HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML

K142153 · Teleflexmedical, Inc. · CAF · Apr 29, 2015 · Anesthesiology

Device Facts

• Record ID: K142153
• Device Name: HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML
• Applicant: Teleflexmedical, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Apr 29, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hudson RCI® Addipak® Unit Dose Vial, 0.9% Full Normal Saline Solution may be used in conjunction with a non-ventilatory nebulizer for lavage therapy, or for tracheal irrigation.

Device Story

Device is a pre-filled, single-use, disposable vial containing 0.9% sterile sodium chloride solution for inhalation therapy. Vials are constructed of translucent, color-coded polyethylene with a perforated, break-away twist cap for dispensing. Clinicians use the device in home, hospital, or sub-acute settings by twisting off the cap and squeezing the vial to dispense saline into a non-ventilatory nebulizer for lavage or directly for tracheal irrigation. Inverted graduations on the vial allow for volume monitoring during dispensing. The device provides a sterile, ready-to-use saline source, simplifying preparation for respiratory therapy and irrigation procedures.

Clinical Evidence

Bench testing only. Testing included leak detection (vacuum method), twist-off cap functionality, and shipping simulation (ISTA 1A). Biocompatibility testing (cytotoxicity, irritation, sensitization, genotoxicity, implantation) performed per ISO 10993-1. Material testing performed per USP <661> for nonvolatile residue, heavy metals, and buffering capacity.

Technological Characteristics

Single-use, disposable, translucent LDPE vials (DuPont DPE-20, Dow HEALTH+ 692). Available in 3mL, 5mL, 15mL volumes. Manufactured via aseptic Blow-Fill-Seal process. Conforms to USP monograph for Sodium Chloride Inhalation Solution. Sterilization per USP <71>. No energy source or software.

Indications for Use

Indicated for any patient requiring lavage therapy or tracheal irrigation. No known contraindications.

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® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution (Pre-amendment)
• Nephron Pharmaceuticals, Sodium Chloride Solution USP, 0.9% (K113033)

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

April 29, 2015

Teleflex Medical, Inc. James A. Cochie Sr. Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, NC 27709

Re: K142153

Trade/Device Name: Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer (Direct Patient Interface) Regulatory Class: II Product Code: CAF Dated: March 30, 2015 Received: April 1, 2015

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Teiashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known)

K142153

Device Name

Hudson RCI® Addipak® Unit Dose Vial, 0.9% Full Normal Saline Solution

#### Indications for Use (Describe)

The Hudson RCI® Addipak® Unit Dose Vial, 0.9% Full Normal Saline Solution may be used in conjunction with a non-ventilatory nebulizer for lavage therapy, or for tracheal irrigation.

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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## Section 25 - 510(k) Summary

### 510(k) SUMMARY

### Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution

#### A. Name, Address, Phone and Fax Number of Applicant

Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: [phone] Fax: [phone]

#### B. Contact Person

James Cochie Sr. Regulatory Affairs Specialist

#### C. Date Prepared

July 25, 2014 (Revised April 28, 2015)

#### D. Device Name

| Trade Name: | Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full<br>Normal Saline Solution |
|----------------------|--------------------------------------------------------------------------|
| Common Name: | Saline Solution for Inhalation |
| Classification Name: | Nebulizer (Direct Patient Interface)<br>CFR - 868.5630, Class II |

#### E. Device Description

Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution is a pre-filled vial of sterile 0.9% saline for inhalation therapy. The content of this product is a 0.90% sodium chloride solution (normal saline). Vials are factory-sealed, made of translucent, color-coded polyethylene, and are available in three sizes (3mL, 5mL, and 15mL). These products are single-use, disposable, and intended for inhalation only.

Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution filled with sterile saline solutions conforms to the specifications of the USP monograph for Sodium Chloride Inhalation Solution.

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## Section 25 – 510(k) Summary

Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution have a perforated, break-away twist cap for dispensing the solution. When twisted by the user, the cap breaks away and opens a small hole for solution to pass through. The Hudson RCT® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution are designed with inverted graduations to allow the clinician to read volume while dispensing the solution.

### F. Indications for Use

The Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution may be used in conjunction with a non-ventilatory nebulizer for lavage therapy, or for tracheal irrigation.

#### G. Target Population

This device is intended for use on any patient requiring lavage therapy or tracheal irrigation.

## H. Environments of Use

This device is intended for home, hospital, and sub-acute facilities.

This product is single use only.

#### I. Contraindications

There are no known contraindications.

