Why Apple Didn't Need FDA Approval for the Blood Oxygen Tracking Feature in the Apple Watch Series 6

[iPadified]

It only means that you cannot make any medical decision based on AW. Lot's of research equipment is labelled "not for medical use" or " not for diagnostics use", which essentially can be ignored if you do an in-house verification.

AW sensors are the way to go for general health monitoring but as is apparent, also from this thread , that absolute quantification or high accuracy is not possible. The reason is likely due to how people wears their AW. A tight fitting fingertip sensor is easier to standardise regarding how the device interfaces with the skin.

AW constantly screen a significant potion of the population for some heath parameters and any positive diagnosis that can be acted on is a win. Any false negative will not be Apple responsibility by labelling it "not for medical use". However, medical grade analysis instruments does not necessarily have better performance. The difference is that a medical instrument has the documentation about its accuracy, consistency, sensitive and selectivity when it is operated in a certain way. AW doesn't have this documentation and hence does not get FDA approval.

 

[tCdemon]

Gets me all excited

The hairy arm is the best part of the article.

 

[seanmcbay]

They knew the feature was inconsistent trash. Glad I returned mine. Hopefully the 7 will be more reliable. I personally think it’s a bit irresponsible of Apple to release a feature like this “for fun”.

 

[MareLuce]

Apple was smart to do this. Maybe down the line they will see FDA approval.

I compared my watch pulse ox to a medical fda proved device yesterday, and each time, there was only a 1% differential between the watch and the device.

Same for me. My Apple Watch pulse ox is always same or 1% different from my Innovo fingertip pulse ox.

 

[G4DPII]

Check the manual for your fingertip device. I have a good brand, and it says 2% accuracy. It’s not as good as the hospital device, which still isn’t the whole picture as blood tests are needed to confirm adequate O2.

Notice how it matters how long you have the fingertip device on as well. The number fluctuates over time and may not show an average (only if you upload it to a smartphone).

So if your Apple Watch consistently gives a 30 second reading at 97, but your fingertip monitor fluctuates from 97-99, averaging about 98, but both have 2% accuracy, what does that mean?

It means they both are going to help you know if you are dropping below 95% a lot, which is all that matters. They won’t truly let you know if you are 99 or 98 or 97 or 96, but if you read 95 consistently it could be 93...

O2 levels also fluctuate through out the day, they are lower first thing when you wake up. You can increase the amount of O2 in your blood by breathing deeply. There are so many variables that will effect the readings.

If the O2 sensor in the Apple Watch are always the same it's pretty shocking and shows how crap it truly is.

 

[sdz]

This feature will come handy as sleep apnoe or snoring detector.

 

[smokesletsgo]

Today's Apple is all about milking their average Apple sheep. 10 years ago this **** wouldn't even be added, either it works 100% accurate or gtfo - Steve Jobs style, that's what made Apple trustable and great, now it's just marketing trash.

 

[Apple_Robert]

O2 levels also fluctuate through out the day, they are lower first thing when you wake up. You can increase the amount of O2 in your blood by breathing deeply. There are so many variables that will effect the readings.

If the O2 sensor in the Apple Watch are always the same it's pretty shocking and shows how crap it truly is.

Consistent as I and others mentioned, means consistent with what we already know to be true from past readings and or compared to the fingertip device. I wasn’t saying the watch gave the same number reading every time. If it did that, I agree. It would be worthless.

 

[nt5672]

Another Apple lets make the keynote sound good, but don't really spend the time to make it work right, feature that Cook is so known for. Let the masses rejoice.

 

[Mojohanna32]

You sure it is not FDA clearance but FDA approval? Huge difference there

Actually, there is not huge difference. FDA does not technically "approve" devices. It reviews them and provides an ok to market the device based on comparisons to predicate devices.
Devices are handled under a different set of rules than drugs.

 

[reig3]

Correctomundo.

I work up last year with two alerts that I had an abnormal rhythm... prob a dream or something.

Sleep apnea perhaps?

 

[BuddyTronic]

So just call it a gimmick, and you're good? If you're sick with COVID, and worried about your breathing, I could see O2 Sats monitoring as a medical feature. Jus' sayin'.

Well, I hear what you are saying, but if you play through the alternative, what would you post be sayin' ?

Let's look at it. Let us say that Apple makes an application to some government health authorities, maybe it gets passed by FDA, and then Canada and Europe has to wait for 2 years maybe while they copycat and do the usual bureaucratic stuff? Look at what happened with ECG functions. Canada and other countries had to wait for invevitable approvals. Why wait? Best to call it a toy, even if it saves our lives is my opinion.

My mentor told me many times - "Don't let facts get in the way of the truth"

 

[msackey]

For people who don't know about FDA regulations, this could read like Apple is being sly, skirting regulatory approval or somehow gaming the system.

