LC SPRINT NEBULIZER

K060399 · Pari Innovative Manufacturers, Inc. · CAF · Mar 2, 2006 · Anesthesiology

Device Facts

• Record ID: K060399
• Device Name: LC SPRINT NEBULIZER
• Applicant: Pari Innovative Manufacturers, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Mar 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 Sprint is a handheld nebulizer, designed to aerosolize medication approved for nebulization and prescribed by a physician. The LC Sprint is intended for adult and pediatric patients consistent with the indications for the aerosol medication.

Device Story

LC Sprint is a handheld, air-powered, reusable jet nebulizer; intended for single-patient use. Device connects to an external air compressor to aerosolize liquid medications for inhalation. Operates via a 2-way valve system and breath-enhanced design to deliver medication to the lungs. Used in hospital, clinic, or home environments; operated by patients or caregivers under physician prescription. Output is an aerosolized mist of medication; enables targeted respiratory drug delivery for patients with respiratory conditions. Bench testing confirms performance metrics (MMAD, respirable mass, total mass) are comparable to predicate devices.

Clinical Evidence

No clinical data provided. Substantial equivalence established via bench testing comparing MMAD, respirable mass, and total mass to predicate devices.

Technological Characteristics

Air-powered jet nebulizer; breath-enhanced design; 2-way valve system. Non-sterile, reusable, single-patient use. Energy source: external air compressor. Materials are similar to the PARI LC Star nebulizer.

Indications for Use

Indicated for adult and pediatric patients requiring aerosolized medication delivery via nebulization, consistent with the specific indications of the prescribed medication.

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

• Airlife® Misty Max 10TM Nebulizer (K023602)
• PARI LC® Star Nebulizer (K963924)

Submission Summary (Full Text)

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K060399

#### MAR 2 2006

# I.C Sprint Reusable Nebulizer 510(k) Submission 510(k) Summary

## Submitter Information

| Name: | PARI Innovative Manufacturers, Inc. | |
|----------------|---------------------------------------------|--|
| 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: | November 22, 2005 | |
| Device Name | | |
| Common Name: | Nebulizer | |

Proprietary Name: Multiple Nebulizer (Direct Patient Interface), 21 CFR 868.5630, Product Code CAF Classification Name:

### Legally Marketed Predicate Device(s)

| Manufacturer | Device | 510(k) Number |
|-------------------------------------|-----------------------------------|---------------|
| Allegiance Healthcare Corporation | Airlife® Misty Max 10TM Nebulizer | K023602 |
| PARI Innovative Manufacturers, Inc. | PARI LC® Star Nebulizer | K963924 |

#### Device Description

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

#### Technological Characteristics Compared to Predicate Device

I.C Sprint, Misty Max 10, and I.C Star are all nebulizers used to aerosolize medication for inhalation. All three devices are air compressor-driven jet nebulizers using the same acrosolization method.

LC Sprint employs similar materials compared to the I.C. Star nebulizer, has a similar breath-enhanced design, and utilizes a 2-way valve system similar to that used by the I.C Star.

#### Non-Clinical Test Summary

I.C Sprint was tested to compare performance to the predicate devices, including:

- . MMAD: LC Sprint MMAD is comparable to the predicate devices
- . RM: I.C. Sprint RM is comparable to the predicate devices
- Total Mass: LC Sprint 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

I.C Sprint meets performance requirements and raises no new issues of safety or effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 MAR 2

Mr. Robert Mosenkis President Citech 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298

Re: K060399

Trade/Device Name: LC Sprint Reusable Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: February 14, 2006 Received: February 15, 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. Robert Mosenkis

Please be advised that FDA's issuance of a substantial equivalence determination Joes 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,

Susan Runyes
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): K060399

Device Name: LC Sprint

Indications for Use:

The LC Sprint is a handheld nebulizer, designed to aerosolize medication approved for nebulization and The LO Ophili is a handinor, as a manufact for adult and pediatric 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)

Quysehom

(Division Sian-Off) Division o hesthesiology, General Hos Infection ontrol, Dental Devi

510(k), sumber:

(Posted November 13, 2003)