FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1

K060382 · Ameriflo Corp. · NFB · Apr 19, 2006 · Anesthesiology

Device Facts

• Record ID: K060382
• Device Name: FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1
• Applicant: Ameriflo Corp.
• Product Code: NFB · Anesthesiology
• Decision Date: Apr 19, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Flo-Rite Conserving Device Regulator is intended for prescription use only, to be used in conjunction with a portable oxygen tank for supplemental oxygen therapy for in home or ambulatory application.

Device Story

Flo-Rite, Flo-Rite II, Neumatix, Simpulse, and Simpulse II are oxygen conserving device regulators; used with portable oxygen tanks to provide supplemental oxygen therapy. Devices regulate flow for home or ambulatory patients; operated by patients or caregivers. Function involves mechanical gas flow control to conserve oxygen supply during therapy. Output is regulated oxygen delivery to the patient. Benefit includes extended duration of portable oxygen supply for ambulatory use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Oxygen conserving device regulators; mechanical gas flow control; intended for use with portable oxygen tanks. No specific materials, software, or electronic components described.

Indications for Use

Indicated for patients requiring supplemental oxygen therapy, for use in home or ambulatory settings in conjunction with a portable oxygen tank.

Regulatory Classification

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of a human figure with three wavy lines extending upwards, enclosed within a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 9 2005

Mr. Matthew Thie Ameriflo Corporation 478 Gradle Drive Carmel Industrial Park Carmel, Indiana 46032

Re: K060382

Trade/Device Name: Flo-Rite, Flo-Rite II, Neumatix, Simpulse and Simpulse II Regulation Number: 21 CFR 868.5905 Regulation Name: Non-continuous ventilator Regulatory Class: II Product Code: NFB Dated: March 16, 2006 Received: March 21, 2006

Dear Mr. Thie:

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. Matthew Thie

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,

Ynitta Y. Mcharlins.

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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Image /page/2/Picture/0 description: The image shows the logo for AMERIFLO Corporation. The word "AMERIFLO" is in large, bold, sans-serif font, with the letters slightly slanted to the right. To the right of the word "AMERIFLO" are five horizontal lines of varying lengths, creating a sense of motion or speed. Below the word "AMERIFLO" is the word "CORPORATION" in a smaller, sans-serif font.

478 Gradle Dr. • Carmel Industrial Park • Carmel, IN 46032 • 800-976-2390 • Fax [phone] • www.ameriflo.com

## Indications for Use

510(k) Number (if known): K060382 Device Name: _ Flo-Rite, Flo-Rite II, Nuematix, Simpulse and Simpulse II.

The Flo-Rite Conserving Device Regulator is intended for Indications for Use: prescription use only, to be used in conjunction with a portable oxygen tank for supplemental oxygen therapy for in home or ambulatory application.

Prescription Use X (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)

Vinu Abraham

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AMP

Manufacturers of quality gas flow control equipment and medical products