OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-03

{0}------------------------------------------------ K033863 # AUG 2 2 2005 # 510(k) PREMARKET SUMMARY General Information: | 1. | Original Date Submitted: | November 10, 2003 | |----|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2. | Submitted By: | OX-GEN Corporation<br>P.O. Box 5867<br>Boise, ID 83705<br>Tel: (208) 336-0773<br>Fax: (208) 336-0775<br>Contact Person:<br>Frank Fosella, Jr. | | 3. | Device Trade Name: | OX-GEN Rigid O2 Generation System, Model 5-OX-03 | | | Common Name: | Portable Oxygen Generator | | | Classification Name: | Portable Oxygen Generator | | 4. | Legal to Market<br>Predicate Device: | Jet Research Center, Model 415 Oxygen Canister and<br>Dispenser, Model 3445-c.<br>510(k): K780020<br><br>Canogen International LTD., Model 615 Portable<br>Oxygen Generator.<br>510 (k): K982243 | ### ડ. Device Description: The OX-GEN Rigid O2 Generation System, Model 5-OX-03 is found to be substantially equivalent in that it produces a minimum of 6 liters per minute of 99% pure oxygen for a 15 minute interval, by means of a chemical reaction. The OX-GEN Rigid O2 Generation System is composed of three self-contained chambers that when opened are activated and begin to generate instant, non-pressurized oxygen. The second part of the device consists of the plastic tubing, an inline filter and an oxygen mask, which are attached to the outlet of the oxygen generator. - 6. Indications for Use: The OX-GEN Rigid O2 Generation System, Model 5-OX-03 is intended to produce instant, non-pressurized oxygen for emergency uses. {1}------------------------------------------------ ## TECHNOLOGICAL COMPARISON The OX-GEN Rigid O2 Generation System, the Jet Research Center Model 415 and the TIC OX-OLN Right O7 Seneration Model 615 are all designed to generate oxygen as a Callogen I ortable Oxygen Generatives devices are comprised of a kit containing the result of a enembed reaction. In themicals and accessories to provide oxygen for emergency use. Jet Research Center Model 415 and the Canogen Portable Oxygen Generator Model 615 see a hard plastic multi-chambered reaction container. The container provides several use a nard plastic many cas the packaging for the Jet Research Center Model 415 and the runctions: I mbl, I be reator Model 615 kits and contains the pre-measured Canogen I oriable Oxygen Ocenond, when oxygen is to be created, it serves as the container enomising the pre-measured chemicals. Third, the container serves as the chamber that houses the chemically created oxygen that is then delivered through the accessories. Finally, the reaction container can be reused. The Jet Rescarch Center Model 415 and the Canogen Portable Oxygen Generator Model 615 requires combining the chemicals in a sequential process to create oxygen which takes in excess of seven minutes. The initiation of the process is a manual action performed by the user. After mixing the chemicals, the oxygen creation begins immediately. The OX-GEN Rigid O2 Gencration System Model 5-OX-03 is a rigid three chambered container with the pre-measured chemicals that are needed for the generation of oxygen ebready in place in the appropriate chambers. The top chamber contains water for cooling and cleaning the oxygen that is produced. The middle chamber contains the dilute hydrogen peroxide. The top and middle chambers are connected by a rotary valve with orings, Valve #3, to create a seal between the chambers and the outside of the device. The bottom chamber contains the granular sodium percarbonate. The middle and bottom chambers are connected with a flat valve, Valve #1, which is opened or closed by a rotary cam shaft. The cam shaft has o-rings to seal it from the outside of the device. The flat valve has several o-rings for sealing purposes as well as an area for catalyst storage. The catalysts can also be contained within a special chamber-type valve, Valve #2, located in the bottom chamber area. The three valves are opened in a numbered sequence to allow the chemicals and catalyst to mix and react. The reaction that occurs creates the release of oxygen. The oxygen exits the device by first entering the now empty middle chamber where any foam or bubbles break up. It then enters the top chamber where it bubbles through the water for cooling and scrubbing (cleaning) for removal of any possible carryover of the react chemicals. It leaves the device through the top nipple and is conveyed by the Salter Labs Three-channel Oxygen Safety Tubing to the inline moisture trap/activated carbon filter and then on through more Three-channel tubing to the Slater Labs Oxygen Mask. The generation of oxygen begins immediatcly when the chemicals mix and increases to a flow rate of at least 6 liters per minute within 1 to 1 ½ minutes. The flow rate of 6 liters per minute or more is maintained for at least 15 minutes and then decreases to zero over the next 10 minutes. {2}------------------------------------------------ The maximum tcmperature of the oxygen measured at the mask is 33°C. The water The than an top of the device cools and cleans the oxygen after it is produced by the exothermic reaction of generating chemicals. The chemical reaction that occurs within the OX-GEN Rigid O2 Generation System Model 5-OX-03 is as follows: The reaction can be considered a two phase reaction; first the liquid hydrogen peroxide reacts with the catalysts to produce oxygen and water and then that water and the sodium percarbonate and catalysts react to produce additional oxygen. The chemical formulas are as follows: $$2 \text{ H}_2\text{O}_2 \xrightarrow[\text{Pt}]{\text{MnO}_2} 2\text{ H}_2\text{O} + \text{O}_2$$ $$2(2\text{Na}_2\text{CO}_3 \cdot 3\text{H}_2\text{O}_2) \xrightarrow[\text{Water}]{\text{MnO}_2 + \text{Pt}} 4 \text{ Na}_2\text{CO}_3 + 6 \text{ H}_2\text{O} + 3 \text{ O}_2$$ The chemicals used in the OX-GEN Rigid O2 Generation System Model 5-OX-03 consist of water in the top chamber, 6.0% hydrogen peroxide in