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 its 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.
Labeling always asserts that LiveO2 is intended to be used as one part of a two-part system. The regulation constrains a medical device to a single instrument that works on its own an instrument.
The statutory definition requires a single instrument and arguably excludes a two-part system from the definition of an instrument.
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 the 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 the 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 a simultaneous maximum blood flow and with maximum oxygen.
Exercise is well understood and accepted to increase the amount of oxygen delivered to tissue. Increased oxygen from exercise is well documented to optimize the 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’ mechanisms or means of exercise because that would likely be found unconstitutional in light of the 9th Amendment. Congress and its agencies lack the authority to tell people how they may, or may not exercise.
The statutory exclusion of exercise equipment is because exercise is generally deemed to affect structure or function via chemical mechanisms within the body. The statute generally excludes “Which does not achieve its primary intended purposes through chemical action”.
Exercise equipment generally achieves its primary intended purpose through chemical action, the metabolism of oxygen, with energy substrates like carbohydrates and oxygen. This criterion generally excludes all exercise equipment from the statutory classification of device.
What is included in the definition of device? A device thus includes any mechanism which improves structure or function without a chemical reaction. An example would be a prosthetic limb. This is a device that affects structure or function but does not involve a chemical reaction within the body.
Exercise Basics
As exercise depletes tissue oxygen, the body compensates by increasing blood flow volume to the 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.
What is the statutory definition Device relative to exercise equipment pursuant to to intended structure/function change
Exercise broadly describes voluntary actions conducted by a user to produce functional changes in their own body. Exercise is an active verb and involves doing work. The act of doing literal work, or exercise, establishes a de-facto intent on behalf of the user to produce a change in their own body. This change is deemed a structure or function change within the statute.
In this example, there are two parties with intent relative to affect a structure or function change. A manufacturer that created the product and a user that uses the product during exercise. Each party has a distinct intent.
The intent of the user is to cause a structure-function change in their body by exercising with the product. The intent of the manufacturer is to enable the user to exercise in pursuit of their own goals.
The manufacturer cannot possess an intent on behalf of a user. Let’s do a simple analysis by considering a simple exercise device like a barbell.
Why isn’t barbell 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.”
Let’s start by observing that this is pretty confusing.
Clause 1 — False. A barbell is a device but since it is not listed in the official National Formulary, or United States Pharmacopeia, or a supplement. this is not true.
Clause — 2 — False. The barbell is not intended by the manufacturer for use in the diagnosis of disease. It is intended by the manufacturer to enable a user to exercise by lifting it.
Clause — 3 — True but structure or function changes occur by chemical reaction. It is clear our dumbell is intended to affect the structure or function of a user, such as building muscle or increasing strength.
Calling a barbell a medical device is absurd — but why?
When a user acts on their intent by exercising with the barbell the frequency, intensity, and nature of the exercise determine the structure or functional change the user achieves. Only the user’s actions driven by the user’s intent cause the structure or functional change referenced within the statute. The user’s intent for exercising with the barbell is outside the authority of the FDA.
The work performed when the user lifts the barbell causes a series of internal chemical reactions which in turn affect the structure or function of the user.
There are two actual reasons our barbell isn’t a medical device:
- Our barbell is not intended to affect the structure or function because, by itself, it has no ability to change anything. By itself it has no utility and cannot be considered a device within the context of the statute;
- The intent of the manufacturer, not the user, determines the statutory applicability of intent. In the case of our barbell, the intent of the manufacturer is to enable the user to exercise effectively. It remains wholly within the intent of the user to pursue the intended utility of the barbell to affect a structure or function change by exercising with it.
Now we can see why a barbell is not a medical device. This analysis holds true for any exercise equipment because the exercise equipment lacks the utility to independently affect the structure or functional change, thus falling short statutory definition of a medical device.
Only the user’s actions known as exercise, cause the changes in the user’s body. The barbell itself is an artifact or tool that enables the user to perform the act of exercise, which in turn causes the structure/function to change in the user’s body.
Revisiting the statute:
“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is…
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.”
These phrases are both singular and declarative. The word “an” expresses a single device. The word “intended” presupposes the device incorporates sufficient utility to affect the structure or function.
The barbell example illustrates a device that presents insufficient utility to meet the statutory definition of a medical device.
The same holds true for any device that by its nature lacks stand-alone utility to affect a structure or function change. This generally excludes any device that requires the user to exercise and includes generally all exercise equipment, and LiveO2.
Point 3: User Choice determines effect
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 manufacturer’s 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.
Moreover, any structure or function only occurs as an indirect result of chemical changes within the body of the user.
Point 4 : Intent relative to any disease
The statute associates the instrument with an intent to affect 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 that may be affected by a disease condition.
Point 5 : Chemical action and not metabolized
There are two categories of device, regulated and unregulated.
Devices are excluded from regulation by:
- Omission from listing in a registry;
- All devices branded for all other effects except to affect a disease conditions affect structure or function.
Certain devices branded to affect structure/function are also exempt from regulation when:
- They achieve their effects through chemical action
- The device itself is not-itself metabolized.
These last two criteria identify exceptions for exercise equipment that is clearly intended by some party to affect structure (gaining muscle) or function as an increase of strength or endurance.
Analysis of chemical action:
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 an 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 that is the basis of life. Oxygen is metabolized as the basis of life during exercise. The chemical reaction of oxidation of energy metabolites exempts exercise equipment even though it may be intended by the user or manufacturer to affect a structure or function.
- First criteria for exemption: The effects of the device are caused by chemical action, specifically the oxidation of energy metabolites.
- Second criteria for exemption: The device itself is not metabolized.
Other Considerations
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 the 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 selectable by the exercising user.
The amount of oxygen available to the LiveO2 system user in the air selection streams averages ambient air.
The LiveO2 system concentrates and rarifies the natural metabolite, oxygen which is present in the 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.
Uncertainty — There is no statutory definition of for a medical device
There is no statutory definition of Medical Device. 21 U.S. Code § 321 defines only a device. The phrase medical device is used to distinguish a medical from non-medical device — but statutory language only enables an individual to distinguish a medical from a non-medical device using confusing linguistics.
Back to the Barbell Example
It is absurd to deem a barbell a medical device.
The same logic applies to all exercise equipment because absent exercise — the equipment does not definition of a device because it performs no function.
The vagueness doctrine inflicts a harsh requirement on lawmakers to use clear language understandable by an average citizen. Laws that do not meet this clarity standard are simply void.
The barbell example scrutinizes the statutory definition of a device.
How does using a barbell fit or not the linguistically perplexing remainder of a device definition?
In the dumbbell example, the statutory language confounds whether the definition of medical devices depends on the intent of the user, the intent of the manufacturer, or the intent of the manufacturer on behalf of the user.