DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC

K983601 · Medical Electronic Devices, Inc. · NFB · Dec 15, 1998 · Anesthesiology

Device Facts

• Record ID: K983601
• Device Name: DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC
• Applicant: Medical Electronic Devices, Inc.
• Product Code: NFB · Anesthesiology
• Decision Date: Dec 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DOCD Demand Oxygen Conserving Device is indicated for use to conserve oxygen for patients prescribed 0 to 6 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.

Device Story

DOCD is a battery-operated, microprocessor-controlled oxygen conserver; installed between USP bottled oxygen supply and patient nasal cannula. Device uses capacitive breath sensor to detect negative pressure from patient inhalation; microprocessor triggers valve to open for 1 second, delivering oxygen flow set at regulator; valve closes during exhalation to conserve oxygen. Device includes battery status indicator and alarm system for cannula disconnection, restriction, or internal malfunction (audible tone if no inhalation detected within 30 seconds or self-check failure). Used in clinical or home settings by patients; provides oxygen delivery efficiency; reduces wasted oxygen during exhalation.

Clinical Evidence

Bench testing only. Testing included functional performance, impact/drop, storage temperature, electromagnetic interference, electrostatic discharge, surface temperature, battery life, and low power indicator testing. Results demonstrated compliance with performance objectives and FDA guidelines.

Technological Characteristics

Battery-operated, microprocessor-controlled electronic device. Features capacitive pressure transducer for breath sensing and normally closed valve for oxygen flow control. Dimensions/form factor not specified. Connectivity: standalone. Sterilization: not specified. Software: microprocessor-based control logic.

Indications for Use

Indicated for patients prescribed 0 to 6 liters per minute of supplemental oxygen requiring conservation of oxygen supply via nasal cannula and USP bottled 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.

Predicate Devices

• Invacare IPD Oxygen Conserving Device (K953852)
• CHAD Therapeutics, Inc. Oxymatic Electronic Oxygen Conserver (K852650)

Submission Summary (Full Text)

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# MEDICAL ELECTRONIC DEVICES CORP.

Image /page/0/Picture/2 description: The image shows a handwritten sequence of characters, which appears to be a code or identifier. The characters are 'K983601', written in a bold, somewhat rough style. The characters are distinct, but the handwriting gives them a slightly irregular appearance.

Demand Oxygen Conserving Device 510(k) Summary

## Submitter's Name, Address, Telephone Number, and Contact Person

### Submitter

Thomas Wenzel Medical Electronic Devices Corp. 2807 Oregon Court., "D6" Torrance, California 90503 [phone] Telephone: Facsimile: [phone]

### Contact Person

Thomas Wenzel Medical Electronic Devices Corp. 2807 Oregon Court., "D6" Torrance, California 90503 Telephone: [phone] [phone] Facsimile:

### Date Prepared

October 15, 1998.

### Name of Device

| Trade Name: | Demand Oxygen Conserving Device<br>or "DOCD" or "The DOC" |
|----------------------|-----------------------------------------------------------|
| Common name: | Oxygen Conserver |
| Classification name: | Ventilator, Non-Continuous (Respirator)<br>21CFR 868.5905 |

### Predicate Devices

(1) Invacare IPD Oxygen Conserving Device (K953852)

(2) CHAD Therapeutics, Inc. Oxymatic Electronic Oxygen Conserver (K852650)

#### Intended Use

The DOCD Demand Oxygen Conserving Device is indicated for use to conserve oxygen for patients prescribed 0 to 6 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.

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# MEDICAL ELECTRONIC DEVICES CORP.