the middle chamber, manganese dioxidc and platinum powder in the flat valve cavity and the chamber-type valve, and sodium percarbonate in the bottom chamber. The catalysts promote the decomposition of the liquid hydrogen pcroxide to water and oxygen and in turn the sodium percarbonate decomposes to sodium carbonate, water, and oxygen. These reactions are exothermic and heat is therefore generated. By the completion of the oxygen generating reaction, the temperature of the reactant products reaches 89 to 90℃. After the oxygen generating reaction is complete, usually about 27 to 28 minutes, Valve #3 should be closed and the red cap should be replaced on the outlet nipple to seal the device closed. All components of the OX-GEN Rigid O2 Generation System Model 5-OX-03 are designed for single use only and need to be returned to the manufacturer for any recharging. In the event that the unit gets disposed of the contents are not a toxic hazard. They are water, sodium carbonate (soda ash) which is a naturally occurring salt, and the manganese dioxide and platinum which occur naturally in the environment as minerals. If any of the unreacted chemicals get spilled or leak from the OX-GEN Rigid O2 Generation System Model 5-0X-03 they will be either water, a weak hydrogen peroxide solution, granulated or liquefied sodium percarbonate, and the two catalysts manganese dioxide and platinum. The hydrogen peroxide should be rinsed down with water. The granulated or liquefied sodium percarbonate is the samc compound as that found in common powdered oxygen bleaching products that are used for household, laundry, carpet, and deck cleaning chores. It should be rinsed down with water. The two catalysts are present in very small amounts and can be washed down along with the other chemicals without undue concern. If any of these chemicals come in contact with the skin or eves. {3}------------------------------------------------ rinse the affected area with cool water. If irritation persists medical advice should be sought. The OX-GEN Rigid O2 Generation System, the Jet Research Center Model 415 and the Canogen Portable Oxygen Generator Model 615 use different pre-measured chemicals. The rcsults of combining these chemicals are all the same. They all gencrate emcrgency oxygen. {4}------------------------------------------------ ## SUBSTANTIAL EQUIVALENCE DATA SUMMARY The OX-GEN Rigid O2 Generation System Model 5-OX-03, the Jet Research Center Model 415, and the Canogen Portable Oxygen Generator Model 615 are substantially equivalent in that they are designed to generate oxygen as a result of a chemical reaction. All three devices are provided in kit form with the necessary containers, chemicals, and accessories to provide oxygen for cmergency use. The Jet Research Center Model 415 and Canogen Model 615 use cartridges containing chemicals inserted into the reaction vessel which contains the reaction and ports the gas to the face mask tubing. While substantially equivalent, the OX-GEN Rigid O2 Generation System Model 5-OX-03 uses a three chamber container with valves that connect the chambers. The valves are opened enabling the chemicals to mix, react, and port the oxygen to the face mask tubing. All devices are substantially cquivalent to one another in that they are intended to be emergency use devices. The targeted population is also equivalent by directing marketing to healthy individuals in emergency situations" {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows a circular seal with the logo of the U.S. Department of Health and Human Services. The seal features the department's emblem, which is a stylized caduceus-like symbol with a human figure in the center. The text "HEALTH & HUMAN SERVICES USA" is arranged around the emblem in a circular fashion. The image is in black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 2 2 2005 Mr. Frank Fosella Ox-Gen Incorporated P.O. Box 5867 Boise, Idaho 83702 Re: K033863 Trade/Device Name: OX-GEN, Incorporated Regulation Number: 21 CFR 868.5440 Regulation Name: Portable oxygen generator Regulatory Class: II Product Code: CAW Dated: June 17, 2005 Received: June 20, 2005 Dear Mr. Fosella: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for the enated in the 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, de rices that have been 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. {6}------------------------------------------------ Page 2 – Mr. Foscella Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that i Dri 3 issualtes vith other requirements of the requirements of the Act that IDA has made a determination administered by other Federal agencies. You must of ally I cacial statutes und registments, including, but not limited to: registration and listing (21 Comply with an the Hot 810 cart 801); good manufacturing practice requirements as set CITY art 607); adoming (Dr OS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by sell w (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro neviolo (« seting your device as described in your Section 510(k) This letter will anow you to begin mailsoning of substantial equivalence of your device to a legally premaired 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 If you dom's operate as not any and (240) 276-0120. Also, please note the regulation entitled, Connect the Office of Connerset notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Intrem O. hot fer 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 {7}------------------------------------------------ # Indication for use 510(k) Number (if known): K033863 Device Name: OX-GEN Rigid O2 Generation System Model 5-OX-03 Indication for use: The OX-GEN Rigid O2 Generation System, Model 5-OX-03 is intended to produce oxygen for emergency use. Prescription Use (Part 21 CFR 801 Subpart D) AND / OR X Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Oue Subon (Division Sign-Off) Division of Anesthesiology, o Infection Control, Dental 510(k) Number: Page 1 of __ 1 3-2