(364 days)
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.
The eVolution 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.
The eVolution 3e Ventilator is intended for continuous and intermittent mechanical ventilation for pediatric to adult patients (5 kg or more) requiring respiratory support in various healthcare settings.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list acceptance criteria in a quantitative table with corresponding device performance metrics for specific clinical or technical outcomes. Instead, it relies on demonstrating substantial equivalence to a predicate device (eVent Inspiration™ Ventilator System K072590) by comparing technical characteristics and compliance with recognized standards.
The "Comparison Parameter" table serves as the primary document for demonstrating equivalence, highlighting features that are "same as" or have minor differences that do not raise new questions of safety or effectiveness. For example:
| Comparison Parameter | Predicate Device (Inspiration Ventilator System K072590) | eVolution Ventilator System |
|---|---|---|
| Vt (Inspiratory Tidal Volume) | 5 to 2000 ml | 50 - 2000 ml |
| Ti (Inspiratory Time) | 0.1 to 10 sec | 0.2 - 5.0 sec |
| PEEP | 0 to 50 cmH2O | 0 to 40 cmH2O |
| O2 (FiO2) | 21 - 100% | 21 - 100% |
| Operating temperature | 10 to 40 °C | 5-40 °C |
| Operating humidity | 10% - 80% | 15% - 95% |
The overall acceptance criterion is demonstrating that the eVolution 3e Ventilator is as safe and effective as the predicate device by showing:
- Same intended use.
- Similar technological characteristics, or differences that do not raise new questions of safety or effectiveness.
- Performance data demonstrating compliance with recognized consensus standards.
2. Sample Size Used for the Test Set and Data Provenance
The provided text focuses on engineering and performance testing against standards, rather than clinical trials with patient data. Therefore, there isn't a "test set" in the sense of patient data.
- Sample size for test set: Not applicable in the context of clinical patient data. Performance testing would have involved multiple identical devices and defined test conditions as per the standards listed.
- Data Provenance: Not applicable for patient data. The provenance of the performance data stems from engineering tests conducted in a laboratory setting to verify compliance with industry standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The assessment for this device is based on demonstrating technical equivalence and compliance with established engineering and safety standards (e.g., IEC, ASTM). There is no "ground truth" established by clinical experts in the context of diagnostic accuracy for this type of device.
4. Adjudication Method for the Test Set
Not applicable, as this is not a diagnostic device requiring human expert adjudication for ground truth. The compliance with standards would be evaluated by qualified test engineers and quality assurance personnel.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The eVolution 3e Ventilator is a life-support device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a ventilator, a physical medical device, not an algorithm or software-only system. Its performance is inherent to its mechanical and software functions, which are always "standalone" in their operation (though used by humans).
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is compliance with established international and national consensus standards for medical electrical equipment and critical care ventilators. Specifically:
- IEC 60601-1: 1995 (General Requirements for Safety)
- IEC 60601-1-2:2004 (Electromagnetic compatibility)
- IEC 60601-2-12:2001 (Particular requirements for the safety of lung ventilators. Critical care ventilators.)
- EPA Method TO-15 (Determination of Volatile Organic Compounds (VOCs) In Air) - This might be related to material safety or off-gassing, not direct functional performance.
- ASTM F1100-90 (Standard Specification for Ventilators Intended for Use in Critical Care)
The device's performance parameters (e.g., tidal volume accuracy, pressure control, oxygen delivery accuracy, alarm limits) are measured against the specifications and limits defined within these standards.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML system that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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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: 949-492-8382 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
