TROOPER OXYGEN CONCENTRATOR

{0}------------------------------------------------ #### 510(k) Summary 12/260 : 5.0 VBOX. Inc. Submitter: WH TI Contact Person: 2340 East County Road J White Bear Lake, MN 55110 Theodore Jagger Director, Regulatory & Test Telephone: 651-407-6206 Fax: 651-407-6206 Email: jagger@vboxinc.com Trooper Oxygen Concentrator Portable Oxygen Concentrator September 19, 2012 Date Prepared: Trade Name: Common Name: Classification: Product Code: Class II, 21 CFR 868.5440 CAW Predicate Devices: The subject device is substantially equivalent to the following devices: SEP 2 1 2012 - · Inogen One Oxygen Concentrator (K032818) - · EverGo Portable Oxygen Concentrator (K043615) Device Description: The Trooper oxygen concentrator utilizes a molecular sieve and differential pressure swing adsorption to separate the gases in ambient air. The device takes the room air and concentrates the oxygen portion to produce a pulse of oxygen between 87-94 % in purity. When the patient inhales, the device senses the pressure change and is triggered to release the oxygen pulse. In between breaths, the device regenerates an oxygen pulse and waits for the next inhalation breath before dispensing it. The front panel of the Trooper contains controls and indicators such as, device status indicator LEDs, an ON/OFF button, oxygen flow rate controls, and flow rate and battery status displays. The oxygen outlet is also located on the front panel of the device. The VBOX Trooper oxygen concentrator system will be provided under a single model number, A-1000, which includes the following items: - One (1) Trooper Oxygen Concentrator Unit . - Two (2) Li-Ion Batteries (only one connected to the device . at a time) - One (1) Auxiliary AC Power Supply . - One (1) Battery Charger ● - One (1) Carrying case . - One (1) nasal cannula . {1}------------------------------------------------ - User manual . # per Device Specifications: | Trooper Device Specifications: | | |----------------------------------------|----------------------------------------------------------------------| | Dimensions (LxWxH) | 6 x 2.5 x 6.25 inches | | Weight | 3.2 lbs (includes battery) | | Materials | | | Sieve Bed | Synthetic zeolite | | Nasal Cannula | PVC (standard cannula supplied<br>by Salter Labs) | | Battery | Li-Ion | | Performance Specifications | | | Method of oxygen<br>concentration | Molecular sieve (mechanical) | | Process by which Oxygen is<br>released | Differential pressure swing<br>adsorption | | Flow Rate | 5 settings: 1 to 5 (flow rates<br>equivalent to 1 LPM to 5 LPM) | | Duration of flow | Pulsed | | Trigger Sensitivity | $ \leq $ 0.13 cm water ( $\leq$ 12.7 Pa) | | Oxygen concentration | 87-94% at all settings | | Software/ Hardware | Analog and digital electronics<br>with microprocessor | | Rechargeable Battery | Yes | | Power Options | Battery, AC | ### Intended Use: The VBOX Trooper oxygen concentrator device is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The VBOX Trooper may be used in home, institution, vehicle and various mobile environments. ## Summary Comparison to Predicate Devices: | | VBOX Trooper<br>Oxygen Concentrator<br>(Subject Device) | Inogen One Oxygen<br>Concentrator<br>(Predicate Device) | EverGo Portable<br>Oxygen Concentrator<br>(Predicate Device) | |-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | VBOX, Inc. | Inogen | Philips Respironics | | Classification | Class II | Class II | Class II | | Product Code | CAW | CAW | CAW | | Indications for<br>Use | The VBOX Trooper oxygen concentrator<br>device is used on a<br>prescriptive basis by<br>patients requiring<br>supplemental oxygen. It<br>supplies a high<br>concentration of oxygen<br>and is used with a nasal<br>cannula to channel<br>oxygen from the<br>concentrator to the<br>patient. The VBOX<br>Trooper may be used in<br>home, institution,<br>vehicle and various<br>mobile environments. | The Inogen One<br>Oxygen Concentrator is<br>used on a prescriptive<br>basis by patients<br>requiring supplemental<br>oxygen. It supplies a<br>high concentration of<br>oxygen and is used<br>with a nasal cannula to<br>channel oxygen from<br>the concentrator to the<br>patient. The Inogen<br>One may be used in<br>home, institution,<br>vehicle and various<br>mobile environments. | The EverGo Portable<br>Oxygen Concentrator is<br>intended for prescription<br>use by patients requiring<br>high concentrations of<br>oxygen on a<br>supplemental basis. It is<br>small, portable and is<br>capable of continuous<br>use in home,<br>institutional, and travel /<br>mobile environments. | | Prescription<br>Required | Yes | Yes | Yes | | Patient<br>Interface | Standard nasal cannula | Standard nasal cannula | Standard nasal cannula | | Dimensions<br>(LxWxH) | 6 x 2.5 x 6.25 inches | 11.6 x 6.0 x 10.7 inches | 12 x 6 x 8.5 inches | | Weight | 3.2 lbs<br>(includes battery) | 9.8 lbs<br>(includes battery) | 10 lbs<br>(includes batteries) | | Materials | | | | | Sieve Bed | Synthetic zeolite | Synthetic zeolite | Synthetic zeolite | | Nasal Cannula | PVC (standard