FLOTEC OXYSAVRR (S)

K970371 · Flotec, Inc. · NFB · Jul 10, 1997 · Anesthesiology

Device Facts

• Record ID: K970371
• Device Name: FLOTEC OXYSAVRR (S)
• Applicant: Flotec, Inc.
• Product Code: NFB · Anesthesiology
• Decision Date: Jul 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

THERE ARE NO INDICATIONS FOR USE OF THIS DEVICE BY ITSELF. THE DEVICE IS AN OPTIONAL COMPONENT OF THE OXYGEN DELIVERY SYSTEM PRESCRIBED FOR USE BY PATIENTS, SUFFERING FROM CHRONIC OBSTRUCTIVE PULMONARY DISEASE. THE SOLE PURPOSE OF THIS DEVICE IS TO CONSERVE OXYGEN BY STOPPING THE FLOW WHEN THE PATIENT IS EXHALING OR PAUSING BETWEEN EXHALATION AND INHALING. FLOW RESUMES WHEN THE DEVICE SENSES THE BEGINNING OF INHALATION BY THE USER.

Device Story

The FLOTEC Oxysavrr™ is an oxygen-conserving device used as an accessory to oxygen delivery systems for patients with COPD. It functions by monitoring the patient's breathing cycle; it stops oxygen flow during exhalation and pauses, and automatically resumes flow upon sensing the onset of inhalation. This mechanism reduces oxygen waste, extending the duration of oxygen supply for the patient. It is intended for prescription use in clinical or home settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical oxygen-conserving device; functions as a noncontinuous ventilator accessory; senses inhalation to trigger oxygen flow; pneumatic operation.

Indications for Use

Indicated for patients with chronic obstructive pulmonary disease (COPD) requiring oxygen delivery systems. Used as an optional component to conserve oxygen.

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

FEB 26 2002

Mr. Gilbert Davidson
Flotec, Inc.
8132 Woodland Drive
Indianapolis, IN 46278

Re: K970371
FLOTEC Oxysavrr™
Regulation Number: 868.5905
Regulation Name: Noncontinuous Ventilator
Regulatory Class: II (two)
Product Code: 73 NFB

Dear Mr. Davidson:

This letter corrects our substantially equivalent letter of July 10, 1997, regarding the FLOTEC Oxysavrr™. Our letter identified the product code as 73 BZD. This is in error; the correct product code is 73 NFB as indicated above.

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. Gilbert Davidson

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,


Bram D. Zuckerman, M.D.
Acting Director
Division of Cardiovascular and Respiratory Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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Page one of one

510(k) Number (if known): K970371

FLOREC OXYSAVAN

Device Name: OXYGEN CONSERVER

(VENTILATOR - NON CONTINUOUS)

Indications For Use:

THERE ARE NO INDICATIONS FOR USE OF THIS DEVICE BY ITSELF.

THE DEVICE IS AN OPTIONAL COMPONENT OF THE OXYGEN DELIVERY SYSTEM PRESCRIBED FOR USE BY PATIENTS, SUFFERING FROM CHRONIC OBSTRUCTIVE PULMONARY DISEASE. THE SOLE PURPOSE OF THIS DEVICE IS TO CONSERVE OXYGEN BY STOPPING THE FLOW WHEN THE PATIENT IS EXHALING OR PAUSING BETWEEN EXHALATION AND INHALING. FLOW RESUMES WHEN THE DEVICE SENSES THE BEGINNING OF INHALATION BY THE USER.

FLOREC INC

[Signature]

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

Concurrence of CORH, Office of Device Evaluation (ODE)

[Signature]

(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K970371

[Signature]

Description Use ☑ (Per 21 CFR 801 109)

Over-the-Counter Use ☐

(Optional Format 1-2-96)