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, inter-hospital and transport settings.

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
Environment filters

AI/ML Overview

The provided document is a 510(k) summary for the Oxymag - Transport and Emergency Ventilator. It focuses on demonstrating substantial equivalence to a predicate device (O-two e700, K141595) rather than establishing novel performance acceptance criteria or conducting a comprehensive study to prove these criteria.

Therefore, the document does not contain the specific information requested in most of your numbered points, as it's not a study designed to establish and prove acceptance criteria for a new device's performance in a clinical setting with human subjects. Instead, it describes bench testing, software verification, electrical safety, and biocompatibility to confirm the device operates as intended and is comparable to an already cleared device.

Here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance (Based on Comparison to Predicate):

The submission demonstrates substantial equivalence by comparing the Oxymag's parameters and features to those of the predicate device, e700. The "acceptance criteria" are implicitly that the Oxymag's performance is equivalent or does not raise new safety or effectiveness concerns compared to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) summary, formal "acceptance criteria" for a study are not explicitly stated in the way one might find in a clinical trial protocol. Instead, the performance is demonstrated by comparison with a predicate device and through various forms of engineering and non-clinical testing.

The provided "Table 1. Comparison table between the subject and predicate devices" serves as the primary evidence for this. Instead of a 'reported device performance' against a strict new acceptance criterion, it shows 'equivalence' or 'similarity' to the predicate.

Characteristic	Acceptance Criteria (Implied: Equivalent/Similar to Predicate)	Reported Device Performance (Oxymag)	Discussion/Proof of Equivalence
Indications for Use	Equivalent to e700	Controlled volume, pressure and time cycled emergency and transport ventilator for infant, child, and adult patients (tidal volume 50ml upwards) in respiratory/cardiac arrest or distress requiring ventilatory support. For pre-hospital and hospital use (intra-hospital, inter-hospital, transport settings).	The indications for use are equivalent to e700.
Patient Population	Equivalent to e700	Infant, child, and adult patients	The patient population is equivalent to e700.
Environment of Use	Equivalent to e700	Pre-hospital and hospital use including intra-hospital, inter-hospital and transport settings.	The environment of use is equivalent to e700.
Product Code	Equivalent to e700	BTL	The product code is equivalent to e700.
Ventilation Modes	Similar to e700	VCV, PCV, V-SIMV, P-SIMV, CPAP/PS	Similar to e700. Except for CPR (not in Oxymag), other modes have different nomenclature but are equivalent (e.g., ACV = VCV/PCV, SIMV = V-SIMV, BiLVL = P-SIMV, CPAP is same).
Breathing Circuit	Performance similar to e700	Dual limb, unique for all patient types	Different from e700 (which is single limb). "Despite the difference, the performance of both devices is similar as demonstrated in bench test."
Exhalation Valve	Performance similar to e700	Connected to the equipment in the exhalation connector. Electronically controlled.	Different from e700 (which has pneumatic control, valve in circuit). "Despite this difference, the exhalation for both devices is similar."
Waveforms	Equivalent to e700	Volume-time, pressure-time and flow-time	Waveforms are equivalent to e700 as demonstrated in bench test.
Flow Sensor	Equivalent to e700	Pneumotachograph	Flow sensor is equivalent to e700.
Flow Control	Performance similar to e700	Proportional valves controlled by microprocessor	Similar to e700 (solenoid valves). "Despite the difference, the performance of both devices is similar as demonstrated in bench test."
Trigger Sensitivity	Parameter range equivalent to e700	OFF; 1 to 15 L/min	Parameter range is equivalent to e700.
Input Pressure	Performance not affected by difference from e700	39 to 87 psi	Different to e700 (45-87 PSI). "The lower limit of Oxymag's input pressure is lower than e700, but the difference does not affect the performance of Oxymag. Oxymag delivers all ventilation parameters between 39 and 87 psi."
PSV (Pressure Support Ventilation)	Parameter range equivalent to e700	OFF; 4 to 35 cmH2O (± 10% or ± 2 cmH2O)	Parameter range is equivalent to e700.
Ventilation Frequency	Parameter range equivalent to e700	5 to 60 breath/min (± 10% or ± 1 bpm)	Parameter range is equivalent to e700.
Tidal Volume (L)	Parameter range equivalent to e700	50 to 2000 mL (±20ml or ±15%)	Parameter range is equivalent to e700.
Manual Ventilation/Inspiration Hold	Equivalent to e700	Yes	Parameter range is equivalent to e700.
Inspiration time to expiration time ratio	Parameter range equivalent to e700	1:4 to 3:1 (± 20%)	Parameter range is equivalent to e700.
Inspiration time Ti (sec.)	Parameter range equivalent to e700	0.2 to 9 s (± 20%)	Parameter range is equivalent to e700.
PEEP/CPAP (cm H2O)	Parameter range equivalent to e700	OFF; 4 to 20 (± 10% or ± 2 cmH2O)	Parameter range is equivalent to e700.
FiO2 (%)	Parameter range equivalent to e700	60 or 100 (± 15%)	Parameter range is equivalent to e700.
Pmax	Does not raise safety questions	10 to 60 (± 10% or ± 2 cmH2O)	Different to e700 (10-80 cmH2O). Oxymag has a more restricted upper limit, which generally implies enhanced safety.
Safety relief valve	Equivalent to e700	Yes	Safety valve is equivalent to e700.
Inhalation pressure (cmH2O)	Parameter range equivalent to e700	OFF; 4 to 50 cmH2O (± 10% or ± 2 cmH2O)	Parameter range is equivalent to e700.
Apnea Backup time	Parameter range equivalent to e700	10 to 60 sec	Parameter range is equivalent to e700.
Monitoring	Similar to e700, does not affect performance	Minute Volume, Volume Measured, Instant pressure measured, maximum inspiratory pressure, Respiratory Rate, Plateau pressure, PEEP, Flow, inspiratory time, expiratory time, Ratio I:E, Airway resistance, Dynamic compliance, Static compliance, FiO2, O2 consumption	Oxymag has monitored parameters that e700 has and additional others, but the difference does not affect the performance of Oxymag.
Waveform Displayed	Equivalent to e700	Pressure and flow	Waves are equivalent to e700.
Alarms Audible/Visual & Indications	Significant alarms similar to e700; differences do not raise safety questions	Disconnection, Low airway pressure, High airway pressure, Low minute volume, High minute volume, Obstruction, Low supply pressure, Apnea, Low battery, High PEEP, Low PEEP, AC input fail, High volume and Low volume, High r. rate, Low r. rate, Low internal temperature, High internal temperature, Flow sensor off, HW:High O2 int.	Significant alarms are similar to e700. Differences like additional ISO-required alarms or different alarm trigger mechanisms are stated not to raise safety questions.
Accessories	Significant accessories equivalent to e700	AC/DC power supply, Patient ventilation circuit, Oxygen supply hose, Environment filter	Significant accessories are equivalent to e700.
Reprocessing of Patient Circuit	Equivalent to e700	Single use	Patient circuit reprocessing is equivalent to e700.

