(141 days)
No
The description focuses on standard ventilator functionality, user-adjustable settings, and basic monitoring. There is no mention of AI, ML, or any adaptive or learning algorithms.
Yes
The device is a ventilator intended to provide ventilatory support for individuals requiring mechanical ventilation, which is a therapeutic intervention.
No
The device is a ventilator, designed to provide ventilatory support, not to diagnose medical conditions. It delivers therapy based on configured settings and allows for monitoring of patients, but does not identify or characterize diseases.
No
The device description explicitly mentions hardware components such as a motor-blower system, breathing circuit, pressure monitoring line, flow sensor, touch screen input, and the ability to run on AC power and/or batteries. It also mentions electrical safety and electromagnetic compliance testing, which are relevant to hardware.
Based on the provided text, the VM-2000 ventilator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device provides "continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation." This is a life support function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details how the device delivers air to the patient and monitors physiological parameters related to breathing. It does not describe any process of analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in these samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of samples.
The VM-2000 is a therapeutic medical device used to support breathing in patients.
N/A
Intended Use / Indications for Use
The VM-2000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation in emergency and transport situations. The ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult patients, who require the following types of ventilatory support:
- Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask).
- Assist/Control, SIMV, CPAP and NPPV modes of ventilation.
The ventilator is suitable for use in institutional or transport settings.
Product codes (comma separated list FDA assigned to the subject device)
CBK
Device Description
The VM-2000 allows for rapid initiation of emergency ventilation based on default parameters. An operator can quickly begin ventilation by connecting the patient to the breathing circuit, and if necessary, adjusting ventilatory settings using the touch screen input before selecting start.
Once the therapy is initiated, breaths are delivered to the patient based on the configured settings. If the situation allows, qualified operators can adjust desired Mode, Tidal Vol, Respiratory Rate, PEEP, PIP, T Insp, P Insp and Sensitivity. Operators can monitor patients closely through a graphical breath-by-breath display to deliver highquality care. Audio and visual alarm indicators help troubleshoot issues.
The VM-2000 uses a single-patient-use breathing circuit with a Pressure Monitoring Line, and Flow Sensor to deliver air to patients using a motor-blower system. The unit has a Type BF Applied Part, which is the breathing circuit. The device can run on AC wall power and / or batteries. To support use in environments where compressed Oxygen is unavailable or ill-advised, the device does not require compressed Oxygen. The VM-2000 is compatible with low pressure oxygen sources and blenders but will function without supplemental FiO2.
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
Adult patients
Intended User / Care Setting
Qualified, trained personnel under the direction of a physician.
Institutional or 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The VM-2000 was subjected to performance tests including: reliability testing, alarm tests, design control verification, software verification, and electromagnetic compliance, electrical safety, packaging verification, environmental testing, waveform testing and biocompatibility testing. The non-clinical performance testing included testing of a set of ventilation modes as described. The data demonstrates that the technological characteristics of the VM-2000 ventilator are substantially equivalent with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Cardinal Health LTV 1200 - K083688, Respironics Trilogy EVO – K181166
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Inovytec - Ventway Sparrow – K202970
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 13, 2024
Ventis Medical, Inc. % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Drive NE Saint Petersburg, Florida 33704
Re: K240807
Trade/Device Name: VM-2000 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: July 15, 2024 Received: July 15, 2024
Dear Paul Dryden:
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 (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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices
2
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240807
Device Name VM-2000
Indications for Use (Describe)
The VM-2000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation in emergency and transport situations. The ventilator is a medical for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult patients, who require the following types of ventilatory support:
- Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask). - Assist/Control, SIMV, CPAP and NPPV modes of ventilation.
