Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a microprocessor-controlled, software-driven ventilator with sensors and valves, but there is no mention of AI, ML, or related concepts in the intended use, device description, or other sections.

Therapeutic

Yes
The device is a ventilator, which delivers mechanical ventilation to patients requiring respiratory support, directly treating a medical condition.

Diagnostic

No

The document describes the device as a ventilator intended for providing mechanical ventilatory support, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "electrically powered microprocessor-controlled software-driven ventilator with an electrically controlled exhalation valve" and mentions hardware components like "dual valve technology," "three hot wire flow sensors," and an "integrated high performance internal gas source (blower)." This indicates it is a hardware device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, the eVolution 3e ventilator is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states that the device provides "continuous and or intermittent mechanical ventilation to patients requiring ventilatory support through invasive or non-invasive interfaces." This describes a device that directly supports a patient's respiratory function, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
Device Description: The description details the mechanical and electrical components of a ventilator, such as valves, flow sensors, a blower, and an exhalation valve. These are components of a life-support device, not an IVD.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical characteristics of an IVD device.

Therefore, the eVolution 3e ventilator is a therapeutic medical device, specifically a ventilator, and not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

CBK

Device Description

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.

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

pediatric to adult

Intended User / Care Setting

trained and qualified healthcare professionals in hospitals or healthcare facilities and intended for sale by or on the order of a physician only.

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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K072590

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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: 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