#### J. Comparative Equivalence Characteristics

The proposed Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution is substantially equivalent to the predicate devices:

| Comparative<br>Characteristics | Proposed Device,<br>Hudson RCI®<br>AddiPak® Unit Dose<br>Vial, 0.9% Full<br>Normal Saline<br>Solution | Predicate Device,<br>Hudson RCI®<br>AddiPak® Unit Dose<br>Vial, 0.9% Full<br>Normal Saline<br>Solution | Predicate Device,<br>Nephron<br>Pharmaceuticals,<br>Sodium Chloride<br>Solution USP, 0.9% |
|--------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Manufacturer | Teleflex Medical, Inc. | Teleflex Medical, Inc. | Nephron<br>Pharmaceuticals |
| 510(k) Number | K142153 | Pre-amendment | K113033 |
| Indications for<br>Use | The Hudson RCI®<br>AddiPak® Unit Dose<br>Vial, 0.9% Full Normal<br>Saline may be used in<br>conjunction with a | The Hudson RCI®<br>AddiPak® Unit Dose<br>Vial, 0.9% Full<br>Normal Saline may<br>be used in | Sterile, single use<br>device is intended to<br>be used as an<br>accessory to<br>medicinal |

Teleflex Medical, Inc.

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| | non-ventilatory<br>nebulizer for lavage<br>therapy, or for<br>tracheal irrigation. | conjunction with a<br>non-ventilatory<br>nebulizer for lavage<br>therapy, or tracheal<br>irrigation | nonventilatory<br>nebulizers for<br>respiratory therapy or<br>for tracheal irrigation<br>or lavage therapy |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prescription | Yes | Yes | Yes |
| Environment of<br>Use | Home, hospital, sub-<br>acute facilities | Home, hospital, sub-<br>acute facilities | Home, hospital, sub-<br>acute facilities |
| Patient<br>Population | Any patient requiring<br>lavage therapy or<br>tracheal irrigation | Any patient requiring<br>lavage therapy or<br>tracheal irrigation | Same |
| Contraindications | None | None | None |
| Materials in Fluid<br>Contact | Vial LDPE - DuPont<br>DPE-20 and Dow<br>HEALTH+ 692 | Vial LDPE - DuPont<br>DPE-20 and<br>Celanese EVA 7110 | Vial LDPE |
| Solutions | 0.90% Saline<br>Inhalation Solution,<br>USP: 3ml, 5ml, 15ml | 0.90% Saline<br>Inhalation Solution,<br>USP: 3ml, 5ml, 15ml | 0.9% Saline<br>Inhalation Solution,<br>USP: 3ml, 5ml |
| Vial Design | Pinched seam<br>between vial and cap<br>for opening<br>Nozzle opening<br>design to keep<br>contents within when<br>inverted<br>Raised inverted<br>graduations | Pinched seam<br>between vial and cap<br>for opening<br>Nozzle opening<br>design to keep<br>contents within when<br>inverted<br>Raised inverted<br>graduations | Pinched seam<br>between vial and cap<br>for opening<br>Nozzle opening<br>design to keep<br>contents within when<br>inverted<br>Raised inverted<br>graduations |
| Manufacturing<br>Process | Per USP monograph<br>Blow-Fill-Seal aseptic<br>process | Per USP monograph<br>Blow-Fill-Seal aseptic<br>process | Per USP monograph<br>Blow-Fill-Seal aseptic<br>process |
| Sterilization | Per USP <71> | Per USP <71> | Per USP <71> |
| Single Use | Yes | Yes | Yes |
| Shelf Life | 2 years from date of<br>manufacture | 2 years from date of<br>manufacture | Unknown |
| Packaging | 3ml and 5ml vials<br>packaged 100/box, 10<br>boxes/case<br>15ml vials packaged<br>48/box, 3 boxes/case | 3ml and 5ml vials<br>packaged 100/box, 10 boxes/case<br>15ml vials packaged<br>48/box, 3 boxes/case | 3ml and 5ml vials<br>packaged 100/box or<br>30 individually<br>wrapped and bar-<br>coded vials |

# Section 25 – 510(k) Summary

# K. Non-clinical Comparative Performance Testing

Bench testing has been performed to verify that the performance of the proposed Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution is substantially equivalent to the predicate devices, and that the Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution will perform as intended.

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| Test<br>Performed | Reference to Standard (if<br>applicable) | Principle of Test |
|-------------------|------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Leak Test | N/A | Leak detection in polyethylene vial by<br>vacuum method |
| Twist-Off<br>Test | N/A | A manual removal of the twist-off cap to<br>ensure proper dispensing of solution<br>when inverted and squeezed |
| Ship Test | ISTA 1A | Shipping simulation to ensure vials are<br>damage-free and do not leak |

#### Section 25 - 510(k) Summary

All patient contacting materials are in compliance with ISO 10993-1. Testing included cytotoxicity, irritation, sensitization, genotoxicity and implantation testing.

In addition, the vial material was tested to USP <661> physiochemical test for plastics and found to meet the criteria for nonvolatile residue, heavy metals and buffering capacity.

#### L. Substantial Equivalence

The proposed Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution is substantially equivalent in intended use for lavage therapy and tracheal irrigation, design, performance and principles of operation to the identified predicate devices. The differences between the Hudson RC1® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution and the predicate devices are minor and raise no new issues of safety and efficacy. The Hudson RC1® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution are substantially equivalent to the currently marketed predicate device.