EMOX

K954506 · Medtrak Intl., Inc. · CAW · Apr 30, 1996 · Anesthesiology

Device Facts

• Record ID: K954506
• Device Name: EMOX
• Applicant: Medtrak Intl., Inc.
• Product Code: CAW · Anesthesiology
• Decision Date: Apr 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The emOx™ device by MedTrak is intended to generate 99% pure oxygen for emergency first aid administration.

Device Story

Lightweight, portable chemical oxygen generator; produces >99% pure oxygen via chemical reaction. Oxygen bubbles pass through water-filled chamber for humidification; delivered to patient via flexible, ribbed tubing and standard adult or pediatric face mask. Device (excluding mask) does not contact patient. Used in emergency settings for first aid; operated by first responders or laypersons. Provides supplemental oxygen to assist patients in respiratory distress; benefits include immediate availability of high-purity oxygen without external power or compressed gas tanks.

Clinical Evidence

No clinical data. Bench testing performed by independent laboratories confirmed >99% oxygen purity, absence of CO/CO2 contaminants, stability (no fire/explosion hazard), non-toxic decomposition products, and a mean flow rate of 4.6 L/min.

Technological Characteristics

Chemical oxygen generator; polypropylene construction. Produces >99% pure oxygen via chemical reaction; humidified via water chamber. Flow rate 4.6 L/min. No electrical energy source. Non-patient contacting (except mask).

Indications for Use

Indicated for emergency first aid oxygen administration in adult or pediatric patients requiring supplemental oxygen.

Regulatory Classification

Identification

A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).

Predicate Devices

• Model 415 Oxygen Canister (K780020)

Submission Summary (Full Text)

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APR 30 1996
510(k) Premarket Notification for MedTrak International Inc: emOx™
Appendix VI, Page 1

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA

## 1. General Information

A. Submitted By:
MedTrak International, Inc.
9841 Broken Land Parkway, Suite 107
Columbia, MD 21406
Tel: [phone]
Fax: [phone]

Contact Person:
Belinda E. Berning at address above

B. Device Trade Name:
emOx™
Common Name
Emergency Oxygen Generator
Classification Name:
Portable Oxygen Generator

C. Predicate Device:
Model 415 Oxygen Canister
(Jet Research, Inc. - k780020)

D. Device Description:
The emOx™ device is a lightweight, portable device that produces oxygen of greater than 99% purity by a chemical reaction. The evolved oxygen bubbles pass through a water-filled chamber to humidify the gas on its way to the patient via flexible, ribbed tubing and an open adult or pediatric face mask.

The device, other than the face mask, does not come into contact with the patient. The mask is a currently legally marketed adult or pediatric mask. The oxygen container is constructed of polypropylene. Therefore, the biocompatibility of the materials used is without significance.

E. Intended Use:
The emOx™ device by MedTrak is intended to generate 99% pure oxygen for emergency first aid administration.

F. Device Comparison:
The MedTrak emOx™ Emergency Oxygen Generator is substantially equivalent to various other currently legally marketed devices, including the Model 415 Oxygen Canister by Jet Research Center, Inc. Each of these devices generates a minimum of 60 liters of oxygen of greater than 99% purity by chemical

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510(k) Premarket Notification for MedTrak International Inc: emOx™
Appendix VI, Page 2

reaction, which can be delivered to the patient at 4.0 L/min. or greater mean flow rates.

## II. Testing

### A. Non-clinical Tests:

Testing was performed by independent test laboratories for the following:

1. Purity of oxygen produced >99% pure
2. Contaminants No detectable CO or CO₂
3. Stability No fire or explosion hazard
4. Decomposition products Non-toxic
5. Mean Flow rate 4.6 L/min

### B. Clinical Tests:

No clinical tests were performed.

### C. Test Conclusions:

MedTrak’s emOx™ device meets product specifications and requirements of the Food and Drug Administration for classification as a Portable Oxygen Generator.