AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS

K141214 · Teleflexmedical, Inc. · CAF · Dec 18, 2014 · Anesthesiology

Device Facts

• Record ID: K141214
• Device Name: AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS
• Applicant: Teleflexmedical, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Dec 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Hudson RCI® AquaPak® Prefilled Nebulizer adds sterile water or saline solution in aerosol form to a patient's breathing gases.

Device Story

Device consists of prefilled sterile water or saline reservoirs (440ml, 760ml, 1070ml) paired with specific nebulizer adaptors (028 standard or 033 quiet). Adaptors connect to 50 PSI oxygen flow-metered gas sources; utilize jet nebulization principle with adjustable air entrainment windows to control oxygen concentration (FiO2) and aerosolize liquid into fine mist. Used in hospitals, sub-acute/long-term care facilities, and home environments; operated by clinicians or patients. Output is aerosolized humidity delivered to patient breathing gases. Benefits include provision of particulate humidity for respiratory therapy. Single-use device.

Clinical Evidence

Bench testing only. Performance verified through lift pressure, oxygen entrainment, nebulization rate, and particle size distribution (MMAD/GSD) testing.

Technological Characteristics

Jet nebulizer; 50 PSI oxygen gas source; adjustable air entrainment window; reservoir volumes 440ml, 760ml, 1070ml; single-use; non-sterile adaptors; sterile water/saline reservoirs processed via reverse osmosis, distillation, and aseptic fill.

Indications for Use

Indicated for pediatric (ages 2 years and above) 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

• Smiths Medical Portex™ Thera-Mist® Large Volume Nebulizer (K962534)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 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: [phone] 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.

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# 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<br>Characteristics | Proposed Device:<br>Hudson RCI® AquaPak®<br>Prefilled Nebulizer | Predicate Device:<br>Smiths Medical Portex™M<br>Thera-Mist® Large Volume<br>Nebulizer |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Teleflex Medical, Inc. | Smiths Medical ASD, Inc. |
| 510(k) Number | TBD | K962534 |
| Indications for Use | The Hudson RCI®<br>AquaPak® Prefilled<br>Nebulizer adds sterile<br>water or saline solution in<br>aerosol form to a patient's<br>breathing gases. | The Smiths Medical<br>Portex™ Thera-Mist®<br>Large Volume Nebulizer<br>delivers particulate<br>humidity in the 3 to 5<br>micron range for chronic<br>secretion patients. |

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| Section 29 - 510(k) Summary - Updated | | | | | | |
|---------------------------------------|--|--|--|--|--|--|
|---------------------------------------|--|--|--|--|--|--|

| Principle of<br>Operation | Jet nebulizer with<br>adjustable air entrainment | Jet nebulizer with<br>adjustable air entrainment |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Gas source | 50 Psi oxygen regulated via<br>a flow meter | 50 Psi oxygen regulated via<br>a flow meter |
| Flow rate and FiO2<br>Control<br>Capabilities | 028 Model:<br>28% at 5 LPM<br>35% at 8 LPM<br>40% - 98% at 10 LPM<br><br>033 Model:<br>28% - 35% at 8 LPM<br>40% - 98% at 10 LPM | Normal Flow LVN:<br>28% - 60 %<br><br>High Flow LVN:<br>36% - 95% at 14 - 15 LPM |
| Aerosol Particle<br>Size Delivery | 1.5 to 3 micron range | 3 to 5 micron range |
| Sterilization | Adaptors - Non-sterile<br>Sterile Water/Saline<br>Reservoirs - Reverse<br>osmosis, distillation, and<br>aseptic fill | Adaptors - Non-sterile<br>Sterile Water/Saline<br>Reservoirs - Reverse<br>osmosis, distillation, and<br>aseptic fill |
| Single Use | Yes | Yes |
| Shelf Life | Adaptors - N/A<br>Sterile Water/Saline – 2<br>years from date of<br>manufacture | Adaptors - N/A<br>Sterile Water/Saline – 2<br>years from date of<br>manufacture |
| Packaging | Adaptors - 50/case, 10 or<br>20/case when packaged with<br>water/ saline<br>Sterile water/saline - 10 or<br>20/case | LVN Adaptors - 40/case,<br>12/case when packaged with<br>water<br>Sterile Water - 12/case<br>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.

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| Test<br>Performed | Reference to Standard (if<br>applicable) | Principle of Test |
|-------------------------------|------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Lift Pressure | N/A | Measures the amount of negative<br>pressure required to pull liquid up for<br>nebulization |
| Oxygen<br>Entrainment | N/A | Measures the percentage of oxygen/air<br>mixture when adjusted to preset oxygen<br>percentage |
| Nebulization<br>Rate | N/A | Determines the basic rate at which the<br>liquid is aerosolized and emitted in<br>mL/min |
| Particle Size<br>Distribution | N/A | Determines the particle size (MMAD)<br>and geometric standard deviation (GSD)<br>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.