O-TWO E700,O-TWO E600,O-TWO E500

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 16, 2015 O-Two Medical Technologies Inc. Mr. David Zhang Ouality Assurance Manager 7575 Kimbel Street Mississauga, Ontario CANADA Re: K141595 Trade/Device Name: o two e700, e600 and e500 Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: II Product Code: BTL Dated: February 12, 2015 Received: February 18, 2015 Dear Mr. Zhang: 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, Tejashri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH 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) K141595 #### Device Name o two e700, e600, e500 Electronic Transport Ventilators Indications for Use (Describe) o two e700, e600 and e500 are a time-cycled, volume-constant and pressure-controlled (only e700) emergency and transport ventilator designed for use in the pre-hospital, inter-hospital and transport settings. It is intended for use with adult, child, infant patients with a tidal volume from 50 ml (100 ml for e500) upwards who are in respiratory and/or cardiac arrest or respiratory distress and who require ventilatory support. Type of Use (Select one or both, as applicable) | <div> <span style="font-size:12px">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span style="font-size:12px">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | |-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| |-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | Submitter's Name & Address: | O-Two Medical Technologies<br>7575 Kimbel St.<br>Mississauga, Ontario L5S1C8<br>Canada<br>Tel - 905-677-9410 | |-----------------------------|--------------------------------------------------------------------------------------------------------------| | Official Contact: | David Zhang | | Application Date: | 2014-04-25 | | Proprietary or Trade Name: | o_two e700, o_two e600, o_two e500 | | Common/Usual Name: | Electronic Transport Ventilators | | Classification Name: | Ventilator, emergency, powered (resuscitator)<br>(21 CFR 868.5925, product code: BTL) | | Device Class: | Class II | | Classification Panel: | Anesthesiology | Oxylog 3000 Carevent PAR ## 510k Summary #### Device Description: Predicate Devices: The proposed o_two e700, o_two e600 and o_two e500 are time-cycled, volume-constant and pressure controlled (o_two e700 only) emergency and transport ventilators. • 510(k) number K062267 • 510(k) number K081330 · Manufactured Draeger medical GmbH · Manufactured by O-Two Medical Technologies Inc. They are electronically controlled, pneumatically powered ventilators which can be run using AC/DC power adapter or an internal rechargeable Lithium Ion battery pack. The devices use a 4.3" TFT screen to display live ventilation parameters (Tidal and minute volumes, proximal airway pressure and breathing rate) as well as ventilation pressure & volume wave forms, ventilation modes, settings, alarm limits and battery status. The wide range of both visual and audible alarms provides the healthcare professional with warnings of any changes in patient or device parameters. {4}------------------------------------------------ ## Indications for Use: o_two e700, e600 and e500 are a time-cycled, volume-constant and pressure-controlled (only e700) emergency and transport ventilator designed for use in the pre-hospital, intra-hospital, inter-hospital and transport settings. It is intended for use with adult, child and infant patients with a tidal volume from 50 ml (100 ml for e500) upwards who are in respiratory and/or cardiac arrest or respiratory distress who require ventilatory support. ### Patient Population: Adult, child and infant patients with a tidal volume from 50 ml (100 ml for o_two e500) upwards. #### Contraindications: NA #### Environment of Use: They are intended for use in the prehospital, intrahospital and ground transport settings. | Intended<br>use | Proposed<br>o_two e700, o_two e600, o_two e500 | Predicate<br>K062267 Oxylog 3000® | Substantial<br>Equivalence | |----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | Operating<br>principle | time-cycled, volume-constant and<br>pressure-controlled (only o_two<br>e700) emergency and transport<br>ventilators | time-cycled, volume-constant and<br>pressure controlled<br>emergency and transport ventilator | Yes | | Patient<br>population | intended for adult, child and infant<br>patients with a tidal volume from 50<br>ml* upwards who are in respiratory<br>and/or cardiac arrest or respiratory<br>distress and who require ventilatory<br>support.<br>* o_two e500: from 100 ml upwards | intended for patients with a tidal volume<br>from 50 ml upwards. | Yes | | Environment<br>of use | pre-hospital, intra-hospital, inter-<br>hospital and ground transport settings | Mobile use for emergency medical care or<br>primary care of emergency patients:<br>- During transport in emergency rescue<br>vehicles or aircrafts including helicopters<br>(pre-hospital, transport);<br>- In accident and emergency departments,<br>in the recovery room. (intra-hospital)<br>Mobile use for secondary transfers:<br>- During transfer by road or air(inter-<br>hospital, transport)<br>- When moving ventilated patients around<br>in the hospital. (intra-hospital) | Yes (air<br>transport<br>excluded) | | Operating<br>principle | Proposed<br>o_two e700, o_two e600, o_two e500 | Predicate<br>K062267 Oxylog 3000® | Substantial<br>Equivalence | | Control logic | time-cycled, volume-constant and<br>pressure-controlled emergency and<br>transport ventilators | time-cycled, volume-constant and<br>pressure controlled emergency and<br>transport ventilator | Yes | | Flow & frequency<br>control | Solenoid Valves activated by the<br>microprocessor at the controlled<br>intervals to deliver the desired flow Gas blender controlled by the<br>microprocessor to deliver the<br>variable flow rates as per the<br>ventilation mode Yes | | | | | During inhalation, the pressure control<br>valve (VCA) controls the breathing<br>valve (Anti-Lock up valve) blocking<br>the exhaust path resulting in all gas<br>delivered to patient | During inspiration, the pressure<br>control (V6) controls the Breathing<br>Valve (V10) to seal off against<br>atmosphere air | Yes | | Expiration | During expiration , the VCA controls<br>the breathing valve (Anti-Lock up<br>valve) to open the patient airway<br>exhaust path and releasing all exhaled<br>gas to ambient. | During expiration, the V6 controls<br>Breathing Valve (V10) to adjust the<br>required patient pressure by<br>controlling the pressure in the<br>inspiration hose. | Yes | | Pressure Control | the pressure control valve (VCA)<br>provide pressure ventilation and<br>support by controlling Airway<br>pressure to desired values | the pressure control (V6) reduces the<br>pressure in the inspiration hose to<br>control pressure support or Pmax<br>when the target values are reached | Yes | | Safety | In the event of a fault, the pressure<br>control valve (VCA) opens to<br>atmosphere to vent excess pressure;<br>A safety valve limits patient airway<br>pressure to 80 cm H2O in the presence<br>of an excesses pressure | In the event of a fault, the pressure<br>control (V6) opens to atmosphere to<br>vent excess pressure;<br>The relieve SV (set to 80 cmH2O)<br>opens in the presence of an excesses<br>pressure | Yes | | Monitoring | The flow and airway pressure signals<br>measured on the patient side are<br>transmitted to the pressure sensors for<br>flow and airway pressure curve<br>display as well as the measured tidal<br>volume and Pmax, Pmean. | The flow and airway pressure signals<br>measured on the patient side are<br>transmitted to the pressure sensors for<br>flow and airway pressure curve<br>display as well as the measured tidal<br>volume and Pmax, Pmean. | Yes | | Characteristic | Proposed<br>o_two e700, o_two e600 and<br>o_two e500 | Predicate<br>K062267 Oxylog 3000 