization of health care products -Radiation Part 2: Establishing thesterilization dose	The packaging passed all of the acceptancecriteria for the tests.
Lift Pressure	N/A	Measures the amount of negative pressurerequired to pull liquid up for nebulization.The device passed all of the acceptancecriteria for the tests.
OxygenEntrainment	N/A	Measures the percentage of oxygen/air mixturewhen adjusted to preset oxygen percentage.The device passed all of the acceptancecriteria for the tests.
NebulizationRate	N/A	Determines the basic rate at which the liquid isaerosolized and emitted in mL/min.The device passed all of the acceptancecriteria for the tests.
Particle SizeDistribution	N/A	Determines the particle size (MMAD) andgeometric standard deviation (GSD) of theaerosolized 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.

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).