OCD2001

K992935 · Contemporary Products, Inc. · NFB · Jun 20, 2000 · Anesthesiology

Device Facts

• Record ID: K992935
• Device Name: OCD2001
• Applicant: Contemporary Products, Inc.
• Product Code: NFB · Anesthesiology
• Decision Date: Jun 20, 2000
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The OCD2001 is indicated for use to conserve oxygen for patients prescribed 1/2 to 6 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.

Device Story

OCD2001 is a battery-operated, microprocessor-controlled oxygen conserving device; installed between oxygen supply and patient nasal cannula. Device uses a sensing diaphragm to detect 0.5cm negative pressure from patient inhalation; microprocessor triggers a normally closed valve to deliver a preset bolus of oxygen based on flow rate settings (1/2 to 6 LPM). Valve closes during exhalation to conserve oxygen. Device includes visual/audible alarms for low battery, cannula disconnection, or microprocessor failure. Used in clinical or home settings to reduce oxygen consumption; helps patients manage supplemental oxygen therapy by extending supply duration.

Clinical Evidence

Bench testing only. Testing included functional performance, impact/drop, storage temperature, electromagnetic interference, electrostatic discharge, surface temperature, and power supply/battery life testing.

Technological Characteristics

Battery-operated electronic device; microprocessor-controlled. Components: sensing diaphragm, normally closed valve, selector switch, LED indicators, audible alarm. Connectivity: standalone. Sterilization: not specified. Software: microprocessor-based control logic.

Indications for Use

Indicated for patients prescribed 1/2 to 6 LPM supplemental oxygen using nasal cannulas 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

• Medical Electronic Devices Corp. DOCD (K983601)
• Invacare IPD Oxygen Conserving Device (K953852)
• Chad Therapeutics, Inc. Oxymatic Electronic Oxygen Conserver (K852650)

Submission Summary (Full Text)

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JUN 2 0 2000

# Demand Oxygen Conserving Device 510(k) Summary

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

# Submitter

Barry A. Schwartz Contemporary Products, Inc. 530 Riverside Industrial Pkwy. Portland, ME 04103 Telephone: [phone] Facsimile: 207-797-9411 FDA Establishment No.: 1223412

# Contact Person

Barry A. Schwartz Contemporary Products, Inc. 530 Riverside Industrial Pkwy. Portland, ME 04103 Telephone: [phone] Facsimile: 207-797-9411

# Date Prepared

August 27, 1999

#### Name of Device

| Trade Name: | OCD2001 |
|----------------------|-----------------------------------------------------------|
| Common Name: | Oxygen Conserver |
| Classification Name: | Ventilator, Non-Continuous (Respirator)<br>21CFR 868.5905 |

# Predicate Devices

- 1. Medical Electronic Devices Corp. DOCD (K983601)
- 2. Invacare IPD Oxygen Conserving Device (K953852)
- 3. Chad Therapeutics, Inc. Oxymatic Electronic Oxygen Conserver (K852650)

# Intended Use

The OCD2001 is indicated for use to conserve oxygen for patients prescribed 1/2 to 6 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.

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# Technological Characteristics and Substantial Equivalence

The OCD2001 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 OCD2001 is a battery operated electronic device that is microprocessor controlled and contains a 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 according to the flow rate set on the device and delivers a preset bolus of oxygen to the patient as determined by the device flow rate algorithm. The valve closes and conserves the oxygen that would have been wasted during the end of inhalation and during exhalation.

The OCD2001 is intended to be used with USP bottled oxygen and nasal cannulas and is installed as shown in Figure 1.

Image /page/1/Figure/3 description: The image is a technical drawing of an oxygen delivery system, labeled as "FIGURE 1". The system includes an oxygen supply tank connected to a pressure regulator and valve assembly. Tubing runs from the regulator to an oxygen conserving device, and then to a nasal cannula.

The top panel of the OCD2001 has a selector switch, battery status light and flow fault/apnea light. The battery LED winks every four (4) seconds when about 3 hours remain in the batteries and once every second when about 30 minutes remain. An audible alarm "chirp" accompanies the LED blinking. It

Demand Oxygen Conserving Device 510(k) Summary Contemporary Products, Inc.

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then lights steady if batteries can no longer properly power the unit informing the patient that the unit has shut down.

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

The sensing diaphragm closes its circuit in response to .5cm negative pressure produced by the user's inhalation effort. This circuit closing is input into the microprocessor. The microprocessor then opens the valve to allow the appropriate bolus of oxygen to flow (based upon the chart that follows) and then waits for the next negative pressure.

