LC STAR WITH NASAL ADAPTER

K061381 · Pari Innovative Manufacturers, Inc. · CAF · Jun 2, 2006 · Anesthesiology

Device Facts

• Record ID: K061381
• Device Name: LC STAR WITH NASAL ADAPTER
• Applicant: Pari Innovative Manufacturers, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Jun 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

The LC Star is a handheld nebulizer, designed to aerosolize medication approved for nebulization and prescribed by a physician. The nasal adapter facilitates delivery to the upper airways. The LC Star with nasal adapter is intended for adult and pediatric patients consistent with the indications for aerosol medication.

Device Story

The LC Star with nasal adapter is an air-powered, jet-style, reusable nebulizer. It functions by aerosolizing liquid medication for inhalation. The device is intended for use in hospital, clinic, or home settings by patients under physician prescription. It consists of the LC Star nebulizer body with an added nasal adapter to facilitate delivery to the upper airways. The device is operated by connecting it to an external air compressor. The healthcare provider or patient fills the nebulizer with prescribed medication; the compressor drives the aerosolization process. The resulting aerosol is inhaled by the patient. The device benefits patients by providing a targeted delivery method for aerosolized medications to the upper respiratory tract.

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated through bench testing comparing MMAD, RM, and Total Mass to predicate devices.

Technological Characteristics

Air-powered jet nebulizer; reusable; single-patient use; breath-enhanced design. Materials are identical to the predicate PARI LC Star. Operates via external air compressor. Non-sterile.

Indications for Use

Indicated for adult and pediatric patients requiring aerosolized medication delivery to the upper airways via a nasal adapter, as prescribed by a physician.

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

• Mabis NB-02 Ultrasonic Nebulizer (K990506)
• PARI LC® Star Nebulizer (K963924)

Submission Summary (Full Text)

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## LC Star Reusable Nebulizer with Nasal Adapter 510(k) Submission 510(k) Summary

K061381

#### Submitter Information

| Name: | PARI Innovative Manufacturers, Inc. | JUN - 2 2006 |
|----------------------|-------------------------------------------------------------------------|--------------|
| Address: | 2943 Oak Lake Blvd.<br>Midlothian, VA 23112 | |
| Phone Number: | 804-253-7274 x269 | |
| Fax Number: | 804-639-7244 | |
| Contact Name: | Michael Judge | |
| Date Prepared: | March 8, 2006 | |
| Device Name | | |
| Common Name: | Nebulizer | |
| Proprietary Name: | LC Star with Nasal Adapter | |
| Classification Name: | Nebulizer (Direct Patient Interface), 21 CFR 868.5630, Product Code CAF | |

#### Legally Marketed Predicate Device(s)

| Manufacturer | Device | 510(k) Number |
|-------------------------------------|----------------------------------|---------------|
| MABIS Healthcare | Mabis NB-02 Ultrasonic Nebulizer | K990506 |
| PARI Innovative Manufacturers, Inc. | PARI LC® Star Nebulizer | K963924 |

#### Device Description

The LC Star reusable nebulizer with nasal adapter is a small, single patient use, reusable air-powered nebulizer for the inhalation treatment of aerosolized medications. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.

#### Indications For Use

The LC Star is a handheld nebulizer, designed to aerosolize medication approved for nebulization and prescribed by a physician. The nasal adapter facilitates delivery to the upper airways. The LC Star with nasal adapter is intended for adult and pediatric patients consistent with the indications for aerosol medication.

#### Technological Characteristics Compared to Predicate Device

The LC Star with nasal adapter, MABIS NB-02, and LC Star are all nebulizers used to aerosolize medication for inhalation. The LC Star with nasal adapter and LC Star devices are air compressor-driven jet nebulizers using the same aerosolization method.

The LC Star with nasal adapter employs identical materials compared to the LC Star nebulizer and has a similar breath-enhanced design. The nasal adapter added to the system is similar to that used with the MABIS Mist Ultrasonic nebulizer.

#### Non-Clinical Test Summary

The LC Star with nasal adapter was tested to compare performance to the predicate devices, including:

- MMAD: LC Star with nasal adapter MMAD is comparable to the predicate devices ■
- . RM: LC Star with nasal adapter RM is comparable to the predicate devices
- Total Mass: LC Star with nasal adapter Total Mass is comparable to the predicate devices

#### Clinical Performance Summary

Clinical testing was not completed/is not required to show substantial equivalence.

#### Conclusions from Testing

LC Star with nasal adapter meets performance requirements and raises no new issues of safety or effectiveness.

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JUN - 2 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pari Innovative Manufacturers, Incorporated C/O Mr. Robert Mosenkis Responsible Third Party Official CITECH 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298

Re: K061381

Trade/Device Name: LC Star with Nasal Adapter Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: May 17, 2006 Received: May 18, 2006

Dear Mr. Mosenkis:

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. Mosenkis

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 (Sections 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.

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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# Indications for Use

510(k) Number (if known): N/A

Device Name: LC Star with Nasal Adapter

## Indications for Use:

The LC Star is a handheld nebulizer, designed to aerosolize medication approved for nebulization and prescribed by a physician. The nasal adapter facilitates delivery to the upper airways. The LC Star with nasal adapter is intended for adult and pediatric patients consistent with the indications for aerosol medication.

Prescription Use XXX (Part 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Auysufiom

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

510(k) Number: K061381

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