The ventilator is suitable for use in institutional or transport settings.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
| Date Prepared: | 09-Aug-2024 |
|---|---|
| Sponsor: | Ventis Medical, Inc. |
| 515 Executive Drive | |
| Princeton, NJ 08540 | |
| (609) 373-6229 | |
| Sponsor Contact: | Glenn W. Laub, M.D. - CEO |
| Submission Contact: | Paul Dryden |
| ProMedic Consulting, LLC | |
| Proprietary or Trade Name: | VM-2000 |
| Common/Usual Name: | Emergency and Transport Ventilator |
| Classification Name: | Continuous ventilator |
| CFR: | 868.5895 |
| Product Classification: | CBK |
| Primary Predicate Device: | Cardinal Health LTV 1200 - K083688 |
| Classification Name: | Continuous ventilator |
| CFR: | 868.5895 |
| Product Classification: | CBK |
| Secondary Predicate Device: | Respironics Trilogy EVO – K181166 |
| Classification Name: | Continuous ventilator |
| CFR: | 868.5895 |
| Product Classification: | CBK and NOU |
| Reference Device: | Inovytec - Ventway Sparrow – K202970 |
| Classification Name: | Continuous ventilator |
| CFR: | 868.5895 |
| Product Classification: | CBK |
Device Description:
The VM-2000 allows for rapid initiation of emergency ventilation based on default parameters. An operator can quickly begin ventilation by connecting the patient to the breathing circuit, and if necessary, adjusting ventilatory settings using the touch screen input before selecting start.
Once the therapy is initiated, breaths are delivered to the patient based on the configured settings. If the situation allows, qualified operators can adjust desired Mode, Tidal Vol, Respiratory Rate, PEEP, PIP, T Insp, P Insp and Sensitivity. Operators can monitor patients closely through a graphical breath-by-breath display to deliver highquality care. Audio and visual alarm indicators help troubleshoot issues.
The VM-2000 uses a single-patient-use breathing circuit with a Pressure Monitoring Line, and Flow Sensor to deliver air to patients using a motor-blower system. The unit has a Type BF Applied Part, which is the breathing circuit. The device can run on AC wall power and / or batteries. To support use in environments where compressed Oxygen is unavailable or ill-advised, the device does not require compressed Oxygen. The VM-2000 is compatible with low pressure oxygen sources and blenders but will function without supplemental FiO2.
5
Principle of Operation:
The VM-2000 Ventilator is a portable ventilator designed to provide continuous or intermittent ventilatory support for individuals who require mechanical ventilation. The VM 2000 is a blower based positive pressure ventilator. It includes pressure and flow sensors as well as alarms.
Indications for Use:
The VM-2000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation in emergency and transport situations. The ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult patients, who require the following types of ventilatory support:
- Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask).
- Assist/Control, SIMV, CPAP and NPPV modes of ventilation. -
The ventilator is suitable for use in institutional or transport settings.
6
510(k) Summary Page 3 of 10
| Comparison | ||||
|---|---|---|---|---|
| Features | Subject Device | |||
| Ventis - VM-2000 | Primary Predicate – K083688 | |||
| LTV 1200 | Secondary Predicate – K181166 | |||
| Respironics Trilogy Evo | Remarks, Substantial equivalence | |||
| Picture | Image: Ventis - VM-2000 | Image: LTV 1200 | Image: Respironics Trilogy Evo | |
| Indications for | ||||
| Use | The VM-2000 ventilator is intended | |||
| to provide continuous or intermittent | ||||
| ventilatory support for the care of | ||||
| individuals who require mechanical | ||||
| ventilation in emergency and | ||||
| transport situations. The ventilator is | ||||
| a medical device intended for use by | ||||
| qualified, trained personnel under the | ||||
| direction of a physician. Specifically, | ||||
| the ventilator is applicable for adult | ||||
| patients, who require the following | ||||
| types of ventilatory support: |
- Positive Pressure
Ventilation, delivered invasively (via
endotracheal tube or trach tube) or
non-invasively (via mask). - Assist/Control, SIMV,
CPAP and NPPV modes of
ventilation.
