MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM

{0}------------------------------------------------ # AGA Linde Healthcare Image /page/0/Picture/2 description: The image shows the word "Linde" in a stylized, cursive font. The word is written in black ink on a white background. The "L" has a large, decorative swirl at the top, and the other letters are connected in a flowing script. ## 510(k) Summary MEDICYL-E-Lite Portable Oxygen System 510(k) Number: K033897 Submitted in accordance with the requirements of SMDA 1990 and 21CFR807.92. | 1. APPLICANT'S INFORMATION: | | |--------------------------------------------------|-----------------------------------------------------------------------------------| | Edward W. Siurek III | | | Dir., Operational Quality, IBD Global Operations | | | PH: | (216) 328-9801 | | FX: | (216) 328-9818 | | Internet: | <a href="http://www.agalindehealthcare.com">http://www.agalindehealthcare.com</a> | | Medical Establishment Registration No.: | pending | | 2. SUBMITTER'S INFORMATION | | | James Jochen Rogers | | | General Manager | | | Coastal Consulting Group, Ltd. | | | P.O. Box 391117 | | | Solon, OH 44139 | | | PH/FX: | 440.546.4936 | | Mobile: | 724.713.2298 | | E-mail: | <a href="mailto:coastalcg@earthlink.net">coastalcg@earthlink.net</a> | | Internet: | <a href="http://www.immersive-reality.biz">http://www.immersive-reality.biz</a> | | 3. Date: | December 15, 2003 | | 4. DEVICE INFORMATION | | | Trade/Proprietary Name: | MEDICYL-E-Lite Portable Oxygen delivery system | | Common Name: | MEDICYL-E-Lite Portable Oxygen delivery system | | DEVICE NAME: | Cylinder, Compressed Gas, and Valve | | Classification Panel: | Cardiovascular and Respiratory Devices | | Classification Number: | 868.2700 | | Product Nomenclature: | Regulator, Pressure, Gas Cylinder | | Product Code(s): | CAN | | Classification Number: | 868.2610 | | Product Nomenclature: | Gauge, Gas Pressure, Cylinder/Pipeline | | Product Code(s): | BXH | | Classification Number: | unclassified | | Product Nomenclature: | Cylinder, Compressed Gas, and Valve | | Product Code(s): | ECX | | Classification Number: | unclassified | | Product Nomenclature: | Cylinder, Gas (Empty) | | Product Code(s): | KGA | Helping You Care More Effectively 6055 Rockside Woods Blvd. Corporate Office (216) 642-6600 {1}------------------------------------------------ # AGA Linde Healthcare Image /page/1/Picture/1 description: The image shows the word "Linde" in a stylized, cursive font. The letters are connected, and the "L" has a large, decorative swirl at the top. The word appears to be a logo or brand name. #### 5. DEVICE CLASSIFICATION: Empty compressed gas cylinders and compressed gas cylinder with valve assemblies are unclassified devices, and reviewed by the Anesthesiology and Respiratory Devices Branch, Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices. Gas cylinder pressure regulators and gas pressure gauges are Class I devices and exempted from pre-market notification. ## 6. PREDICATE DEVICE(s): - MEDICYL-E-Lite Portable Oxygen System . - . Praxair Grab n' Go Portable Medical Oxygen System ## 7. DEVICE DESCRIPTION: The MEDICYL-E-Lite is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR imaging for MRI systems up to 3.0T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling. The intearated system includes an aluminum cylinder, valve, requlator and flow meter. The device offers low flow settings that may be clinically appropriate for certain classes of patients. #### 8. INDICATIONS FOR USE: The MEDICYL-E-Lite is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR imaging for MRI systems up to 3.0T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling. # 9. TECHNOLOGICAL CHARACTERISTICS: A summary comparison of technological characteristics, including design and materials is provided in the table below: | Parameter | MEDICYL-E-Lite<br>(MRI) | MEDICYL -E-Lite | Praxair Grab n'<br>Go | |-----------------------|-------------------------|-----------------|-----------------------| | Valve/Regulator | | | | | Low Flow Settings | yes | yes | no | | Flow Between Settings | no | no | no | | Cylinder On/Off | yes | yes | no | | Filling Port | active | active | active | | Contents Gauge | non-active | non-active | active | | Filters | 3 | 3 | 1 | | Pressure Design | 4350psi | 4350psi | 3000psi | | Excess Flow Device | yes | yes | no | {2}------------------------------------------------ # AGA Linde Healthcare Image /page/2/Picture/1 description: The image shows the word "Linde" in a stylized, cursive font. The word is written in black ink and appears to be a logo or brand name. The letters are connected, and the "L" has a decorative swirl at the top. | Parameter | MEDICYL-E-Lite<br>(MRI) | MEDICYL -E-Lite | Praxair Grab n'<br>Go | |------------------------------------------|---------------------------|-----------------|-----------------------| | Single stage piston<br>style | yes | yes | yes | | Guard | | | | | Hand grip | 2 grip | 2 grip | 1 grip | | Access Ports | yes | yes | no | | Flow selector/hose<br>barb/gauge aligned | yes | yes | no | | Color | green | green | green | | Height | 6.75" | 6.75" | 8" | | Cylinder | | | | | Sizes | D, E | D, E | E | | Weight (E) | 900gr | 900gr | 1060gr | | Materials/construction | Aluminum | Aluminum | Steel | | MRI Compatibility | | | | | MRI Safe | yes; tested up to<br>3.0T | no | no | | MRI Compatible | yes; tested up to<br>3.0T | no | no | The manufacturer believes that the technological characteristics of the MEDICYL-E-Lite portable oxygen system is substantially similar to those of the predicate devices. - 10. PERFORMANCE DATA: The aluminum cylinders conform to the requirements of 21 CFR49 § 178.46, Specification SAL seamless aluminum cylinders. The MEDICYL-E-Lite portable oxygen delivery system has been evaluated in accordance with the draft CDRH Magnetic Resonance Working Group document, A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems, dated February 7, 1997. # 11. STATEMENT OF SUBSTANTIAL EQUIVALENCE: Based upon the safety and performance testing and compliance with voluntary standards, the manufacturer believes that the MEDICYL-E-Lite portable oxygen delivery system is substantially equivalent to the predicate devices, and does not raise any new questions of safety or effectiveness. {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 1 9 2004 AGA-Linde Healthcare, Incorporated C/O Mr. James Jochen Rogers General Manager Coastal Consulting Group, Limited P.O. Box 391117 Solon, Ohio 44139 Re: K033897 Trade/Device Name: Medicyl-E-Lite Portable Oxygen Delivery System Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: ECX Dated: May 15, 2004 Received: May 19, 2004 Dear Mr. Rogers: 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. {4}------------------------------------------------ Page 2 -Mr. Rogers 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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Cluls 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 {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): K033897 Device Name: Medicyl-E-Lite Portable Oxygen Delivery System Indications for Use: The MEDICYL-E-Lite is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRIcompatible, and intended for use during MR imaging for MRI systems up to 3.0T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling. Sta y/t 7/16/2001 Division of Anesthesiology. General Hospital. Infection Control. Dental Devices 510(k) Number: X Prescription Use (Part 21 CFR 801 Subpart D) AND 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) Page 1 of ____________________________________________________________________________________________________________________________________________________________________