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
System K072590 | eVolution Ventilator System |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description | The Inspiration® ventilator is
a fifth generation, electrically
powered, microprocessor and
servo controlled, software-
driven ventilator. It has a
dynamic range of breathing
gas delivery that provides for
infant through adult patients.
It utilizes a flat panel color
LCD with real time graphic
displays and digital
monitoring capabilities, a
touch screen for easy
interaction, membrane keys
and a dial for changing | The eVolution® 3e ventilator
is a fifth generation,
electrically powered,
microprocessor and servo
controlled, software-driven
ventilator. It has a dynamic
range of breathing gas
delivery that provides for
pediatric through adult
patients. It utilizes a flat panel
color LCD with real time
graphic displays and digital
monitoring capabilities, a
touch screen for easy
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.
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 Ventilator
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;
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 Setting
Adaptable | All ventilation modes;
Leakage Comp; Alarm Setting
Adaptable |
| Leakage Compensation | Auto Leak Compensation;
Automatic Flow Trigger
Adjust to Leak; Expiratory
Criteria Adaptation; Leak
Monitoring | Auto Leak Compensation;
Automatic Flow Trigger
Adjust to Leak; Expiratory
Criteria Adaptation; Leak
Monitoring |
| BTPS Compensation | Selection Humidifier;
Selection HME | Selection Humidifier;
Selection HME |
| Automatic Weaning System | Auto Control; Algorithm
Based System; Control
(CMV) Modes Only | Auto Control; Algorithm
Based System; Control
(CMV) Modes Only |
| Settings/Controls | | |
| Patient Options | New Patient; Previous Patient | New Patient; Previous Patient |
| Ideal Body Weight
Calculator | Patient Height; Gender; IBW | Patient Height; Gender; Frame
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
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
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 /
ramp) | 1, 5, 10 | 1, 5, 10 |
| Flow Pattern | Decelerating; Decelerating
50%; Square; NIV; Pause | Decelerating; Decelerating
50%; Square; NIV; Pause |
| Auto Control | Auto; Auto Time; Leak Comp;
Base Flow | Auto; Auto Time; Leak Comp
Base 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 Oxygen
Delivery; Manual Breath;
Alarm Silence; Alarm Pause;
Standby mode; Prox. Flow
Sensor On/Off; Oxygen
Sensor On/Off; Audio Level
Control; Screen Clicks On /
Off; Screen Brightness
Control | 100% Oxygen Delivery;
Manual Breath; Alarm
Silence; Alarm Pause;
Standby mode; Low Flow O2
Inlet Pressure On/Off; Oxygen
Sensor On/Off; Audio Level
Control; Screen Clicks On /
Off; Screen Brightness
Control |
| Maneuvers | Insp. Hold; Exp. Hold | Insp. Hold; Exp. Hold |
| Nebulizer (Smart Nebulizer) | Nebulizer On / Off; Nebulizer
Time; Interval On / Off;
Interval Time | Nebulizer On / Off; Nebulizer
Time; Interval On / Off;
Interval Time |
| Sigh (Smart Sigh) | Sigh On / Off; Sigh %; Sigh | Sigh On / Off; Sigh %; Sigh |
| Comparison Parameter | Inspiration Ventilator
System K072590 | eVolution Ventilator System |
| Monitored Parameters | | |
| Pressure (monitors) | Ppeak (peak inspiratory
pressure); Pmean (mean
airway pressure); PEEP;
Pplateau (Plateau pressure);
Auto PEEP | Ppeak (peak inspiratory
pressure); Pmean (mean
airway pressure); PEEP;
Pplateau (Plateau pressure);
Auto PEEP |
| Volume (monitors) | Vti (Insp. tidal volume)
Vte (exp. tidal volume)
Ve (exp. minute volume)
Ve Spont (exp. minute
volume spontaneous)
Vi (insp. minute volume)
Vi Spont (insp. minute
volume spontaneous)
Vti/kg
Vte/kg
Ve/kg
Leak
PF (peak flow)
PFe (exp. peak flow) | Vti (Insp. tidal volume)
Vte (exp. tidal volume)
Ve (exp. minute volume)
Ve Spont (exp. minute
volume spontaneous)
Vi (insp. minute volume)
Vi Spont (insp. minute
volume spontaneous)
Leak
PF (peak flow)
PFe (exp. peak flow) |
| Breathing Frequency
(monitors) | Rate (breath raté total)
Rate Spont. (breath rate
spontaneous)
Insp. Time
Exp. Time
I:E Ratio
H:L Ratio
Spont %1 hr
Spont %8 hr | Rate (breath rate total)
Rate Spont. (breath rate
spontaneous)
Insp. Time
Exp. Time
I:E Ratio
H:L Ratio
Spont %1 hr
Spont %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/kg
Cdyn/kg
RSBI (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 Ventilator
System K072590 | eVolution Ventilator System |
| Other calculated values | Ti/Ttot (Ti / by total cycle
time) | Ti/Ttot (Ti / by total cycle
time) |
| Trended Parameters | | |
| Pressure (trends) | Ppeak (peak inspiratory
pressure)
Pmean (mean airway
pressure)
PEEP
Pplateau (Plateau pressure)
Auto PEEP | Ppeak (peak inspiratory
pressure)
Pmean (mean airway
pressure)
PEEP
Pplateau (Plateau pressure) |
| Volume (trends) | Vti (Insp. tidal volume)
Vte (exp. tidal volume)
Ve (exp. minute volume)
Ve Spont (exp. minute
volume spontaneous)
Vi (insp. minute volume)
Vi Spont (insp. minute
volume spontaneous)
Vti/kg
Vte/kg
Ve/kg
Leak
PF (peak flow)
PFe (exp. peak flow) | Vti (Insp. tidal volume)
Vte (exp. tidal volume)
Ve (exp. minute volume)
Ve Spont (exp. minute
volume spontaneous)
Vi (insp. minute volume)
Vi Spont (insp. minute
volume spontaneous)
Leak
PF (peak flow)
PFe (exp. peak flow) |
| Breathing Frequency
(trends) | Rate (breath rate total)
Rate Spont (breath rate
spontaneous)
Insp. Time
Exp. Time | Rate (breath rate total)
Rate Spont (breath rate
spontaneous)
Insp. Time
Exp. 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/kg
Cdyn/kg
RSBI (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 total
cycle time) | Ti/Ttot (insp time / by total
cycle time) |
| Comparison Parameter | Inspiration Ventilator
System K072590 | eVolution Ventilator System |
| Alarm Settings | High Minute Volume (Ve
high) | High Minute Volume (Ve
high) |
| | Low Minute Volume (Ve
low) | Low Minute Volume (Ve
low) |
| | High Tidal Volume (Vte
high) | High Tidal Volume (Vte
high) |
| | Low Tidal Volume (Vte low)
Vti Limit High (Insp. Tidal
volume alarm) | Low Tidal Volume (Vte low)
Vti Limit High (Insp. Tidal
volume alarm) |
| | High Respiratory Rate (Rate
high) | High Respiratory Rate (Rate
high) |
| | Low Respiratory Rate (Rate
low) | Low Respiratory Rate (Rate
low) |
| | High Peak Pressure (Ppeak
high) | High Peak Pressure (Ppeak
high) |
| | Low Peak Pressure (Ppeak
low) | Low Peak Pressure (Ppeak
low) |
| | High Mean Airway Pressure
(Pmean high) | High PEEP Pressure (PEEP
high) |
| | Low Mean Airway Pressure
(Pmean low) | Low PEEP Pressure (PEEP
low) |
| | High leak rate (High leak)
Apnea Time | High leak rate (High leak)
Apnea Time |
| | AUTO SET (Auto adjusts all
alarms) | AUTO SET (Auto adjusts all
alarms) |
| 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 Failure
Power Failure
Ventilator Inoperative
Low Internal Battery
Low External Battery
Self Diagnostics | Gas Supply Failure
Power Failure
Ventilator Inoperative
Low Internal Battery
Low External Battery
Self Diagnostics |
| Gas Supply Management | High Pressure Air Inlet
Internal Compressed Gas
Source
High Pressure Oxygen Inlet | High Pressure Air Inlet (HP
Model Only)
Blower (Blower Model Only)
Source
High Pressure Oxygen Inlet
Oxygen via low pressure inlet |
| Human Interface | | |
| Graphic Settings | 1, 2, 3 , 4 graphs displayed | 1, 2, 3, 4 graphs displayed |
| Comparison Parameter | Inspiration Ventilator
System 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) above
sea level | Up to 9,999 ft (3,048m) above
sea level |

The following table provides a comparison to the predicate device:

2

.

3

.

and the comments of the comments of

.

4

:

5

:

6

7

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:

1. IEC 60601-1: 1995, Medical Electrical Equipment, Part 1: General Requirements for Safety

9

1. IEC 60601-1-2:2004, Medical Electrical Equipment Part 1-2: General requirements for safety-Collateral standard: Electromagnetic compatibility-Requirements and tests
1. IEC 60601-2-12:2001, Medical Electrical Equipment. Particular requirements for the safety of lung ventilators. Critical care ventilators.
1. 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)
1. 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: