EVOLUTION 3E VENTILATOR

K113743 · Event Medical, Inc. · CBK · Dec 18, 2012 · Anesthesiology

Device Facts

• Record ID: K113743
• Device Name: EVOLUTION 3E VENTILATOR
• Applicant: Event Medical, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Dec 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The eVolution 3e ventilator is intended for and designed to provide continuous and or intermittent mechanical ventilation to patients requiring ventilatory support through invasive or non-invasive interfaces and is suitable for use in the ICU, sub acute, long-term acute care, rehabilitation, and emergency room venues. This product is intended for a wide range of patients from pediatric to adult having body weights in the range of 5 kg (11 lb) or more who require pressure-based or volume-based continuous respiratory support, as prescribed by an attending physician. The eVolution 3e ventilator system is a class IIb medical device to be used by trained and qualified healthcare professionals in hospitals or healthcare facilities and intended for sale by or on the order of a physician only.

Device Story

Electrically powered, microprocessor-controlled ventilator; provides invasive/non-invasive respiratory support. Inputs: gas flow/pressure via three hot wire flow sensors; internal blower or external compressed air source. Operation: servo-controlled inhalation/exhalation valves; software-driven breath delivery. Output: mechanical ventilation; real-time graphic displays (pressure, flow, volume) on color LCD. Used in ICU/clinical settings by trained healthcare professionals. Clinicians adjust settings via touchscreen/dial; device monitors respiratory mechanics/gas parameters. Benefits: precise breath delivery; reduced work of breathing; automated weaning/leak compensation; alarm management for patient safety.

Clinical Evidence

Bench testing only. Performance verified against ASTM F1100-90 standards for critical care ventilators to demonstrate durability and equivalence to predicate. No clinical data presented.

Technological Characteristics

Electrically powered, microprocessor-controlled, software-driven. Features: dual valve technology, three hot wire flow sensors, internal blower or external air source. Connectivity: Ethernet, RS232, nurse call. Power: 100-240 VAC, Lithium Ion battery. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-12, ASTM F1100-90.

Indications for Use

Indicated for pediatric to adult patients (≥5 kg) requiring invasive or non-invasive continuous or intermittent mechanical ventilation (pressure or volume-based) in ICU, sub-acute, long-term acute care, rehabilitation, or emergency settings. Prescription only.

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

• eVent Medical Inspiration™ Ventilator System (K072590)

Submission Summary (Full Text)

{0}------------------------------------------------

#### Section C: 510(k) Summary

# [As required by 21 CFR 807.92]

# DEC 1 8 2012

# eVolution 3e Ventilator

This summary of safety and effectiveness information is submitted in accordance with the · requirements of 21 CFR 807.92.

Submitter: eVent Medical, Ltd. 971 Calle Amanecer San Clemente, CA 92672

Registration Number: 3003638180

Contact Person: Rick Waters Vice President, Regulatory Affairs and Quality Assurance 949-492-8312 x232 Phone: [phone] Fax:

Date Prepared: June 10, 2010 -

Device Trade Name: .

eVolution 3e Ventilator

Common Name: Continuous Ventilator

Device Class:

per 21 CFR 868.5895

Product Code: 73 CBK

The predicate devices are: Predicate Device:

Class II

Table 1 - Predicate Devices

| Manufacturer/Product | 510(k) | Classification |
|----------------------|--------|----------------|
|----------------------|--------|----------------|

eVent Medical Inspiration™ Ventilator System K072590

Class II Continuous Ventilator per 21 CFR 868.5895

{1}------------------------------------------------

# Device Description:

The e Volution 3e Ventilator utilizes dual valve technology and three hot wire flow sensors for precise breath delivery and lower work of breathing. The eVolution 3e is an electrically powered microprocessor-controlled software-driven ventilator with an electrically controlled exhalation valve. The eVolution 3e is available in two configurations; one version of The eVolution 3e utilizes an integrated high performance internal gas source (blower) and the second version of the eVolution 3e utilizes outside compressed air source and does not utilize a blower.

### Intended Use:

The eVolution 3e ventilator is intended for and designed to provide continuous and or intermittent mechanical ventilation to patients requiring ventilatory support through invasive or non-invasive interfaces and is suitable for use in the ICU, sub acute, long-term acute care, rehabilitation, and emergency room venues.

