DEVILBISS PULMO-AIDE COMPACT COMPRESSOR

K020932 · Sunrise Medical · CAF · Jun 28, 2002 · Anesthesiology

Device Facts

• Record ID: K020932
• Device Name: DEVILBISS PULMO-AIDE COMPACT COMPRESSOR
• Applicant: Sunrise Medical
• Product Code: CAF · Anesthesiology
• Decision Date: Jun 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

The DeVilbiss compressor / nebulizer Model 3655 includes an AC powered air compressor that provides a source of compressed air for home health care use. The compressor is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatric patients.

Device Story

DeVilbiss Model 3655 is a piston-type AC-powered air compressor; designed for home health care use. Operates by providing compressed air to a jet (pneumatic) nebulizer; converts liquid medication into aerosol form for patient inhalation. Majority of aerosol mass consists of particles < 5 microns in diameter. Used under physician order for respiratory disorders (asthma, cystic fibrosis, COPD). Patient self-administers treatment via inhalation. Benefits include effective delivery of aerosolized medication for respiratory disease management.

Clinical Evidence

Bench testing only. Performance evaluations compared aerosol output and particle size distribution against the predicate device. Results demonstrate that the Model 3655 produces aerosol particle size performance comparable to legally marketed devices.

Technological Characteristics

Piston-type air compressor; AC motor-driven; metal and plastic construction. Complies with UL1431 and IEC 60601-1 safety standards. Produces aerosol with mass median diameter < 5 microns. Standalone device.

Indications for Use

Indicated for adult and pediatric patients requiring aerosolized medication for respiratory diseases including asthma, cystic fibrosis, and chronic obstructive pulmonary disease (COPD).

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

• DeVilbiss Model 3650 (K970289)

Submission Summary (Full Text)

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K020932

JUN 2 8 2002

#### 11.0 510(k) Summary

| Submitter's Name: | Sunrise Medical HHG, Inc.<br>Respiratory Products Division<br>100 DeVilbiss Drive<br>Somerset PA 15501<br>Ray Hoffman<br>(PH)814-443-7442<br>(Fax)814-443-7571 |
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| Date Prepared: | February 28, 2002 |
| Device Name: | Compressor / Nebulizer FDA Classification CAF |
| Common or Usual Name: | Compressor / Nebulizer |
| DeVilbiss Model Number: | 3655 Series |
| Trade Proprietary Name: | DeVilbiss Pulmo-Aide Compact Compressor |
| Established Registration Number: | DeVilbiss # 2515872 |
| FDA Classification: | Class II |
| Equivalent Legally Marketed Predicate Devices: | |

Legally Marketed Predicate Devices 510(k) Registration # K 970289 DeVilbiss Model 3650

### Description of Device:

The DeVilbiss Model 3655 Compressor/Nebulizer is a small, piston-type air compressor, sized to provide the proper flow and pressure sufficient to power jet (pneumatic) nebulizers. The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device (Underwriter's Laboratory Standard UL1431 and IEC 60601-1).

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Image /page/1/Picture/0 description: The image shows the word "SUNRISE" in bold, black letters. To the left of the word is a symbol that resembles a rising sun with horizontal lines representing the sun's rays. The symbol is also in bold, black color, matching the font of the word.

When the compressor is used in conjunction with a therapeutic nebulizer, the system converts liquid medication into an aerosol form that can be inhaled by the patient for the treatment of a variety of respiratory disorders. The DeVilbiss Model 3655 compressor/nebulizer system produces an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter.

#### Statement of Intended Use:

The DeVilbiss compressor / nebulizer Model 3655 includes an AC powered air compressor that provides a source of compressed air for home health care use. The compressor is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatric patients.

### Statement of Safety and Effectiveness:

The DeVilbiss Model 3655 aerosol compressor / nebulizer is equivalent in both function and indications for use to the DeVilbiss Model 3650 aerosol compressor / nebulizer legally marketed predicate device.

The DeVilbiss Model 3655 Compressor / Nebulizer is designed for use on the order of a physician for the treatment of respiratory diseases such as asthma, cystic fibrosis and chronic obstructive pulmonary disease. The compressor is constructed of materials, both metal and plastic, that are similar or identical to legally marketed devices. The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device

Used in conjunction with a jet (pneumatic) nebulizer, the system converts liquid medication into an aerosol form that can be inhaled by the patient for the treatment of a variety of respiratory disorders. The DeVilbiss Model 3655 compressor / nebulizer system produces an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter. This aerosol particle size performance is comparable to other legally marketed devices as noted in the Table of Comparison and the Discussion of Similarities and Performance Data (Sections 4.0 & 5.0),

The Table of Comparison and the Performance Evaluations (Sections 4.0 & 7.0) show that in terms of safety and effectiveness, the new DeVilbiss Model 3655 Compressor / Nebulizer is substantially equivalent to legally marketed predicate devices.

Legally Marketed Predicate Devices DeVilbiss Model 3650

510(k) Registration # K 970289

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## Technological Characteristics:

The DeVilbiss Model 3655 aerosol compressor / nebulizer is equivalent in functional characteristics to the existing legally marketed predicate devices. The devices all utilize an AC motor driven air compressor to provide a source of compressed air for operating a jet (pneumatic) nebulizer. All of the devices are tested and approved to recognized agency safety standards.

Testing performed on the aerosol output and particle size show that the new DeVilbiss Model 3655 is substantially equivalent to the existing legally marketed predicate devices and that all of these devices will produce a similar aerosol treatment.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 8 2002

Sunrise Medical HHG. Inc. c/o Ned Devine Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548

Re: K020932

Devilbiss Model 3655 Compressor/Nebulizer Regulation Number: 21 CFR 868.5630 and 21 CFR 868.6250 Regulation Name: Nebulizer and Portable Air Compressor Regulatory Class: II (two) Product Code: 73 CAF and 73 BTI Dated: June 14, 2002 Received: June 18, 2002

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. Ned Devine

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 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,

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

020932

Page 1 of 1

510(k) Number: (if known): ___________________________________________________________________________________________________________________________________________________

Device Name:

Indications For Use:

The DeVilbiss compressor / nebulizer Model 3655 includes an AC powered air compressor that provides a source of compressed air for home health care use. The compressor is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatric patients.

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(Division/Sign-Off)

Division of Cardiovascular and Respiratory Devices

| 510(k) Number | 14020932 |
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X Prescription use
-OR-
Over-the-counter use