VM-2000

K240807 · Ventis Medical, Inc. · CBK · Aug 13, 2024 · Anesthesiology

Device Facts

• Record ID: K240807
• Device Name: VM-2000
• Applicant: Ventis Medical, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Aug 13, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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.

Device Story

VM-2000 is a portable, blower-based positive pressure ventilator for emergency and transport use. It delivers air to patients via a single-patient-use breathing circuit with a proximal flow sensor. The device operates without compressed oxygen, though it is compatible with low-pressure oxygen sources and blenders. Operators configure ventilation settings (Mode, Tidal Vol, Respiratory Rate, PEEP, PIP, T Insp, P Insp, Sensitivity) via a touch screen interface. The system provides breath-by-breath graphical monitoring and includes audio/visual alarms for physiological and technical conditions. It is powered by AC or internal batteries. The device is intended for use by qualified personnel in institutional or transport environments to provide ventilatory support, aiding in patient stabilization and care.

Clinical Evidence

Bench testing only. Testing included reliability, alarm functionality, design verification, software verification, electromagnetic compliance (IEC 60601-1-2), electrical safety (ES 60601-1), environmental testing (MIL-STD-810G, altitude), biocompatibility, and waveform comparison against predicates. Summative usability testing was conducted with respiratory therapists.

Technological Characteristics

Blower-based positive pressure ventilator; microprocessor-controlled. Features proximal flow sensor, galvanic oxygen sensor, and single-limb breathing circuit. Power: 100-240VAC, 24VDC, and rechargeable Li-Ion/disposable batteries. Standards: ISO 80601-2-12, ISO 80601-2-55, ISO 80601-2-84, IEC 60601-1, IEC 60601-1-8, IEC 60601-1-12, AIM 7351731. Biocompatibility: Externally communicating, tissue, prolonged duration.

Indications for Use

Indicated for adult patients requiring continuous or intermittent mechanical ventilatory support in emergency and transport settings. Applicable for invasive (endotracheal/trach tube) or non-invasive (mask) positive pressure ventilation. Modes include Assist/Control, SIMV, CPAP, and NPPV. For use by qualified, trained personnel under physician direction.

Regulatory Classification

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.

Predicate Devices

• Cardinal Health LTV 1200 (K083688)
• Respironics Trilogy EVO (K181166)

Reference Devices

• Inovytec - Ventway Sparrow (K202970)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ethan L. Nyberg -S

Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices

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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) 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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| Date Prepared: | 09-Aug-2024 |
|-----------------------------|--------------------------------------------------------------------------------------|
| Sponsor: | Ventis Medical, Inc.<br>515 Executive Drive<br>Princeton, NJ 08540<br>[phone] |
| Sponsor Contact: | Glenn W. Laub, M.D. - CEO |
| Submission Contact: | Paul Dryden<br>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.

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## 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.

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## 510(k) Summary Page 3 of 10

