Laminaria - Is a Biocompatibility Study Required?

sherley13

Involved In Discussions
#1
Laminaria it is Ocean Kelp dried and cut to 60mm size and classified by mm thickness size. It is a natural product of vegetable origin. Being a Class 2 Device by FDA and by Medical Device Directives of the European Union, we are required to study the BIOCOMPATIBILITY when it remains inserted in the female cervix for 12-24 hrs to dilate the cervix for carrying out examination of the uterus.

DOES THIS PRODUCT NEED FOR BIO COMPATIBILITY STUDY ????

IF ANY ARTICLES ON LAMINARIA BIOCOMPATIBILITY STUDY OR GUIDELINES OR PROCEDURE AVAILABLE ON THIS PLEASE SHARE WITH ME.

Regards,
Sherley13
 
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Ronen E

Problem Solver
Staff member
Moderator
#3
Laminaria it is Ocean Kelp dried and cut to 60mm size and classified by mm thickness size. It is a natural product of vegetable origin. Being a Class 2 Device by FDA and by Medical Device Directives of the European Union, we are required to study the BIOCOMPATIBILITY when it remains inserted in the female cervix for 12-24 hrs to dilate the cervix for carrying out examination of the uterus.

DOES THIS PRODUCT NEED FOR BIO COMPATIBILITY STUDY ????

IF ANY ARTICLES ON LAMINARIA BIOCOMPATIBILITY STUDY OR GUIDELINES OR PROCEDURE AVAILABLE ON THIS PLEASE SHARE WITH ME.

Regards,
Sherley13
Hi,

It falls under ProCode HDY.

If you look at 510k summaries, such as this one, you will see that biocompatibility information is definitely required.

Cheers,
Ronen,
 

rangani_rj

Involved In Discussions
#4
Hi,

Any medical devices, sterile or non-sterile that come into contact with the human body directly or indirectly will require biocompatibility testings.

As Laminaria comes into contact with mucosal membrane of cervix, it will require Biocompatibility testings according to ISO 10993, acceptable in EU and US.

Find attachment of Reference guidance document by FDA for Use of International Standard ISO- 110993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"

simple biocompatibility chart is available here
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080735.htm


For your device, according to 10993-1 and as given on FDA website, surface device coming into contact with mucosal membrane will require three testings 1) Cytotoxicity, 2) Sensitization and 3) Irritation or Intracutaneous reactivity

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080742.htm

Ensure that Laminaria is used for less than 24 hrs. If its used more than this period it will need extra biocompatibility testings as mentioned in table.
 

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milagre

#5
Ensure that Laminaria is used for less than 24 hrs. If its used more than this period it will need extra biocompatibility testings as mentioned in table.
For compliance with ISO 10993-1, I don't think there are any additional tests for greater than 24h of mucosal membrane exposure. The additional tests only come when you reach Class C (>30 days).

However, per this table (https://www.namsa.com/Portals/0/Documents/biocompatibility-matrix.pdf) there may be additional tests required in the U.S. for Class B devices with mucosal contact. I am not familiar with those requirements though.
 

rangani_rj

Involved In Discussions
#6
Hi Milagre,

A, B, C are not any device classes here (further, US classifies devices in class I, II, III) ,

A, B, C are indicating contact duration for devices with body tissues irrespective class

CONTACT DURATION
A = Limited (<_ 24 Hours)
B = Prolonged (24 Hours - 30 Days)
C = Permanent (>30 Days)

In simple word, if your device (irrespective of class) is coming in contact with body for prolonged period it will have more chances of altering body tissues and so you will need more testings.

Cheers,
:bigwave:
 
M

milagre

#7
Right. Sorry for the confusion. I guess "class" isn't a flexible term. I meant contact duration.
 
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