PHARMACARIBE INHALED SALINE SOLUTIONS

K101424 · Pharmacaribe · CAF · Aug 17, 2010 · Anesthesiology

Device Facts

• Record ID: K101424
• Device Name: PHARMACARIBE INHALED SALINE SOLUTIONS
• Applicant: Pharmacaribe
• Product Code: CAF · Anesthesiology
• Decision Date: Aug 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2

Intended Use

PharmaCaribe inhaled saline solutions are used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production where sputum production is indicated. Concentrations of 3%, 3.5%, 6%, 7%, and 10%

Device Story

PharmaCaribe inhaled saline solutions are sterile, homogeneous mixtures of USP sterile water and sodium chloride in concentrations of 3%, 3.5%, 6%, 7%, and 10%. Packaged in 5ml flexible vials with tear-off tops. Used in hospital, sub-acute care, or home settings. Operated by clinicians or patients in conjunction with a nebulizer to induce sputum production for diagnostic specimen collection. Device is marked 'Not for Injection'.

Clinical Evidence

Bench testing only. Device performance verified through USP monograph testing including pH, osmolality, appearance, pre-filtration bioburden, sterility (USP 71), identification of sodium and chloride (USP 191), bacterial endotoxin (USP 85), iron content (USP 241), heavy metals (USP 231), and sodium chloride assay. 3-month stability testing performed.

Technological Characteristics

Sterile saline solution (3%, 3.5%, 6%, 7%, 10% NaCl). Manufactured per USP monograph. Packaged in 5ml flexible vials. Used with external nebulizer. No electronic components or software.

Indications for Use

Indicated for patients requiring sputum induction for specimen collection. No specific age or gender restrictions. Contraindications: None.

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

• DEY Laboratories (K972778)
• Pari (K070498)

Submission Summary (Full Text)

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510(k) Summary Page 1 of 3 14-Jul-10

K101424
AUG 17 2010

| PharmaCaribe | |
|----------------------------|--------------------------------------------------------|
| 3513 Di Leuca St. | Tel - [phone] |
| Punta Gorda, FL 33950 | Fax - [phone] |
| Official Contact: | W. Randolph Warner |
| Proprietary or Trade Name: | PharmaCaribe inhaled saline solutions |
| Common/Usual Name: | Saline solution |
| Classification Name: | Nebulizer (Direct Patient Interface)<br>CAF - 868.5630 |
| Device: | Inhaled saline solutions - 3%, 3.5%, 6%, 7%, and 10% |
| Predicate Devices: | DEY Laboratories - K972778<br>Pari - K070498 |

### Device Description:

PharmaCaribe Sodium Chloride Solutions are homogeneous mixtures (complete solutions) and are composed of USP sterile water and sodium chloride only and provided in 3%, 3.5%, 6%, 7%, and 10% concentrations. They are packaged sterile in standard 5ml (4ml fill) flexible material vials. The vials have a tear-off top. They are marked NOT FOR INJECTION.

### Indications for Use:

PharmaCaribe inhaled saline solutions are used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production where sputum production is indicated. Concentrations of 3%, 3.5%, 6%, 7%, and 10%

## Patient Population:

Any patient population where sputum specimens are indicated

# Environment of Use: Hospital, sub-acute care or home

# Contraindications: None

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510(k) Summary

| Features | Proposed<br>Inhaled saline solutions | Predicate<br>DEY K972778 | Predicate<br>Pari K070498 |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Used in conjunction with a nebulizer.<br>The contents of these vials are for the<br>induction of sputum production where<br>sputum production is indicated. | Used in conjunction with a<br>nebulizer. For induction of sputum<br>production where specimen<br>collection is indicated. | Used in conjunction with a<br>nebulizer for an induction of<br>sputum production where<br>specimen collection is indicated. |
| Prescription | Yes | Yes | Yes |
| Environment of Use | Home, Hospital, Sub-acute Institutions | Same | Same |
| Patient Population | For those required sputum specimens | Same | Same |
| Used with a nebulizer | Yes | Yes | Yes |
| Contraindications | None | None | None |
| Marked Not for Injection | Yes | Yes | Yes |
| Packaged sterile in a<br>flexible tear-off top vial | Yes | Similar | Identical |
| Solutions | 3%, 3.5%, 6%, 7% and 10% | 3% and 10% | 3.5%, 6% and 7% |
| Manufactured | Per USP monograph | Same | Same |
| Manufacturing process<br>and formulation per USP | Osmolality, Appearance, Pre-filtration<br>Bioburden, Sterility USP (71),<br>Identification of Sodium and Chloride<br>USP (191), pH USP (791),<br>Bacterial Endotoxin USP (85), Iron<br>Content USP (241), Heavy Metals<br>Content USP (231), Sodium Chloride<br>Assay USP Monograph, 3 month<br>stability of solution | Similar | Identical |

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# 510(k) Summary Page 3 of 3 14-Jul-10

## Performance Testing Summary:

The PharmaCaribe inhaled saline solutions are manufactured and tested in an identical manner to the predicate Pari (K070498). This includes:

- . USP Water
- . Filtration - sterility grade filters
- Testing for .
- o pH
- Osmolality 0
- Appearance 0
- Pre-filtration Bioburden O
- Sterility per USP (71) 0
- Identification of Sodium and Chloride per USP (191) 0
- pH per USP (791) 0
- Bacterial Endotoxin per USP (85) O
- 0 Iron Content per USP (241)
- Heavy Metals Content per USP (231) O
- Sodium Chloride Assay per USP Monograph 0
- Testing for 3 month stability of solution o

## Differences between Other Legally Marketed Predicate Devices

Based upon formulation requirements as specified by the USP monograph the proposed inhale saline solutions are viewed as substantially equivalent (identical) to the predicates - DEY K972778 and Pari -- K070498.

There are no differences and thus there are no new concerns of safety or effectiveness between the intended device and the predicates.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right. The image is in black and white.

#### Public Health Service

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

Pharmacaribe C/O Mr. Paul Dryden Promedic 24301 Woodsage Drive Bonita Springs, Florida 34134

AUG 1 7 2010

Re: K101424

Trade/Device Name: PharmaCaribe Inhaled Saline Solutions 3%, 3.5%, 6%, 7% and 10% Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: July 14, 2010 Received: July 16, 2010

Dear Mr. Dryden:

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. Dryden

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 vours.

Wh for

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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# Indications for Use Statement

K101424

Page 1 of 1

510(k) Number:

K101424

Device Name:

Indications for Use:

PharmaCaribe Inhaled saline solutions 3%, 3.5%, 6%, 7%, and 10%

PharmaCaribe inhaled saline solutions are used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production where sputum production is indicated.

Concentrations of 3%, 3.5%, 6%, 7%, and 10%

Prescription Use XX (Part 21 CFR 801 Subpart D)

or

Over-the-counter use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schutter

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

-10(k) Number: ______ 10/424

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