PARI VIOS

K092918 · Pari Respiratory Equipment, Inc. · CAF · Feb 4, 2010 · Anesthesiology

Device Facts

• Record ID: K092918
• Device Name: PARI VIOS
• Applicant: Pari Respiratory Equipment, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Feb 4, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The PARI Vios is a tabletop, AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The PARI Vios is intended for adult and pediatric patients for use in hospital, clinic, or home environments.

Device Story

PARI Vios is a tabletop, AC-powered, piston-driven, oil-free, reciprocating air compressor. It provides a source of compressed air to drive jet nebulizers for aerosolized medication delivery. The device is intended for use by adult and pediatric patients in hospitals, clinics, or home environments. It features a fan-cooled shaded pole AC motor, an integrated carry handle, and a front-panel air outlet with filter access. The device operates by generating compressed air, which is delivered to a connected jet nebulizer to facilitate patient inhalation of medication. It does not involve complex software or automated analysis.

Clinical Evidence

No clinical data was required or provided. Substantial equivalence was established through bench testing comparing the device's performance (total output rate, MMD, volume percentage <5 µm, and operating pressure) to the predicate devices.

Technological Characteristics

Piston-driven, oil-free, reciprocating air compressor. Materials: polymeric cylinder and housing, Teflon piston seal, silicone valves. Energy source: AC-powered, fan-cooled shaded pole motor. Form factor: tabletop unit with integrated carry handle, front-panel air outlet, and filter access. Non-sterile. No software or algorithm components.

Indications for Use

Indicated for adult and pediatric patients requiring compressed air for jet nebulizer therapy in hospital, clinic, or home settings.

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

• Trek S Nebulizer Compressor (K061381)
• Proneb Ultra (K002862)

Submission Summary (Full Text)

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K092918

## FEB - 4 2010

## PARI Vios 510(k) Submission 510(k) Summary

#### Submitter Information

| Name: | PARI Respiratory Equipment, 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; | September 18, 2009 |

#### Device Name

| Common Name: | Nebulizer Compressor |
|----------------------|-------------------------------------------------------------------|
| Trade Name: | PARI Vios |
| Classification Name: | Nebulizer (Direct Patient Interface), §868.5630, Product Code CAF |

#### Legally Marketed Predicate Device(s)

| Manufacturer | Device | 510(k) Number |
|----------------------------------|-----------------------------|---------------|
| PARI Respiratory Equipment, Inc. | Trek S Nebulizer Compressor | K061381 |
| PARI Respiratory Equipment, Inc. | Proneb Ultra | K002862 |

#### Device Description

The PARI Vios nebulizer compressor is a small, lightweight AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The device is non-sterile and prescriptionuse only.

#### Indications For Use

The PARI Vios is a tabletop, AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The PARI Vios is intended for adult and pediatric patients for use in hospital, clinic, or home environments.

#### Technological Characteristics Compared to Predicate Devices

The PARI Vios, PARI Proneb Ultra, and PARI Trek.S are all air compressors intended to provide a source of compressed air for use with jet nebulizers. All three devices are piston-driven, oil-free, reciprocating air compressors.

PARI Vios employs similar materials compared to the predicate devices, including a polymenc cylinder and housing, Teflon piston seal, and silicone valves. PARI Vios is similar to the Proneb Ultra compressor regarding the fan-cooled shaded pole AC motor, integrated carry handle, and front-panel air outlet and filter access. Operating pressure and jet flow produced by the PARI Vios is comparable to the predicates.

#### Non-Clinical Test Summary

PARI Vios was tested with various nebulizers to compare performance to the predicate devices, including:

- Total Output Rate: PARI Vios TOR is comparable to the predicate devices. #
- MMD: PARI Vios MMD is comparable to the predicate devices .
- Volume % <5 µm: PARI Vios is comparable to the predicate devices ..
- Operating Pressure: PARI Vios is comparable to the predicate devices I

#### Clinical Performance Summary

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

#### Conclusions from Testing

PARI Vios meets performance requirements and raises no new issues of safety or effectiveness.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

Mr. Michael Judge Director of Quality Assurance/Regulatory Affairs PARI Respiratory Equipment, Incorporated 2943 Oak Lake Boulevard Midlothian, Virginia 23112

FEB - 4 2010

Re: K092918

Trade/Device Name: PARI Vios Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: January 11, 2010 Received: January 12, 2010

Dear Mr. Judge:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Judge

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Anthony D. Watson, B.S., M.S., M.B.A. 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: PARI Vios

#### Indications for Use:

The PARI Vios is a tabletop, AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The PARI Vios is intended for adult and pediatric patients for use in hospital, clinic, or home environments.

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)

L. Schultheis

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

510(k) Number: KD 92918

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