FLO-RITE

K041057 · Ameriflo Corp. · NFB · Aug 12, 2004 · Anesthesiology

Device Facts

• Record ID: K041057
• Device Name: FLO-RITE
• Applicant: Ameriflo Corp.
• Product Code: NFB · Anesthesiology
• Decision Date: Aug 12, 2004
• Decision: SESE
• Submission Type: Traditional
• 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 and Flo-Rite II are oxygen-conserving regulators designed for use with portable oxygen tanks. The device attaches to an oxygen cylinder to regulate flow and conserve oxygen supply during supplemental therapy. It is intended for use in home or ambulatory settings by patients under prescription. The device functions as a mechanical regulator to manage oxygen delivery, extending the duration of portable oxygen supplies for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical oxygen-conserving regulator for portable oxygen tanks. Designed for supplemental oxygen therapy delivery.

Indications for Use

Indicated for patients requiring supplemental oxygen therapy in home or ambulatory settings. Prescription use only.

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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2004

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

Re: K041057

Trade/Device Name: Flo-Rite and Flo-Rite II Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: NFB Dated: July 9, 2004 Received: July 13, 2004

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. Thie

Please be advised that FDA's issuance of a substantial equivalence determination does not r least 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. of the Act of ally I oderal states and engirements, including, but not limited to: registration I ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CF RT at 807), abouting systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in are qt 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) I mis letter will anon yourse of substantial equivalence of your device to a premailed notification - I 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), If you desire specific at 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 may 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 vours,

Ouls
Shih-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

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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, black letters. To the right of the word is a graphic of six horizontal lines that are parallel to each other and decrease in length from top to bottom. Below the word "AMERIFLO" is the word "CORPORATION" in smaller, black letters.

478 Gradle Dr. • Carmel Industrial Park • Carmel, IN 46032 • 800-976-2390 • 317-844-2019 • Fax [phone] www.ameriflo.com

## Indications for Use

## 510 (k) Number (if known): K041057

Device Name: Flo-Rite and Flo-Rite II

Indications for 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.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ques

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

510(k) Number:

2-1

AP