The ventilator is suitable for use in
institutional or transport settings. | The LTV® 1200 ventilator is
intended to provide continuous or
intermittent ventilatory support for
the care of the individuals who
require mechanical ventilation. The
ventilator is a medical device
intended for use by qualified, trained
personnel under the direction of a
physician. Specifically, the ventilator
is applicable for adult and pediatric
patients weighing at least 5kg (11
lbs.), who require the following types
of ventilatory support:
• Positive Pressure Ventilation,
delivered invasively (via
endotracheal tube or trach tube) or
non-invasively (via mask).
• Assist/Control, SIMV, CPAP, and
NPPV modes of ventilation. The | The Trilogy Evo ventilator provides
continuous or intermittent positive
pressure ventilation for the care of
individuals who require mechanical
ventilation. Trilogy Evo is intended
for pediatric through adult patients
weighing at least 2.5 kg. The
ventilator can measure, display,
record, and alarm SpO2, FiO2, CO2,
Respiratory Rate, and Pulse Rate
data when integrated with the
appropriate accessories. The
ventilator is suitable for use in
institutional, home, and non-
emergency transport settings for
example wheelchair or personal
vehicle. It may be used for both
invasive and noninvasive ventilation. | All devices provide ventilatory
support and can be considered
substantially equivalent.
The Indications for Use for the
application device is a subset of the
Indications for Use of the predicates.
In particular, the application device
treats only adult patients, whereas the
predicate have a broader range of
patients.
The ventilation modes are identical
between the subject and the primary
predicate device, and are a subset of
the secondary predicate.
VM-2000 environment of use is a
subset of the primary predicate. |
| Features | Subject Device
Ventis - VM-2000 | Primary Predicate – K083688
LTV 1200 | Secondary Predicate – K181166
Respironics Trilogy Evo | Remarks, Substantial equivalence |
| | | ventilator is suitable for use in
institutional, home, or transport
settings. | | The VM-2000 is not intended for
home use. |
| Environment of
Use | Institutional and transport settings. | Institutional, home, and transport
settings. | Institutional, home, and non-
emergency transport settings for
example wheelchair or personal
vehicle. | VM-2000 is intended to be used in a
subset of environments (institutional
and transport) of use of the primary
predicate.
The lack of home use does not raise
different safety concerns for the |
| | | | | intended Environments of Use. |
| Qualified users | Intended for use by qualified, trained
personnel under the direction of a
physician. | Intended for use by qualified, trained
personnel under the direction of a
physician. | Intended for use by qualified, trained
personnel under the direction of a
physician. | Identical |
| Patient
population | Adult patients | Pediatric through adult patients
weighing at least 5 kg. | Pediatric through adult patients
weighing at least 2.5 kg. | The subject device is intended for
adult patients. This is a subset of the
intended cohorts of the predicate
devices. |
| MRI suite | No | No | No | Identical |
| Ventilation
Modes | • Assist/Control (AC)
• SIMV
• CPAP
• NPPV | • Assist/Control (AC)
• SIMV
• CPAP
• NPPV | • Assist/Control (AC)
• SIMV
• CPAP
• NPPV
• Other Modes | The subject device offers an identical
set of modes as the Primary Predicate
(LTV) and a subset of the Secondary
Predicate (Trilogy EVO). |
| Features | Subject Device
Ventis - VM-2000 | Primary Predicate - K083688
LTV 1200 | Secondary Predicate - K181166
Respironics Trilogy Evo | Remarks, Substantial
equivalence |
| Use Interface | Graphical User Interface using a
touch screen display, status LEDs
and dedicated keys for user input. | Graphical User Interface using a 7-
segment display, status LEDs and
dedicated keys / knob for user input. | Graphical User Interface using a
touch screen display, status LEDs
and dedicated keys for user input. | Subject device use
interface is similar to that
of the Secondary Predicate
(Trilogy EVO). Any
difference in user interface
would not be considered
significant based upon
Human Factors testing. |
| Waveform
comparison | We have performed waveform comparison to the predicates, K181166 Respironics Trilogy Evo and K083688 LTV 1200 | | | |
| Flow
measurement | Proximal flow sensor | Proximal flow sensor | Proximal flow sensor | Identical |
| EtCO2 | In-line EtCO2 sensor (conforms with
ISO 80601-2-55) | External EtCO2 sensor available | In-line EtCO2 sensor (conforms with
ISO 80601-2-55) | All devices can measure
EtCO2. The subject device
and the secondary
predicate (Trilogy EVO)
both support the use of an
EtCO2 sensor |
| Accessories
User supplied | Standard single limb ventilator
circuit with Exhalation Valve
In-line EtCO2 adapter | Standard single limb ventilator
circuit with Exhalation Valve
and Proximal flow sensor | Standard single limb ventilator
circuit with Exhalation Valve
In-line EtCO2 adapter | All devices utilize a single
limb circuit.
