Let's play... Classify My Medical Device!!!

What is the medical device classification?

  • Class I (non-measuring)

    Votes: 2 20.0%
  • Class IIa

    Votes: 5 50.0%
  • Class IIb

    Votes: 3 30.0%

  • Total voters
    10
  • Poll closed .
W

wking

#1
OK, ladies and gentleman, we've got a range of opinions on this one from our notified body, our distributor, and ourselves ranging from Class I (non-measuring), to Class IIa, and to Class IIb. What say you? Here is the device intended use:
DEVICE is intended to acquire, store, analyze, and report on ECG data collected from infants. DEVICE is intended to be used by trained operators under the direct supervision of a licensed health care practitioner in a hospital neonatal or pediatric ICU environment.

DEVICE is intended to be used for the analysis of the variability in RR Intervals (heart rate) and to report measurements of the variability of heart rate data (HRV). The HRV measurements reported by DEVICE are specialized in nature, and intended to identify periods of transient decelerations and/or reduced baseline variability in the heart rate.

DEVICE is intended to provide specialized HRV measurements and may detect arrhythmias, that when combined with other risk factors, can be used as an aid in assessing the risk of sepsis in infants. The use of the DEVICE monitoring improves survival in very low birth weight neonates.

DEVICE acquires data from a user-supplied ECG monitor, and requires a user-supplied local area network.

Installation, training, maintenance and support are to be performed by MANUFACTURER employees or contractors who have been certified by MANUFACTURER as qualified to perform such duties.

This case for Class I:
Rule 12 is the default for an Active Device for Diagnosis which does not fit into Rule 10. Page 45 of MedDEV 2.4/1 lists thermography, an active device for diagnosis, as Class I by Rule 12. On page 42, an electronic thermometer is listed as IIa under Rule 10 because it allows "direct diagnosis or monitoring of vital physiological processes".

[FONT=&quot]thermography [/FONT]
[FONT=&quot]a technique wherein an infrared camera photographically portrays the body's surface temperature, based on self-emanating infrared radiations; used as a diagnostic aid in the detection of breast tumors and the assessment of rheumatic joints; also used in the study of pain.
[/FONT]
[FONT=&quot]Miller-Keane Encyclopedia and Dictionary of Medicine, Nursing, and Allied Health, Seventh Edition[/FONT]

Hence, thermography must be not providing *direct* diagnosis, but rather indirect diagnosis (of breast cancer, for instance).

Further, thermography must be not monitoring a "vital physiological process", even though it is looking at patterns in body temperature (Note 1 on page 43 lists "body temperature as a vital physiological process".)

Similar to thermography, heart rate variability analysis is looking at the *patterns of* a vital sign in order to provide a risk assessment of sepsis, but not a direct diagnosis.

Hence, the device is Class I.


The Case for Class IIa:
By rule 10, we've got an Active Device for Diagnosis, but one where the nature of the variations is such that it could NOT result in *immediate* danger to the patient.

In the context of a Neonatal Intensive Care Unit, where babies stop breathing routinely and must be revived before they suffer results of hypoxia, harboring a case of sepsis that brews over days does not require *immediate* intervention.

Hence IIa.


The Case for IIb:
By rule 10, we've got an Active Device for Diagnosis where the nature of the variations DOES result in *immediate* danger to the patient. Sepsis is dangerous and it needs to be treated ASAP.

Hence IIb.


***
Looking forward to your opinions!
 
Last edited by a moderator:
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S

Sarah Stec

#2
Re: Let's play... Classify My Device!!!

As a last resort, you could ask the competent authority, or have your notified body ask the competent authority. :bigwave:
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
Re: Let's play... Classify My Device!!!

True, but often getting feedback from others helps. Many times one asks "the competent authority" and one person there says one thing and another says another. Discussions here can help in understanding the different requirements so that when one speaks with someone at "the competent authority" one is as informed as possible.