Chart 1

| Liter Flow Setting | Bolus Size |
|--------------------|------------|
| 1/2 lpm | 5 ml |
| 1 lpm | 10 ml |
| 2 lpm | 20 ml |
| 3 lpm | 30 ml |
| 4 lpm | 40 ml |
| 5 lpm | 50 ml |
| 6 lpm | 60 ml |

The OCD2001 contains an alarm package that is designed to alert the user in the event of disconnection of the cannula or unit malfunction. The OCD2001 will produce an audible alarm tone to alert the user if it has not detected sufficient negative pressure to close the circuit on the sensing diaphragm with in 30 seconds. The OCD2001 will cause the flow/apnea light to light a steady red if the microprocessor should fail.

The OCD2001 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 OCD2001, are electronic products that use a breath sensor and normally closed valve. Additionally, the Invacare IPD Oxygen Conserving Device, like the OCD2001 opens the valve and delivers the oxygen to the patient on every detected inhalation.

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#### Performance Data

Extensive functional testing of the OCD2001 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 guidelines.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 2002

Mr. Barry A. Schwartz President Contemporary Products, Inc. 530 Riverside Industrial Pkwy. Portland, ME 04103

K992935 Re:

OCD2001 Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II (two) Product Code: 73 NFB

Dear Mr. Schwartz:

This letter corrects our substantially equivalent letter of June 20, 2000, regarding the OCD2001.
This is and the CC-FC TC TC TC TC This is in orror: the correct product odde This letter corrects our substantially equivalent iciter of Julio 20, 2017 - 3:40
Our letter identified the product code as 73 BZD. This is in error; the correct product code NFB as indicated above.

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > I (t) promatice is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to regally manced to dedical Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Pedical Of the Federal Food. Drue, commerce prior to May 28, 1976, the ellacinch and of the Federal Food, Drug, devices that have been reclassified in accordance when are approval application (PMA).
and Cosmetic Act (Act) that do not require and a premarket approval applicions of the A and Cosmetic Act (Act) that do ice, subject to the general controls provisions of the Act. The
You may, therefore, market a for a leaders of the general contrasts of the Ac You may, therefore, market the device, subject of the gents for annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act mender required in the management misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into entire) as iffective your device can
may be subject to such additional controls. Existing major regulations affection, FDA may may be subject to such additional controls. Extisting major regaleto 898 In addition, FDA may
be found in the Code of Federal Regulations, Title Foreign Fegulation FDA may be found in the Code of Pederal Regalations, Friday, Friday of the Federal Register.

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# Page 2 – Mr. Barry A. Schwartz

Please be advised that FDA's issuance of a substantial equivalence determination does not mean
ts of the Active the states of a subsition complies with other requirements of Please be advised that FDA's issuance of a substance of the requirements of the Act
that FDA has made a determination that your device aderacies. You must that FDA has made a determination inal your devec on other Federal agencies. You must
or any Federal statutes and regulations administered by other for and listin or any Federal statutes and regulations and limited to: registration and listing (21)
comply with all the Act's requirements, including, but not limited to set comply with all the Act s requirements, including, but not ministrative requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirement CFR Part 807); labeling (21 CFR Parl 801); good manufactures and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat 820); and 1f applicabl forth in the quality systems (QS) regulation (21 Of the Act); 21 CFR 1000-1050.
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)
. In the supportune and of a lines of shetertial squivalence of your device to a This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA innding of susun device and this, permit premarket notification. The FDA finding of substantal equivalence or your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your device on on stice devices), please contact the Office of
additionally 21 CFR Part 809.10 for in the commention on the promotion and ad additionally 21 CFR Part 809.10 for my life only, for questions on the promotion and advertising of
Compliance at [phone]. Additionally, for questions on the Compliance at [phone]. Additionally, 10thquest [phone]. Also, please note the your device, please confact the Office of Companies notification" (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket not the obtained from the regulation entitled, "Misbranding by relective to promation and the Act may be obtained from the
Other general information on your responsibilities under the Act its toll-fre Other general information on your responsional and Consumer Assistance at its toll-free number
Division of Small Manufacturers, International and Consumer Assistance at its t Division of Sinan Manafacts, or at its Internet address [phone] 01 [phone]-08-2017 (48-12-20-17) 11-12-20-17 (4

Sincerely yours,

Dale Tellin

A 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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Contemporary Products, Inc. Demand Oxygen 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:

The OCD2001 Demand Oxygen Conserving Device is indicated for use to conserve oxygen for patients prescribed 1/2 to 6 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

for Mark n Melkerson
(Division Sign-Off)
Division of Cardiovascular, Respiratory and Neurological Devices
510(k) Number: K992935

Prescription Use ✓
(Per 21 CFR 801.109)
OR
Over-the-Counter Use **__**

(Optional Format 1-2-96)