ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER

K024023 · Essex Medical Systems Plus · NFB · Oct 1, 2003 · Anesthesiology

Device Facts

• Record ID: K024023
• Device Name: ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER
• Applicant: Essex Medical Systems Plus
• Product Code: NFB · Anesthesiology
• Decision Date: Oct 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Essex High Pressure (HP) OCD and Essex Escort Pneumatic Conserver are used to deliver a prescribed flow of gas to the patient while conserving gas, by sensing the patient inhalation cycle and supplying gas only during that phase of breathing.

Device Story

Essex High Pressure (HP) OCD and Essex Escort Pneumatic Conserver are pneumatic oxygen delivery devices. They function by sensing patient inhalation cycles and delivering oxygen flow only during the inhalation phase to conserve gas. Used in clinical or home settings to manage supplemental oxygen delivery. Operated by patients or caregivers under physician prescription. Output is controlled oxygen flow synchronized with breathing. Benefits include extended duration of oxygen supply from portable tanks.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pneumatic oxygen delivery system; mechanical sensing of inhalation cycle; non-electric; designed for high-pressure oxygen tanks.

Indications for Use

Indicated for patients requiring supplemental oxygen therapy who need a prescribed flow of gas delivered via a pneumatic conserver to optimize gas usage by synchronizing delivery with the patient's inhalation cycle.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 1 2003

Essex Medical Systems Plus c/o Ms. Susan D. Goldstein-Falk mdi Consultants 55 Northern Blvd Suite 200 Great Neck, New York 11021

Re: K024023

Trade/Device Name: Essex High Pressure (HP) OCD Essex Escort Pneumatic Conserver Regulation Number: 21 CFR 868.5905 Regulation Name: Ventilator, Non-Continuous (Respirator) Regulatory Class: II Product Code: NFB Dated: July 2, 2003 Received: July 3, 2003

Dear Ms. Goldstein-Falk:

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 - Ms. Goldstein-Falk

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 vour device to proceed to the market.

If vou 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 Runge

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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Attachment 1

Page ______ of __ 1

510(k) Number (if known): _ ¥024023

Device Name: Essex High Pressure (HP) OCD and Essex Escort Pneumatic Conserver

Indications For Use:

The Essex High Pressure (HP) OCD and Essex Escort Pneumatic Conserver are used to deliver a prescribed flow of gas to the patient while conserving gas, by sensing the patient inhalation cycle and supplying gas only during that phase of breathing.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
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| | <div> (Division Sign-Off) </div> | |
| | Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number: | K024023 | |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The Counter Use (Optional Format 1-2-96) |