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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 VentilatorSystem K072590 | eVolution Ventilator System |
|---|---|---|
| Description | The Inspiration® ventilator isa fifth generation, electricallypowered, microprocessor andservo controlled, software-driven ventilator. It has adynamic range of breathinggas delivery that provides forinfant through adult patients.It utilizes a flat panel colorLCD with real time graphicdisplays and digitalmonitoring capabilities, atouch screen for easyinteraction, membrane keysand a dial for changing | The eVolution® 3e ventilatoris a fifth generation,electrically powered,microprocessor and servocontrolled, software-drivenventilator. It has a dynamicrange of breathing gasdelivery that provides forpediatric through adultpatients. It utilizes a flat panelcolor LCD with real timegraphic displays and digitalmonitoring capabilities, atouch screen for easyinteraction, 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.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 |
| Comparison Parameter | Inspiration VentilatorSystem K072590 | eVolution Ventilator System |
| order of a physician only. | ||
| Patient Types | Adult, Pediatric, Infant | Adult, Pediatric |
| Acuity Level | High/Level 3; Mid/Level 2;Low/Level 1 | High/Level 3; Mid/Level 2;Low/Level 1 |
| Ventilation Modes | ||
| Volume Controlled | VC-CMV; VC-SIMV | VC-CMV; VC-SIMV |
| Mixed Modes | PRVC-CMV; PRVC-SIMV;VS | PRVC-CMV; PRVC-SIMV;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;P-SIMV; PRVC-CMV;PRVC-SIMV; SPAP; OFF | V-CMV; V-SIMV; P-CMV;P-SIMV; PRVC-CMV;PRVC-SIMV; SPAP; OFF |
| Ventilation Application | ||
| Non Invasive (NIV) | All ventilation modes;Leakage Comp; Alarm SettingAdaptable | All ventilation modes;Leakage Comp; Alarm SettingAdaptable |
| Leakage Compensation | Auto Leak Compensation;Automatic Flow TriggerAdjust to Leak; ExpiratoryCriteria Adaptation; LeakMonitoring | Auto Leak Compensation;Automatic Flow TriggerAdjust to Leak; ExpiratoryCriteria Adaptation; LeakMonitoring |
| BTPS Compensation | Selection Humidifier;Selection HME | Selection Humidifier;Selection HME |
| Automatic Weaning System | Auto Control; AlgorithmBased System; Control(CMV) Modes Only | Auto Control; AlgorithmBased System; Control(CMV) Modes Only |
| Settings/Controls | ||
| Patient Options | New Patient; Previous Patient | New Patient; Previous Patient |
| Ideal Body WeightCalculator | Patient Height; Gender; IBW | Patient Height; Gender; FrameSize 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 VentilatorSystem 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 settinglevel) | 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 /ramp) | 1, 5, 10 | 1, 5, 10 |
| Flow Pattern | Decelerating; Decelerating50%; Square; NIV; Pause | Decelerating; Decelerating50%; Square; NIV; Pause |
| Auto Control | Auto; Auto Time; Leak Comp;Base Flow | Auto; Auto Time; Leak CompBase Flow |
| SPAP Settings | Cycle; Phigh; Plow; Thigh;Tlow; Psup high; Psup low | Cycle; Phigh; Plow; Thigh;Tlow; Psup high; Psup low |
| SPAP Type | Time Only; Cycle + Time;Cycle + Ratio; H:L | Time Only; Cycle + Time;Cycle + Ratio; H:L |
| Functions/Special Features | 100% Oxygen Delivery;+20% Infant OxygenDelivery; Manual Breath;Alarm Silence; Alarm Pause;Standby mode; Prox. FlowSensor On/Off; OxygenSensor On/Off; Audio LevelControl; Screen Clicks On /Off; Screen BrightnessControl | 100% Oxygen Delivery;Manual Breath; AlarmSilence; Alarm Pause;Standby mode; Low Flow O2Inlet Pressure On/Off; OxygenSensor On/Off; Audio LevelControl; Screen Clicks On /Off; Screen BrightnessControl |
| Maneuvers | Insp. Hold; Exp. Hold | Insp. Hold; Exp. Hold |
| Nebulizer (Smart Nebulizer) | Nebulizer On / Off; NebulizerTime; Interval On / Off;Interval Time | Nebulizer On / Off; NebulizerTime; Interval On / Off;Interval Time |
| Sigh (Smart Sigh) | Sigh On / Off; Sigh %; Sigh | Sigh On / Off; Sigh %; Sigh |
| Comparison Parameter | Inspiration VentilatorSystem K072590 | eVolution Ventilator System |
| Monitored Parameters | ||
| Pressure (monitors) | Ppeak (peak inspiratorypressure); Pmean (meanairway pressure); PEEP;Pplateau (Plateau pressure);Auto PEEP | Ppeak (peak inspiratorypressure); Pmean (meanairway pressure); PEEP;Pplateau (Plateau pressure);Auto PEEP |
