Oxymag - Transport and Emergency Ventilator

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May 24, 2023 Magnamed Tecnologia Medica S/A % Claudio Bacelar Chief Business Officer and Official Correspondent Magnamed USA 4737 NE 25th Ave - unit 205 Fort Lauderdale, Florida 33308 Re: K221634 Trade/Device Name: Oxymag - Transport and Emergency Ventilator Regulation Number: 21 CFR 868.5925 Regulation Name: Powered emergency ventilator Regulatory Class: Class II Product Code: BTL Dated: May 18, 2023 Received: May 22, 2023 Dear Claudio Bacelar: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Ethan L. Nyberg -S for James Lee, Ph.D. Division Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K221634 Device Name Oxymag - Transport and Emergency Ventilator #### Indications for Use (Describe) Oxymag is a controlled volume, pressure and time cycled emergency and transport ventilator. It is intended for use with infant, child, and adult patients with a tidal volume from 50 ml upwards who are in respiratory and/or cardiac arrest or respiratory distress and who require the ventilatory support. It is intended for pre-hospital and hospital use including intra-hospital and transport settings. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | <span> <span style="padding-right: 5px;">☑</span>Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="padding-right: 5px;">☐</span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### 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}------------------------------------------------ #### Page 1 of 8 24-May-23 ## 510k Summary #### SUBMITTER: l. MAGNAMED Medical Technology INC 3590 NW 54th Street - Suite 6 Fort Lauderdale FL, 33309 - USA Phone: 954-980-6477 Contact Person: Claudio Bacelar Contact Title: Chief Business Officer and Official Correspondent Date Prepared: Apr 24, 2023 #### II. DEVICE Name of device: Oxymag - Transport and Emergency Ventilator Common or Usual Name: Electronic Transport Ventilator Classification Name: Powered Emergency Ventilator (21 CFR 868.5925) Regulatory Class: Class II Product code: BTL #### lll. PREDICATE DEVICE O-two e700, K141595 Manufactured by O-Two Medical Technologies Inc This predicate has not been subject to a design-related recall. No reference devices were used in this submission. #### IV. DEVICE DESCRIPTION Oxymag provides a mixture of ambient air and oxygen at concentrations adjusted by the operator using the accurate oxygen concentration system using the venturi principle. O2 concentration is obtained through a galvanic cell by passing gas through the sensor. In addition, it performs the control of flows and pressures in the respiratory circuit to provide the ventilation modalities appropriate to the patient's condition. The associated accessories include: - . Power outlet 12V/3,34A - AC cable ● - Disposable respiratory circuit ● - 02 extension {4}------------------------------------------------ - . Environment filters #### V. INDICATION FOR USE Oxymag is a controlled volume, pressure and time cycled emergency and transport ventilator. It is intended for use with infant, child, and adult patients with a tidal volume from 50 ml upwards who are in respiratory and/or cardiac arrest or respiratory distress and who require the ventilatory support. It is intended for pre-hospital and hospital use including intra-hospital, interhospital and transport settings. #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The table 1 shows the comparison between Oxymag and the predicate e700. | | Subject | Predicate<br>E700 (K141595) | Discussion | |-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for<br>use | Oxymag<br>Oxymag is a controlled<br>volume, pressure and<br>time cycled emergency<br>and transport ventilator. It<br>is intended for use with<br>infant, child, and adult<br>patients with a tidal<br>volume from 50 ml<br>upwards who are in<br>respiratory and/or cardiac<br>arrest or respiratory<br>distress and who require<br>the ventilatory support.