RTubeVOC™
End Tidal Air Collector

Overview

Portable Collection Devices for the Study of Deep-Lung Volatile Organic Compounds (VOC’s)

The RTubeVOC™ End Tidal Air Collector is designed for ease of use by the supervised patient in the clinic, home, school, or hospital. This non-invasive handheld device is fully self-contained and disposable. The RTubeVOC selectivly traps the last bit of exhalate containing primarily alveolar air as the subject fully exhales a single breath into the device.

This unique feature allows for easy integration of the RTubeVOC into deep-lung VOC studies and when used in conjunction with Mass Spectrometry allows data to be collected with ease from subjects in nearly any environment. The simplicity and environmental flexibility of this collector offers the potential for rapid development of clinical diagnostics utilizing Volatile Organic Compounds derived from the deep lung and alveoli.

How to Use

The video outlines the procedures for use. A couple of points to consider:

• In an adult, End Tidal Air is typically considered to be the last bit of exhalate trapped after a single continuous exhalation lasting 6 seconds or more
• In a child, End Tidal Air is typically considered to be the last bit of exhalate trapped after a single continuous exhalation lasting 3 seconds or more
• Continuous exhalation is required for the device to work correctly. Inhaling through the device at the end of the exhalation may contaminate the sample with ambient air

Regulatory

USA: FDA Regulatory Status of the RTube family of products

RTube is registered with the United States Food and Drug Administration as a Class I device for Research Use Only. You may see our device registration at:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=198613&lpcd=KGK

As such all use of the RTube must be conducted under the supervision of an Investigational Review Board (IRB), which is common to almost all human studies, and no therapeutic or medical decisions may be based on the outcome of analyses using the RTube collector.

Europe: The RTube falls outside the EU IVD Directive and requires no CE mark

The RTube Exhaled Breath Condensate Collector is clearly and permanently labelled “For Research Use Only” on the device itself, is not an In-Vitro diagnostic (IVD), and therefore falls outside the EU IVD Directive and requires no CE mark.  As such all use of the RTube must be conducted under the supervision of an Investigational Review Board (IRB), which is common to almost all human studies, and no therapeutic or medical decisions may be based on the outcome of analyses using the RTube collector.

Please see references below:

Recital 8 of the IVD Directive 98/79/EC states: “Whereas instruments, apparatus, appliances, materials or other articles, including software, which are intended to be used for research purposes, without any medical objective, are not regarded as devices for performance evaluation.”

Further based on guidance document MEDDEV. 2.14/2 rev.1 Section 5 (a):

5. Potential Situations where “RUO” Labeled Products could be used

The following are a list of possible situations where RUO products could be used and which therefore fall outside the scope of the IVD Directive.

(a) RUO products used for Basic Research:

These are products used for research conducted to study all aspects of human life in an attempt to better understand all underlying mechanisms. In such studies / experiments animal and / or human models are used. No medical purpose is defined, as the specimens taken are not being used for the purpose identified in the definition of an IVD device in the IVD Directive, article 1 2(b). In such practice there is no potential to misuse RUO products.

Institutional Review Board/ Human Investigation Committee Consideration of the RTube family of products

Over 230,000 samples have been collected from ambulatory subjects worldwide with the RTube over the last 20 years with zero adverse events attributed to its use. Our device and methods have been considered non-significant risk by multiple Institutional Review Boards. Each individual Institutional Review Board/ Human Investigation Committee may wish to make its own determination as to the non-significant risk nature of the device, especially if the device is modified or incorporated into other equipment.

Technical Information

How it Works

The RTubeVOC is strictly a non-rebreathing device and utilizes two one-way valves to maintain unidirectional flow throughout the entire breathing cycle as the subject exhales through the mouthpiece.

Quality

Our commitment to quality extends far beyond our product. At Respiratory Research, Inc., it is a way of business. We require that leading industry quality practices be applied to all products and processes. This includes Supplier Qualifications, Engineering, Procurement, Manufacturing, Order Fulfillment, and Technical Support.

We work with ISO 9000-certified suppliers only. Top-tier suppliers are provided current engineering documentation at all times and apply their own internal quality systems to ensure that all products supplied to Respiratory Research, Inc. are in full conformance with these engineering specifications. Respiratory Research, Inc. thoroughly and completely documents all product requirements using engineering drawings bills of material, assembly procedures, environmental specifications, and component specifications. These are maintained by Respiratory Research, Inc. and are under full revision control.

RTubeVOC Materials and Performance

The Rtube Exhaled Breath Condensate Collector is specifically designed to meet the needs of a wide range of subjects, investigators, and clinicians. Its size, weight, materials, and performance characteristics have been carefully selected to provide the maximum safety, effectiveness, and flexibility.

Cautions and Warnings

A WARNING, if unheeded, could potentially affect the patient.

A CAUTION, if unheeded, could potentially affect the quality of the sample or present a hazard to the medical and laboratory staff.

The RTube is a disposable device designed for single use. It is assembled to stringent specifications and cleaned under strictly controlled clean-room conditions to ensure proper operation, safety, and cleanliness. Any subsequent rebuilding or tampering with the device will reduce the effectiveness of the device, risk the quality of your data, and potentially pose a safety risk to the patient.

The RTube is an investigational device only and is designed for research purposes. Due to the non-invasive nature of the device, the RTube is exempt from the Investigational Device Exemption of the United States Food and Drug Administration. Any invasive use of the device or use outside of protocols approved by local Institutional Review Boards is not supported by Respiratory Research, Inc.

The RTubeVOC should be handled with a slow, steady, controlled motion when inserting onto plunger. This steady motion should be maintained even if unpredictable resistance levels are met. If excessive force is used and the resistance unexpectedly drops, the rapid motion of the RTube as it is forced over the plunger can distort the internal parts and can result in partial loss of sample

Prior to use, please check to ensure the red arrow at the end of the collection chamber is pointing AWAY from the blue mouthpiece assembly.

The RTube collection chamber houses one of the two internal one-way check valves and must be properly oriented when attached to the mouthpiece. This collection chamber is easily identified as the long semi-clear polypropylene tube sitting atop the blue mouthpiece assembly. By design, these parts can easily be separated to allow isolation and transport of the sample within the chamber. The initial mating is done at the factory and quality checked to ensure correctness. However, during handling by patients or medical staff they can become separated. This is not a problem as long as they are mated correctly prior to use.

Note: The word “UP” is printed in red letters beneath the red arrow and pertains to the overall device orientation during use, not the assembly of the collection chamber to the mouthpiece.

This resistance is due to minor adhesion internal to the duckbill valve. The duckbill valve is made of silicone rubber. Silicone rubber, especially at warm temperatures, is a naturally tacky material. We minimize this tackiness through a curing process ensuring all volatiles are removed and that all residual reactions of the two-part reagent chemical mix used to create the compound are complete.

Even with this cure, the area around the slit of the valve may still experience light sticking when the RTubes are stored for longer than 30 months or stored in warm ambient temperatures.

This sticking is expected and normally has no effect, but in rare cases it can be enough to impair usage of the RTube. Apply the procedure shown here prior to using RTube to verify proper operation and eliminate any potential impairment. Please Note: It is important that all staff handling the RTubeVOC be made aware of this procedure.