| Volume (monitors) | Vti (Insp. tidal volume)Vte (exp. tidal volume)Ve (exp. minute volume)Ve Spont (exp. minutevolume spontaneous)Vi (insp. minute volume)Vi Spont (insp. minutevolume spontaneous)Vti/kgVte/kgVe/kgLeakPF (peak flow)PFe (exp. peak flow) | Vti (Insp. tidal volume)Vte (exp. tidal volume)Ve (exp. minute volume)Ve Spont (exp. minutevolume spontaneous)Vi (insp. minute volume)Vi Spont (insp. minutevolume spontaneous)LeakPF (peak flow)PFe (exp. peak flow) |
| Breathing Frequency(monitors) | Rate (breath raté total)Rate Spont. (breath ratespontaneous)Insp. TimeExp. TimeI:E RatioH:L RatioSpont %1 hrSpont %8 hr | Rate (breath rate total)Rate Spont. (breath ratespontaneous)Insp. TimeExp. TimeI:E RatioH:L RatioSpont %1 hrSpont %8 hr |
| Gas Concentration(monitors) | O2 (FiO2)HeO2 (Heliox %) | O2 (FiO2) |
| Respiratory Mechanics(monitors) | Rinsp (insp. resistance)Rexp (exp.p resistance)Cstat (static compliance)Cdyn (dynamic compliance)Cstat/kgCdyn/kgRSBI (rate / VT ratio)C20/C (Cdyn20% / Cdyn .ratio) | Rinsp (insp. resistance)Rexp (exp.p resistance)Cstat (static compliance)RSBI (rate / VT ratio) |
| Comparison Parameter | Inspiration VentilatorSystem K072590 | eVolution Ventilator System |
| Other calculated values | Ti/Ttot (Ti / by total cycletime) | Ti/Ttot (Ti / by total cycletime) |
| Trended Parameters | ||
| Pressure (trends) | Ppeak (peak inspiratorypressure)Pmean (mean airwaypressure)PEEPPplateau (Plateau pressure)Auto PEEP | Ppeak (peak inspiratorypressure)Pmean (mean airwaypressure)PEEPPplateau (Plateau pressure) |
| Volume (trends) | Vti (Insp. tidal volume)Vte (exp. tidal volume)Ve (exp. minute volume)Ve Spont (exp. minutevolume spontaneous)Vi (insp. minute volume)Vi Spont (insp. minutevolume spontaneous)Vti/kgVte/kgVe/kgLeakPF (peak flow)PFe (exp. peak flow) | Vti (Insp. tidal volume)Vte (exp. tidal volume)Ve (exp. minute volume)Ve Spont (exp. minutevolume spontaneous)Vi (insp. minute volume)Vi Spont (insp. minutevolume spontaneous)LeakPF (peak flow)PFe (exp. peak flow) |
| Breathing Frequency(trends) | Rate (breath rate total)Rate Spont (breath ratespontaneous)Insp. TimeExp. Time | Rate (breath rate total)Rate Spont (breath ratespontaneous)Insp. TimeExp. Time |
| Gas Concentration(trends) | O2 (FiO2)HeO2 (Heliox %) | O2 (FiO2) |
| Respiratory Mechanics(trends) | Rinsp (insp. resistance)Rexp (exp. resistance)Cstat (static compliance)Cdyn (dynamic compliance)Cstat/kgCdyn/kgRSBI (rate / VT ratio) | Rinsp (insp. resistance)Rexp (exp. resistance)Cstat (static compliance)RSBI (rate / VT ratio) |
| Other calculated values(trends) | Ti/Ttot (insp time / by totalcycle time) | Ti/Ttot (insp time / by totalcycle time) |
| Comparison Parameter | Inspiration VentilatorSystem K072590 | eVolution Ventilator System |
| Alarm Settings | High Minute Volume (Vehigh) | High Minute Volume (Vehigh) |
| Low Minute Volume (Velow) | Low Minute Volume (Velow) | |
| High Tidal Volume (Vtehigh) | High Tidal Volume (Vtehigh) | |
| Low Tidal Volume (Vte low)Vti Limit High (Insp. Tidalvolume alarm) | Low Tidal Volume (Vte low)Vti Limit High (Insp. Tidalvolume alarm) | |
| High Respiratory Rate (Ratehigh) | High Respiratory Rate (Ratehigh) | |
| Low Respiratory Rate (Ratelow) | Low Respiratory Rate (Ratelow) | |
| High Peak Pressure (Ppeakhigh) | High Peak Pressure (Ppeakhigh) | |
| Low Peak Pressure (Ppeaklow) | Low Peak Pressure (Ppeaklow) | |
| High Mean Airway Pressure(Pmean high) | High PEEP Pressure (PEEPhigh) | |
| Low Mean Airway Pressure(Pmean low) | Low PEEP Pressure (PEEPlow) | |
| High leak rate (High leak)Apnea Time | High leak rate (High leak)Apnea Time | |
| AUTO SET (Auto adjusts allalarms) | AUTO SET (Auto adjusts allalarms) | |
| Oxygen (FiO2) Alarms | High Oxygen (automatic 7%above set FiO2) | High Oxygen (automatic 7%above set FiO2) |
| Low Oxygen (automatic 7%below set FiO2) | Low Oxygen (automatic 7%below set FiO2) | |
| Equipment Alarms | Gas Supply FailurePower FailureVentilator InoperativeLow Internal BatteryLow External BatterySelf Diagnostics | Gas Supply FailurePower FailureVentilator InoperativeLow Internal BatteryLow External BatterySelf Diagnostics |
| Gas Supply Management | High Pressure Air InletInternal Compressed GasSourceHigh Pressure Oxygen Inlet | High Pressure Air Inlet (HPModel Only)Blower (Blower Model Only)SourceHigh Pressure Oxygen InletOxygen via low pressure inlet |
| Human Interface | ||
| Graphic Settings | 1, 2, 3 , 4 graphs displayed | 1, 2, 3, 4 graphs displayed |
| Comparison Parameter | Inspiration VentilatorSystem K072590 | eVolution Ventilator System |
| Pressure | Pressure | |
| Flow | Flow | |
| Volume | Volume | |
| Flow / Volume | Flow / Volume | |
| Pressure / Volume | Pressure / Volume | |
| Dynamic Auto Scaling | Dynamic Auto Scaling | |