This product is intended for a wide range of patients from pediatric to adult having body weights in the range of 5 kg (11 lb) or more who require pressure-based or volume-based continuous respiratory support, as prescribed by an attending physician.

The eVolution 3e ventilator system is a class IIb medical device to be used by trained and qualified healthcare professionals in hospitals or healthcare facilities and intended for sale by or on the order of a physician only.

#### Summary of Performance Data and Substantial Equivalence:

The eVolution 3e Ventilator has the same intended use as that for the eVent Inspiration Series Ventilators identified as cleared predicate device. The technical characteristics of the eVolution 3e Ventilator do not introduce new questions regarding safety or effectiveness associated with critical care ventilators.

| Comparison Parameter | Inspiration Ventilator<br>System K072590 | eVolution Ventilator System |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description | The Inspiration® ventilator is<br>a fifth generation, electrically<br>powered, microprocessor and<br>servo controlled, software-<br>driven ventilator. It has a<br>dynamic range of breathing<br>gas delivery that provides for<br>infant through adult patients.<br>It utilizes a flat panel color<br>LCD with real time graphic<br>displays and digital<br>monitoring capabilities, a<br>touch screen for easy<br>interaction, membrane keys<br>and a dial for changing | The eVolution® 3e ventilator<br>is a fifth generation,<br>electrically powered,<br>microprocessor and servo<br>controlled, software-driven<br>ventilator. It has a dynamic<br>range of breathing gas<br>delivery that provides for<br>pediatric through adult<br>patients. It utilizes a flat panel<br>color LCD with real time<br>graphic displays and digital<br>monitoring capabilities, a<br>touch screen for easy<br>interaction, membrane keys |
| Comparison Parameter | Inspiration Ventilator System K072590 | eVolution Ventilator System |
| | settings and operating parameters, a gas delivery engine with servo-controlled active inhalation and exhalation valves as well as an integrated internal compressor. The Inspiration Ventilator System is intended to provide continuous ventilation for patients requiring respiratory support. | and a dial for changing settings and operating parameters, a gas delivery engine with servo-controlled active inhalation and exhalation valves, three hot wire flow sensors for precise breath delivery and lower work of breathing. The eVolution 3e Ventilator System is intended to provide continuous ventilation for patients requiring respiratory support. |
| Indications for Use | The Inspiration Ventilator is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport. | The eVolution 3e ventilator is intended for and designed to provide continuous and or intermittent mechanical ventilation to patients requiring ventilatory support through invasive or non-invasive interfaces and is suitable for use in the ICU, sub acute, long-term acute care, rehabilitation, and emergency room venues.<br>This product is intended for a wide range of patients from pediatric to adult having body weights in the range of 5 kg (11 lb) or more who require pressure-based or volume-based continuous respiratory support, as prescribed by an attending physician.<br>The eVolution 3e ventilator system is a class IIb medical device to be used by trained and qualified healthcare professionals in hospitals or healthcare facilities and |