The subject device and
secondary predicate are
very similar to each other
regarding the external
patient circuit. |
| Features | Subject Device
Ventis - VM-2000 | Primary Predicate - K083688
LTV 1200 | Secondary Predicate - K181166
Respironics Trilogy Evo | Remarks, Substantial
equivalence |
| Sponsor supplied | Proximal flow sensor | Proximal flow sensor | Proximal flow sensor | Identical |
| Transport Case
and Mounting
System | Ambulance and Helicopter Transport
Case and Mounting System | Transport mountings not specified | Not specified | There are similar third
party supplied mounting
systems for these transport
modes. Shock and
Acceleration testing was
performed and when
compared to the predicate
mount does not raise new
or different questions of
safety or effectiveness. |
| Power supply | 100 - 240VAC, 24VDC | 110V or 220V AC power source, or
11V to 15V DC power source. | 100 - 240VAC, 24VDC | Similar for all devices. |
| Battery | Rechargeable Li-Ion and disposable
batteries | Rechargeable lead acid batteries | Rechargeable Li-Ion batteries | All devices contain backup
batteries. |
| System
architecture | Microprocessor controlled.
VM-2000's pneumatics deliver gas,
and its electrical systems control
pneumatics, monitor alarms, and
distribute power. | Microprocessor controlled.
LTV 's pneumatics deliver gas, and
its electrical systems control
pneumatics, monitor alarms, and
distribute power. | Microprocessor controlled.
Trilogy EVO 's pneumatics deliver
gas, and its electrical systems control
pneumatics, monitor alarms, and
distribute power. | All devices utilize similar
technology. |
| Control
architecture | User inputs become instructions for
the VM-2000 pneumatics to deliver
precisely controlled ventilation to the
patient. | User inputs become instructions for
the LTV pneumatics to deliver
precisely controlled ventilation to the
patient. | User inputs become instructions for
the Trilogy EVO pneumatics to
deliver precisely controlled
ventilation to the patient. | All devices utilize similar
technology and are
substantially equivalent. |
| Features | Subject Device
Ventis - VM-2000 | Primary Predicate - K083688
LTV 1200 | Secondary Predicate - K181166
Respironics Trilogy Evo | Remarks, Substantial
equivalence |
| Exhalation Valve
Control | During exhalation, a solenoid valve is
modulated to allow airway pressure to
return to PEEP via a pilot line to a
single limb circuit.
The blower is used as a pressure
source for this control. | During exhalation, an accumulator is
controlled via solenoids to allow
airway pressure to return to PEEP
via a pilot line to a single limb
circuit.
The blower is used as a pressure
source for this control. | During exhalation, a valve module
consisting of a solenoid and
proportional valve are modulated to
allow airway pressure to return to
PEEP via a pilot line to a single limb
circuit.
The blower is used as a pressure
source for this control. | All devices utilize similar
technology and have
substantially equivalent
performance. |
| Gas source | Blower + low flow 02 | Blower + low flow 02
High pressure 02 source | Blower + low flow 02 | Similar and use of
Reference K202970 for
similarity of oxygen
reservoir tube
configuration. |
| Gas source and
delivery | Electronically controlled pneumatic
ventilation system with an integrated
air compressing system.
