OXYTOTE INFINITY SERIES VIPR SYSTEMS

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 17, 2015 Western/Scott Fetzer Co. Mr. David C. Simo Director of Quality and Regulatory 875 Bassett Road Westlake, OH 44145-1142 ### Re: K142149 Trade/Device Name: OxyTote Infinity Series VIPR Systems and Praxair Grab 'n Go Opti Series VIPR systems Regulation Number: Unclassified Regulation Name: Cylinder, Compressed Gas, and Valve Regulatory Class: Unclassified Product Code: ECX Dated: March 17, 2015 Received: March 20, 2015 Dear Mr. Simo: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {1}------------------------------------------------ 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Tina Kiang -S for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use #### 510(k) Number (if known): K142149 Device Name: OxyTOTE Infinity series VIPR systems and Praxair Grab 'n Go Opti series VIPR systems Indications for Use: For OxyTOTE Infinity: "The OxyTOTE Infinity system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla and cannot be used directly in the MRI bore. The device is intended for limited duration use, such as would be necessary during patient transports. " For Praxair Grab 'n Go Opti: "The Grab 'n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla and cannot be used directly in the MRI bore. The device is intended for limited duration use, such as would be necessary during patient transports. " Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the text "OxyTOTE Infinity series and Praxair Grab 'n Go Opti series VIPR Systems". The text appears to be a product name or a description of a product line. The text is written in a clear, sans-serif font and is easy to read. Image /page/3/Picture/1 description: The image shows the logo for Western, a Scott Fetzer company, above the text "510(k) Premarket Notification". The Western logo is a brown circle with a white design inside. The text "510(k) Premarket Notification" is in a larger font size than the company name. #### 510(k) SUMMARY AS REQUIRED BY SECTION 807.92(c) ## 1. 510(k) Owner's Name, Address, Telephone Number, Fax Number, Contact Person Western / Scott Fetzer Co 875 Bassett Rd. Westlake, Ohio 44145 Phone: (440) 871-2160 Fax: (440) 835-8283 Contact Person: David C. Simo Director of Quality & Regulatory Western / Scott Fetzer Co 875 Bassett Rd. Westlake, Ohio 44145 Phone: (440) 871-2160 Fax: (440) 835-8283 Email: dsimo@westernenterprises.com ### 2. Date Prepared April 17, 2015 ### 3. Device Information | Trade/Proprietary Name: | OxyTOTE Infinity series VIPR systems and Praxair Grab 'n Go Opt<br>series VIPR systems | |------------------------------|----------------------------------------------------------------------------------------| | Common Name: | Portable Oxygen Delivery System | | Device Classification Name: | Cylinder, Compressed Gas, and Valve | | Classification Product Code: | ECX | ### 4. Predicate Device The predicate device for the OxyTOTE Infinity and Praxair Grab 'n Go Opti series VIPR Systems is the EZ-OX Plus Generation II, which was cleared under 510(k) K131386. Western would like to advise that they were also the manufacturer of this device. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for Western, a Scott Fetzer company. The logo features a circular emblem on the left, with a brown background and a white interwoven design in the center. To the right of the emblem, the word "WESTERN" is written in bold, black letters, and below it, the phrase "a Scott Fetzer company" is written in a smaller font, enclosed in a curved banner. OxyTOTE Infinity series and Praxair Grab 'n Go Opti series VIPR Systems # 5. Device Description The OxyTOTE Infinity and Praxair Grab 'n Go Opti series VIPR (Valve Integrated Pressure Regulator) Systems provide a package for those who need medical oxygen from portable cylinders. The oxygen regulator, analog pressure gauge, cylinder contents indicator and gas supply valve are combined, and permanently attached to the gas cylinder as one system. This design allows medical personnel the ability to provide patient care and treatment without the need to mount a conventional separate regulator. The regulator reduces cylinder pressure and provides 10 user selectable flow rates (½, 1, 1½, 2, 3, 4, 6, 8, 15, 25 LPM) of USP oxygen that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides flow rates up to 100 LPM oxygen delivery. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. Key features include; hose barb connection, protective shroud, carrying handle, cylinder content gauge, indexed flow meter, shutoff valve, and AUX (DISS-1240) connection. ### 6. Device Function The device is an integrated portable oxygen delivery system intended to provide supplemental oxygen to patients. This is a multiple use product that is used in healthcare applications (hospitals, clinics and ambulance use), where medical grade oxygen gas is required at prescribed flow rates or as determined by the emergency medical provider. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. In comparison to the predicate device, the OxyTOTE Infinity and Praxair Grab 'n Go Opti series VIPR systems incorporate the following additional features: - The fill valve includes a reverse flow check valve to prevent gas from exiting the fill port. The 1 predicate device has a manual shutoff valve that requires a proprietary tool to actuate. - The fill valve is biased in an open position during cylinder evacuation process, and closes 2. automatically when the device is disconnected from the fill rack. The valve on the predicate device must be manually opened during the evacuation process and manually closed before disconnecting from the fill rack. - The cylinder Pressure Relief Device (PRD) operates when a specific pressure has been reached. The 3. predicate device PRD only operates when specific temperature and pressure requirements are met, meaning the PRD will not open if the cylinder is overfilled until exposed to an external heat source. - 4. A Cylinder Contents Indicator (CCI) provides an indication of the cylinder contents in addition to the pressure gauge providing an assessment of cylinder content levels. - 5. A high pressure shutoff valve which prevents gas from flowing into the pressure regulator. The predicate device is less redundant since it does not have a high pressure shutoff function resulting in more potential leak paths to be pressurized during transport and storage. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for Western, a Scott Fetzer company. The logo features a circular emblem on the left, with a brown border and a woven design inside. To the right of the emblem, the word "WESTERN" is written in bold, black letters. Below "WESTERN" is the phrase "a Scott Fetzer company" in a smaller font, enclosed in a curved box. OxyTOTE Infinity series and Praxair Grab 'n Go Opti series VIPR Systems # 7. Design Description The cylinder (Figure 1, item 13) is filled with Oxygen gas through the gas specific fill port (1) connection. The gas entering the fill port pushes open the check valve (2) allowing gas to flow through the valve body and into the cylinder (13). Once the cylinder is filled, the connection is detached from the fill port (1), and the fill port check valve (2) will automatically close to retain the device. The gas pressure in the cylinder is indicated on the pressure gauge (12). To deliver calibrated flow the practitioner opens the shutoff valve (3) by rotating the flow control knob (4) clockwise to the desired flow setting. Gas is then permitted to flow into the regulator (5) portion of the device where cylinder pressure (up to 3000 psig) is reduced to around 50 psig. This regulated gas goes downstream to feed the flow control (6) portion of the device where thee gas flows through an orifice (8) to provide a calibrated flow out the outlet barb (9). The gas flows through a nasal cannula or mask (not shown and not provided with the device) to the patient. The flow control knob (7) can also be rotated to the AUX position, which opens the shutoff valve (3) and allows the gas to flow into the pressure regulator (5) portion of the device. This permits gas to be supplied through the AUX port connection (10) while preventing simultaneous flow from the outlet barb (9). The AUX port will provide flow up to 100 LPM when the demand valve is actuated by connecting fitting to the AUX outlet connection. Image /page/5/Figure/7 description: The image shows three cross-sectional diagrams of a device, labeled as Cross Section 1, Cross Section 2, and Cross Section 3. Each diagram highlights different internal components with labels and arrows pointing to them. Some of the labeled components include a fill port, check valve, shutoff valve, regulator, demand valve, and cylinder pressure relief device. Figure 1 - OxyTOTE Infinity and Praxair Grab 'n Go Opti series VIPR Systems {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for Western, a Scott Fetzer company. The logo consists of a circular emblem on the left and the word "WESTERN" in bold, black letters on the right. Below "WESTERN" is the phrase "a Scott Fetzer company" in a smaller font, enclosed in a decorative border. The emblem features a brown circular design with a woven pattern inside. ### 8. Intended Use #### For OxyTOTE Infinity: "The OxyTOTE Infinity system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla and cannot be used directly in the MRI bore. The device is intended for limited duration use, such as would be necessary during patient transports. " #### For Praxair Grab 'n Go Opti: "The Grab 'n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla and cannot be used directly in the MRI bore. The device is intended for limited duration use, such as would be necessary during patient transports." ### 9. Summary of Technological Characteristics | | A summary comparison of technological characteristics, including design and