SBS - The Best Value in QMS software

Is 510k Required for Adding a section on use of Disinfectants to Product Manual?

M

missjenny

#1
Is 510k Required for Adding Disinfectants to Manual?

We are a small medical device manufacturer of an existing 510(k) listed in vitro device (OTC). As you can infer from the subject line, we would like to inquire whether 510(k) submission is necessary if we are merely adding a disinfectant to our product manual for cleaning & disinfection for lay-users. We have already validated the use of the to be added disinfectant to ensure that it is effective against relevant viruses and that the use of the disinfectant over the course of its lifespan does not physically deteriorate the device in accordance with FDA suggestions. This is an EPA-registered disinfectant and is in competitor product manuals.

Assuming that we have, in fact, done what is necessary as far as validating the disinfectant procedure, would this normally require a 510(k) submission or could we stop at documenting the changes and the rationale for it?

Thank you in advance!! :bigwave:

---------------------------------------

Additional Information per ascherp below:
We had validated Clorox Germicidal Wipes with 0.55% sodium hypochlorite as active ingredient for disinfecting our device. The information of the disinfectant, including how to purchase it and use it, was included in our manual. The disinfectant procedure would not change except for the fact we would like to add PDI Super Sani-Cloth, CaviWipes 1, and Dispatch with bleach to the manual, which we have validated already. The method of using it and cleaning and disinfecting our device would be the same.
 
Last edited:
Elsmar Forum Sponsor
A

ascherp

#2
Re: Is 510k Required for Adding Disinfectants to Manual?

What do the cleaning and disinfection instructions that were included in your submission prescribe? Has the procedure changed or have you added an additional disinfectant with similar disinfection properties (low, medium, or high level) as the one in the submission?

Please provide more information.
 
M

missjenny

#3
Re: Is 510k Required for Adding Disinfectants to Manual?

We had validated Clorox Germicidal Wipes with 0.55% sodium hypochlorite as active ingredient for disinfecting our device. The information of the disinfectant, including how to purchase it and use it, was included in our manual. The disinfectant procedure would not change except for the fact we would like to add PDI Super Sani-Cloth, CaviWipes 1, and Dispatch with bleach to the manual, which we have validated already. The method of using it and cleaning and disinfecting our device would be the same.
 
A

ascherp

#4
I am not familiar with your specific products, but you need to answer at least the following basic questions:
  1. Is the level of disinfection offered by your newly validated products the same as that of the Clorox Germicidal Wipes? Were the acceptance criteria for your validation of the new products identical to the acceptance criteria for your validation of the Clorox Wipes?
  2. Does the change impact on performance specifications of your device? For instance, do the chemical components of the new products affect the surface of your device or could they potentially cause it any damage?
If your answer to 1 is yes and that to 2 is no, my guess would be that you probably don't need a new 510(k). But be sure to evaluate it yourself in detail as described in the guidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device" and document your decision process well. And don't forget to update your design history file!
 
Thread starter Similar threads Forum Replies Date
S Examples of software changes that required a 510k US Food and Drug Administration (FDA) 2
S IEC 62133 - CB Scheme Required by FDA 510k Other Medical Device Related Standards 3
P Is a different 510k is required for each (stand alone) software configurations? Other US Medical Device Regulations 3
N Is a new 510K required for change of manufacturing location for an existing device? US Food and Drug Administration (FDA) 1
W New 510k required for a material change? Other US Medical Device Regulations 9
G Is a 510K required for a Home Use Class I Exempt Medical Device? US Food and Drug Administration (FDA) 4
N Traditional 510K Submission-Financial Certification or Disclosure Statement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
P Letter to file or special 510k or traditional 510k 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Y 510k requirement for bringing in gloves Medical Device and FDA Regulations and Standards News 0
G Special 510K possible? Only the packaging has changed Other US Medical Device Regulations 0
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
H 510k with Contract Manufacturer Other US Medical Device Regulations 2
K FDA 510k electrosurgery 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
J Leveraging FDA 510k Clearance for International Registrations Other Medical Device Regulations World-Wide 2
K 510K new manufacturer but same components Other US Medical Device Regulations 6
S Two or more predicates suitable? 510K submission US Food and Drug Administration (FDA) 5
S 510k: What to include if your own device is the predicate US Food and Drug Administration (FDA) 5
L 510K - Trade Name Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Ed Panek Adverse Event Clinical Trial using a 510K approved Device Other US Medical Device Regulations 6
R Countries that accept 510k approvals - Class II nonsterile medical device Other Medical Device Regulations World-Wide 2
M Timing of 510k submission Other US Medical Device Regulations 9
D 510K and Changes to Verification and Validation US Food and Drug Administration (FDA) 2
Ronen E Can anyone please explain this? (510k submission requirement) Other US Medical Device Regulations 14
H New 510K VS Documents about design change. Other US Medical Device Regulations 2
P Medical Device not on commercial distribution but installed in the establishment. 510k? Other US Medical Device Regulations 10
V Presubmission FDA for 510k US Food and Drug Administration (FDA) 4
A How to deal with changed shared components in 510k 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Can we take a part from 510k cleared medical device and use it in class I device? Other US Medical Device Regulations 3
D Contents of a 510k Q submission Other US Medical Device Regulations 1
L Class IIa Medical Device, CE Mark & 510k - Labeling Content CE Marking (Conformité Européene) / CB Scheme 4
Ed Panek Other company wants to use our FDA 510K bundled with their product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
L 510k exemption process - Do you still need to submit technical dossier? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S The key differences in 510k types - Traditional vs. Abbreviated vs. Special US Food and Drug Administration (FDA) 0
P V&V for Special 510k 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Clarity on requirements for a 510k exempt Class I device - Suture removal kit US Food and Drug Administration (FDA) 9
T Is 510k Anesthesia group particularly picky/difficult to work with during 510k? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
J 510k - Product shelf life validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K 510K statement Questions 21 CFR 807.93 - Discontinued or never released for sale US Food and Drug Administration (FDA) 0
J Applying for 510K - What is a significant process change and what is not US Food and Drug Administration (FDA) 5
K 510K Interactive Review 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
I Celsius and Fahrenheit in 510k US Food and Drug Administration (FDA) 4
R FDA 510K - Does the FDA accept the testing report from other countries? Other US Medical Device Regulations 1
I 510k Performance Testing Studies (Raw Data) - What does the FDA expect 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
K ISO 10993 Requirements For 510k - Substantial Equivalence Other US Medical Device Regulations 11
P Two separate 510k submissions for one device from the same company Other US Medical Device Regulations 10
I Special 510k Imported Legacy Blogs 0
K 510k "Premarket" Submission for Existing Class II Software Medical Device US Food and Drug Administration (FDA) 3
Q 510k Submission for a New Medical Device Product Other US Medical Device Regulations 3
M What if information in predicate 510k is obviously wrong? Other US Medical Device Regulations 5
E 'Special' 510k as a Predicate Medical Device? Other US Medical Device Regulations 3

Similar threads

Top Bottom