INSPIRATION VENTILATOR SYSTEM 5I/7I

{0}------------------------------------------------ Inspiration 5i/7i 510(k) Premarket Submission eVent Medical Ltd. Section E: 510(k) Summary [As required by 21 CFR 807.92] # Inspiration 5i/7i Ventilator System This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92. | Submitter: | eVent Medical, Ltd.<br>60 Empire Drive<br>Lake Forest, CA 92630 | |----------------------|-------------------------------------------------------------------------| | Registration Number: | 3003638180 | | Contact Person: | Rick Waters<br>Vice President, Regulatory Affairs and Quality Assurance | | Phone: | 949-900-1917 x232 | | Fax: | 949-900-1905 | | Date Prepared: | January 18, 2013 | | Device Trade Name: | Inspiration 5i/7i Ventilator System | | Common Name: | Continuous Ventilator | | Device Class: | Class II<br>per 21 CFR 868.5895 | | Product Code: | 73 CBK | | Predicate Device: | The predicate devices are: | Table 1 - Predicate Devices OCT 2 9 2013 | Manufacturer/Product | 510(k) | Classification | |-------------------------------------------------|-----------|----------------------------------------------------------| | eVent Medical<br>Inspiration™ Ventilator System | - K072590 | Class II<br>Continuous Ventilator<br>per 21 CFR 868.5895 | | Hamilton G-5 Ventilator | K103803 | Class II<br>Continuous Ventilator<br>per 21 CFR 868.5895 | {1}------------------------------------------------ ## Device Description: The Inspiration™ 71 / 51 Ventilator System provides continuous ventilation to patients requiring respiratory support by means of pressure-based and volume-based mandatory and spontaneous breaths. The device is identical to the cleared device, the Inspiration™ Ventilator System (K072950), with the following additions: - . a GUI change to deliver a GUI similar to that of the eVolution ventilator. - Additional monitored and trended parameters. . - . Additional waveforms and loops. - Additional medium and high priority alarms. . - . Additional patient setup and default setting criteria. - . : Integration of SNMP fields for settings, monitored and trended data. - . Integration of Volumetric and Sidestream Capnography capability (7i model only) The capnography addition will require specific adaptors and sensors to allow use of this feature. - Integration of various maneuvers ## Intended Use: The Inspiration® 7i / 5i Ventilator System is intended for use with patients having body weights in the range of 0.3kg to 200kg and Tidal Volumes of 5ml to 2000ml. The Inspiration® Ventilator System is to be used by healthcarc professionals in hospitals or healthcare facilities. This product is intended for a wide range of patients from infant to adult and for a wide variety of clinical conditions. The intended patient population includes infant through adult patients who require pressurebased or volume-based continuous respiratory support with tidal volumes as low as 5 ml and inspiratory pressures as low as 1 cm H2O. The device is intended for use in hospital-type facilities, which provide respiratory care for patients requiring respiratory support. The device is not to be used in the presence of flammable anesthetics. The device is intended for sale by or on the order of a physician only. The device is intended for operation by trained and qualified personnel. {2}------------------------------------------------ ## Summary of Performance Data and Substantial Equivalence: The Inspiration 5i/7i ventilator has the same intended use as that for the eVent Inspiration Series Ventilators identified as cleared predicate device. The technical characteristics of the Inspiration 5i/7i ventilator do not introduce new questions regarding safety or effectiveness associated with critical care ventilators. The following table provides a comparison to the predicate device: | Comparison Parameter | Predicate: Inspiration<br>Ventilator System K072590 | Inspiration 5i/7i Ventilator<br>System | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Description | The Inspiration® LS ventilator is an<br>electrically powered,<br>microprocessor and servo<br>controlled, software-driven<br>ventilator. It has a dynamic range of<br>breathing gas delivery that provides<br>for infant through adult patients. It<br>utilizes a flat panel colour LCD with<br>real time graphic displays and digital<br>monitoring capabilities, a touch<br>screen for easy interaction,<br>membrane keys and a dial for<br>changing settings and operating<br>parameters, a gas delivery engine<br>with servo-controlled active<br>inhalation and exhalation valves.