HELONTIX VENT

K072926 · Linde Gas Therapeutics · CBK · Oct 15, 2008 · Anesthesiology

Device Facts

• Record ID: K072926
• Device Name: HELONTIX VENT
• Applicant: Linde Gas Therapeutics
• Product Code: CBK · Anesthesiology
• Decision Date: Oct 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

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. The Helontix Vent delivery system is not intended as a life support device and is not intended for intubated patients.

Device Story

Helontix Vent is a standalone, trolley-mounted system delivering helium/oxygen (heliox) mixtures to spontaneously breathing patients via facemask. Device inputs include O2 and heliox gas cylinders; user-selected ventilation modes (Pressure Support Mode or Constant Flow Mode) via interface (display, control wheel, keys). Device provides non-invasive positive pressure ventilation (NPPV) or constant flow; monitors set values, alarms, and ventilation parameters. Used in clinical facilities by healthcare providers to manage respiratory gas delivery. Output informs clinicians of patient status and ventilation performance; assists in respiratory therapy by providing heliox mixtures, potentially improving gas distribution in airways. Not for life support or intubated patients.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with voluntary standards (UL 60601-1, EN/IEC 60601-1, EN/IEC 60601-1-2, EN/IEC 60601-1-4, EN 60601-2-12/ASTM F100, EN 60601-1-8, EN 980, EN ISO 21647, EN 739/ISO 5359, EN 14971, EN 60601-1-6, ISO 5356-1) and draft reviewer guidance for ventilators was used to demonstrate substantial equivalence.

Technological Characteristics

Standalone trolley-mounted system with built-in battery. Delivers heliox (79% He, 21% O2) and O2. Modes: Pressure Support (3-30 mbar) and Constant Flow (5-60 SLPM). User interface includes display, diodes, speaker, keys, and control wheel. Complies with EN/IEC 60601-1, EN/IEC 60601-1-2, and EN/IEC 60601-1-4. Software-controlled. Uses standard conical connectors (ISO 5356-1) and low-pressure hose assemblies (ISO 5359).

Indications for Use

Indicated for spontaneously breathing patients requiring helium/oxygen mixture delivery via facemask, with or without pressure support, in a facility setting. Not indicated for intubated patients or as a life support device.

Regulatory Classification

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

Predicate Devices

• 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)

Reference Devices

• Aerogen Aoroneb Pro (K021175)

Submission Summary (Full Text)

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# 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: [phone] Mobile: [phone] 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

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### 1.4 OFFICIAL CORRESPONDENT

Ann-Cathrin Jareman Director Regulatory Affairs

AGA AB Linde Gas Therapeutics SE-181 81 Lidingö Sweden

Tel: [phone] Mobile: [phone] 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.

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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

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### 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.

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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

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### 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.

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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.

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### 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 [phone]. 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 [phone] or [phone] 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

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# 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

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