TREK S NEBULIZER COMPRESSOR

K060357 · Pari Innovative Manufacturers, Inc. · CAF · Apr 5, 2006 · Anesthesiology

Device Facts

• Record ID: K060357
• Device Name: TREK S NEBULIZER COMPRESSOR
• Applicant: Pari Innovative Manufacturers, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Apr 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

The Trek S nebulizer compressor is a portable, DC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The Trek S is intended for adult and pediatric patients.

Device Story

Trek S is a portable, DC-powered air compressor providing compressed air for jet nebulizers. Used in hospital, clinic, or home environments by adult and pediatric patients. Device features piston-driven, oil-free reciprocating mechanism. Powered by DC motor with AC-to-DC adapter or optional battery pack. Healthcare providers use device to facilitate aerosolized medication delivery to patients. Benefits include portability for patient use in various settings.

Clinical Evidence

No clinical data; bench testing only. Performance compared to predicate devices regarding Total Output Rate, MMD, and volume % < 5 um demonstrated comparability.

Technological Characteristics

Piston-driven, oil-free reciprocating air compressor. Materials: polymer cylinder and housing, Teflon piston seal, silicon valves. Power: DC motor, AC-to-DC adapter, optional battery pack. Non-sterile. Portable form factor.

Indications for Use

Indicated for adult and pediatric patients requiring a source of compressed air for use with jet nebulizers.

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

• Walkhaler Portable Compressor (K960675)
• Proneb® Ultra (K002862)

Submission Summary (Full Text)

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K060357

5 2006 APR

PARI rek™ S 510(k) submission 510(k) Summary

#### Submitt r Information PARI Innovative Manufacturers, Inc. Name: 2943 Oak Lake Blvd. Address Midlothian, VA 23112 804-253-7274 x269 Phone N imber: 804-639-7244 Fax Nun ber: Contact lame: Michael Judge December 19, 2005 Date Pre ared:

| Device Name | | |
|----------------------|--|-------------------------------------------------------------------------|
| Common Name: | | Nebulizer compressor |
| Proprietary Name: | | PARI Trek™ S |
| Classification Name: | | Nebulizer (Direct Patient Interface), 21 CFR 868.5630, Product Code CAF |

### Legally Marketed Predicate Device(s)

| Manufa turer | Device | 510(k) Number |
|--------------------------------------|-------------------------------|---------------|
| PARI Ir ovative Manufacturers, Inc. | Walkhaler Portable Compressor | K960675 |
| PARI Ir. ovative Manufacturers, Inc. | Proneb® Ultra | K002862 |

#### Device | escription

The Trel MS nebulizer compressor is a portable, DC-powered air compressor intended to provide a source of comp ssed air for use with jet nebulizers. The Trek™ S is intended for adult and pediatic patients. The dev e is non-sterile, prescription-use only, intended for use in bospital, clinic, or home environments.

#### Intende Use

The Tre TM S nebulizer compressor is a portable, DC-powered air compressor intended to provide a source of comp ssed air for use with jet nebulizers. The Trek™ S is intended for adult and pediatic patients.

#### Technol gical Characteristics Compared to Predicate Device

PARI Ti :k™ S, PARI Proneb® Ultra, and PARI Walkhaler® are all air compressors intended to provide a source o compressed air for use with jet nebulizers. All three devices are piston-driven, oil-free reciproc ting air compressors.

PARI Ti :k™ S employs similar materials compared to the predicate devices, including a polymer cylinder and hou ng, Teflon piston seal and silicon valves. PARI Trek™ S is similar to the Walkhaler® compres or regarding the DC motor, AC-to-DC adapter, and optional battery pack for portable use. Operati 3 pressure and jet flow produced by the PARI Trek™ S is comparable to the predicates.

#### Non-Cli rical Test Summary

PARI T km S was tested with various nebulizers to compare performance to the predicate devices, includin :

- Tot 1 Output Rate: PARI Trek™ S TOR is comparable to the predicate devices D
- a MN D: PARI Trek™ S MMD is comparable to the predicate devices
- Voi me % < 5 um: PARI TrekTM S is comparable to the predicate devices l

#### Clinical Performance Summary

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

#### Conclu: ons from Testing

PARI I x™ S meets performance requirements and raises no new issues of safety or effectiveness.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA". The logo is black and white.

5 2006 APR

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K060357

Trade/Device Name: Trek S Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: March 27, 2006 Received: March 28, 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.

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.

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# Page 2 - Mr. Robert Mosenkis

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Smith. Y. Michael Davis

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

Kolo 35

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

Device Name: Trck S

・・

# Indications for Use:

The Trek S nebulizer compressor is a portable, DC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The Trek S is intended for adult and pediatric patients.

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)

llion like m

gy, General Hospital,
Control Dental Devices

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