MASTER NEB II

K970542 · Bremed Italia, S.R.L. · CAF · Jun 24, 1997 · Anesthesiology

Device Facts

• Record ID: K970542
• Device Name: MASTER NEB II
• Applicant: Bremed Italia, S.R.L.
• Product Code: CAF · Anesthesiology
• Decision Date: Jun 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This product is an air compressor that when used in conjunction with a hand held nebulizer, produces the nebulization of a liquid prescribed medication. The compressor produces an air source that is channeled through tubing into the hand held nebulizer. The nebulizer creates an aerosol mist by forcing the compressed air through the nebulizer baffle. This creates negative pressure in which the liquid medication is vacuumed into the air, creating the aerosol mist.

Device Story

Master Neb II is an air compressor system for aerosolizing liquid medications; operates by driving compressed air through tubing into a hand-held nebulizer; negative pressure created at the nebulizer baffle draws liquid medication into the airstream to produce aerosol mist; intended for use with various commercially available hand-held nebulizers; device components include a thermally protected motor, cylinder and piston assembly, housing, switch, electrical cord, and a printed circuit board for wiring stability; operated by patients or caregivers in home or clinical settings to facilitate respiratory therapy.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and performance characteristics.

Technological Characteristics

System includes a thermally protected motor, cylinder and piston compressor assembly, housing, switch, electrical cord, and a printed circuit board. Operates as an air compressor for nebulization. No specific material standards or connectivity features described.

Indications for Use

Indicated for patients requiring nebulized liquid medication delivery via a hand-held nebulizer powered by an external air compressor.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 24 1997

Bremed Italia
c/o Mr. Mark Hebenstreit
1337 Rockwood Forest Drive
Arnold, Missouri 63010

Re: K970542
Master Neb II
Regulatory Class: II (two)
Product Code: 73 CAF
Dated: May 15, 1997
Received: May 16, 1997

Dear Mr. Hebenstreit:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Mark Hebenstreit

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular,
Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

510(k) Number: Pending

Device Name: Master Neb II

## Indications for Use:

This product is an air compressor that when used in conjunction with a hand held nebulizer, produces the nebulization of a liquid prescribed medication. The compressor produces an air source that is channeled through tubing into the hand held nebulizer. The nebulizer creates an aerosol mist by forcing the compressed air through the nebulizer baffle. This creates negative pressure in which the liquid medication is vacuumed into the air, creating the aerosol mist.

This product contains the exact same technological characteristics of similar devices currently on the market. The product functions exactly as these similar devices.

The product is designed with similar performance characteristics as devices currently on the market. The performance of the device allows it to be used in conjunction with various hand held nebulizers that are currently in distribution in the United States and Europe.

The components found within this product are common items. The product consists of a thermally protected motor, a cylinder and piston assembly (the compressor) attached to the motor, the case, a switch, an electrical cord, and a printed circuit board. The circuit board makes the wiring more stable and organized, thus ensuring higher quality and safety.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use XXXXX

OR

Over-The-Counter

Richard N. Phillips
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K970542