HYPER SAL

K070498 · Pari Innovative Manufacturers, Inc. · CAF · Apr 26, 2007 · Anesthesiology

Device Facts

• Record ID: K070498
• Device Name: HYPER SAL
• Applicant: Pari Innovative Manufacturers, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Apr 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2

Intended Use

Used in conjunction with a nebulizer for induction of sputum production where specimen collection is indicated.

Device Story

Hyper Sal is a sterile saline solution (3.5%, 6%, and 7% concentrations) packaged in 4 ml vials. It is used in conjunction with a nebulizer to induce sputum production for diagnostic specimen collection. The device is intended for use in hospital, sub-acute care, or home settings. It is a prescription-only device. The solution is administered via nebulization to the patient's respiratory tract to facilitate the collection of sputum samples for clinical analysis.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the use of USP monograph-compliant sodium chloride solutions and comparison to a legally marketed predicate device.

Technological Characteristics

Sterile USP sodium chloride solutions in 3.5%, 6%, and 7% concentrations. Packaged in 4 ml vials. Designed for use with a nebulizer. No electronic or software components.

Indications for Use

Indicated for any patient population requiring sputum induction for specimen collection. 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)

Submission Summary (Full Text)

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....

# Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 26-Apr-07

| PARI Innovative Manufacturers, Inc.<br>2943 Oak Lake Blvd.<br>Midlothian, VA 23112 | APR 26 2007 |
|------------------------------------------------------------------------------------|--------------------------------------------|
| Tel - [phone]<br>Fax - [phone] | |
| Official Contact: | Mike Judge - RA |
| Proprietary or Trade Name: | Hyper Sal |
| Common/Usual Name: | Saline solution |
| Classification Name: | CAF – Nebulizer (Direct Patient Interface) |
| Device: | Inhaled saline solutions – 3.5%, 6% and 7% |
| Predicate Devices: | DEY Laboratories – K972778 |
| Device Description: | |

The proposed inhaled saline solutions are in 3.5%, 6% and 7% concentrations. They are packaged sterile in 4 ml vials for use as indicated.

| Indications for Use: | |
|-----------------------|------------------------------------------------------------------------------------------------------------------|
| Indicated Use -- | Used in conjunction with a nebulizer for induction of sputum production where specimen collection is indicated.. |
| Patient Population -- | Any patient population |
| Environment of Use -- | Hospital, sub-acute care or home |
| Contraindications -- | None |

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# Premarket Notification 510(k) K070498

. .

### Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 26-Apr-07

| Attributes | |
|---------------------|-----------------------------------------------------------------------------------------------------------------------|
| Intended use | Used in conjunction with a nebulizer for induction of<br>sputum production where specimen collection is<br>indicated. |
| Environments of use | Hospital, sub-acute care or home |
| Patient Population | Any |
| Contraindications | None |
| Prescription | Yes |
| Design | USP sodium chloride solutions of 3.5%, 6% and 7% |
| Performance | None applicable<br>USP monograph |

# Differences between Other Legally Marketed Predicate Devices

The proposed inhale saline solutions are viewed as substantially equivalent to the following predicate device – DEY K972778.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pari Innovative Manufacturers, Incorporated C/O Mr. Paul Dryden President ProMedic, Incorporated 3460 Pointe Creek Court #102 Bonita Springs, Florida 34134

APR 2 6 2007

Re: K070498

Trade/Device Name: Inhaled Saline Solutions 3.5%, 6%, and 7% Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: February 14, 2007 Received: February 20, 2007

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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/cdrh/industry/support/index.html.

Sincerely yours.

Chiu Lin, Ph.D.

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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Premarket Notification 510(k) Section 4 - Indications for Use Statement

#### Indications for Use Statement 4

Page 1 of 1

| 510(k) Number: | K070498 (To be assigned) |
|----------------------|-----------------------------------------------------------------------------------------------------------------|
| Device Name: | Inhaled saline solutions 3.5%, 6%, and 7% |
| Indications for Use: | Used in conjunction with a nebulizer for induction of sputum production where specimen collection is indicated. |

Prescription Use XX (Part 21 CFR 801 Subpart D) or Over-the-counter use __ (21 CFR 807 Subpart C)

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