### Technological Characteristics and Substantial Equivalence

The Demand Oxygen Conserving Device or "DOCD" is intended to be used as an accessory to an oxygen supply system to reduce or conserve the amount of oxygen used by the patient. The DOCD is a battery operated electronic device that is microprocessor controlled and contains a capacitive breath sensor and a normally closed valve. When installed between the oxygen supply and patient's nasal cannula, the device detects the patient's inhalation opens the valve for 1 second and delivers the flow rate of oxygen set at the regulator to the patient. The valve closes and conserves the oxygen that would have been wasted during exhalation. The 1 second valve open time was chosen based on the typical breathing pattern of inhalation for 1/3 of the time and exhalation for 2/3 of the time and a typical breath rate of 20 per minute and is equivalent to the predicate Impulse Venture Demand Oxygen Delivery Device.

The DOCD is intended to be used with USP bottled oxygen and nasal cannulas and is installed as shown in Figure 1.

Image /page/1/Figure/4 description: The image shows a diagram of an oxygen delivery system. The system includes a USP bottled oxygen tank connected to a pressure regulator and valve assembly. Oxygen flows through tubing to a DOCD oxygen conserver, and then to a nasal cannula (Hudson RCI No. 1103 or equivalent).

The front panel of the DOCD has a selector switch and a battery status light. When the selector switch is set to the "Bat" position the battery status light will illuminate to give the user an indication of the condition of the battery in the device. In addition to providing battery status information to the user while in the "Bat" setting, the DOCD will indicate a low battery condition by flashing the battery status light Red if the unit is in "On" position and the battery voltage falls below 1.10V.

When the selector switch is set to "ON" the device operates as follows:

The capacitive pressure transducer changes its capacitance in response to the negative pressure produced by the user's inhalation effort. This change in capacitance is converted into a change in voltage and is amplified. When this amplified voltage exceeds the reference voltage of the comparator, the comparator's output changes state. This change is input into the microprocessor. The microprocessor then opens the valve for 1 second and waits for the next negative pressure.

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# MEDICAL ELECTRONIC DEVICES CORP.

The DOCD contains an alarm package which is designed to alert the user in the event of disconnection or restriction of the cannula or unit malfunction. The DOCD will produce an audible alarm tone to alert the user if it has not detected sufficient negative pressure to cause the comparator output to change states within 30 seconds. The DOCD will also produce an intermittent audible tone if the device's continuous self check routine has detected a malfunction in the microprocessor or software control code.

The DOCD is substantially equivalent in intended use and principal of operation to other oxygen conserving devices including the Invacare IPD Oxygen Conserving Device (K953852) and the CHAD Therapeutics Oxymatic Electronic Oxygen Conserver (K852650). These predicate devices, like the DOCD, are electronic products that use a breath sensor and normally closed valve. Additionally, the Invacare IPD Oxygen Conserving Device, like the DOCD, opens the valve for 1 second and delivers the oxygen flow set on the regulator to the patient on every detected inhalation.

### Performance Data

Extensive functional testing of the DOCD has been performed. In addition, testing of the device has been performed under various environmental conditions, including impact/drop testing, storage temperature testing, electromagnetic interference testing, electrostatic discharge testing and surface temperature testing. Power supply testing was also performed; these tests included battery life testing and low power indicator testing. The functional, environmental and power supply testing performed on the device demonstrated that it meets its performance objectives and complies with applicable FDA quidelines.

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font and is aligned to the left. The text is likely part of a document or letterhead from a government agency.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 2002

Mr. Thomas Wenzel Medical Electronic Devices Corp. 2807 Oregon Court D6 Torrance, CA 90503

Re: K983601

> Demand Oxygen Conserving Device Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II (two) Product Code: 73 NFB

Dear Mr. Wenzel:

This letter corrects our substantially equivalent letter of December 15, 1998, regarding the Demand Oxygen Conserving Machine. 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. Thomas Wenzel

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,

Dana Telh

for 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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## Medical Electronic Devices Corp. Medical Lieban Conserving Device Indications for Use Statement

## 510(k) Reference Number:

This is an initial submission; no number has yet been assigned.

# Statement of Indications for Use:

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Cardiovascular, Respiratory,

510(k) Number ***_***

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use

(Optional Format 1-2-96)