Regarding the Study (Performance Data provided for Substantial Equivalence):

The document explicitly states: "There were no animal or clinical studies done for the subject device." This means that most of the specific questions about sample sizes, human experts, adjudication, and MRMC studies are not applicable to the data presented for this 510(k) submission.

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable. No human test subjects were used. Performance data was derived from bench testing.
Data Provenance: Not applicable for human data. Bench testing was performed on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No human test set requiring expert ground truth was used.

4. Adjudication method for the test set:

Not applicable. No human test set was used for adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. No MRMC study was done, as this is a ventilator and not an AI-assisted diagnostic device, and no human studies were conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable in the context of an algorithm's diagnostic performance. However, "Performance testing was conducted on the Oxymag to determine its specifications regarding ventilatory parameters" and "verification of technical data, comparison between Oxymag and the predicate e700, human factors evaluation, validation of ventilatory modes, alarm system, monitored parameters, auto test, hardware and mechanical specifications" serve as standalone device performance evaluations in a non-clinical setting.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For Biocompatibility: International standard ISO 10993-1 and FDA Guidance as recognized by FDA.
For Electrical Safety and EMC: IEC 60601-1, IEC 60601-1-8, IEC 60601-1-12, IEC 80601-2-12, IEC 80601-2-55 for safety; IEC 60601-1-2 for EMC; AIM 7351732 for RFID.
For Software: FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
For Mechanical Testing: Device specifications based on engineering design and comparison to the predicate device's established performance. The "ground truth" here is the established and expected performance curves and parameter ranges for ventilators, often derived from industry standards and the predicate device's known capabilities.