Actually, this is working as intended. Prior to FDA creating guidance for 'general wellness products', such items like the Watch oximeter would have had to go through a different regulatory process. With the rise of general 'general wellness' products like Fitbit, heart rate monitors, and fitness oximeters, FDA created a different regulatory pathway in which they are basically saying that these items, if it meets the criteria for 'general wellness', then would not be considered "devices" (which has specific regulatory meaning) and will not need to go through the the typical medical device regulatory clearance or regulatory approval pathways. (FDA clearance and FDA approval mean different things.)

The FDA guidance on 'general wellness' products indicate that if the item is: " 'for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition' [then it] is not a device under section 201(h) of the FD&C Act."

For a start, here's the FDA guidance:

General Wellness: Policy for Low Risk Devices - Guidance

This guidance provides clarity on FDA's compliance policy for low risk products that promote a healthy lifestyle (general wellness products).

www.fda.gov

FDA regulations on devices is quite complicated. There's even guidance that basically indicates even though some products would meet the definition of 'device', that for certain products FDA would exercise discretion and NOT review those low-risk items.

Also, someone was considering that perhaps because another company that makes oximeter got the go-ahead without FDA approval that that applied to other companies also making oximeters. I don't think that's the case. Each product is examined separately.

 

[BuddyTronic]

The ECG physically can't diagnose heart attacks because you're not getting a full picture. Take a look at this 12-lead of a STEMI

This guy is having an anterior and probably inferior STEMI based on leads V1-V5 as well is II/III/AVF. But lead I, which is equivalent to the lead your Apple watch checks, is pretty much normal. The Apple watch would have totally missed it, which is why they warn you every time that it cannot diagnose a heart attack.

It is useful for detecting afib, since that shows up in all leads. And it could probably also be useful for detecting things like heart block or QT prolongation and various other arrhythmias, but Apple decided to focus on afib.

Cool stuff - and yeah, it cannot do this or that right now maybe. Current best practices medical techniques are better. Better is the enemy of good they say. But who knows where things may go in the future. This is a start - a wonderful start for convenient and non-invasive quantitative health data measurement. If they release it in the Apple Toy product and do not over-reach, even the toy grade medical devices are going to catch some problems and hopefully do not give too many false positives that would over burden the health care system. Technology is like that. Maybe it's feasible to have several Apple devices. One on the ankle and two apple watches, one on each wrist - now you have a 3-lead ECG possibly - maybe one that the general public does not want, but the potential is there.

Apple is sneaking the health functions into the product. They want you to buy the Apple Watch because it has many other interesting and useful features - cellular, Siri Texting, Apple Pay, and many other "at a glance" features. The toy grade health monitoring features are sneakily thrown in there. . It's seeming like the Apple Watch is the very best health monitoring device, but part of the genius of the product is that every user gets every feature built-in. I'm trying to say that Apple knows the importance of "health" very well. But the Apple Watch is so good and so interesting, we are going to have people buying the same device but maybe for different reasons. Very clever strategy by Apple. It's big stuff I think!

 

[Deinocheirus]

What a cagey headline. It should be: Why Apple couldn't get, so they didn't seek, FDA approval for BO2 feature. Because it's not medically accurate. Unlike the ECG feature.

Unfortunately, I think that really downgrades the feature. Apple has been very careful about adding only top quality health features to Apple Watch, and avoiding gimmicks...to this point. The BO2 feature is very likely a health gimmick to sell Series 6 models (considering there is virtually nothing else new to sell it on).

 

[Bart1230]

if 100% oxygen in blood - it means 100% oxygen and 0% blood = you are DEAD

 

[joey_bigpuss]

It doesn't have to be 100% accurate, but absolutely should/must be consistent. Doesn't matter what my 'normal' is as long as I can trust the deviation number. Sounds like the Watch version is neither accurate NOR consistent. So... why bother?

Personally I have thus far been using the Apple Watch and my finger tip blood oximeter reader, my results are consistent between both devices. If this is not the case for others I can still see the benefit in having a measurement that could at least identify a significant drop in blood oxygen levels.

 

[zenkikid]

IMO with the direction Apple is going with the watch its only a matter of time before theyre FSA Eligible.

 

[deeddawg]

if 100% oxygen in blood - it means 100% oxygen and 0% blood = you are DEAD

 

[123]

the monitor does not read above 100%, so if you're reading at 100%, are you really 100? or are you 101? 103? Hence, keep it at 99%

What?

 

[Tech198]

"If a pulse oximeter is marketed as being for general wellness or fun rather than for a medical purpose, FDA documentation is not required."

Sounds like a loophole. Because testing for it serves the same purpose... It sill depends on weather Apple marked it or not

You could say the same about ECG... couldn't you? It's only well-being until it turns to 'bad'

 

[K4VKS]

IMO with the direction Apple is going with the watch its only a matter of time before theyre FSA Eligible.

That's a good point. Wishful thinking, but I still hope to see it happen.

 

[liberte1776]

The feature is not ready for prime time. 😤