To me it's sort of like calling the IRS (in the US) about a tax issue. You can speak with several different people and each often has a different "slant" on the interpretation of the rules. The more one knows about the rules, the better one can assess the differences between conflicting advice from different people in "the competent authority" when it occurs.

I would offer my opinion on this specific poll but its outside my field of expertise.
 
#4
My vote is Class IIa.

By using rule 10.
- Active device
- intended to ....monitor vital physiological process

The bit about "immediate danger" is, in my opinion, referring to cardiac arrest VF / loss of breathing etc.

But, having said that, it may not be important anyway. Depending upon your route to the CE mark (that is, which annex are you using to get approval) the difference between IIa and IIb can be minimal. If you are using Annex II (full QA) then compare paragraphs 7.2 and 7.3 - there is very little practical difference.

Getting the opinion of others can be helpful but it is your Notified Body that matters. If I remember correctly there is a committee of NBs to decide on controversial / borderline cases. If you can wait that long!
 
P

phloQS

#6
Also agree with pads38! The intend of use does not specify, that the diagnosis is used to gain information as to used for immediate treatment or something like that. For me it looks like longterm diagnosis to gain information on success of therapy or something like that. Mabe you can expand something like that in the intend of use, so you directly exclude "immediate danger".

Regards

phloQS
 

Marcelo

Inactive Registered Visitor
#7
The main rationale is on note 1 from Rule 10 on the MEDDEV:

Medical devices intended to be used for continuous surveillance of vital physiological processes in anaesthesia, intensive care or emergency care are in Class IIb, whilst medical devices intended to be used to obtain readings of vital physiological signals in routine check ups and in self-monitoring are in Class IIa.
 
Last edited:
W

wking

#8
You make an excellent point. However, let's go back to Rule 10 in the MDD. I believe the distinction between IIa and IIb lies in the word *immediate* in the following:

Active devices intended for diagnosis are in Class IIa:
...
– if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of CNS in which case they are in Class IIb.
So, I *believe* that the explanation of the rule in MEDDEV is based on the fact that anesthesia, intensive care, and emergency care environments nearly universally involve immediate threats to the patient, whereas routine checkups do not.

So, is the distinction between IIa and IIb based solely on the environment (ICU vs doctor's office), or is it based on the immediacy of the threat to the patient?

I would think the *intention* of the rule is the latter, but that 99% of the time, the latter and the former are the same. So that in *general*, we can use the environment to distinguish between IIa and IIb, but there are in fact some situations where it doesn't work.

Thoughts on that?

Moving further, I'm really curious as to why no one has voted for Class I. I can't see any reason why the MEDDEV would have explicitly listed thermography as a Class I by Rule 12 (while leaving temperature as a Class IIa/b (depending on environment) by Rule 10) that does not correspond to Heart Rate Variability as a Class I (while Heart Rate is a Class IIa/b).

What am I missing?


Thanks to everyone who has voted and weighed in. I think this is a really interesting topic-- I hope you do as well!
 

Marcelo

Inactive Registered Visitor
#9
I would think the *intention* of the rule is the latter, but that 99% of the time, the latter and the former are the same. So that in *general*, we can use the environment to distinguish between IIa and IIb, but there are in fact some situations where it doesn't work.
Agreed. The official distinction is on immediacy because that´s what written on the directive.

The note on the MEDDEV is guidance, however, I think the original rationale is exactly as you said.

Anyway, the way you describe your device, it seems to fit into the official and into the note as being class IIb.
 

Miner

Forum Moderator
Staff member
Admin
#10
One distinction that I see is that the thermometer is directly measuring temperature, a parameter considered a "vital physiological process". No interpretation is necessary. Thermography does not directly measure a vital physiological process. It measures indirect parameters, which then must be interpreted to make a diagnosis.

Your product is directly measuring heart rate, a vital physiological process. I believe this would move it into the Class II product. Now a classification must be made as to whether it is IIa or IIb.

Is the diagnosis of sepsis the only use to which this device will be applied? Or might it be used for situations that are clearly "immediate"?
 
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