Medical Device Definition
What is a medical device?
The FDA defines a medical device as:
- “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
This definition utilizes several key concepts:
- “an instrument…” — this is a singular form word suggesting whatever device must be intended for stand-alone use, and lacks dependency on any other device to produce an effect;
- intended — declares the intended use of the item relative to affecting any disease. This appears to reflect legislative intent to exclude devices with the intention to improve the delivery of any essential nutrient to any tissue.
- Or intended — to affect the structure or any function through chemical action
- Which does not achieve it’s primary intended purposes through chemical action
- And which is not dependent upon being metabolized…
Point 1: an instrument:
LiveO2 is never sold, marketed or documented for use as a stand-alone instrument. It is clearly labeled only for use with exercise equipment during exercise or physical challenge.
Mechanically — LiveO2 provides an exercising user a choice of alternating respiratory mixtures during exercise. The average of the air offered to the user is the same as ambient air.
Users with no exercise capacity gain no benefit from LiveO2. LiveO2 is not branded, documented or represented to produce any benefit in any way for any user who does not use it during some sort of physical challenge which increases respiration.
Switching respiratory mixtures has no documented effect absent exercise. No known product materials suggest LiveO2 should ever be used without some sort of physical challenge that increases respiration.
LiveO2 labeling and usage materials universally assert that LiveO2 is not intended to be used as a stand-alone device.
Point 2: “intended”
The intended effect and mechanism of LiveO2 is only intended to improve the effects of exercise. The mechanism of action relies exclusively on the user’s natural respiratory process to deliver oxygen to tissue inherent to exercise.
Generally, LiveO2 is intended to enable users to:
- Optimize endurance training: The low-oxygen selection enables a user to increase the functional intensity of exercise by a simulated altitude. This is equivalent to well established hypoxic training systems.
- Optimize strength training: The high-oxygen selection enables a user exert at elevated intensity enabled by a rich oxygen mixture.
- Accelerate training effects: Post sprint recovery with rich oxygen enables users to quickly recover from sprints for rapid-fire training which produces more results in less time.
- Maximize tissue oxygen levels created by training: A Switch from low-oxygen to high-oxygen mixture during an exertion event enables an exercising user to maximize blood flow to an exerting tissue. A switch to oxygen-rich air during the exertion enables the user to simultaneously maximize the oxygen in the blood going to the tissue. This creates maximum oxygen delivery to the tissue with simultaneous maximum of blood flow and with maximum oxygen.
Exercise is well understood and accepted to increase the amount of oxygen delivered to a tissue. Increased oxygen from exercise is well documented to optimize energetic performance of tissue. The energetic performance of tissue indirectly governs health as resistance to disease and healing.
Exercise is well understood to improve the structure and function of tissue because it increases oxygen. These effects occur regardless of any disease state that may affect the tissue.
FDA statutory authority omits jurisdiction over users mechanism or means of exercise because that would likely be found unconstitutional in light of the 9th Amendment. Congress and its agencies lack authority to tell people how they may, or may not exercise.
As exercise depletes tissue oxygen, the body compensates by increasing blood flow volume to tissue and the respiratory rate to increase oxygen absorption in the lungs. This process delivers more oxygen to the tissue.
LiveO2 increases the efficiency of tissue oxygen delivery to the natural physiological maximum achievable within the exercise capacity of the user.
Each of these effects is the result of the intent of the user exercising in a particular manner using a combination of an exercise device and LiveO2.
These effects are physiologically unnatural, except that LiveO2 enables levels of vigor typical at a relative age less than the actual age of the user.
Point 3: Choice
LiveO2 is controlled by user choice. This choice enables to user to switch respiratory mixtures made by separating ambient air into oxygen rich and oxygen reduced mixtures.
The average oxygen in these streams is exactly the same as ambient air. The user has an anytime choice to consume oxygen rich or oxygen reduced air during exercise.
