Laminaria - Is a Biocompatibility Study Required?

S

sherley13

Involved In Discussions
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
 
Ronen E

Ronen E

Problem Solver
Moderator
sherley13 said:
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
Click to expand...

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,
 
R

rangani_rj

Involved In Discussions
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.
 

Attachments

  • ISO-10993, Biological Evaluation of Medical Devices Part 1 114 Evaluation and Testing..pdf
    522.4 KB · Views: 251
  • is.en.iso.10993.jpg
    is.en.iso.10993.jpg
    216.7 KB · Views: 848
M

milagre

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.
Click to expand...

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.
 
R

rangani_rj

Involved In Discussions
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

Right. Sorry for the confusion. I guess "class" isn't a flexible term. I meant contact duration.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S Laminaria - Biocompatibility Study? Imported Legacy Blogs 1
S Laminaria Stick (Cervical Dilator) - Biocompatibility Test required? ISO 13485:2016 - Medical Device Quality Management Systems 1
A New biocompatibility testing? US Medical Device Regulations 1
A Biocompatibility Exemption Rationale Other Medical Device Related Standards 2
Dirk S 1.5x instead of 2x EtO Sterilization Cycles on Biocompatibility Other Medical Device Related Standards 2
P Biocompatibility testing ISO-10993 for FDA submission Other Medical Device Related Standards 7
A Biocompatibility: Selection of worst-case device Medical Device and FDA Regulations and Standards News 2
Judy Abbott Biocompatibility requirements for submission to Chile Other Medical Device Related Standards 1
J Biocompatibility for endoscope external handle/grip US Food and Drug Administration (FDA) 3
S Validity of biocompatibility reports ISO 13485:2016 - Medical Device Quality Management Systems 4
O ISO10993 - Biocompatibility in medical vacuum systems (vacuum pumps) Medical Device and FDA Regulations and Standards News 2
E Biocompatibility testing of our applied part seems redundant Other Medical Device Related Standards 2
S Biocompatibility requirement for electrode adapters Other Medical Device Related Standards 1
S ASTM F86 x Biocompatibility Issues Medical Device and FDA Regulations and Standards News 1
Judy Abbott The impact of laser power on biocompatibility of the products Manufacturing and Related Processes 6
Watchcat Summary of De Novo Biocompatibility Information, 2015-2018 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
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
F Biocompatibility evaluation for Hardware/Interface Components? Other Medical Device Related Standards 13
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
Beliz Biocompatibility Testing for Laser Epilation Device EU Medical Device Regulations 2
L FDA Biocompatibility Requirements - Transitory Contact Other US Medical Device Regulations 1
K Biocompatibility Testing - Multile products of different sizes and shapes US Food and Drug Administration (FDA) 2
K Biocompatibility evaluation of gas pathways Medical Device and FDA Regulations and Standards News 5
K Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1 Manufacturing and Related Processes 7
Judy Abbott Activation of complement at 90 min - BSI requested for justifications to support the biocompatibility of the device EU Medical Device Regulations 2
Judy Abbott Can any one help me with an urgent BIOCOMPATIBILITY Impact assessment? Internal Auditing 9
S ISO 10993 Biocompatibility Evaluation - Electronic thermometer Other Medical Device Related Standards 3
shimonv Referring to previously submitted biocompatibility results in a new 510(k) submission Other US Medical Device Regulations 1
I ISO 10993 Biocompatibility Requirements - manufacturing process chemicals Other Medical Device Related Standards 8
R 510(k) Biocompatibility vs Cleaning Validation Other Medical Device Related Standards 4
K Biocompatibility classification for Lancet CE Marking (Conformité Européene) / CB Scheme 7
F Sample Size for Biocompatibility Tests Other Medical Device Related Standards 4
F Biocompatibility Device Categorization: Priming with Blood Other Medical Device Related Standards 1
W Biocompatibility Risk Analysis for Clinical Practitioner 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
F Biocompatibility on aged devices Other Medical Device Related Standards 4
Gamula Biocompatibility GLP conform tests outside China China Medical Device Regulations 1
K Biocompatibility Testing - Component Level or Assembled Medical Device? ISO 13485:2016 - Medical Device Quality Management Systems 7
H Biocompatibility Impact on Autoclaved Silicone Other Medical Device Related Standards 3
D Should Biocompatibility Tests be performed on Production Samples? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
R What is the expectation for Biocompatibility Testing when switching Suppliers? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
C Biocompatibility Test for a Non Contact Medical Device US Food and Drug Administration (FDA) 11
R Biocompatibility - ISO 10993 and SVHC Requirements Other Medical Device Related Standards 4
planB Biocompatibility: Blue Book Memorandum #G95-1 superseded by new FDA guidance Other Medical Device Related Standards 1
S ISO 10993-1: External Communicating Device biocompatibility test requirements Other ISO and International Standards and European Regulations 4
M Biocompatibility - why are animal studies necessary? Other Medical Device and Orthopedic Related Topics 11
R Biocompatibility Test of Blue Gown vs Blue Drape 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R FDA Biocompatibility questions for Surgical Gown 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Biocompatibility requirements for a Class IIa medical device CE Marking (Conformité Européene) / CB Scheme 7

Similar threads

Top Bottom