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Statutory analysis of regulatory compliance

Medical Device Definition

Source FDA doc­u­ment 

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:

  1. 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. 
  2. Opti­mize strength train­ing: The high-oxy­gen selec­tion enables a user exert at ele­vat­ed inten­si­ty enabled by a rich oxy­gen mix­ture.
  3. 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.
  4. 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.

Exercise Basics

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

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.

Updated on August 27, 2019

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