Hudson RCI AquaPak Sterile Prefilled Nebulizers

K153010 · Teleflexmedical, Inc. · CAF · Jul 26, 2016 · Anesthesiology

Device Facts

• Record ID: K153010
• Device Name: Hudson RCI AquaPak Sterile Prefilled Nebulizers
• Applicant: Teleflexmedical, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Jul 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Device is a jet nebulizer with adjustable air entrainment; consists of a sterile adaptor (type 028 or 033) and a prefilled sterile reservoir (440ml, 760ml, or 1070ml). Operates by connecting to a 50 PSI oxygen source via flow meter; oxygen stream entrains room air to achieve specific oxygen concentrations (FiO2). Produces aerosolized sterile water or saline (1.5-3 micron particle size) for inhalation therapy. Used in hospitals, sub-acute/long-term care facilities, and home environments; operated by clinicians or patients. Single-use device. Benefits patient by providing humidified or medicated aerosol therapy to breathing gases.

Clinical Evidence

Bench testing only. Testing included lift pressure, oxygen entrainment, nebulization rate, and particle size distribution, all showing results identical to the predicate. Packaging and shelf-life validated per ASTM F1980-07 and ASTM F2096. Sterility validated per ISO 11137-1:2006 and ISO 11137-2:2013.

Technological Characteristics

Jet nebulizer with adjustable air entrainment window. Components: sterile adaptor (gamma sterilized) and prefilled reservoir (sterile water or saline). Dimensions: 440ml, 760ml, 1070ml reservoirs. Energy source: 50 PSI oxygen gas. Connectivity: None. Standards: ASTM F1980-07 (accelerated aging), ASTM F2096 (leak detection), ISO 11137-1/2 (gamma sterilization).

Indications for Use

Indicated for pediatric (ages 2+) and adult patients requiring aerosolized sterile water or saline solution added to breathing gases.

Regulatory Classification

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.

Predicate Devices

• Hudson RCI® AquaPak® Prefilled Nebulizer (K141214)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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 | |
| <b>Indications for Use</b> | |

| 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) | |
|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <div style="display:inline-block"><span style="text-decoration: underline;">Prescription Use</span> (Part 21 CFR 801 Subpart D)</div> | <div style="display:inline-block">Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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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: [phone] Fax: [phone]

#### 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.

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#### 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<br>Characteristics | Proposed Device:<br>Hudson RCI® AquaPak®<br>Sterile Prefilled Nebulizer | Predicate Device:<br>Hudson RCI® AquaPak®<br>Prefilled Nebulizer |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Manufacturer | Teleflex Medical, Inc. | Same |
| 510(k) Number | K153010 | K141214 |
| Indications for<br>Use | The Hudson RCI®<br>AquaPak® Sterile Prefilled<br>Nebulizer adds sterile<br>water or saline solution in<br>aerosol form to a<br>patient's breathing gases.<br>lt may be used with<br>pediatric (ages 2 years<br>and above) and adult<br>patients. | Same |
| Principle of<br>Operation | Jet nebulizer with<br>adjustable air<br>entrainment | Same |
| Gas source | 50 Psi oxygen regulated<br>via a flow meter | Same |
| Flow rate and | 028 Model: | Same |

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Section 31 - Updated 510(k) Summary

| FiO2 Control<br>Capabilities | 28% at 5 LPM<br>35% at 8 LPM<br>40% - 98% at 10 LPM<br><br>033 Model:<br>33% - 35% at 8 LPM<br>40% - 98% at 10 LPM | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------|---------------------|
| Aerosol Particle<br>Size Delivery | 1.5 to 3 micron range | Same |
| Sterilization | Adaptor sterilized by<br>Gamma Sterilization | Non-sterile adaptor |
| Single Use | Single Use only device | Same |
| Shelf Life | Adaptor – 5 years from<br>date of manufacture | Adaptor – N/A |
| Packaging | Adaptors – 50/case, 10 or<br>20/case when packaged<br>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<br>Performed | Reference to Standard (if<br>applicable) | Principle of Test |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Packaging<br>Configuration<br>/ Shelf life<br>Testing | ASTM F1980-07, Standard Guide for<br>Accelerated Aging of Sterile Barrier<br>Systems for Medical Devices. | Establishes integrity of the package materials<br>and sterile barrier after shelf life testing, visual<br>inspections and nebulization function test. |
| | ASTM F2096, Standard Test Method<br>for Detecting Gross Leaks in<br>Packaging by Internal Pressurization<br>(Bubble Test) | The packaging passed all of the acceptance<br>criteria for the tests. |
| Sterility<br>Testing | ISO 11137-1:2006 Sterilization of<br>health care products Radiation Part<br>1: Requirements for development,<br>validation and routine control of a | Validates the correct dose of gamma radiation<br>to ensure a sterile product at the point of use<br>when manufactured, stored, and handled<br>according to the instructions for use. |

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# Section 31 – Updated 510(k) Summary

| | sterilization process for medical<br>devices<br>ISO 11137-2:2013 (third edition)<br>Sterilization of health care products -<br>Radiation Part 2: Establishing the<br>sterilization dose | The packaging passed all of the acceptance<br>criteria for the tests. |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Lift Pressure | N/A | Measures the amount of negative pressure<br>required to pull liquid up for nebulization.<br>The device passed all of the acceptance<br>criteria for the tests. |
| Oxygen<br>Entrainment | N/A | Measures the percentage of oxygen/air mixture<br>when adjusted to preset oxygen percentage.<br>The device passed all of the acceptance<br>criteria for the tests. |
| Nebulization<br>Rate | N/A | Determines the basic rate at which the liquid is<br>aerosolized and emitted in mL/min.<br>The device passed all of the acceptance<br>criteria for the tests. |
| Particle Size<br>Distribution | N/A | Determines the particle size (MMAD) and<br>geometric standard deviation (GSD) of the<br>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.