SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML

K120051 · Nephron Pharmaceuticals Corp. · CAF · Apr 20, 2012 · Anesthesiology

Device Facts

• Record ID: K120051
• Device Name: SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML
• Applicant: Nephron Pharmaceuticals Corp.
• Product Code: CAF · Anesthesiology
• Decision Date: Apr 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2

Intended Use

To be used in conjunction with a nebulizer, the contents of these vials are for the induction of sputum production where sputum production is indicated.

Device Story

Device consists of 4mL single-use, blow-fill-sealed LDPE vials containing sterile, preservative-free Sodium Chloride Inhalation Solution (3%, 7%, or 10% w/v). Used in clinical or home settings in conjunction with a nebulizer; operated by healthcare providers or patients under prescription. Solution is aerosolized by the nebulizer to induce sputum production for diagnostic specimen collection. Benefits include standardized, sterile delivery of saline for sputum induction. No complex electronics or software involved.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via in vitro analytical methods including assay, fill uniformity, sterility, and container integrity testing, alongside adherence to USP monograph criteria.

Technological Characteristics

Single-use 4mL LDPE vials; Blow/Fill/Seal manufacturing; sterile, preservative-free aqueous solution (3%, 7%, 10% w/v NaCl); meets USP monograph requirements; polyethylene resins meet direct food/drug contact criteria.

Indications for Use

Indicated for patients requiring induction of sputum production for diagnostic specimen collection. Requires prescription. Not for parenteral use.

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

• Pari Innovative (K070498)
• PharmaCaribe (K101424)
• Dey-Laboratories (K972778)

Submission Summary (Full Text)

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Section 5: 510(k) Summary

120051

# Date Premarket Notification Summary was Prepared

This 510(k) premarket notification summary was prepared January 02, 2012 in conjunction with the notification.

## Applicant Name & Address

Nephron Pharmaceuticals Corporation 4121 SW 34th Street Orlando, FL 32811 Phone: [phone] Fax: [phone]

# Contact Persons:

Lou Kennedy President/CEO

# Marcus Juliano Vice President, Quality Assurance & Regulatory Affairs (regulatory contact)

Kimberly Grevera Manager, Regulatory Affairs (regulatory contact)

# Proprietary or Trade Name: Sodium Chloride Inhalation Solution USP, 3%, 7% and 10% Common/Usual Name: Saline Solution Classification Name: Nebulizer (Direct Patient Interface) - Accessory CAF - 868.5630 Class II Device: Inhaled saline solution Pari Innovative - K070498 Predicated Devices: PharmaCaribe - K101424 Dey-Laboratories - K972778

## Device Description

The subject devices are 4mL Sodium Chloride Inhalation Solution USP, 3%, 7% or 10%. The single-use devices are a clear blow-fill-sealed, low density polyethylene (LDPE) vials containing sterile, preservative-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. Sodium Chloride Inhalation Solution USP, 3%, 7% or 10% are used in conjunction with a nebulizer. The product contains 3%, 7% or 10% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives.

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Image /page/1/Picture/0 description: The image shows the logo for Nephron Pharmaceuticals Corporation. The logo features two Erlenmeyer flasks with tubes coming out of the top on the left side of the image. To the right of the flasks is the text "nephron pharmaceuticals corporation" stacked on top of each other.

Section 5: 510(k) Summary

| Contents | Volume | Container |
|----------------------------------------------|----------|-----------------------|
| 3% Sodium Chloride Inhalation Solution, USP | 4mL Fill | Clear, Embossed Label |
| 7% Sodium Chloride Inhalation Solution, USP | 4mL Fill | Clear, Embossed Label |
| 10% Sodium Chloride Inhalation Solution, USP | 4mL Fill | Clear, Embossed Label |

#### Indications for Use

To be used in conjunction with a nebulizer, the contents of these vials are for the induction of sputum production where sputum production is indicated.

#### Limitations for Use

These devices are not intended for parenteral use or for preparations intended for parenteral use. The use of this device requires a prescription.

#### Technological Characteristics of the Subject Devices and Predicate Devices

The subject unit-dose devices of this premarket notification are formed of polyethylene resins meeting the direct food and drug contact criteria. The formed units meet the criteria for direct food and drug contact as prefilled unit containers. The solution component, at the stated concentration of Sodium Chloride Inhalation Solution, meets the USP monograph requirements.

The single-use containers are embossed with identifying product text.

The finished device product configuration characteristics of this inhalation device are similar to those of the predicate devices.

The Blow/Fill/Seal system on which these devices are manufactured represents technological advances in the production of these devices for inhalation therapy and in the control of the manufacturing environment. These devices are manufactured under conditions of current Good Manufacturing Practices (cGMP).

There are no technological differences between the subject devices and predicate devices that raise new questions of safety and effectiveness. Performance characteristics of these devices that are the subject of this notification are equal to or greater than the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for Nephron Pharmaceuticals Corporation. The logo consists of two Erlenmeyer flasks on the left, followed by the company name in a sans-serif font. The word "nephron" is on the top line, "pharmaceuticals" is on the second line, and "corporation" is on the third line.

Section 5: 510(k) Summary

#### Nonclinical and Clinical Testing

The component materials of the accessory device container have been substantiated to each meet the criteria for direct food and drug contact or additive respectively. The formulation components of the filled device solution have been substantiated to each meet their respective USP monograph criteria. The finished device undergoes testing to meet the stated USP monograph and container criteria.

Clinical testing is not necessary to show substantial equivalence for either safety or efficacy of intended use to the predicate devices as there are several various in vitro analytical methods (assay; fill uniformity; sterility; container integrity) and physicalchemical characteristics (solution properties; unit configuration) available which demonstrate this equivalence.

#### Summary Conclusions

The subject devices:

3% Sodium Chloride Inhalation Solution, USP 7% Sodium Chloride Inhalation Solution, USP 10% Sodium Chloride Inhalation Solution, USP

as manufactured by Nephron Pharmaceuticals Corporation of Orlando, FL claims substantial equivalence, with the same intended use, to several devices which have received market clearance through established equivalence.

These devices are designed to meet current USP specifications. The device containers have embossed unit identification and shelf carton labeling so that label requirements are met.

Analytical testing to the stated specifications demonstrates that these devices will have comparable safety and efficacy in use.

The devices, as manufactured by Nephron, are produced using Blow Fill Seal technology specifically designed filling operations. These manufacturing systems represent a technological advance for the production of these types of devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Marcus Juliano Vice President. Ouality Assurance & Regulatory Affairs Nephron Pharmaceuticals Corporation 4121 SW 34th Street Orlando, Florida 32811

APR 2 0 2012

Re: K120051

Trade/Device Name: Sodium Chloride Inhalation Solution USP, 3%, 7%, AND 10% Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: March 30, 2012 Received: April 2, 2012

Dear Mr. Juliano:

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. Juliano

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

ph too

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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Image /page/5/Picture/0 description: The image shows the logo for Nephron Pharmaceuticals Corporation. The logo consists of two beakers on the left side of the image. To the right of the beakers is the text "nephron pharmaceuticals corporation" in a sans-serif font.

Section 4: Indications for Use Statement

#### Not Known 510(k) Number:

Sodium Chloride Inhalation Solution USP, 3%, 7%, and 10% Device Name:

#### Indications for Use:

To be used in conjunction with a nebulizer, the contents of these vials are for the induction of sputum production where sputum production is indicated.

Prescription Use X (21 CFR 801 Subpart D) and/or

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schillito

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K120051