The choice of air supply enables an exercising user to pursue an expanded and enhanced combination of exercise effects. This process is controlled only by the user and is independent of any intent of the manufacturer.
User choice governs the type, intensity and duration of exercise further potentiated by the user’s selection of respiratory mixture during exertion.
Because user choices govern the physiology that occurs during use, the manufacturers only meaningful intent can be to endow the user with the enhanced training effect of selecting from variable respiratory mixtures during exercise.
The nature of this choice prohibits the manufacturer from enforcing any specific intent upon a user.
Point 4: Intent relative to any disease
The statute associates the instrument with an intent to effect a disease process.
Point 2 illustrates that the manufacturer’s intent of the device is to maximize the effects of exercise to optimize energy production in tissue.
Point 3 illustrates how the choices made by the user during exercise entirely govern the effects of device use.
The manufacturer represents no intent of the product to be used for any specific disease or medical purpose other than to optimize energy production, which in turn promotes health.
The manufacturer supports the product by suggesting combinations of exercise and respiratory mixture switches to increase oxygen levels in the whole body and to preferentially maximize oxygen levels in specific tissues including the brain, skin, and other organ systems.
The intent of these disclosures is to enable exercise-capable users to better optimize the structure and function of all body tissues regardless of the absence or presence of medical conditions.
It remains the choice of the user to choose and execute an exercise method that targets a specific tissue which may be affected by a disease condition.
Point 3: The statutory language is a bit confusing in that the LiveO2 system is not metabolized.
LiveO2 presents a user with two air mixtures by separating ambient air. The average oxygen in the combined streams is exactly the same as ambient air. The user has equal choice to consume either the oxygen-rich or oxygen-reduced stream. The existence of choice further disqualifies LiveO2 from a medical device.
Oxygen use is a chemical process which is the basis of life. Oxygen is metabolized as the basis of life during exercise.
While exercise increases the metabolization of oxygen, LiveO2 does not alter the amount of oxygen metabolized during exercise.
If we presume the statute language applies to the “product” of the system as choice of filtered air.
The low-oxygen air approximates the oxygen concentration in a commercial airline cabin. The high-oxygen mixture approximates a diver breathing nitrox at a depth of 30 feet. Both concentrations are widely accepted as safe and not harmful for prolonged durations.
Analysis of the airflow streams shows the average of oxygen available to a user from a LiveO2 is exactly the same as from ambient air. The air is not chemically altered from ambient form. It is , simply filtered into oxygen rich and oxygen reduced streams which are select-able by the exercising user.
The amount of oxygen available to the LiveO2 system user in the air selection streams averages to ambient air.
The LiveO2 system concentrates and rarifies the natural metabolite, oxygen which is present in air, but it also rarifies that same metabolite. On average the LiveO2 system does NOT alter the chemical composition or even the average concentration of oxygen available to the user.
Oxygen Partial Pressure Safety
Both the low and high oxygen levels are well within accepted safe ranges, and have been in public use since 1949, 1965, and military use since World War 2.
Oxygen Rich Mixture
LiveO2 uses respiratory oxygen levels of about 85% under ambient pressure.
This level is within well established safety limits established over 50 years of recreational diving. LiveO2 simulates breathing a NITROX mixture at a depth of 60 feet, or a football player breathing oxygen on the bench after an exhaustive play.
The LiveO2 oxygen-rich mixture mirrors NFL best practice to provide players with an oxygen mixture at the bench when returning from play. This practice provides a margin of safety and enables players to expedite recovery from high exertion plays and return to the game more quickly.
Oxygen toxicity only occurs at an oxygen partial pressure of 140% which is impossible under normal atmospheric conditions.
Oxygen Reduced Mixture
The low oxygen mixture simulates the oxygen partial pressure about the same as during commercial air travel. This air mixture has a history dating back to about 1949.
Barotrauma is an injury from pressure change. It occurs when external pressure changes faster than the body can adapt.
LiveO2 operates only under normobaric conditions. Barotrauma cannot occur.