EASY PULSE II OXYGEN CONSERVER

K032018 · Precision Medical, Inc. · NFB · Aug 25, 2003 · Anesthesiology

Device Facts

• Record ID: K032018
• Device Name: EASY PULSE II OXYGEN CONSERVER
• Applicant: Precision Medical, Inc.
• Product Code: NFB · Anesthesiology
• Decision Date: Aug 25, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Precision Medical, Inc. Easy Pulse II Oxygen Conserver is intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. The patients would normally receive the oxygen via a nasal cannula. The system delivers 100% oxygen at 5 different flow settings. It is intended to be used as ambulatory source of oxygen both inside and out side of the patient's home. It is not intended as a life supporting device. The device has no contraindications.

Device Story

Easy Pulse II Oxygen Conserver provides supplemental oxygen to patients; delivers 100% oxygen via nasal cannula at 5 flow settings. Used as ambulatory oxygen source inside/outside home. Operated by patient. Device functions as oxygen conserver; not life-supporting. Benefits patient by providing portable oxygen therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Oxygen conserver; delivers 100% oxygen at 5 flow settings; ambulatory use; non-life supporting.

Indications for Use

Indicated for patients requiring supplemental oxygen due to difficulty extracting oxygen from ambient air. Used with nasal cannula. No contraindications. Not for life support.

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 & Human Services. The logo is circular and contains the text "HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines that resemble an abstract bird in flight. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2003

Mr. James Parker Ouality Assurance Manager Precision Medical, Incorporated 300 Held Drive Northampton, Pennsylvania 18067

Re: K032018

Trade/Device Name: Easy Pulse II Oxygen Conserver Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: NFB Dated: June 26, 2003 Received: June 30, 2003

Dear Mr. Parker:

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 ensctment 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. Parker

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/dsma/dsmamain.html

Sincerely yours,

Susan Ruoary

Susan Runner, DDS, MA Interim 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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Easy Pulsc II

510 (k) number (if known) KO32 2 0 18

Device Name: Precision Medical, Inc.Easy Pulse II Oxygen Conserver

Indications for use:

The Precision Medical, Inc. Easy Pulse II Oxygen Conserver is intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. The patients would normally receive the oxygen via a nasal cannula. The system delivers 100% oxygen at 5 different flow settings. It is intended to be used as ambulatory source of oxygen both inside and out side of the patient's home. It is not intended as a life supporting device. The device has no contraindications.

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Concurrence of CDRH, office of device Evaluation (ODE)

Prescription Use
OrOver the counter use
(Per 21 CFR 801.109)
(Optional Format 1-2-9)

(Per 21

sthesiology, General Hospital

510(k) Number: K032018