K240807

| Comparison | | | | |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Features | Subject Device<br>Ventis - VM-2000 | Primary Predicate – K083688<br>LTV 1200 | Secondary Predicate – K181166<br>Respironics Trilogy Evo | Remarks, Substantial equivalence |
| Picture | Image: Ventis - VM-2000 | Image: LTV 1200 | Image: Respironics Trilogy Evo | |
| Indications for<br>Use | The VM-2000 ventilator is intended<br>to provide continuous or intermittent<br>ventilatory support for the care of<br>individuals who require mechanical<br>ventilation in emergency and<br>transport situations. The ventilator is<br>a medical device intended for use by<br>qualified, trained personnel under the<br>direction of a physician. Specifically,<br>the ventilator is applicable for adult<br>patients, who require the following<br>types of ventilatory support:<br>- Positive Pressure<br>Ventilation, delivered invasively (via<br>endotracheal tube or trach tube) or<br>non-invasively (via mask).<br>- Assist/Control, SIMV,<br>CPAP and NPPV modes of<br>ventilation.<br>The ventilator is suitable for use in<br>institutional or transport settings. | The LTV® 1200 ventilator is<br>intended to provide continuous or<br>intermittent ventilatory support for<br>the care of the individuals who<br>require mechanical ventilation. The<br>ventilator is a medical device<br>intended for use by qualified, trained<br>personnel under the direction of a<br>physician. Specifically, the ventilator<br>is applicable for adult and pediatric<br>patients weighing at least 5kg (11<br>lbs.), who require the following types<br>of ventilatory support:<br>• Positive Pressure Ventilation,<br>delivered invasively (via<br>endotracheal tube or trach tube) or<br>non-invasively (via mask).<br><br>• Assist/Control, SIMV, CPAP, and<br>NPPV modes of ventilation. The | The Trilogy Evo ventilator provides<br>continuous or intermittent positive<br>pressure ventilation for the care of<br>individuals who require mechanical<br>ventilation. Trilogy Evo is intended<br>for pediatric through adult patients<br>weighing at least 2.5 kg. The<br>ventilator can measure, display,<br>record, and alarm SpO2, FiO2, CO2,<br>Respiratory Rate, and Pulse Rate<br>data when integrated with the<br>appropriate accessories. The<br>ventilator is suitable for use in<br>institutional, home, and non-<br>emergency transport settings for<br>example wheelchair or personal<br>vehicle. It may be used for both<br>invasive and noninvasive ventilation. | All devices provide ventilatory<br>support and can be considered<br>substantially equivalent.<br><br>The Indications for Use for the<br>application device is a subset of the<br>Indications for Use of the predicates.<br>In particular, the application device<br>treats only adult patients, whereas the<br>predicate have a broader range of<br>patients.<br><br>The ventilation modes are identical<br>between the subject and the primary<br>predicate device, and are a subset of<br>the secondary predicate.<br><br>VM-2000 environment of use is a<br>subset of the primary predicate. |
| Features | Subject Device<br>Ventis - VM-2000 | Primary Predicate – K083688<br>LTV 1200 | Secondary Predicate – K181166<br>Respironics Trilogy Evo | Remarks, Substantial equivalence |
| | | ventilator is suitable for use in<br>institutional, home, or transport<br>settings. | | The VM-2000 is not intended for<br>home use. |
| Environment of<br>Use | Institutional and transport settings. | Institutional, home, and transport<br>settings. | Institutional, home, and non-<br>emergency transport settings for<br>example wheelchair or personal<br>vehicle. | VM-2000 is intended to be used in a<br>subset of environments (institutional<br>and transport) of use of the primary<br>predicate.<br>The lack of home use does not raise<br>different safety concerns for the |
| | | | | intended Environments of Use. |
| Qualified users | Intended for use by qualified, trained<br>personnel under the direction of a<br>physician. | Intended for use by qualified, trained<br>personnel under the direction of a<br>physician. | Intended for use by qualified, trained<br>personnel under the direction of a<br>physician. | Identical |
| Patient<br>population | Adult patients | Pediatric through adult patients<br>weighing at least 5 kg. | Pediatric through adult patients<br>weighing at least 2.5 kg. | The subject device is intended for<br>adult patients. This is a subset of the<br>intended cohorts of the predicate<br>devices. |
| MRI suite | No | No | No | Identical |
| Ventilation<br>Modes | • Assist/Control (AC)<br>• SIMV<br>• CPAP<br>• NPPV | • Assist/Control (AC)<br>• SIMV<br>• CPAP<br>• NPPV | • Assist/Control (AC)<br>• SIMV<br>• CPAP<br>• NPPV<br>• Other Modes | The subject device offers an identical<br>set of modes as the Primary Predicate<br>(LTV) and a subset of the Secondary<br>Predicate (Trilogy EVO). |
| Features | Subject Device<br>Ventis - VM-2000 | Primary Predicate - K083688<br>LTV 1200 | Secondary Predicate - K181166<br>Respironics Trilogy Evo | Remarks, Substantial<br>equivalence |
| Use Interface | Graphical User Interface using a<br>touch screen display, status LEDs<br>and dedicated keys for user input. | Graphical User Interface using a 7-<br>segment display, status LEDs and<br>dedicated keys / knob for user input. | Graphical User Interface using a<br>touch screen display, status LEDs<br>and dedicated keys for user input. | Subject device use<br>interface is similar to that<br>of the Secondary Predicate<br>(Trilogy EVO). Any<br>difference in user interface<br>would not be considered<br>significant based upon<br>Human Factors testing. |
| Waveform<br>comparison | We have performed waveform comparison to the predicates, K181166 Respironics Trilogy Evo and K083688 LTV 1200 | | | |
| Flow<br>measurement | Proximal flow sensor | Proximal flow sensor | Proximal flow sensor | Identical |
| EtCO2 | In-line EtCO2 sensor (conforms with<br>ISO 80601-2-55) | External EtCO2 sensor available | In-line EtCO2 sensor (conforms with<br>ISO 80601-2-55) | All devices can measure<br>EtCO2. The subject device<br>and the secondary<br>predicate (Trilogy EVO)<br>both support the use of an<br>EtCO2 sensor |
| Accessories<br>User supplied | Standard single limb ventilator<br>circuit with Exhalation Valve<br>In-line EtCO2 adapter | Standard single limb ventilator<br>circuit with Exhalation Valve<br>and Proximal flow sensor | Standard single limb ventilator<br>circuit with Exhalation Valve<br>In-line EtCO2 adapter | All devices utilize a single<br>limb circuit.<br>The subject device and<br>secondary predicate are<br>very similar to each other<br>regarding the external<br>patient circuit. |
| Features | Subject Device<br>Ventis - VM-2000 | Primary Predicate - K083688<br>LTV 1200 | Secondary Predicate - K181166<br>Respironics Trilogy Evo | Remarks, Substantial<br>equivalence |
| Sponsor supplied | Proximal flow sensor | Proximal flow sensor | Proximal flow sensor | Identical |
| Transport Case<br>and Mounting<br>System | Ambulance and Helicopter Transport<br>Case and Mounting System | Transport mountings not specified | Not specified | There are similar third<br>party supplied mounting<br>systems for these transport<br>modes. Shock and<br>Acceleration testing was<br>performed and when<br>compared to the predicate<br>mount does not raise new<br>or different questions of<br>safety or effectiveness. |
| Power supply | 100 - 240VAC, 24VDC | 110V or 220V AC power source, or<br>11V to 15V DC power source. | 100 - 240VAC, 24VDC | Similar for all devices. |
| Battery | Rechargeable Li-Ion and disposable<br>batteries | Rechargeable lead acid batteries | Rechargeable Li-Ion batteries | All devices contain backup<br>batteries. |
| System<br>architecture | Microprocessor controlled.<br>VM-2000's pneumatics deliver gas,<br>and its electrical systems control<br>pneumatics, monitor alarms, and<br>distribute power. | Microprocessor controlled.<br>LTV 's pneumatics deliver gas, and<br>its electrical systems control<br>pneumatics, monitor alarms, and<br>distribute power.…