8. The sample size for the training set:

Not applicable. There is no mention of a training set as this is not an AI/machine learning device requiring such.

9. How the ground truth for the training set was established:

Not applicable. No training set was used.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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.

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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

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Indications for Use

510(k) Number (if known) K221634

Device Name

Oxymag - Transport and Emergency Ventilator

Indications for Use (Describe)

It is intended for pre-hospital and hospital use including intra-hospital and transport settings.

Type of Use (Select one or both, as applicable)
	☑Prescription Use (Part 21 CFR 801 Subpart D) ☐Over-The-Counter Use (21 CFR 801 Subpart C)

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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

The associated accessories include:

. Power outlet 12V/3,34A
AC cable ●
Disposable respiratory circuit ●
02 extension

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. Environment filters

V. INDICATION FOR USE

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	PredicateE700 (K141595)	Discussion
Indications foruse	OxymagOxymag is a controlledvolume, pressure andtime cycled emergencyand transport ventilator. Itis intended for use withinfant, child, and adultpatients with a tidalvolume from 50 mlupwards who are inrespiratory and/or cardiacarrest or respiratorydistress and who requirethe ventilatory support.It is intended for pre-hospital and hospital useincluding intra-hospital,inter-hospital andtransport settings.	o_two e700, e600 ande500 are a time-cycled,volume-constant andpressure-controlled(only e700) emergencyand transport ventilatordesigned for use in thepre-hospital, intra-hospital, inter-hospitaland transport settings.It is intended for usewith adult, child andinfant patients with atidal volume from 50 ml(100 ml for e500)upwards who are inrespiratory and/orcardiac arrest orrespiratory distress whorequire ventilatorysupport.	The indications for use isequivalent to e700.The model e700 is the onlyone being used as thepredicate from K141595
Patientpopulation	Infant, child, and adultpatients	Adult, child, infantpatients	The patient population isequivalent to e700.
Environmentof use	Pre-hospital and hospitaluse including intra-hospital, inter-hospital andtransport settings.	Pre-hospital, intra-hospital, inter-hospitaland transport settings	The environment of use isequivalent to e700.
SubjectOxymag	PredicateE700 (K141595)	Discussion
Product code	BTL	BTL	The product code isequivalent to e700.
Ventilationmodes	VCV, PCV, V-SIMV, P-SIMV, CPAP/PS	A/CV, SIMV, BiLVL,CPAP and CPR	Similar to e700.Except for CPR, that is notdelivered in Oxymag, theother modes have differentnomenclature, but they areequivalent.ACV deliver VCV or PCV,that is equivalent to VCVand PCV.SIMV deliver volumeventilation at the set tidalvolume and rate, that isequivalent to V-SIMV.
			BiLVL is similar to SIMVbut with pressureventilation, that isequivalent to P-SIMV.CPAP has the samenomenclature and isequivalent.Oxymag does not haveCPR mode.
Breathingcircuit	Dual limb, unique for allpatient types	Single limb, unique forall patient types	Different to e700.Both breathing circuits areunique for all patients.The only difference is thatOxymag uses a dual limband e700 uses a singlelimb.A dual limb circuit has onetube for inhalation andanother for exhalationwhile a single limb has onetube for both inhalationand exhalation.Despite the difference, theperformance of bothdevices is similar asdemonstrated in benchtest.
Exhalationvalve	Connected to theequipment in theexhalation connector	Connected in thebreathing circuit	Different to e700.In e700, the control ofinhalation and exhalation ispneumatic. Duringinspiration, the exhalationvalve, that is in thebreathing circuit, is closedvia the pressurization linefrom the ventilator.Oxymag electronicallycontrols the exhalation by
	SubjectOxymag	PredicateE700 (K141595)	Discussion
Waveforms	volume-time, pressure-time and flow- time	volume-time, pressure-time and flow- time	Waveforms are equivalentto e700 as demonstratedin bench test.
Flow sensor	Pneumotachograph	Pneumotachograph	Flow sensor is equivalentto e700.
Flow control	Proportional valvescontrolled by themicroprocessor	Solenoid Valvesactivated by themicroprocessor	Similar to e700.Solenoid valves have anon/off control and has a setof solenoids with differentflow passages, and todeliver a flow, it opens andcloses certain solenoids.Proportional valves converta variable current orvoltage signal into aproportional flow output.Despite the difference, theperformance of bothdevices is similar asdemonstrated in benchtest.
TriggerSensitivity	OFF; 1 to 15 L/min	OFF; 1 to 15 L/min	Parameter range isequivalent to e700.
Input pressure	39 to 87 psi	45 PSI to 87 PSI	Different to e700. Thelower limit of Oxymag'sinput pressure is lowerthan e700, but thedifference does not affectthe performance ofOxymag. Oxymag deliversall ventilation parametersbetween 39 and 87 psi.
PSV (pressuresupportventilation)	OFF; 4 to 35 cmH2O(± 10% or ± 2 cmH2O)	OFF, 4- 35 cmH2O(± 10% or ± 2 cmH2O)	Parameter range isequivalent to e700.
VentilationFrequency	5 to 60 breath/min(± 10% or ± 1 bpm)	5 to 60 breath/min(± 10% or ± 1 bpm)	Parameter range isequivalent to e700.
Tidal Volume(L)	50 to 2000 mL(±20ml or ±15%)	50 ml to 2000 mL(±20ml or ±15%)	Parameter range isequivalent to e700.
Manualventilation/Inspirationhold	Yes	Yes	Parameter range isequivalent to e700.
Inspirationtimetoexpirationtime ratio	1:4 to 3:1(± 20%)	1:4 to 3:1(± 20%)	Parameter range isequivalent to e700.
	SubjectOxymag	PredicateE700 (K141595)	Discussion
Inspirationtime Ti (sec.)	0,2 to 9 s(± 20%)	0,2 to 9 s(± 20%)	Parameter range isequivalent to e700.
PEEP/ CPAP(cm H2O)	OFF; 4 to 20(± 10% or ± 2 cmH2O)	OFF; 4 to 20(± 10% or ± 2 cmH2O)	Parameter range isequivalent to e700.
FiO2 (%)	60 or 100(± 15%)	60% or 100%(± 15%)	Parameter range isequivalent to e700.
Pmax	10 to 60(± 10% or ± 2 cmH2O)	10- 80 cmH2O(± 10% or ± 2 cmH2O)	Different to e700. Oxymaghas a more restrictedupper limit.
Safetyreliefvalve	Yes	Yes	Safety valve is equivalentto e700.
Inhalationpressure(cmH2O)	OFF; 4 to 50 cmH2O(± 10% or ± 2 cmH2O)	4 - 50 cmH2O(± 10% or ± 2 cmH2O)	Parameter range isequivalent to e700.
backApneaup time	10 to 60 sec	10 to 60 sec	Parameter range isequivalent to e700.
	Minute Volume, VolumeMeasured,Instant pressuremeasured, maximuminspiratory pressure,Respiratory Rate	Mve, Vte, Paw(AV),Paw(Peak), Fbpm	Similar to e700.
Monitoring	Plateau pressure, PEEP,Flow, inspiratory time,expiratory time, Ratio I:E,Airway resistance,Dynamic compliance,Static compliance, FiO2,O2 consumption	None	Oxymag has the monitoredparameters that e700 hasand additional others, butthe difference does notaffect the performance ofOxymag.
Waveformdisplayed	Pressure and flow	Pressure and flow	Waves are equivalent toe700.
AlarmsAudible/Visual& indications	Disconnection, Lowairway pressure, Highairway pressure, Lowminute volume, Highminute volume, Lowminute volume,Obstruction, Low supplypressure, Apnea, Lowbattery,	Patient circuitdisconnect, Low airwaypressure, High airwaypressure, Low minutevolume, High minutevolume, Blocked airway,Low oxygen, Apnea,Low battery, Lowinhalation pressure,No Oxygen, Emptybattery, Patient effort.	Significant alarms aresimilar to e700.Low inhalation pressureand Low airway pressureis equivalent to low airwaypressure in Oxymag.No Oxygen alarm isequivalent to low supplypressure in Oxymag.Empty battery is equivalentto low battery alarm ofOxymag.Patient effort alarm isequivalent to triggermessage in Oxymag.Oxymag does not haveleak alarm, but when there
	SubjectOxymag	PredicateE700 (K141595)	Discussion
	High PEEP, Low PEEP,AC input fail,High volume and Lowvolume, High r. rate, Lowr. rate, Low internaltemperature, High internaltemperature, Flow sensoroff, HW:High O2 int.		breathing circuit, thedisconnection alarm istriggered.Oxymag does not have ahigh input pressure alarm,but it has a regulator valve,and in case of a high inputpressure, the regulatorvalve will reduce thepressure and theperformance of the devicewill not be affected.Oxymag has high and lowFiO2 alarms that arerequirements of ISO80601-2-12 and ISO80601-2-55. Oxymag alsohas FiO2 < 18% alarm thatis required by ISO 80601-2-55.High PEEP , Low PEEP ,AC input fail, High volumeand Low volume alarmsare ISO 80601-2-12requirements.High r. rate, Low r. rate,Low internal temperature,High internal temperature,Flow sensor off andHW:High O2 int. are notstandard requirementalarms, but they contributeto increase the devicesafety.So, the differences in thealarm system does notraise safety questions.
Accessories	- AC/DC power supply -Patient ventilation circuit -Oxygen supply hose –Environment filter	Input pressure hose,Intake filter, Powersupply cord, Batterypack, Ventilator externalpower supply, Mountingbracket for roadambulance, Test lungand Transport ventilatorcarrying case	Significant accessories areequivalent to e700.
Reprocessingof Patientcircuit	Single use	Single use	Patient circuit reprocessingis equivalent to e700.