or<br>K081330 CAREvent PAR | Substantial<br>Equivalence | | Product code | BTL | BTL | Equivalent to<br>CAREvent PAR | | Ventilation modes | CMV, ACV,<br>SIMV, SIMV / PS<br>BiLVL, BiLVL /PS,<br>CPAP, CPAP /PS | CMV, CMVassist (ACV)<br>SIMV, SIMV /PS<br>BIPAP(BiLVL), BIPAP (BiLVL)/PS<br>CPAP, CPAP /PS | Equivalent to<br>Oxylog 3000 | | CPR mode | CPR mode synchronized with<br>audible prompts and visual<br>animated display | CPR mode synchronized with<br>audible prompts and visual<br>animated display | Equivalent to<br>CAREvent PAR | | | Chest<br>compression | 30 compression within 18 sec<br>audible prompts and visual<br>animation | 30 compression within 18 sec<br>audible prompts and visual<br>animation | | | Ventilation | Two 1 sec mandatory breaths ;<br>Breath interval: 2 sec<br>Compression/ ventilation rate: 30:2<br>visual animation | Two 1 sec mandatory breaths;<br>Breath interval: 2 sec<br>Compression/ ventilation rate: 30:2<br>visual animation | | | | Pmax:<br>60 cmH2O-adult,<br>40 cmH2Ol-child & infant | Pmax:<br>60 cmH2O-adult only | | Waveforms | volume-time, pressure-time and<br>flow- time | volume-time, pressure-time and<br>flow- time | Equivalent to<br>Oxylog 3000 | | Trigger Sensitivity | 1 to 15 L/min | 3 to 15 L/min | Equivalent to<br>Oxylog 3000 | | Input pressure | Compressed O2<br>45 PSI to 87 PSI | Compressed O2<br>43.5 PSI to 87 PSI | Equivalent to<br>Oxylog 3000 | | PSV (pressure<br>support ventilation) | 0, 4- 35 cmH2O (e700) | 0- 35 cmH2O | Equivalent to<br>Oxylog 3000 | | Ventilation<br>Frequency | 5 to 60 breath/min | 2 to 60 breath/min (SIMV, BIPAP)<br>5 to 60 breath/min (CMV, ACV) | Equivalent to<br>Oxylog 3000 | | Tidal Volume (L) | 50 ml to 2.0 L | 50 ml to 2.0 L | Equivalent to<br>Oxylog 3000 | | Manual ventilation/<br>Inspiration hold | Yes | Yes | Equivalent to<br>Oxylog 3000 | | Inspiration time to<br>expiration time ratio | 3: 1 to 1: 4 | 3:1 to 1: 4 | Equivalent to<br>Oxylog 3000 | | Inspiration time Ti<br>(sec.) | 0.3 - 9 sec | 0.2 to 10 sec | Equivalent to<br>Oxylog 3000 | | PEEP/ CPAP<br>(cm H2O) | 0 - 20 cm H2O | 0 - 20 cm H2O | Equivalent to<br>Oxylog 3000 | | F;O2 (%) | 60% & 100% | 60% & 100% | Equivalent to<br>Oxylog 3000 | | | | | | | Pmax | 10- 80 cmH2O | 20- 60 cmH2O | Equivalent to<br>Oxylog 3000 | | Safety relief valve | Opens at 80 cmH2O | Opens at 80 cmH2O | Equivalent to<br>Oxylog 3000 | | Inhalation pressure<br>(cm H2O) | 4 - 50 | 3 - 55 | Equivalent to<br>Oxylog 3000 | | Apnea back up time | 10 to 60 sec | 15 to 60 sec | Equivalent to<br>Oxylog 3000 | | Battery Operating<br>time | 18 hrs | 4 hrs | Better than<br>Oxylog 3000 | | Live monitoring | Mve, Vte,<br>Paw(AV), Paw(Peak),<br>Fbpm | Mve, Vte,<br>Paw(AV), Paw(Peak), Pplat, PEEP<br>Fbpm, FiO2 (%) | Equivalent to<br>Oxylog 3000 | | Wave form<br>displayed | Pressure and flow | Pressure and flow | Equivalent to<br>Oxylog 3000 | | Alarms<br>Audible/Visual &<br>indications | Pmax, Pmin,<br>MVHigh, MVLow,<br>Low Battery (20% increments)<br>BCI,<br>Supply pressure Low or No,<br>APNEA | Pmax, Pmin,<br>MVHigh, MVLow,<br>Low Battery (25% increments)<br>Leakage,<br>Supply pressure,<br>APNEA | Equivalent to<br>Oxylog 3000 | | Accessories | - AC/DC power supply<br>- Lithium ion battery pack<br>- Patient ventilation circuit<br>- Oxygen supply hose | - AC/DC power supply Input:<br>- Lithium ion battery pack<br>- Patient ventilation circuit<br>- Oxygen supply hose | Equivalent to<br>Oxylog 3000 | ### Comparative table- Intended use {5}------------------------------------------------ # Comparative table- Operating principle {6}------------------------------------------------ # Comparative table- Technological characteristics/specifications of performance {7}------------------------------------------------ ## Substantially equivalence to the predicate devices: The proposed devices (o two e700, o two e600 and o two e500) have the equivalent intended use, Patient populations, environment of