HELONTIX VENT

{0}------------------------------------------------ # OCT 1 5 2008 ### 510 (K) SUMMARY: LINDE GAS THERAPEUTICS HELONTIX VENT 1.1 072926 Preparer/Contact Ann-Cathrin Jareman Director Regulatory Affairs AGA AB Linde Gas Therapeutics SE-181 81 Lidingö Sweden Tel: +468 731 1031 Mobile: +4670 250 0874 Email: ann.cathrin.jareman(a)linde-gas.com Linde Gas GmbH Wolfholzgasse 28 2345 Brunn am Gerbirge AUSTRIA Date summary was prepared: Manufacturer Name(s) of the device: Identification of predicate device(s): October 1, 2007 Helontix Vent Puritan Bennett 840 Ventilator System K970460 GE Datex-Ohmeda Aptaér Heliox Delivery system, K041524 Maquet Critical Care AB, Servo-i Ventilator system NIV option, K041223 ### 1.2 ESTABLISHMENT REGISTRATION NUMBER Will be applied for with submission and review of this 510(k) ### 1.3 ADDRESS OF MANUFACTURING SITE: Manufacturing Location: Linde Gas GmbH Wolfholzgasse 28 2345 Brunn am Gerbirge AUSTRIA {1}------------------------------------------------ ### 1.4 OFFICIAL CORRESPONDENT Ann-Cathrin Jareman Director Regulatory Affairs AGA AB Linde Gas Therapeutics SE-181 81 Lidingö Sweden Tel: +468 731 1031 Mobile: +4670 250 0874 Email: ann.cathrin.jareman(a)linde-gas.com ### 1.5 CLASSIFICATION 21 CFR 868.5895 Regulation Name: 868.5895 Continuous ventilator Regulatory Class: Class II Product Code: CBK ### 1.6 CLASSIFICATION NAME Ventilator, continuous, facility use ### 1.7 COMMON OR USUAL NAMES Continuous Ventilator ### 1.8 PROPRIETARY NAME Linde Therapeutics Helontix Vent ### 1.9 INTENDED USE The Helontix Vent is designed to deliver helium/oxygen mixtures to spontaneously breathing patients via a facemask with or without pressure support. The system is designed for facility use and should only be used under the orders of a clinician. Image /page/1/Picture/17 description: The image shows the text "Page 3 of 164". The text is in a simple, sans-serif font and is positioned at the bottom left of the image. The numbers indicate that this is page 3 of a document that is 164 pages long. {2}------------------------------------------------ The Helontix Vent delivery system is not intended as a life support device and is not intended for intubated patients. ### 1.10 PREDICATE DEVICES Puritan Bennet 840 Ventilator System K970460 GE Datex-Ohmeda Aptaér Heliox Delivery system, K041524 Maquet Critical Care Servo-I Ventilator system NIV option, K041223 ### 1.11 DESCRIPTION OF THE DEVICE: The Helontix vent is a stand alone assembly to deliver heliox or oxygen. To accomplish this, the Helontix vent consists of a device with a built in battery and a trollev with mounted oxygen and Heliox gas cylinders. When connected to O2 and Heliox (79%He, 21%O2) the Helontix vent delivers a mixture of oxygen and helium in the required fraction to the patient who can breathe over a mask that is connected to the device via a hose system. The Helontix vent interacts with the user via a user interface, i.e. a display, diodes, speaker, several keys and a control wheel. The device informs the user on the screen about set values, monitored values, alarms, ventilation modes and the navigation through the menus while the user can choose the ventilation mode, set values, silence alarms and navigate through menus by using keys and control wheel. The Helontix vent is device designed for Non-invasive Positive Pressure Ventilations (NPPV) for spontaneous breathing patients. The inspiration flow can be either triggered by the patient with a surplus support of pressure (pressure support mode, PSM, 3-30mbar@peak flow 160SLPM) or alternatively a constant flow from 5-60 SLPM without a pressure support (constant flow mode, CFM) can be selected. The breathing circuit, mask and filter used are purchased previously cleared devices. ### 1.12 5 10(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION Proprietary Name: Linde Gas Therapeutics Helontix Vent Common name: Ventilator, Continuous Helontix Vent Helium Oxygen Delivery System Image /page/2/Picture/13 description: The image shows the text "Page 4 of 164". This text appears to be a page number within a larger document. The page number is 4, and the total number of pages in the document is 164. {3}------------------------------------------------ ### Premarket Notification Classification: Anesthesiology, 73 CBK, 21 CFR 868.5895 The 5 10(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992. The Linde Gas Therapeutics Helontix Vent is substantially equivalent to the following currently marketed device: #### GE Datex-Ohmeda Aptaér Heliox Delivery System K041524 The GE Datex-Ohmeda Aptaér Heliox delivery system is designed to deliver heliox from a source gas cylinder to spontaneously breathing patients via a sealed facemask using pressure support. A built in nebulizer, the Aerogen Aoroneb Pro (K021175) is provided for adding nebulized medication to the delivered heliox. The system is designed for facility use and should only be used under the orders of a clinician. The Aptaér Heliox Delivery system is not intended as a life support device and is not intended for intubated patients. #### Puritan-Bennett 