VM-2000 uses room air and low flow
oxygen. Air enters through a fresh
gas intake port and is compressed
together with the oxygen by the
blower. Low flow oxygen enters
through a reservoir coupled to the
intake port. | Electronically controlled pneumatic
ventilation system with an integrated
air compressing system.
LTV uses room air and low flow
oxygen. Air enters through a fresh
gas intake port and is compressed
together with the oxygen by the
blower. Low flow oxygen enters
through a reservoir coupled to the
intake port. | Electronically controlled pneumatic
ventilation system with an integrated
air compressing system.
Trilogy EVO uses air and low flow
oxygen. Air enters through a fresh
gas intake port and is compressed
together with the oxygen by the
blower. Low flow oxygen enters
through a reservoir coupled to the
intake port. | Similar |
| Features | Subject Device
Ventis - VM-2000 | Primary Predicate - K083688
LTV 1200 | Secondary Predicate - K181166
Respironics Trilogy Evo | Remarks, Substantial
equivalence |
| Exhalation | Gas exhaled by the patient passes
through the flow sensor and exits
through the expiratory exhalation
valve with a membrane.
The exhalation valve is part of the
circuit thus ensuring that no exhaled
gas comes into contact with any
internal part of the VM-2000. | Gas exhaled by the patient passes
through the flow sensor and exits
through the expiratory exhalation
valve with a membrane.
The exhalation valve is part of the
circuit thus ensuring that no exhaled
gas comes into contact with any
internal part of the LTV. | Gas exhaled by the patient passes
through the flow sensor and exits
through the expiratory exhalation
valve with a membrane.
The exhalation valve is part of the
circuit thus ensuring that no exhaled
gas comes into contact with any
internal part of Trilogy EVO. | Similar |
| Sensors and
Monitoring | VM-2000 receives inputs from the
proximal Flow Sensor and other
sensors within the ventilator.
Monitored data is also displayed by
the graphic user interface.
A galvanic oxygen sensor (oxygen
cell) monitors the concentration of
the gas to be delivered | LTV receives inputs from the
proximal Flow Sensor and other
sensors within the ventilator.
Monitored data is also displayed by
the graphic user interface.
An external galvanic oxygen sensor
is available. | Trilogy EVO receives inputs from the
proximal Flow Sensor and other
sensors within the ventilator.
Monitored data is also displayed by
the graphic user interface.
A galvanic oxygen sensor (oxygen
cell) monitors the concentration of
the gas to be delivered | All devices have similar
sensors and technology. |
| Alarming | A comprehensive system of visual
and audible alarms helps ensure the
patient is monitored. Clinical alarms
can indicate an abnormal
physiological condition. Technical
alarms, triggered by the ventilator's
self-tests, including ongoing
background checks, can indicate a
hardware or software failure. | A comprehensive system of visual
and audible alarms helps ensure the
patient is monitored. Clinical alarms
can indicate an abnormal
physiological condition. Technical
alarms, triggered by the ventilator's
self-tests, including ongoing
background checks, can indicate a
hardware or software failure. | A comprehensive system of visual
and audible alarms helps ensure the
patient is monitored. Clinical alarms
can indicate an abnormal
physiological condition. Technical
alarms, triggered by the ventilator's
self-tests, including ongoing
background checks, can indicate a
hardware or software failure. | All devices have similar
and applicable alarms.