| Comparison Parameter | Inspiration Ventilator<br>System K072590 | eVolution Ventilator System |
| | | order of a physician only. |
| Patient Types | Adult, Pediatric, Infant | Adult, Pediatric |
| Acuity Level | High/Level 3; Mid/Level 2;<br>Low/Level 1 | High/Level 3; Mid/Level 2;<br>Low/Level 1 |
| Ventilation Modes | | |
| Volume Controlled | VC-CMV; VC-SIMV | VC-CMV; VC-SIMV |
| Mixed Modes | PRVC-CMV; PRVC-SIMV;<br>VS | PRVC-CMV; PRVC-SIMV;<br>VS |
| Pressure-Controlled | PC-CMV; PV-SIMV | PC-CMV; PV-SIMV |
| Spontaneous | PS; VC; SPAP; NCPAP+ | PS; VC; SPAP |
| Apnea backup | V-CMV; V-SIMV; P-CMV;<br>P-SIMV; PRVC-CMV;<br>PRVC-SIMV; SPAP; OFF | V-CMV; V-SIMV; P-CMV;<br>P-SIMV; PRVC-CMV;<br>PRVC-SIMV; SPAP; OFF |
| Ventilation Application | | |
| Non Invasive (NIV) | All ventilation modes;<br>Leakage Comp; Alarm Setting<br>Adaptable | All ventilation modes;<br>Leakage Comp; Alarm Setting<br>Adaptable |
| Leakage Compensation | Auto Leak Compensation;<br>Automatic Flow Trigger<br>Adjust to Leak; Expiratory<br>Criteria Adaptation; Leak<br>Monitoring | Auto Leak Compensation;<br>Automatic Flow Trigger<br>Adjust to Leak; Expiratory<br>Criteria Adaptation; Leak<br>Monitoring |
| BTPS Compensation | Selection Humidifier;<br>Selection HME | Selection Humidifier;<br>Selection HME |
| Automatic Weaning System | Auto Control; Algorithm<br>Based System; Control<br>(CMV) Modes Only | Auto Control; Algorithm<br>Based System; Control<br>(CMV) Modes Only |
| Settings/Controls | | |
| Patient Options | New Patient; Previous Patient | New Patient; Previous Patient |
| Ideal Body Weight<br>Calculator | Patient Height; Gender; IBW | Patient Height; Gender; Frame<br>Size IBW |
| Humidification Selection | Humidifier; HME; None | Humidifier; HME; None |
| Gas Type | Air; Heliox | Air |
| Patient Info | Patient ID; Room/Bed ID | Not Available |
| Comparison Parameter | Inspiration Ventilator<br>System K072590 | eVolution Ventilator System |
| O2 (FiO2) | 21 - 100% | 21 - 100% |
| Rate (Respiratory Rate) | 1 to 150 b/min | 1 - 120 b/min |
| Vt (Inspiratory Tidal Volume) | 5 to 2000 ml | 50 - 2000 ml |
| Ti (Inspiratory Time) | 0.1 to 10 sec | 0.2 - 5.0 sec |
| Flow (Inspiratory Peak Flow) | 1 to 120 l/min (mandatory) | 5 to 120 l/min (mandatory) |
| PEEP | 0 to 50 cmH2O | 0 to 40 cmH2O |
| Pcontrol (Inspiratory Pressure) | 2 to 80 cmH2O | 2 to 80 cmH2O |
| Psupport (Pressure Support) | 0 to 80 cmH2O | 0 to 60 cmH2O |
| Trigger Type | Flow Trigger; Pressure | Flow Trigger; Pressure |
| | Trigger | Trigger |
| Ftrig | 0.2 - 25.0 l/min | 0.5 – 20.0 l/min |
| Ptrig (Pressure trigger setting<br>level) | 0.5 – 20.0 cmH2O | 0.5 - 20.0 cmH2O |
| Esens (exhalation sensitivity) | 10 to 80% of peak flow | 10 to 80% of peak flow |
| Rise Time (pressure slope /<br>ramp) | 1, 5, 10 | 1, 5, 10 |
| Flow Pattern | Decelerating; Decelerating<br>50%; Square; NIV; Pause | Decelerating; Decelerating<br>50%; Square; NIV; Pause |
| Auto Control | Auto; Auto Time; Leak Comp;<br>Base Flow | Auto; Auto Time; Leak Comp<br>Base Flow |
| SPAP Settings | Cycle; Phigh; Plow; Thigh;<br>Tlow; Psup high; Psup low | Cycle; Phigh; Plow; Thigh;<br>Tlow; Psup high; Psup low |
| SPAP Type | Time Only; Cycle + Time;<br>Cycle + Ratio; H:L | Time Only; Cycle + Time;<br>Cycle + Ratio; H:L |
