(352 days)
Not Found
No
The summary describes a standard emergency and transport ventilator with mechanical and electronic controls, without mentioning any AI or ML capabilities. The performance studies focus on safety, electrical compatibility, software validation, and mechanical performance, not on algorithmic learning or adaptation.
Yes
The device is a ventilator intended for ventilatory support for patients in respiratory and/or cardiac arrest or respiratory distress, directly treating a medical condition.
No
The device is described as a ventilator, providing ventilatory support. It measures O2 concentration and controls flows and pressures, but these are for delivering therapy, not for diagnosing a condition.
No
The device description explicitly mentions hardware components such as a galvanic cell, venturi principle system, power outlet, AC cable, respiratory circuit, O2 extension, and environment filters, indicating it is a physical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Oxymag is a ventilator used for providing ventilatory support to patients. This is a therapeutic and life-support function, not a diagnostic one.
- Device Description: The description details how the device mixes air and oxygen, controls flows and pressures, and uses a galvanic cell to measure oxygen concentration. These are all related to delivering and monitoring respiratory support, not analyzing samples from the human body for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Oxymag's function is to directly support respiration, which falls outside the scope of an IVD.
N/A
Intended Use / Indications 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.
Product codes
BTL
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Infant, child, and adult patients
Intended User / Care Setting
It is intended for pre-hospital and hospital use including intra-hospital, inter-hospital and transport settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for Oxymag 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
- 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 Oxymag 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
O-two e700, K141595
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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) | |
|---|---|
| ☑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
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
E700 (K141595) | Discussion |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
use | Oxymag
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. | 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. | The indications for use is
equivalent to e700.
The model e700 is the only
one being used as the
predicate from K141595 |
| Patient
population | Infant, child, and adult
patients | Adult, child, infant
patients | The patient population is
equivalent to e700. |
| Environment
of use | Pre-hospital and hospital
use including intra-
hospital, inter-hospital and
transport settings. | Pre-hospital, intra-
hospital, inter-hospital
and transport settings | The environment of use is
equivalent to e700. |
| Subject
Oxymag | Predicate
E700 (K141595) | Discussion | |
| Product code | BTL | BTL | The product code is
equivalent to e700. |
| Ventilation
modes | VCV, PCV, V-SIMV, P-
SIMV, CPAP/PS | A/CV, SIMV, BiLVL,
CPAP and CPR | Similar to e700.
Except for CPR, that is not
delivered in Oxymag, the
other modes have different
nomenclature, but they are
equivalent.
ACV deliver VCV or PCV,
that is equivalent to VCV
and PCV.
SIMV deliver volume
ventilation at the set tidal
volume and rate, that is
equivalent to V-SIMV. |
| | | | BiLVL is similar to SIMV
but with pressure
ventilation, that is
equivalent to P-SIMV.
CPAP has the same
nomenclature and is
equivalent.
Oxymag does not have
CPR mode. |
| Breathing
circuit | Dual limb, unique for all
patient types | Single limb, unique for
all patient types | Different to e700.
Both breathing circuits are
unique for all patients.
The only difference is that
Oxymag uses a dual limb
and e700 uses a single
limb.
A dual limb circuit has one
tube for inhalation and
another for exhalation
while a single limb has one
tube for both inhalation
and exhalation.
Despite the difference, the
performance of both
devices is similar as
demonstrated in bench
test. |
| Exhalation
valve | Connected to the
equipment in the
exhalation connector | Connected in the
breathing circuit | Different to e700.
In e700, the control of
inhalation and exhalation is
pneumatic. During
inspiration, the exhalation
valve, that is in the
breathing circuit, is closed
via the pressurization line
from the ventilator.
Oxymag electronically
controls the exhalation by |
| | Subject
Oxymag | Predicate
E700 (K141595) | Discussion |
| Waveforms | volume-time, pressure-
time and flow- time | volume-time, pressure-
time and flow- time | Waveforms are equivalent
to e700 as demonstrated
in bench test. |
| Flow sensor | Pneumotachograph | Pneumotachograph | Flow sensor is equivalent
to e700. |
| Flow control | Proportional valves
controlled by the
microprocessor | Solenoid Valves
activated by the
microprocessor | Similar to e700.
Solenoid valves have an
on/off control and has a set
of solenoids with different
flow passages, and to
deliver a flow, it opens and
closes certain solenoids.