<br>It is intended for pre-<br>hospital and hospital use<br>including intra-hospital,<br>inter-hospital and<br>transport settings. | o_two e700, e600 and<br>e500 are a time-cycled,<br>volume-constant and<br>pressure-controlled<br>(only e700) emergency<br>and transport ventilator<br>designed for use in the<br>pre-hospital, intra-<br>hospital, inter-hospital<br>and transport settings.<br>It is intended for use<br>with adult, child and<br>infant patients with a<br>tidal volume from 50 ml<br>(100 ml for e500)<br>upwards who are in<br>respiratory and/or<br>cardiac arrest or<br>respiratory distress who<br>require ventilatory<br>support. | The indications for use is<br>equivalent to e700.<br>The model e700 is the only<br>one being used as the<br>predicate from K141595 | | Patient<br>population | Infant, child, and adult<br>patients | Adult, child, infant<br>patients | The patient population is<br>equivalent to e700. | | Environment<br>of use | Pre-hospital and hospital<br>use including intra-<br>hospital, inter-hospital and<br>transport settings. | Pre-hospital, intra-<br>hospital, inter-hospital<br>and transport settings | The environment of use is<br>equivalent to e700. | | Subject<br>Oxymag | Predicate<br>E700 (K141595) | Discussion | | | Product code | BTL | BTL | The product code is<br>equivalent to e700. | | Ventilation<br>modes | VCV, PCV, V-SIMV, P-<br>SIMV, CPAP/PS | A/CV, SIMV, BiLVL,<br>CPAP and CPR | Similar to e700.<br>Except for CPR, that is not<br>delivered in Oxymag, the<br>other modes have different<br>nomenclature, but they are<br>equivalent.<br>ACV deliver VCV or PCV,<br>that is equivalent to VCV<br>and PCV.<br>SIMV deliver volume<br>ventilation at the set tidal<br>volume and rate, that is<br>equivalent to V-SIMV. | | | | | BiLVL is similar to SIMV<br>but with pressure<br>ventilation, that is<br>equivalent to P-SIMV.<br>CPAP has the same<br>nomenclature and is<br>equivalent.<br>Oxymag does not have<br>CPR mode. | | Breathing<br>circuit | Dual limb, unique for all<br>patient types | Single limb, unique for<br>all patient types | Different to e700.<br>Both breathing circuits are<br>unique for all patients.<br>The only difference is that<br>Oxymag uses a dual limb<br>and e700 uses a single<br>limb.<br>A dual limb circuit has one<br>tube for inhalation and<br>another for exhalation<br>while a single limb has one<br>tube for both inhalation<br>and exhalation.<br>Despite the difference, the<br>performance of both<br>devices is similar as<br>demonstrated in bench<br>test. | | Exhalation<br>valve | Connected to the<br>equipment in the<br>exhalation connector | Connected in the<br>breathing circuit | Different to e700.<br>In e700, the control of<br>inhalation and exhalation is<br>pneumatic. During<br>inspiration, the exhalation<br>valve, that is in the<br>breathing circuit, is closed<br>via the pressurization line<br>from the ventilator.<br>Oxymag electronically<br>controls the exhalation by | | | Subject<br>Oxymag | Predicate<br>E700 (K141595) | Discussion | | Waveforms | volume-time, pressure-<br>time and flow- time | volume-time, pressure-<br>time and flow- time | Waveforms are equivalent<br>to e700 as demonstrated<br>in bench test. | | Flow sensor | Pneumotachograph | Pneumotachograph | Flow sensor is equivalent<br>to e700. | | Flow control | Proportional valves<br>controlled by the<br>microprocessor | Solenoid Valves<br>activated by the<br>microprocessor | Similar to e700.<br>Solenoid valves have an<br>on/off control and has a set<br>of solenoids with different<br>flow passages, and to<br>deliver a flow, it opens and<br>closes certain solenoids.<br>Proportional valves convert<br>a variable current or<br>voltage signal into a<br>proportional flow output.