| Functions/Special Features | 100% Oxygen Delivery;<br>+20% Infant Oxygen<br>Delivery; Manual Breath;<br>Alarm Silence; Alarm Pause;<br>Standby mode; Prox. Flow<br>Sensor On/Off; Oxygen<br>Sensor On/Off; Audio Level<br>Control; Screen Clicks On /<br>Off; Screen Brightness<br>Control | 100% Oxygen Delivery;<br>Manual Breath; Alarm<br>Silence; Alarm Pause;<br>Standby mode; Low Flow O2<br>Inlet Pressure On/Off; Oxygen<br>Sensor On/Off; Audio Level<br>Control; Screen Clicks On /<br>Off; Screen Brightness<br>Control |
| Maneuvers | Insp. Hold; Exp. Hold | Insp. Hold; Exp. Hold |
| Nebulizer (Smart Nebulizer) | Nebulizer On / Off; Nebulizer<br>Time; Interval On / Off;<br>Interval Time | Nebulizer On / Off; Nebulizer<br>Time; Interval On / Off;<br>Interval Time |
| Sigh (Smart Sigh) | Sigh On / Off; Sigh %; Sigh | Sigh On / Off; Sigh %; Sigh |
| Comparison Parameter | Inspiration Ventilator<br>System K072590 | eVolution Ventilator System |
| Monitored Parameters | | |
| Pressure (monitors) | Ppeak (peak inspiratory<br>pressure); Pmean (mean<br>airway pressure); PEEP;<br>Pplateau (Plateau pressure);<br>Auto PEEP | Ppeak (peak inspiratory<br>pressure); Pmean (mean<br>airway pressure); PEEP;<br>Pplateau (Plateau pressure);<br>Auto PEEP |
| Volume (monitors) | Vti (Insp. tidal volume)<br>Vte (exp. tidal volume)<br>Ve (exp. minute volume)<br>Ve Spont (exp. minute<br>volume spontaneous)<br>Vi (insp. minute volume)<br>Vi Spont (insp. minute<br>volume spontaneous)<br>Vti/kg<br>Vte/kg<br>Ve/kg<br>Leak<br>PF (peak flow)<br>PFe (exp. peak flow) | Vti (Insp. tidal volume)<br>Vte (exp. tidal volume)<br>Ve (exp. minute volume)<br>Ve Spont (exp. minute<br>volume spontaneous)<br>Vi (insp. minute volume)<br>Vi Spont (insp. minute<br>volume spontaneous)<br>Leak<br>PF (peak flow)<br>PFe (exp. peak flow) |
| Breathing Frequency<br>(monitors) | Rate (breath raté total)<br>Rate Spont. (breath rate<br>spontaneous)<br>Insp. Time<br>Exp. Time<br>I:E Ratio<br>H:L Ratio<br>Spont %1 hr<br>Spont %8 hr | Rate (breath rate total)<br>Rate Spont. (breath rate<br>spontaneous)<br>Insp. Time<br>Exp. Time<br>I:E Ratio<br>H:L Ratio<br>Spont %1 hr<br>Spont %8 hr |
| Gas Concentration<br>(monitors) | O2 (FiO2)<br>HeO2 (Heliox %) | O2 (FiO2) |
| Respiratory Mechanics<br>(monitors) | Rinsp (insp. resistance)<br>Rexp (exp.p resistance)<br>Cstat (static compliance)<br>Cdyn (dynamic compliance)<br>Cstat/kg<br>Cdyn/kg<br>RSBI (rate / VT ratio)<br>C20/C (Cdyn20% / Cdyn .<br>ratio) | Rinsp (insp. resistance)<br>Rexp (exp.p resistance)<br>Cstat (static compliance)<br>RSBI (rate / VT ratio) |
| Comparison Parameter | Inspiration Ventilator<br>System K072590 | eVolution Ventilator System |
| Other calculated values | Ti/Ttot (Ti / by total cycle<br>time) | Ti/Ttot (Ti / by total cycle<br>time) |
| Trended Parameters | | |
| Pressure (trends) | Ppeak (peak inspiratory<br>pressure)<br>Pmean (mean airway<br>pressure)<br>PEEP<br>Pplateau (Plateau pressure)<br>Auto PEEP | Ppeak (peak inspiratory<br>pressure)<br>Pmean (mean airway<br>pressure)<br>PEEP<br>Pplateau (Plateau pressure) |
| Volume (trends) | Vti (Insp. tidal volume)<br>Vte (exp. tidal volume)<br>Ve (exp. minute volume)<br>Ve Spont (exp. minute<br>volume spontaneous)<br>Vi (insp. minute volume)<br>Vi Spont (insp. minute<br>volume spontaneous)<br>Vti/kg<br>Vte/kg<br>Ve/kg<br>Leak<br>PF (peak flow)<br>PFe (exp. peak flow) | Vti (Insp. tidal volume)<br>Vte (exp. tidal volume)<br>Ve (exp. minute volume)<br>Ve Spont (exp. minute<br>volume spontaneous)<br>Vi (insp. minute volume)<br>Vi Spont (insp. minute<b…