840 ventilator system K970460 The 840 ventilator system is used to provide continuous ventilation to patient's requiring respiratory support. This device is used for a wide range of patients from infants to adult and for a wide variety of clinical conditions. #### Maquet Critical Care Servo-i Ventilator system NIV option K041223 The Servo-i Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. Servo-i is a ventilator system with advanced functionality. It may be used only by professional health care providers who have sufficient experience in ventilator treatment. {4}------------------------------------------------ The Helontix Vent is not intended as a life support device and is not intended for intubated patients. The intended use is: The Helontix Vent is designed to deliver helium/oxygen mixtures to spontaneously breathing patients via a facemask with or without pressure support. The system is designed for facility use and should only be used under the orders of a clinician. The Helontix Vent delivery system is not intended as a life support device and is not intended for intubated patients. The Helontix Vent was designed to comply with the applicable portions of the following voluntary standards; | Standard | year | | |--------------------------------------------|------|-------------------------------------------------------------------------------------------| | UL 60601-1 | 2003 | Medical electrical equipment - General requirements for safety | | EN/IEC 60601-1: | 1996 | Medical electrical equipment - General requirements for safety | | EN/IEC 60601-1-2: | 2002 | Electromagnetic compatibility- requirements and tests | | EN/IEC 60601-1-4: | 2001 | Safety requirements for programmable systems | | EN 60601-2-12/ ASTM<br>F100 | 2001 | Particular requirements for the safety of lung<br>ventilators - Critical care ventilators | | EN 60601-1-8 | 2006 | Electrical Alarm signals | | EN 980: | 2003 | Graphical symbols | | EN ISO 21647: | 2004 | Medical electrical equipment -Respiratory gas monitors | | EN 739:/ ISO 5359 | 2002 | Low-pressure hose assemblies for use with medical<br>gases | | EN 14971: | 2003 | Medical devices - Application of risk management to<br>medical devices | | EN 60601-1-6: | 2005 | Usability | | ISO 5356-1 | 2004 | Conical connectors | | Draft Reviewer Guidance<br>for Ventilators | 1995 | Draft reviewer guidance for ventilators | For software control, the Helontix Vent is a major concern device even though it is not life supporting because of outcomes that could potentially occur prior to mitigation. The submissions contains full software information regarding the Level of Concern Analysis, Risk Analysis, Software Development, Software Requirements and Design, Verification and Validation testing, and Traceability. EMC, Electrical, Environmental and full performance {5}------------------------------------------------ ### Premarket Notification ## Linde Gas Therapeutics testing is also provided in support of the submission. Positive results from extensive testing demonstrate that the Linde Helontix Vent is substantially equivalent to the predicate devices. The Linde Helontix Vent and the currently marketed device are substantially equivalent in design concepts, technologies and materials. The Linde Helontix Vent has been validated through rigorous testing that, in part, supports the compliance of Helontix Delivery System to the standards listed above. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is drawn in a simple, bold line style, and the text is in a sans-serif font. The overall design is clean and professional. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # OCT 1 5 2008 Ms. Ann-Cathrin Jareman Head of Global Regulatory Affairs Linde Gas Therapeutics AGA AB SE-181 81 Lindingö SWEDEN Re: K072926 Trade/Device Name: Linde Therapeutics Helontix Vent Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: October 3, 2008 Received: October 8, 2008 Dear Ms. Jareman: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Ms. Jareman 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, A. Hommelr Lindens porh Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {8}------------------------------------------------ # Indications for use Statement 510(k) Number (if known): K072926 Device Name: Linde Therapeutics Helontix Vent Indications for Use: The Helontix Vent is designed to deliver helium/oxygen mixtures to spontaneously breathing patients via a facemask with or without pressure support. The system is designed for facility use and should only be used under the orders of a clinician. The Helontix Vent delivery system is not intended as a life support device and is not intended for intubated patients. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) K 072926 (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control. Dental Devices 510(k) Number: Helontix Vent Helium Oxygen Delivery System Image /page/8/Picture/17 description: The image shows the text "Page 20 of 1173". The text is black and is located at the bottom left of the image. The numbers indicate that this is page 20 of a document that has 1173 pages.