Proportional valves convert
a variable current or
voltage signal into a
proportional flow output.
Despite the difference, the
performance of both
devices is similar as
demonstrated in bench
test. |
| Trigger
Sensitivity | OFF; 1 to 15 L/min | OFF; 1 to 15 L/min | Parameter range is
equivalent to e700. |
| Input pressure | 39 to 87 psi | 45 PSI to 87 PSI | Different to e700. 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) | OFF; 4 to 35 cmH2O
(± 10% or ± 2 cmH2O) | OFF, 4- 35 cmH2O
(± 10% or ± 2 cmH2O) | Parameter range is
equivalent to e700. |
| Ventilation
Frequency | 5 to 60 breath/min
(± 10% or ± 1 bpm) | 5 to 60 breath/min
(± 10% or ± 1 bpm) | Parameter range is
equivalent to e700. |
| Tidal Volume
(L) | 50 to 2000 mL
(±20ml or ±15%) | 50 ml to 2000 mL
(±20ml or ±15%) | Parameter range is
equivalent to e700. |
| Manual
ventilation/
Inspiration
hold | Yes | Yes | Parameter range is
equivalent to e700. |
| Inspiration
time
to
expiration
time ratio | 1:4 to 3:1
(± 20%) | 1:4 to 3:1
(± 20%) | Parameter range is
equivalent to e700. |
| | Subject
Oxymag | Predicate
E700 (K141595) | Discussion |
| Inspiration
time Ti (sec.) | 0,2 to 9 s
(± 20%) | 0,2 to 9 s
(± 20%) | Parameter range is
equivalent to e700. |
| PEEP/ CPAP
(cm H2O) | OFF; 4 to 20
(± 10% or ± 2 cmH2O) | OFF; 4 to 20
(± 10% or ± 2 cmH2O) | Parameter range is
equivalent to e700. |
| FiO2 (%) | 60 or 100
(± 15%) | 60% or 100%
(± 15%) | Parameter range is
equivalent to e700. |
| Pmax | 10 to 60
(± 10% or ± 2 cmH2O) | 10- 80 cmH2O
(± 10% or ± 2 cmH2O) | Different to e700. Oxymag
has a more restricted
upper limit. |
| Safety
relief
valve | Yes | Yes | Safety valve is equivalent
to e700. |
| Inhalation
pressure
(cmH2O) | OFF; 4 to 50 cmH2O
(± 10% or ± 2 cmH2O) | 4 - 50 cmH2O
(± 10% or ± 2 cmH2O) | Parameter range is
equivalent to e700. |
| back
Apnea
up time | 10 to 60 sec | 10 to 60 sec | Parameter range is
equivalent to e700. |
| | Minute Volume, Volume
Measured,
Instant pressure
measured, maximum
inspiratory 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 monitored
parameters that e700 has
and additional others, but
the difference does not
affect the performance of
Oxymag. |
| Wave
form
displayed | Pressure and flow | Pressure and flow | Waves are equivalent to
e700. |
| Alarms
Audible/Visual
& indications | Disconnection, Low
airway pressure, High
airway pressure, Low
minute volume, High
minute volume, Low
minute volume,
Obstruction, Low supply
pressure, Apnea, Low
battery, | Patient circuit
disconnect, Low airway
pressure, High airway
pressure, Low minute
volume, High minute
volume, Blocked airway,
Low oxygen, Apnea,
Low battery, Low
inhalation pressure,
No Oxygen, Empty
battery, Patient effort. | Significant alarms are
similar to e700.
Low inhalation pressure
and Low airway pressure
is equivalent to low airway
pressure in Oxymag.
No Oxygen alarm is
equivalent to low supply
pressure in Oxymag.
Empty battery is equivalent
to low battery alarm of
Oxymag.
Patient effort alarm is
equivalent to trigger
message in Oxymag.
Oxymag does not have
leak alarm, but when there |
| | Subject
Oxymag | Predicate
E700 (K141595) | Discussion |
| | 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. | | breathing circuit, the
disconnection alarm is
triggered.
Oxymag does not have a
high input pressure alarm,
but it has a regulator valve,
and in case of a high input
pressure, the regulator
valve will reduce the
pressure and the
performance of the device
will not be affected.
Oxymag has high and low
FiO2 alarms that are
requirements of ISO
80601-2-12 and ISO
80601-2-55. Oxymag also
has FiO2