EOCD

K041568 · Respironics, Inc. · NFB · Jul 21, 2004 · Anesthesiology

Device Facts

• Record ID: K041568
• Device Name: EOCD
• Applicant: Respironics, Inc.
• Product Code: NFB · Anesthesiology
• Decision Date: Jul 21, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EOCD is intended as a pulse dose delivery device for medical-grade oxygen from portable high-pressure oxygen cylinders. Adult patients requiring supplemental oxygen and using ambulatory oxygen can use the EOCD to extend the use time of a fixed volume oxygen source. This device does not provide alarms and is not intended as life support.

Device Story

EOCD is a pulse dose oxygen delivery device for portable high-pressure cylinders; attaches via CGA 870 yoke. Device senses patient inspiration; triggers valve to deliver oxygen pulse; extends oxygen supply use time (4:1 conservation ratio). Features three modes: conserving (pulse), continuous, and off. Operated by ambulatory patients; used in home or clinical settings. Provides no alarms; not for life support. Healthcare providers use device to manage oxygen consumption for patients requiring supplemental therapy.

Clinical Evidence

Bench testing only. Performance, environmental, electrical, mechanical, and electromagnetic compatibility testing performed to verify safety and effectiveness.

Technological Characteristics

Includes regulator, valve, control circuitry, and enclosure. Designed for CGA 870 style yoke. Pulse dose delivery mechanism with 4:1 conservation ratio. Manual rotary switch for mode selection (pulse/continuous/off).

Indications for Use

Indicated for adult patients requiring supplemental ambulatory oxygen to extend the use time of fixed-volume high-pressure oxygen cylinders. Not for life support; no alarms provided.

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

• DeVilbiss Model PD 1000 (K020329)

Submission Summary (Full Text)

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**TAB 10**

| Official Contact | Lou Anne Kinney<br>Director, Regulatory and Clinical Affairs<br>Respironics Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name | EOCD |
| Common/Usual Name | Electronic Oxygen Conserving Device (EOCD) |
| Classification Name | Noncontinuous ventilator (IPPB). |
| Predicate Devices | DeVilbiss Model PD 1000(K020329) |

### Device Description

The EOCD is a pulse dose delivery device for medical-grade oxygen from portable high-pressure oxygen cylinders. Adult patients requiring supplemental oxygen and using ambulatory oxygen can use the EOCD to extend the use time of a fixed volume oxygen source. The device does not provide alarms and is not intended as life support. The device includes a built in regulator, valve, control circuitry, and enclosure. The device will be designed to a standard compressed gas cylinder with a CGA 870 style yoke.

The principle of operation for the EOCD is as follows:

The EOCD is a device that extends the "use time" from a supply of oxygen. As opposed to continuous delivery of oxygen, the EOCD delivers oxygen only when needed and provides a nominal oxygen conservation ratio of 4 to 1. The EOCD senses inspiration and opens a valve for a short duration of time. When the valve is open, oxygen flows to the patient. The duration the valve is opened is based on the flow setting. The patient can select the continuous mode of operation by manually selecting a continuous flow setting on the rotary switch.

The EOCD provides three modes of operation: conserving (pulse) mode, continuous mode, and off mode.

#### Indications for Use

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The EOCD is intended as a pulse dose delivery device for medical-grade oxygen from portable highpressure oxygen cylinders. Adult patients requiring supplemental oxygen and using ambulatory oxygen can use the EOCD to extend the use time of a fixed volume oxygen source.

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This device does not provide alarms and is not intended as life support.

# Technological characteristics, comparison to predicate devices

The Respironics EOCD has the same operating principles and same technology as the predicate device. The difference is that the EOCD conserve ratio is 4:1 compared to the predicate 3:1. However, there is no effect on safety or effectiveness.

#### Performance testing

Performance, environmental, electrical, mechanical and electromagnetic compatibility testing was performed to prove the safety and effectiveness of the EOCD.

## Conclusion

It is the conclusion of Respironics that the EOCD is substantially equivalent to devices already on the market (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.

(End of Tab.)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 21 2004

Ms. Lou Anne Kinney Director, Regulatory Affairs & Clinical Affairs Respironics, Incorporated Homecare Division 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668-8550

Re: K041568

Trade/Device Name: EOCD Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: NFB Dated: June 4, 2004 Received: June 10, 2004

Dear Ms. Kinney:

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 Eederal Register.

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# Page 2 - Ms. Kinney

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,

Chin Lin, Ph.D.

Chiu Lin, Ph.D. 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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# Indications for Use

510(k) Number (if known): _长岭1568

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The EOCD is intended as a pulse dose delivery device for medical-grade oxygen from portable high-pressure oxygen cylinders. Adult patients requiring supplemental oxygen and using ambulatory oxygen can use the EOCD to extend the use time of a fixed volume oxygen source.

This device does not provide alarms and is not intended as life support.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cunnyndagerns

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K041568