Use of reference K202970
for lack of overhead alarm
nurse call capabilities. |
| Features | Subject Device
Ventis - VM-2000 | Primary Predicate – K083688
LTV 1200 | Secondary Predicate – K181166
Respironics Trilogy Evo | Remarks, Substantial
equivalence |
| Safety Features | Conforms to ventilator consensus
standard safety requirements for ISO
80601-2-12, ISO 80601-2-84 such as:
- Maximum limited pressure
protection device - High airway pressure alarm
condition and protection device - Obstruction alarm condition
- Disconnection alarm condition
These safety requirements include
ensuring minimal breathing
resistance to prevent asphyxiation in
case of power supply loss. | Conforms to ventilator consensus
standard safety requirements for ISO
80601-2-12 such as: - Maximum limited pressure
protection device - High airway pressure alarm
condition and protection device - Obstruction alarm condition
- Disconnection alarm condition
These safety requirements include
ensuring minimal breathing
resistance to prevent asphyxiation in
case of power supply loss. | Conforms to ventilator consensus
standard safety requirements for ISO
80601-2-12 such as: - Maximum limited pressure
protection device - High airway pressure alarm
condition and protection device - Obstruction alarm condition
- Disconnection alarm condition
These safety requirements include
ensuring minimal breathing
resistance to prevent asphyxiation in
case of power supply loss. | All devices meet relevant
consensus standards for
critical care ventilators. |
| Performance
Testing | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-8
IEC 60601-1-12
AIM 7351731 RFID
ISO 80601-2-12
ISO 80601-2-55
ISO 80601-2-84
MIL-STD-810G
Altitude Testing
Human Factors | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-1
IEC 60601-1-2
ISO 3864
IEC 417
IEC 60417
IEC 68-2-27
IEC 68-2-6
IEC 68-2-34
MIL-STD-810E | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-8
IEC 60601-1-12
AIM 7351731 RFID
ISO 80601-2-12
ISO 80601-2-55
ISO 80601-2-84
Human Factors
ISO 80601-2-72 | All devices comply with
the applicable standards at
the time of clearance.
Similar standards were
applied, tested, and passed. |
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K240807 510(k) Summary Page 4 of 10
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510(k) Summary
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Comparison of Technological Characteristics
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510(k) Summary Page 7 of 10
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Discussion of the Comparison and Differences
We present the comparison to the predicate in the above tables. The main differences of the subject device and predicate are:
- . Patient population is limited to adult patients.
- This is a subset of the predicates but addresses the intended population O
- Environment of use is a subset of the Primary Predicate
- Subject device is not intended for home setting use o
- . Use of reference - K202970 for similarity of oxygen reservoir design, lack of overhead alarm / nurse call capabilities.
These differences do not raise different concerns of safety or effectiveness compared to the predicates.
Performance Testing
●
The VM-2000 was subjected to performance tests including: reliability testing, alarm tests, design control verification, software verification, and electromagnetic compliance, electrical safety, packaging verification, environmental testing, waveform testing and biocompatibility testing:
- Tested according to .
- ES 60601-1 ●
- . IEC 60601-1-2
- IEC 60601-1-8 ●
- IEC 60601-1-12
- . AIM Standard 7351731
- . ISO 80601-2-12
- ISO 80601-2-55
- ISO 80601-2-84 ●
- Altitude Testing ●
- Reliability testing has been performed for subject device. ●
The non-clinical performance testing included testing of a set of ventilation modes as described above. The data demonstrates that the technological characteristics of the VM-2000 ventilator are substantially equivalent with the predicate device.
Biocompatibility of Materials
The patient contact is Externally Communicating, Tissue, Prolonged. As for ventilators the testing included VOC (gas emission test method), CO, CO2, Ozone and PM2,5 and PM10 testing. We performed a risk based assessment for the results and the materials in patient contact meet the biological endpoints. Use of Reference device - K202970 for a prolonged duration of use.
Usabilitv
Summative usability tests was performed with a user group of respiratory therapists.
Substantial Equivalence Conclusion
Ventis Medical concludes that the VM-2000 ventilator is substantially equivalent in Indications for Use, technology, design, performance, user interface, and use context to the primary predicate LTV 1200 (K083688) and the secondary predicate, the Respironics Trilogy EVO (K181166). The sponsor has demonstrated via comparative bench testing and through non-clinical testing that the subject device does not raise different concerns of safety when compared to the predicates.