Table 1. Comparison table between the subject and predicate devices

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Both Oxymag and e700 receive oxygen via the gas input connection. Oxymag regulates the oxygen pressure by using a regulator valve. E700 does not have a regulator valve. The valves used in e700 withstand a pressure of 100 psi, and e700 recommends a maximum input pressure of 87 psi. Oxymag also recommends a maximum input pressure of 87 psi.

To control the oxygen concentration, If the oxygen concentration adjusted is 100% in Oxymag, the proportional valve will regulate the flow and in e700 the solenoid valves will requlate the flow. If the concentration is adjusted in 60%, the venturi system will mix the oxygen with the ambient air to reach the concentration of 60% in both devices. In order to measure the concentration, Oxymag has a galvanic cell, which is different from e700 that does not have this sensor. This oxygen sensor is an additional control measure to ensure that the concentration delivered to the patient is according the adjusted and do not raise performance or safety risks.

To check the flow delivered to patient, both Oxymag and e700 have a pneumotachograph flow sensor and measure the same parameters of the patient.

In case of a high pressure in the breathing circuit occurs, both Oxymag and e700 have a safety valve to release the pressure by open the system to atmosphere.

While the breathing circuit of e700 is a single limb circuit with an exhalation valve in the breathing circuit. Oxymaq uses a dual limb circuit, composed of an inspiratory and expiratory limb that are connected to the inspiratory and expiratory port. The exhalation valve is connected direct on the expiratory port of the ventilator. Despite this difference, the exhalation for both devices is similar.

PERFORMANCE DATA VII.

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for Oxymaq device was conducted in accordance with the FDA Guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process,"" September 4, 2020, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.

In accordance with ISO 10993-1 and FDA Guidance for Biocompatibility, the components of a ventilator are classified as externally communicating, tissue contact and duration ≤ 24 hours. Therefore, Oxymag was tested in the following tests:

. Particulate matter emission
Volatile organic compounds ●
Ozone gas analysis ●
Carbon monoxide and carbon dioxide gas analysis

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Cytotoxicity ●
Sensitization ●
Irritation
Systemic toxicity ●
Pyrogenicity ●

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Oxymag. The system complies with the IEC 60601-1. IEC 60601-1-8. IEC 60601-1-12. IEC 80601-2-12. IEC 80601-2-55 for safety, IEC 60601-1-2 standard for EMC and AIM 7351732 for RFID.

Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern since a failure or latent failure in the software could directly result in serious injury or death to the patient or operator.

Mechanical testing

Performance testing was conducted on the Oxymag to determine its specifications regarding ventilatory parameters, including validation with nebulizer and mask. It was performed verification of technical data, comparison between Oxymaq and the predicate e700, human factors evaluation, validation of ventilatory modes, alarm system, monitored parameters, auto test, hardware and mechanical specifications.

Animal and clinical studies

There were no animal or clinical studies done for the subject device.

CONCLUSIONS VIII.

The results of the comparative performance and specification as well as bench testing demonstrate that Oxymaq is substantially equivalent as the legally marketed predicate device e700.

Regulation Number and Section

§ 868.5925 Powered emergency ventilator.

(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).