<br>The Inspiration® Ventilator System is<br>intended to provide continuous<br>ventilation for patients requiring<br>respiratory support. | The Inspiration® 7i / 5i ventilator is a<br>fifth generation, electrically<br>powered, microprocessor and servo<br>controlled, software-driven<br>ventilator. It has a dynamic range of<br>breathing gas delivery that provides<br>for neonatal through adult patients.<br>It utilizes a flat panel colour LCD<br>with real time graphic displays and<br>digital monitoring capabilities, a<br>touch screen for easy interaction,<br>membrane keys and a dial for<br>changing settings and operating<br>parameters, a gas delivery engine<br>with servo-controlled active<br>inhalation and exhalation valves.<br>The Inspiration® Ventilator System is<br>intended to provide continuous<br>ventilation for patients requiring<br>respiratory support. | | Indications for Use | The Inspiration® Ventilator is<br>indicated for use with a wide range<br>of patients from infant through<br>adult, requiring respiratory support<br>for a wide range of clinical<br>conditions in hospital, hospital-type<br>facilities and intra-hospital<br>transport. | The Inspiration® 7i / 5i Ventilator<br>System is intended for use with<br>patients having body weights in the<br>range of 0.3kg to 200kg and Tidal<br>Volumes of 5ml to 2000ml. The<br>Inspiration® Ventilator System is to<br>be used by healthcare professionals<br>in hospitals or healthcare facilities.<br>This product is intended for a wide<br>range of patients from infant to<br>adult and for a wide variety of<br>clinical conditions.<br>The intended patient population<br>includes infant through adult<br>patients who require pressure-<br>based or volume-based continuous<br>respiratory support with tidal<br>volumes as low as 5 ml and<br>inspiratory pressures as low as 1 cm<br>H2O.<br>The device is intended for use in | | Comparison Parameter | Predicate: Inspiration<br>Ventilator System K072590 | Inspiration 5i/7i Ventilator<br>System | | | | hospitals and hospital-type facilities,<br>which provide respiratory care for<br>patients requiring respiratory<br>support.<br>The device is not to be used in the<br>presence of flammable anesthetics.<br>The device is intended for sale by or<br>on the order of a physician only. The<br>device is intended for operation by<br>trained and qualified personnel. | | Patient Types | Adult, Pediatric, Infant | Adult, Pediatric, Infant | | Ventilation Modes | | | | Volume Modes | V-CMV, V-SIMV | V-CMV, V-SIMV | | Pressure Modes | P-CMV, P-SIMV, SPAP, SPONT( CPAP<br>+ PS), NCPAP, NCPAP+, NIV | P-CMV, P-SIMV, SPAP, SPONT( CPAP<br>+ PS), NCPAP, NCPAP+, NIV | | VTV Modes | PRVC-CMV, PRVC-SIMV, VS | PRVC-CMV, PRVC-SIMV, VS | | Apnea backup | Volume, Pressure | Volume, Pressure | | Settings/Controls | | | | | Patient Type, Rate, Tidal Volume, | Patient Type, Rate, Tidal Volume, | | | Inspiratory Pressure, Peak Flow, | Inspiratory Pressure, Peak Flow, | | | Primary Settings | Inspiratory Pause, Inspiratory<br>Time, PSV, PEEP, Flow Trigger,<br>Pressure Trigger, Pressure High,<br>Pressure Low, Time High, Time<br>Low | | | Advanced Settings | Bias Flow, PS Tmax, Exp Sens%,<br>Rise Time, Advance Flow Control | | | Monitoring | Inspiratory Tidal Volume,<br>Expiratory Tidal Volume,<br>Spontaneous Tidal Volume,<br>Mandatory Tidal Volume, Vti/Kg,<br>Vte/Kg, Rate, Rate Spont, Minute<br>Ventilation (Ve), Spontaneous<br>Minute Volume (Ve Spont),<br>Ve/Kg, I:E, H:L, Ppeak, Ptrach,<br>Pmean, Pplateau, PEEP, Auto<br>PEEP, Pmin, Inspiratory Peak<br>Flow (PF), Expiratory Peak Flow<br>(PFe), Ti/Ttotal, Inspiratory Time,<br>Expiratory Time, Static<br>Compliance (Cstat), Cstat/kg,<br>Dynamic Compliance (Cdyn),<br>Cdyn/kg, Inspiratory Resistance | | | | | | | | | | | (Rinsp), Expiratory Resistance | | | | (Rexp), Leak, RSBI, O2, HeO2, | | | | Event History, PO.1, PiMax, | | | | PO.1/PiMax, C20/C, WOBimp, | | | Monitoring: Capnography | PetCO2, PeCO2, VCO2/min, | Predicate: Hamilton G-5 | | | VtiCO2, VteCO2, FetCO2, FeCO2, | Ventilator (K103803): | | | Vd ana, Vd alv, Vd/Vt/phy, Valy, | PetCO2, PeCO2, VCO2/min, | | | Valv/min | VtiCO2, VteCO2, FetCO2, FeCO2, | | | | Vd ana, Vd alv, Valy, Valv/min | | | | | | Type | Alternating Current (AC) | Alternating Current (AC) | | Voltage Range | 100 to 240 V | 100 to 240 V | | Frequency | 50 - 60 Hz | 50 - 60 Hz | | Battery Type | Lead Acid (Optional battery pack =<br>Lithium Ion) | Lead Acid (Optional battery pack =<br>Lithium lon) | | Battery Time | 1 Hour (1 hour per optional hot<br>swappable battery) Hold 4-8<br>batteries | 1 Hour (1 hour per optional hot<br>swappable battery) Hold 4-8<br>batteries | | Battery Capacity | Amp/hours | Amp/hours | | Weight | 53 lbs (24kg) without Cart | 53 lbs (24kg) without Cart | | | 98 lbs (44.5kg) with Transport Cart | 98 lbs (44.5kg) with Transport Cart | | Operating Temperature | 10 to 40 º C | 10 to 40 ª C | | Operating Humidity | 10 to 80% | 10 to 80% | | Storage Temperature | -10 to 60 a C | -10 to 60 º C | | Storage Humidity | 5 to 95% | 5 to 95% | {3}------------------------------------------------ . {4}------------------------------------------------ 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 Inspiration 5i/7i based on the determined Level of Concern. The Inspiration 5i/7i 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 - 2. IEC 60601-1-2:2004, Medical Electrical Equipment Part 1-2: General requirements for safety-Collateral standard: Electromagnetic compatibility-Requirements and tests {5}------------------------------------------------ - 3. IEC 60601-2-12:2001, Medical Electrical Equipment. Particular requirements for the safety of lung ventilators. Critical care ventilators. - 4. 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 Inspiration 51/7i ventilator substantial equivalence to the identified predicates currently marketed and previously cleared by the FDA. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three wavy lines representing the branches of government. The logo is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is written in a sans-serif font. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 29, 2013 eVent Medical, Limited Mr. Rick Waters Vice President, Regulatory Affairs and Quality Assurance 971 Calle Amanecer SAN CLEMENTE CA 92673 Re: K130178 Trade/Device Name: Inspiration 5i/7i Ventilator System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: September 25, 2013 Received: September 27, 2013 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. {7}------------------------------------------------ ### Page 2 - Mr. Waters 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportalProblem/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. Image /page/7/Picture/7 description: The image shows a signature above the text "Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID FOR". The text is likely part of a formal letter or document. The signature is illegible but appears to be handwritten. Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ Inspiration 5i7i 510(k) Premarket Submission eVent Medical Ltd. SECTION D: Indications for Use Statement INDICATIONS FOR USE STATEMENT 510(k) Number (if known): K130178 Device Name: {device name(s)} Indications for Use: The Inspiration® 7 / 51 Ventilator System is intended for use with patients having body weights in the range of 0.3kg to 200kg and Tidal Volumes of 5ml to 2000ml. The Inspiration® Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intrahospital transport. This product is intended for a wide range of patients from infant to adult and for a wide variety of clinical conditions. The intended patient population includes infant through adult patients who require pressurebased or volume-based continuous respiratory support with tidal volumes as low as 5 ml and inspiratory pressures as low as 1 cm H2O. The device is intended for use in hospital-type facilities, which provide respiratory care for patients requiring respiratory support. The device is intended for sale by or on the order of a physician only. The device is intended for operation by trained and qualified personnel. Over-The-Counter Use _ Prescription Use X ___________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) lly signed by Anya C. Harry -S o=U.S. Government, ou=HHS, Anva C. Harin People, ChaAnya C. Harry -S, 9200300.100.11.1=00111.1=00111.315590. 9200300.100.11.1=00111.1=00111.315590.100.300.300.300.300.300.300.300.300.300.300.300.300.300.300.300.300.300.300.300.300.300.300.300.3 Concurrence of CDRH, Office of Device Evaluation (ODE) Page _1_ of _1 (Posted November 13, 2003)