materials is provided in the | | | | |--------------|----------------------------------------------------------------------------------------------------------|--|--|--| | table below: | | | | | | Feature | OxyTOTE Infinity and Praxair<br>Grab 'n Go VIPR Systems | EZ-OX Plus Generation II<br>(Predicate) | Explanation of Differences | |---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K142149 | K131386 | NA | | Clearance Date | TBD | March 14, 2014 | NA | | Indications for Use | The (OxyTOTE Infinity /<br>Praxair Grab 'n Go Opti)<br>system is an integrated<br>delivery system intended to<br>provide supplemental oxygen,<br>by Rx only, to patients. When<br>administered by properly<br>trained personnel for oxygen<br>deficiency and resuscitation,<br>the device is for emergency<br>use only. For all other medical<br>applications, the device is Rx<br>only. The device is MR<br>Conditional and suitable for<br>use during MR imaging for<br>MRI systems up to 3.0 Tesla<br>and cannot be used directly in<br>the MRI bore. The device is<br>intended for limited duration<br>use, such as would be<br>necessary during patient<br>transports. | The device is an integrated<br>portable oxygen delivery<br>system intended to provide<br>supplemental oxygen to<br>patients. When administered<br>by properly trained personnel<br>for oxygen deficiency and<br>resuscitation, the device is for<br>emergency use only. For all<br>other medical applications, the<br>device is Rx only. | The OxyTOTE Infinity / Praxair<br>Grab 'n Go Opti statement<br>articulates the MR Conditionality of<br>the device, and states that the<br>device is only intended for limited<br>duration use. The predicate's<br>statement contained neither. | | Valve/Regulator | | | | | Low Flow Settings | Yes (≥ 0.5L), 10 specific<br>calibrated flow rates.<br>(0.5, 1, 1.5, 2, 3, 4, 6, 8, 15, 25<br>SLPM Oxygen) | Yes (≥ 0.5L), 11 specific<br>calibrated flow rates.<br>(0.5, 1, 1.5, 2, 3, 4, 6, 8, 10,<br>15, 25 SLPM Oxygen) | The lack of a 10 LPM position is<br>not a significant difference in<br>performance. | | Cylinder On/off | No | No | NA | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Western, a Scott Fetzer company. The logo consists of a brown circular emblem on the left, featuring a complex interwoven design. To the right of the emblem, the word "WESTERN" is written in bold, black capital letters, with the words "a Scott Fetzer company" written in a smaller font size underneath the word "WESTERN". OxyTOTE Infinity series and Praxair Grab 'n Go Opti series VIPR Systems | Feature | OxyTOTE Infinity and Praxair<br>Grab 'n Go VIPR Systems | EZ-OX Plus Generation II<br>(Predicate) | Explanation of Differences | |------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------| | Filling Port Connection | CGA 540 | CGA 540 | NA | | Auxiliary Port Connection | DISS 1240<br>100 LPM at > 600 PSIG | DISS 1240<br>40 LPM at > 290 PSIG | 100 LPM targeted for Oxy-TOTE<br>and Opti, 40 LPM targeted for<br>predicate | | Contents Gauge | Active | Active | NA | | Cylinder Contents Indicator<br>(CCI) | Yes | No | Red/Green visual indication of<br>remaining gas pressure provides<br>an assessment of cylinder content<br>level. | | Pressure Design | 3,000 psi | 3,000 psi | NA | | Fill Valve | Automatic | Manual | A manual shutoff valve must be<br>opened to evacuate the cylinder. | | Residual Pressure Valve<br>(RPV) | No | Yes | The RPV requires an additional<br>step to be performed at the fill<br>plant to vent the cylinders prior to<br>filling. | | Guard / Shroud | | | | | Hand Grip | Yes | Yes | NA | | Color | Green | Green | NA | | Height (quard & integrated<br>valve regulator) | 5.88" | 7" | NA | | Cylinder | | | | | Sizes | D and E | D and E | NA | | Materials | Aluminum | Aluminum | NA | | MRI Conditionality | Claimed: suitable for<br>use during MR imaging for<br>MRI systems up to 3.0 Tesla<br>and cannot be used directly in<br>the MRI bore. | Claimed: suitable for<br>use during MR imaging for<br>MRI systems up to 3.0 Tesla<br>and cannot be used directly in<br>the MRI bore. | NA | ### 10. Performance Data (Non-clinical Testing) Performance testing was completed and the device passed in accordance with the following standards: - . CGA E-18:2008 (first edition) : Medical Gas Valve Integrated Pressure Regulators - ASTM G175-13: Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications - ASTM F2052-06 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment. - . ASTM F2119-07 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants. Test results confirm that the OxyTOTE Infinity and Praxair Grab 'n Go Opti series VIPR systems meet its performance requirements. #### 11. Substantial Equivalence Based upon the performance testing and subsequent passing results, the manufacturer believes that the OxyTOTE Infinity and Grab 'n Go Opti portable oxygen delivery systems are substantially equivalent to the predicate device, and do not raise any new questions of safety or effectiveness.