use, contra-indications and intended user to predicate devices. The proposed devices and the Oxylog 3000/K062267 provide the similar ventilation modes including CMV, SIMV, ACV, BiLevel, CPAP and Pressure Control and Pressure Support. Furthermore, o two e700, o two e600 and o two e500 use the similar operating principle as the Oxylog 3000. Specific features and range of performance specifications of the o two e700, o two e600 and o two e500 are also found equivalent to those on the Oxylog 3000/K062267. As there are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices regarding the intended patient population, use environment/setting, contraindications, end users, as well as the technological characteristics (operating principles, waveforms, start-up mode, breath triggering and range of performance specifications), the proposed o_two e600 and o_two e500 are viewed as substantially equivalent to the predicate devices - Oxylog 3000/K062267 with the exception of CPR mode. {8}------------------------------------------------ In addition, o_two e700, o_two e600 and o_two e500 incorporate an extra CPR mode which use the same CPR function as the predicate CARevent PAR/K081330. As a result, they are considered as substantially equivalent regarding their intended use, use environment/setting, contraindications, end users and technological characteristics. ## Summary of Performance Testing: A comparative side-by-side bench testing was performed on o_two e700 and Oxylog 3000 to demonstrate substantial equivalence of the proposed to the predicate Oxylog 3000. The summary of the test results follows: - -Both ventilators delivered equivalent volume-time, pressure-time and flow- time wave forms under the same ventilation mode; - Both ventilators were responsive to spontaneous breathing trigger; - - -Ventilation Vt, frequency and I:E ratio or Ti of both units were close to target or preset parameters; - -Both units delivered similar pressure supports We have also performed the following safety/essential performance bench testing as per to IEC60601-1, IEC60601-1-2 and other applicable standards with respect to mechanical, electrical, software, usability and biocompatibility. | Safety & Essential<br>performance testing | Testing standards/ Comparative testing | Test<br>Result | |-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------| | Safety & Essential<br>performance | IEC 60601-1:2005 | Comply | | | EN794-3:1998/A2 :2009, ISO10651-3:1997, Product specifications,<br>ISO 80601-2-12 :2011 | Comply | | EMC | IEC 60601-1-2:2007 w/ increased levels:<br>ESD: ±8kV contact & ±15kV Air<br>Radiated Immunity: 30V/m<br>Power Freq Magnetic: 30A/m | Comply | | Vibration/ Bump | Vibration (sinusoidal) per IEC60068-2-6 Fc<br>Random vibration per IEC60068-2-36 Fdb, IEC60068-2-64 Fh<br>Bump per IEC60068-2-29 Eb, IEC60068-2-27 Type 1<br>Crash (10 g) per EN 1789 :2007 Clause 4.5.9 6.2, 6.3.5 | Comply | | Environmental | ISO10651-3:1997 Clause 10.2.1, EN 794-3:1998/ A1: 2005 Sec.10.2.1 R | Comply | | Altitude | EN794-3:1998/A2 :2009 10.2.1 c) | Comply | | Software | IEC 60601-1:2005 Sec.14, ANSI/AMMI/IEC 62304:2006 | Comply | | Usability | IEC 60601-1-6 :2010, IEC62366 :2007, Human Factor/Usability Validation | Comply | | Safety - Battery | IEC62133:2002, EN60950-1:2006/ A11:2009/ A1:2010/A12:2011 | Comply | | Transportation- battery | UN 38.3 test | Comply | | Bio-compatibility | ISO 10993-1: 2009, ISO 10993-5:2009, ISO 10993-10: 2010 | Comply | | Function/ Validation test | O-Two Validation Protocol-e700/e600 and Validation Protocol-e500 | Comply | {9}------------------------------------------------ ## Conclusion: The results of the above comparative performance and specification as well as bench testing demonstrate that the proposed o_two e700, o_two e600 and o_two e500 are as safe, as effective and perform as well as the legally marketed predicate devices - Oxylog 3000 (K062267) and CARevent PAR (K081330).