To 510(k) or not 510(k), that is the question!

QA-Man

Involved In Discussions
#1
A company I occasionally work with has a line of 510(k) cleared syringes and wants to market it as the perfect size for use with a specific drug.

This is just a normal piston syringe (not prefilled, insulin, or tuberculin). The cleared intended use is "intended to be used for medical purposes to inject fluids into or withdraw fluids from the body".

The company has some concern about marketing it as being the ideal size for a particular drug. I don't see it as a problem but I am not very conservative and would like to get some other points of view.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Are any specific claims planned on why this is the "ideal size for drug X"?

Other than that, I think that (fluid) drug injection falls under "inject fluids into the body".
 

QA-Man

Involved In Discussions
#3
No. The drug is always given at that dose so we just want to say that it is the ideal size. Nothing more than that.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
No. The drug is always given at that dose so we just want to say that it is the ideal size. Nothing more than that.
Then it's the right size. "Ideal" sounds a little like marketspeak and maybe a little misleading from a regulatory point of view. Just maybe.
 

Statistical Steven

Statistician
Staff member
Super Moderator
#5
Unless you did bio compatibility studies showing that their syringe is safe with drug X you cannot claim their syringe is the perfect, ideal, right or can be used with a specific drug. All you can claim is that it is cleared for dispensing or withdrawing fluids. The drug manufacturer then shows their drug can be dispensed in syringes made of certain materials. But as a device manufacturer you cannot claim use with a drug specifically (becomes a combination product), even though sold separately.


A company I occasionally work with has a line of 510(k) cleared syringes and wants to market it as the perfect size for use with a specific drug.

This is just a normal piston syringe (not prefilled, insulin, or tuberculin). The cleared intended use is "intended to be used for medical purposes to inject fluids into or withdraw fluids from the body".

The company has some concern about marketing it as being the ideal size for a particular drug. I don't see it as a problem but I am not very conservative and would like to get some other points of view.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Unless you did bio compatibility studies showing that their syringe is safe with drug X you cannot claim their syringe is the perfect, ideal, right or can be used with a specific drug. All you can claim is that it is cleared for dispensing or withdrawing fluids. The drug manufacturer then shows their drug can be dispensed in syringes made of certain materials. But as a device manufacturer you cannot claim use with a drug specifically (becomes a combination product), even though sold separately.
Claiming that a specific syringe is compatible with a specific drug does not make it a combination device.

Further, such compatibility is established by drug compatibility testing (not biocompatibility testing) which can be done by the syringe manufacturer, not necessarily by the drug manufacturer. I once worked for a disposable (plastic) devices manufacturer that did drug compatibility testing in order to support such claims. Some of the drugs were somewhat difficult to obtain for testing, but other than that it was a straightforward bench verification. Such compatibility testing has two aspects - one being that the device is not adversely affected by the drug, and the other that the drug is not adversely affected by the device materials. The first aspect should be straightforward for the device manufacturer to handle. The other might be difficult. What we did was rely on the theoretical inertness of the device materials and ensure that the drug didn't include any ingredients that are prone to react with the device materials (solvents, ESC agents etc.). It's also important to note that the risk is attenuated due to the fact that it isn't a combination device, and the drug doesn't spend a long time (perhaps under varying conditions) in contact with the device's materials. Drug/device exposure is only transient. I believe that this is also the case for the OP.

Regarding the OP's claim, they didn't suggest that the syringe is "ideal" (or right) for the drug, per-se; they only intended to make a claim regarding the suitability of its size. This has almost nothing to do with chemical compatibility.
 

Statistical Steven

Statistician
Staff member
Super Moderator
#8
Thank you Ronen! I misunderstood the questiom. If you want to make a claim that this syringe can be used with Drug X, you have to do the testing you specified, which few device companies are equipped to do on the impact on the drug side. From my understanding, if the drug is dosed in 10 ml dose, and your syringe is a 10 ml syringe, you can claim it is the best syringe for 10 ml dosage, but cannot claim your syringe is the best syringe for a 10 ml dose of Drug X unless you do testing to show you dose the full dosage with minimal dead space or other criteria that makes it the ideal or best. But you are correct, it becomes a marketing issue at that point.

Claiming that a specific syringe is compatible with a specific drug does not make it a combination device.

Further, such compatibility is established by drug compatibility testing (not biocompatibility testing) which can be done by the syringe manufacturer, not necessarily by the drug manufacturer. I once worked for a disposable (plastic) devices manufacturer that did drug compatibility testing in order to support such claims. Some of the drugs were somewhat difficult to obtain for testing, but other than that it was a straightforward bench verification. Such compatibility testing has two aspects - one being that the device is not adversely affected by the drug, and the other that the drug is not adversely affected by the device materials. The first aspect should be straightforward for the device manufacturer to handle. The other might be difficult. What we did was rely on the theoretical inertness of the device materials and ensure that the drug didn't include any ingredients that are prone to react with the device materials (solvents, ESC agents etc.). It's also important to note that the risk is attenuated due to the fact that it isn't a combination device, and the drug doesn't spend a long time (perhaps under varying conditions) in contact with the device's materials. Drug/device exposure is only transient. I believe that this is also the case for the OP.

Regarding the OP's claim, they didn't suggest that the syringe is "ideal" (or right) for the drug, per-se; they only intended to make a claim regarding the suitability of its size. This has almost nothing to do with chemical compatibility.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
That's why claims such as "best for" or "ideal for" are problematic on the regulatory side (alas, loved by marketing people...). I think "right size for" is quite safe. Dead space considerations are well-known to practitioners and the issues are common to most mainstream syringes. Dedicated designs to eliminate dead space are possible, but those will normally only be used in applications where dosage is very small and accuracy is critical (in which cases practitioners will be very aware of it anyway). To be on the safe side, relevant guidance can be provided in the labeling. On a more general approach, such issues are to be considered and addressed as necessary in the risk management process.

Compatibility aspects on the drug side can usually be addressed by selecting generally inert materials for the syringe (or other device), eg glass, PP etc. In most cases there's enough accumulated experience to establish a material range that is compatible with the majority of drugs. This is what enables generic claims such as "suitable for injection of fluids into the human body", without addressing each and every conceivable drug that might come within this scope.
 
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