<br>Despite the difference, the<br>performance of both<br>devices is similar as<br>demonstrated in bench<br>test. | | Trigger<br>Sensitivity | OFF; 1 to 15 L/min | OFF; 1 to 15 L/min | Parameter range is<br>equivalent to e700. | | Input pressure | 39 to 87 psi | 45 PSI to 87 PSI | Different to e700. The<br>lower limit of Oxymag's<br>input pressure is lower<br>than e700, but the<br>difference does not affect<br>the performance of<br>Oxymag. Oxymag delivers<br>all ventilation parameters<br>between 39 and 87 psi. | | PSV (pressure<br>support<br>ventilation) | OFF; 4 to 35 cmH2O<br>(± 10% or ± 2 cmH2O) | OFF, 4- 35 cmH2O<br>(± 10% or ± 2 cmH2O) | Parameter range is<br>equivalent to e700. | | Ventilation<br>Frequency | 5 to 60 breath/min<br>(± 10% or ± 1 bpm) | 5 to 60 breath/min<br>(± 10% or ± 1 bpm) | Parameter range is<br>equivalent to e700. | | Tidal Volume<br>(L) | 50 to 2000 mL<br>(±20ml or ±15%) | 50 ml to 2000 mL<br>(±20ml or ±15%) | Parameter range is<br>equivalent to e700. | | Manual<br>ventilation/<br>Inspiration<br>hold | Yes | Yes | Parameter range is<br>equivalent to e700. | | Inspiration<br>time<br>to<br>expiration<br>time ratio | 1:4 to 3:1<br>(± 20%) | 1:4 to 3:1<br>(± 20%) | Parameter range is<br>equivalent to e700. | | | Subject<br>Oxymag | Predicate<br>E700 (K141595) | Discussion | | Inspiration<br>time Ti (sec.) | 0,2 to 9 s<br>(± 20%) | 0,2 to 9 s<br>(± 20%) | Parameter range is<br>equivalent to e700. | | PEEP/ CPAP<br>(cm H2O) | OFF; 4 to 20<br>(± 10% or ± 2 cmH2O) | OFF; 4 to 20<br>(± 10% or ± 2 cmH2O) | Parameter range is<br>equivalent to e700. | | FiO2 (%) | 60 or 100<br>(± 15%) | 60% or 100%<br>(± 15%) | Parameter range is<br>equivalent to e700. | | Pmax | 10 to 60<br>(± 10% or ± 2 cmH2O) | 10- 80 cmH2O<br>(± 10% or ± 2 cmH2O) | Different to e700. Oxymag<br>has a more restricted<br>upper limit. | | Safety<br>relief<br>valve | Yes | Yes | Safety valve is equivalent<br>to e700. | | Inhalation<br>pressure<br>(cmH2O) | OFF; 4 to 50 cmH2O<br>(± 10% or ± 2 cmH2O) | 4 - 50 cmH2O<br>(± 10% or ± 2 cmH2O) | Parameter range is<br>equivalent to e700. | | back<br>Apnea<br>up time | 10 to 60 sec | 10 to 60 sec | Parameter range is<br>equivalent to e700. | | | Minute Volume, Volume<br>Measured,<br>Instant pressure<br>measured, maximum<br>inspiratory pressure,<br>Respiratory Rate | Mve, Vte, Paw(AV),<br>Paw(Peak), Fbpm | Similar to e700. | | Monitoring | Plateau pressure, PEEP,<br>Flow, inspiratory time,<br>expiratory time, Ratio I:E,<br>Airway resistance,<br>Dynamic compliance,<br>Static compliance, FiO2,<br>O2 consumption | None | Oxymag has the monitored<br>parameters that e700 has<br>and additional others, but<br>the difference does not<br>affect the performance of<br>Oxymag. | | Wave<br>form<br>displayed | Pressure and flow | Pressure and flow | Waves are equivalent to<br>e700. | | Alarms<br>Audible/Visual<br>& indications | Disconnection, Low<br>airway pressure, High<br>airway pressure, Low<br>minute volume, High<br>minute volume, Low<br>minute volume,<br>Obstruction, Low supply<br>pressure, Apnea, Low<br>battery, | Patient circuit<br>disconnect, Low airway<br>pressure, High airway<br>pressure, Low minute<br>volume, High minute<br>volume, Blocked airway,<br>Low oxygen, Apnea,<br>Low battery, Low<br>inhalation pressure,<br>No Oxygen, Empty<br>battery, Patient effort. | Significant alarms are<br>similar to e700.<br>Low inhalation pressure<br>and Low airway pressure<br>is equivalent to low airway<br>pressure in Oxymag.<br>No Oxygen alarm is<br>equivalent to low supply<br>pressure in Oxymag.<br>Empty battery is equivalent<br>to low battery alarm of<br>Oxymag.<br>Patient effort alarm is<br>equivalent to trigger<br>message in Oxymag.<br>Oxymag does not have<br>leak alarm, but when there | | | Subject<br>Oxymag | Predicate<br>E700 (K141595) | Discussion | | | High PEEP, Low PEEP,<br>AC input fail,<br>High volume and Low<br>volume, High r. rate, Low<br>r. rate, Low internal<br>temperature, High internal<br>temperature, Flow sensor<br>off, HW:High O2 int.…