PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB

K023420 · Medical Electronic Devices, Inc. · NFB · Oct 25, 2002 · Anesthesiology

Device Facts

• Record ID: K023420
• Device Name: PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB
• Applicant: Medical Electronic Devices, Inc.
• Product Code: NFB · Anesthesiology
• Decision Date: Oct 25, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medical Electronic Devices Corp. POCDEs is intended for to conserve oxygen for patients prescribed 1 to 4 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.

Device Story

Battery-operated, microprocessor-controlled oxygen conserver; accessory to oxygen supply systems. Input: breath sensor detects patient inhalation. Operation: microprocessor triggers normally closed valve to deliver bolus of oxygen on every breath; bolus volume equivalent to 1-4 liters per minute constant flow. Output: pulsed oxygen delivery via nasal cannula. Used in clinical or home settings by patients prescribed supplemental oxygen. Benefits: reduces oxygen consumption compared to continuous flow, extending supply duration.

Clinical Evidence

Bench testing only. Performance, mechanical, electromagnetic, and environmental testing performed to demonstrate intended function.

Technological Characteristics

Battery-operated, microprocessor-controlled oxygen conserver. Includes breath sensor and normally closed valve. Dimensions/form factor not specified. Connectivity: standalone. Sterilization: not specified. Software algorithm: rule-based dosing.

Indications for Use

Indicated for patients prescribed 1 to 4 liters per minute of 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 Corporation unmodified POCD (K983459)
• CHAD Therapeutics OXYMATIC Model 311

Submission Summary (Full Text)

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# MED Corporation

OCT 2 5 2002

## Special 510(K)

#### 510(K) Summary

#### Medical Electronic Devices Corporation

#### Modified Medical Electronic Devices Corporation POCD Pulsed Oxygen Conserving Device

### October 2, 2002

#### Submitter Information:

Medical Electronic Devices Corporation 2807 Oregon Court, D6 Torrance, California 90503

| Submitter's Name: | Thomas Wenzel |
|-------------------|----------------|
| Phone: | [phone] |

#### Device Name:

| Proprietary Name: | Medical Electronic Devices Corporation POCD _EB |
|----------------------|-----------------------------------------------------------|
| Common Name: | Oxygen Conserver |
| Classification Name: | Noncontinuous Ventilator |

#### Predicate Device Equivalence:

Substantial equivalence is claimed to the Medical Electronic Devices Corporation unmodified POCD cleared for commercial distribution per K983459 and the CHAD Therapeutics OXYMATIC Model 311.

#### Device Description:

The Medical Electronic Devices Corp. POCDFR 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 POCDEe is a battery operated electronic device that is microprocessor controlled and contains a breath sensor and normally closed valve. It delivers boluses of oxygen every breath that is equivalent to 1 to 4 liters per minute constant flow, depending on the flow setting.

#### Intended Use:

The Medical Electronic Devices Corp. POCDEs is intended for to conserve oxygen for patients prescribed 1 to 4 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.

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#### Comparison of Technological Characteristics:

The POCDEB has the same technological characteristics as the predicate device, i.e. the POCD. The hardware portion of the device is identical to the POCD except for labeling. The software has been modified to deliver a bolus of oxygen on every breath, rather than skipping breaths at lower flow rates. This dosing algorithm is identical to the algorithm used in the predicate device CHAD Therapeutics OXYMATIC Model 311.

#### Summary of Testing:

Appropriate performance, mechanical, electromagnetic and environmental testing was performed to demonstrate that the POCDEB would perform as intended.

#### Conclusions:

Based on the above, we concluded that the POCDEs is substantially equivalent to currently marketed devices and is safe and effective for its intended use.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 5 2002

Mr. Thomas Wenzel President Medical Electronic Devices Corporation 2807 Oregon Court, D6 Torrance, California 90503

Re: K023420

Trade/Device Name: Pulsed Oxygen Conserving Device Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: 73 NFB Dated: October 10, 2002 Received: October 11, 2002

Dear Mr. Wenzel:

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.

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.

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Page 2 - Mr. Wenzel - -

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,

Timothy A. Ulatowski 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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# MED Corporation

# Medical Electronic Devices Corporation POCDEB Premarket Notification

### Indications for Use Statement

K02켜.20

Device Name:

Modified Medical Electronic Devices Corp. POCD Pulsed Oxygen Conserving Device (i.e. POCDEB)

#### Indications for Use:

The modified Medical Electronic Devices Corp. POCD Pulsed Oxygen Conserving Device is intended for use in the same manner as the unmodified device, i.e., to conserve oxygen for patients prescribed 1 to 4 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)

L. Richardson

sion Sign-Off) Division of Anesthesiology. General Hospital. Infection Control, Dental Devices

510(k) Number:

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter-Use _ (Optional Format 1-2-96)