cannula<br>supplied by Salter Labs) | PVC (standard cannula<br>supplied by Salter<br>Labs) | Not supplied with the<br>device | | Battery | Li-Ion | Li-Ion | Li-Ion | | Performance Specifications | | | | | Method of<br>oxygen<br>concentration | Molecular sieve<br>(mechanical) | Molecular sieve<br>(mechanical) | Molecular sieve<br>(mechanical) | | Process by<br>which Oxygen is<br>released | Differential pressure<br>swing adsorption | Differential pressure<br>swing adsorption | Differential pressure<br>swing adsorption | | Flow Rate | 5 settings: 1 to 5 (flow<br>rates equivalent to 1<br>LPM to 5 LPM) | 5 settings: 1 to 5 (flow<br>rates equivalent to 1<br>LPM to 5 LPM) and<br>one setting of<br>"Satellite" | 6 settings: 1 to 6 (flow<br>rates equivalent to 1<br>LPM to 6 LPM) | | Duration of<br>flow | Pulsed | Pulsed | Pulsed | | Trigger<br>Sensitivity | ≤ 0.13 cm water<br>(≤ 12.7 Pa) | 0.12 cm water (12 Pa) | 0.16 cm water (16 Pa) | | Oxygen<br>concentration | 87-94% at all settings | 87-93% at all settings | 86-92% at all settings | | Software/<br>Hardware | Analog and digital<br>electronics with<br>microprocessor | Analog and digital<br>electronics with<br>microprocessor | Analog and digital<br>electronics with<br>microprocessor | | Rechargeable<br>Battery | Yes | Yes | Yes | | Power Options | Battery, AC | Battery, AC | Battery, AC | {2}------------------------------------------------ Pre-Market Notification for the VBOX Trooper Oxygen Concentrator {3}------------------------------------------------ Functional and Safety Testing: Applicable portions of the following standards were applied during development and testing of the Trooper Oxygen Concentrator: - ASTM F1464-93:2005 Oxygen Concentrators for . Domiciliary Use - ISO 8359:1996 Oxygen Concentrators for medical use -. Safety Requirements - EN 60601-1-2:2007 Medical Electrical Equipment-Part 1-. 2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests - . EN 55011:2007 (including Amendment A2:2007) - Limits and Methods of Measurement of Radio Interference Characteristics of Industrial, Scientific and Medical (ISM) Equipment - Federal Communications Commission (FCC) Part 15 . Subpart B - IEC 60601-1:2003 Medical Electrical Equipment Part 1: . General Requirements for Safety - ISO 10993-1:2009 Biological evaluation of medical devices . Bench testing was performed to provide assurance that the proposed device conforms to the requirements for its intended use. This included the following testing: - Output gas composition (e.g. VOCs, particulate matter, � ozone/carbon monoxide/carbon dioxide content) - User display and LED functions . - Oxygen flow rate and concentration ● - Electromagnetic compatibility and electrical safety ● - Functional performance (e.g. trigger sensitivity and delay, . pulse volume and duration) {4}------------------------------------------------ - Output gas temperature . In addition, functional side-by-side comparison testing was performed to demonstrate substantial equivalence of the proposed device to each of the predicate devices. The following parameters were evaluated across all breath rates: - Trigger Sensitivity . - . Oxygen Pulse Timing - o Pulse Time - o Pulse Delay - o Total Time to Deliver Pulse - Pulse Volume � . - · Oxygen Purity - Relative Fraction of Inspired Oxygen (FIO2) . The pulse delivery waveforms (liters per minute flow over time) were also assessed for the proposed device and each of the predicate devices. The similarities between the Trooper (proposed device) and the Conclusion: predicate devices referenced above with respect to the principles of operation, technology, materials, indications for use, and functional performance clearly support a conclusion of substantial equivalence. {5}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002 Vbox, Incorporated C/O Mr. Mark Job Regulatory Technology Services, Limited Liability Company 1394 25TH Street, North West Buffalo, Minnesota 53313 SEP 2 1 2012 Re: K121260 Trade/Device Name: Trooper Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: September 6, 2012 Received: September 7, 2012 Dear Mr. Job: 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. {6}------------------------------------------------ Page 2- Mr. Job 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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. Sincerely yours, Nh for Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ #### 4.0 Indications for Use Statement Device Name: VBOX Trooper Oxygen Concentrator ### Indications for Use: The VBOX Trooper oxygen concentrator device is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The VBOX Trooper may be used in home, institution, vehicle and various mobile environments. Prescription Use X (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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) L. Schultze (Division Division of Anesthesiology, General Hospitai Intection Control, Dental Device 510(k) Number; K L L B VBOX, Inc. Pre-Market Notification for the VBOX Trooper Oxygen Concentrator Page 14 of 57