| Manual Scaling | Manual Scaling | |
| Freeze / Unfreeze | Freeze / Unfreeze | |
| X / Y Axes cursor scroll | X / Y Axes cursor scroll | |
| Connectivity | Nurse call | Nurse call |
| Ethernet | Ethernet | |
| RS232 | RS232 | |
| Remote monitoring | ||
| Other Outputs: SNMP | ||
| Power Management | ||
| Type | Alternating Current (AC) | Alternating Current (AC) |
| Voltage range | 100 - 240 VAC | 100 - 240 VAC |
| Frequency | 50 - 60 Hz | 47 - 63 Hz |
| Battery Type | Lead Acid | Lithium Ion |
| Battery time | > 120 min | > 120 min |
| Battery capacity | Amp/hours | Amp/hours |
| Stand By | > 360 min | > 360 min |
| Physical / Environmental | ||
| Operating temperature | 10 to 40 °C | 5-40 °C |
| Operating humidity | 10% - 80% | 15% - 95% |
| Storage temperature | -10°C to 60°C | -10°C to 60°C |
| Storage humidity | 5% - 95% | 5% - 95% |
| Operating Altitude | Up to 11,600 ft (3,536 m) abovesea level | Up to 9,999 ft (3,048m) abovesea level |
The following table provides a comparison to the predicate device:
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and the comments of the comments of
.
{4}------------------------------------------------
:
:
{5}------------------------------------------------
:
{6}------------------------------------------------
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{8}------------------------------------------------
The design and development process at eVent Medical, Ltd. requires adherence to internal procedures written to comply with the Design Control requirements of the Quality System Regulations defined in 21 CFR 820.30.
FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices, dated May 29, 1998, was used to define the software design and development activities required for the software developed for the eVolution 3e based on the determined Level of Concern.
The eVolution Ventilator System has been tested and shown to be compliant with the following standards documents:
-
- IEC 60601-1: 1995, Medical Electrical Equipment, Part 1: General Requirements for Safety
{9}------------------------------------------------
-
- IEC 60601-1-2:2004, Medical Electrical Equipment Part 1-2: General requirements for safety-Collateral standard: Electromagnetic compatibility-Requirements and tests
-
- IEC 60601-2-12:2001, Medical Electrical Equipment. Particular requirements for the safety of lung ventilators. Critical care ventilators.
-
- EPA Method TO-15, Determination of Volatile Organic Compounds (VOCs) In Air' Collected in Specially Prepared Canisters and Analyzed by Gas Chromatography/Mass Spectrometry (GC/MS)
-
- ASTM F1100-90 Standard Specification for Ventilators Intended for Use in Critical Care.
Performance was conducted using ASTM F1100-90 Standard Specification for Ventilators Intended for Use in Critical Care to demonstrate the durability that the predicate ventilator met and to which compliance has been routinely accepted as requisite to any substantial equivalence claim.
Conclusion:
eVent Medical Ltd. hereby presents data as part of the 510(k) process to support the eVolution 3e Ventilator safety and effectiveness for its stated intended use and presents data claiming substantial equivalence to the identified predicates currently marketed and previously cleared by the FDA.
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three swooping lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2012
Mr. Rick Waters Vice President, Regulatory Affairs and Quality Assurance eVent Medical, Limited 971 Calle Amanecer, Suite 101 SAN CLEMENTE CA 92673
Re: K113743
Trade/Device Name: eVolution 3e Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: December 5, 2012 Received: December 14, 2012
Dear Mr. Waters:
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. 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.
{11}------------------------------------------------
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kwame O. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory. Infection Control and
Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
{12}------------------------------------------------
Section B: Indications for Use Statement
510(k) Number: K113743
eVolution 3e Ventilator Device Name:
Indications for 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.
X AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Albert E. Albert E. Moyal 2012.12.17 Moyal 16:32:28 -05'00' for LS
(Division Sign-Off) (Division Sign-On) Division of Antrol, Dental Devices
K113743 510(k) Number:
§ 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).