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 Description

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Linde Gas Therapeutics Helontix Vent, a device designed to deliver helium/oxygen mixtures to spontaneously breathing patients. The document focuses on establishing substantial equivalence to predicate devices and adherence to regulatory standards, rather than presenting a detailed clinical study with specific acceptance criteria and outcome data in the format requested.

Therefore, the following information can be extracted about the device's validation, but will not fully align with the requested structure of a study proving a device meets acceptance criteria derived from a clinical trial, as that type of study is not described:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the listed voluntary standards and the assertion of "positive results from extensive testing" demonstrating substantial equivalence. The document does not provide a table with specific, measurable performance metrics and corresponding acceptance thresholds for clinical efficacy, nor does it present quantitative results from a specific clinical study for the Helontix Vent. Instead, it refers to regulatory and engineering standards.

Acceptance Criteria (Implied by Standards)	Reported Device Performance (General Statement)
Compliance with UL 60601-1 (Medical electrical equipment - General safety)	"Positive results from extensive testing demonstrate that the Linde Helontix Vent is substantially equivalent to the predicate devices." (Implies compliance)
Compliance with EN/IEC 60601-1 (Medical electrical equipment - General safety)	"Positive results from extensive testing demonstrate that the Linde Helontix Vent is substantially equivalent to the predicate devices." (Implies compliance)
Compliance with EN/IEC 60601-1-2 (Electromagnetic compatibility)	"EMC...testing is also provided in support of the submission." (Implies compliance)
Compliance with EN/IEC 60601-1-4 (Safety requirements for programmable systems)	"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." (Implies compliance)
Compliance with EN 60601-2-12/ASTM F1100 (Lung ventilators - Critical care)	"Positive results from extensive testing..." (Implies compliance, though the device is not for critical care according to the 'intended use' statement). This is a potential discrepancy in the document's presentation or the standard's applicability. The intended use states it is not a life support device.
Compliance with EN 60601-1-8 (Electrical Alarm signals)	"Positive results from extensive testing..." (Implies compliance)
Compliance with EN 980 (Graphical symbols)	"Positive results from extensive testing..." (Implies compliance)
Compliance with EN ISO 21647 (Respiratory gas monitors)	"Positive results from extensive testing..." (Implies compliance)
Compliance with EN 739/ISO 5359 (Low-pressure hose assemblies)	"Positive results from extensive testing..." (Implies compliance)
Compliance with EN 14971 (Risk management)	"The submissions contains full software information regarding the Level of Concern Analysis, Risk Analysis..." (Implies compliance)
Compliance with EN 60601-1-6 (Usability)	"Positive results from extensive testing..." (Implies compliance)
Compliance with ISO 5356-1 (Conical connectors)	"Positive results from extensive testing..." (Implies compliance)
Compliance with Draft Reviewer Guidance for Ventilators	"Positive results from extensive testing..." (Implies compliance)
Software Validation (major concern device)	"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." (Implies successful validation)
Electrical and Environmental Performance	"EMC, Electrical, Environmental and full performance testing is also provided in support of the submission." (Implies successful performance)
Substantial Equivalence to predicate devices	"The Linde Helontix Vent and the currently marketed device are substantially equivalent in design concepts, technologies and materials."

2. Sample size used for the test set and the data provenance:
The document does not describe a clinical study or a test set of patient data. The "extensive testing" mentioned refers to engineering and software validation, not a clinical trial with human subjects. Thus, information on sample size and data provenance (country, retrospective/prospective) for a clinical test set is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no clinical test set with expert-established ground truth is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable as no clinical test set requiring adjudication is described.

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 device is a ventilator for heliox delivery, not an AI-powered diagnostic or reader-assistance tool. No MRMC study is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a hardware device for gas delivery, not an algorithm. Performance assessment would involve engineering and physical testing, not algorithm-only performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context refers to compliance with established engineering standards, software requirements, and safety regulations. These are verified through various physical and software tests, rather than human expert consensus on clinical data or pathology.

8. The sample size for the training set:
Not applicable as no machine learning algorithm with a training set is described.

9. How the ground truth for the training set was established:
Not applicable as no machine learning algorithm with a training set is described.

Summary of Study (Based on Provided Text):

The "study" described in the 510(k) summary is primarily a premarket notification to demonstrate substantial equivalence to legally marketed predicate devices and compliance with relevant voluntary standards and regulatory requirements. It is a technical and regulatory validation process, not a clinical study designed to prove device efficacy through patient outcomes or expert reads.

The document states:

"Positive results from extensive testing demonstrate that the Linde Helontix Vent is substantially equivalent to the predicate devices."
"EMC, Electrical, Environmental and full performance testing is also provided in support of the submission."
"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."

These statements indicate that the device underwent various forms of engineering, software, and performance testing to ensure it met safety requirements and functioned as intended within the parameters of the industry standards listed. The "ground truth" for these tests would be the specifications and requirements defined by those standards and the device's design documentation. No clinical trial with patient-specific outcome data, expert reviews, or AI performance metrics is mentioned or detailed.

Summary

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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: +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

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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: +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

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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:

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 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/ ASTMF100	2001	Particular requirements for the safety of lungventilators - 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 medicalgases
EN 14971:	2003	Medical devices - Application of risk management tomedical devices
EN 60601-1-6:	2005	Usability
ISO 5356-1	2004	Conical connectors
Draft Reviewer Guidancefor 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 (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

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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 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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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).