SILFAB SUPER 2 MAX COMPRESSOR, N28 SERIES

K050183 · Silvestrin Fabris S.R.L. · CAF · Aug 16, 2005 · Anesthesiology

Device Facts

• Record ID: K050183
• Device Name: SILFAB SUPER 2 MAX COMPRESSOR, N28 SERIES
• Applicant: Silvestrin Fabris S.R.L.
• Product Code: CAF · Anesthesiology
• Decision Date: Aug 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The SILFAB model Super 2 Max N28 Compressor / Nebulizer is an ACpowered air compressor that provides compressed air for home health care use. This device is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol for inhalation by a patient. The device can be used with adult or pediatric patients suffering from respiratory disorders such as asthma, allergies, etc

Device Story

AC-powered air compressor; provides compressed air to drive jet (pneumatic) nebulizers. Used in home healthcare settings by patients or caregivers. Device converts liquid medication into aerosol for patient inhalation. Intended for respiratory disorder management. No complex electronics, software, or AI/ML components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

AC-powered air compressor; pneumatic output for jet nebulizer; home-use form factor. No software or digital connectivity.

Indications for Use

Indicated for adult and pediatric patients with respiratory disorders (e.g., asthma, allergies) requiring aerosolized medication delivery via a jet nebulizer.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows a circular logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which is a stylized representation of a human figure with three arms or lines extending upwards, symbolizing health, services, and people. The emblem is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 6 2005

Mr. Federico Silverstrin R&D Manager Silvestrin Fabris S.R.I. Av. La Plata 1560 Burnod Aires ARGENTINA 1250

Re: K050183

Trade/Device Name: SIFAB Super 2 Max Compressor, N28 Sevies Regulation Number: 21 CFR 868.5630 Regulation Name: Compressor/Nebulizer Regulatory Class: II Product Code: CAF Dated: July 18, 2005 Received: July 27, 2005

Dear Mr. Silverstrin:

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.

{1}------------------------------------------------

Page 2 -Mr. Silverstrin

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), 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,

Chih Lin, Ph.D.

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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known): k050183

SILFAB Super 2 Max Compressor, N28 Series Device Name:

Indications For Use:

The SILFAB model Super 2 Max N28 Compressor / Nebulizer is an ACpowered air compressor that provides compressed air for home health care use. This device is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol for inhalation by a patient. The device can be used with adult or pediatric patients suffering from respiratory disorders such as asthma, allergies, etc

Prescription Use × (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Auy Subron

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices KOSO185

510(k) Number:

Page 1 of __ 1________________________________________________________________________________________________________________________________________________________________