LC SPRINT STAR

K062158 · Pari Innovative Manufacturers, Inc. · CAF · Aug 28, 2006 · Anesthesiology

Device Facts

• Record ID: K062158
• Device Name: LC SPRINT STAR
• Applicant: Pari Innovative Manufacturers, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Aug 28, 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 Sprint Star is a handheld nebulizer, designed to aerosolize medication approved for nebulization and prescribed by a physician. The LC Sprint Star is intended for pediatric and adult patients consistent with the indications for the aerosol medication.

Device Story

LC Sprint Star is a reusable, air-powered, handheld nebulizer for aerosolizing prescribed medications; used in hospital, clinic, or home environments. Device features an inspiratory valve on the top component and an expiratory valve on the mouthpiece to provide breath-controlled aerosol output. Operated by patients or caregivers; connects to external air source. Output is an aerosolized mist for inhalation. Benefits include efficient medication delivery via breath-actuation. Device is a modification of the existing LC Sprint nebulizer.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and design comparisons to predicate devices.

Technological Characteristics

Air-powered, reusable handheld nebulizer. Components include nebulizer cup, top, baffle insert, mouthpiece, and optional tubing/mask. Features inspiratory and expiratory valves for breath-controlled aerosol output. Non-sterile, single-patient use design.

Indications for Use

Indicated for pediatric and adult patients requiring aerosolized medication prescribed by a physician, consistent with the indications for the specific medication used.

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 LC® Sprint Nebulizer (K060399)
• PARI LC® Star Nebulizer (K963924)
• Vixone Nebulizer (n/a)

Submission Summary (Full Text)

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AUG 2 8 2006
K062158

## LC Sprint Star Reusable Nebulizer 510(k) Submission Executive Summary

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

LC Sprint Star is a cosmetically and geometrically modified version of the LC Sprint nebulizer currently marketed by PARI. The LC Sprint Star has an inspiratory balve on the top component and an expiratory valve on the mouthpiece, allowing for breathcontrolled aerosol output.

The LC Sprint Star will be available as a stand-alone item or a configuration component containing:

- LC Sprint Star nebulizer (consisting of nebulizer cup, top, and baffle insert) I
- L Mouthpiece
- Oxygen tubing (optional) 트
- 트 Mask (optional)

Predicate devices referenced in this submission are:

| Manufacturer | Device | 510(k) Number |
|-------------------------------------|---------------------------|---------------|
| PARI Innovative Manufacturers, Inc. | PARI LC® Sprint Nebulizer | K060399 |
| PARI Innovative Manufacturers, Inc. | PARI LC® Star Nebulizer | K963924 |
| Westmed, Inc. | Vixone Nebulizer | n/a |

### Indications for Use

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

## Comparison to Predicates

In Section 12 we discuss the proposed device and compare it to the predicate devices. Rather than repeat this comparison in the Executive Summary we refer the reviewer to the appropriate sections of this submission. Below is a summary of the disrovsion.

#### Indications -

- . Identical to predicate PARI LC Sprint - K060399
#### Page 10.1

#### PARI Confidential

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 8 2006

Pari Innovative Manufacturers, Incorporated C/O Mr. Neil E. Devine Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

Re: K062158

Trade/Device Name: LC Sprint Star Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: August 16, 2006 Received: August 17, 2006

Dear Mr. Devine:

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. Devine

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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,

Clive
Chia-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 Sprint Star

## Indications for Use:

The LC Sprint Star is a handheld nebulizer, designed to aerosolize medication approved for nebulization and prescribed by a physician. The LC Sprint Star is intended for pediatric and adult patients consistent with the indications for the 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)

John Sign-Off) on St.(In-C-1)
Can of Anesthesiclogy, General Hospital, on Control. Dental De

Number: K062158

Page of (Posted November 13, 2003)

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