Contains Nonbinding Recommendations 
 
 
Non-Clinical Performance Assessment 
of Tissue Containment Systems Used 
During Power Morcellation 
Procedures  
 
______________________________________________________________________________
Guidance for Industry and
 
Food and Drug Administration Staff 
 
Document issued on May 26, 2023. 
 
The draft of this document was issued on June 21, 2022. 
 
For questions about this document, contact the Office of Science and Engineering Laboratories 
(OSEL), at (301) 796-2530 or by email at OSEL_CDRH@fda.hhs.gov, or the Office of Science 
and Engineering Laboratories, Division of Applied Mechanics at (301) 796-2501, or Prasanna 
Hariharan, Ph.D. at (301) 796-2689 or by email at prasanna.hariharan@fda.hhs.gov.  
 
  
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
   
  Contains Nonbinding Recommendations 
 
 
Preface 
 
 
Public Comment 
 
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852-
1740. Identify all comments with the docket number FDA-2022-D-0737. Comments may not be 
acted upon by the Agency until the document is next revised or updated. 
 
Additional Copies 
 
Additional copies are available from the Internet. You may also send an email request to CDRH-
Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document number 
GUI00019015 and complete title of the guidance in the request. 
 
 
  Contains Nonbinding Recommendations 
 
 
Table of Contents
 
 
I.  Introduction ............................................................................................................................. 1 
II.  Background ............................................................................................................................. 2 
III.  Scope ................................................................................................................................... 3 
IV.  510(k) Submission Recommendations ............................................................................... 4 
  Device Description and Predicate Comparison .................................................................. 5 
  Non-Clinical Performance Testing ..................................................................................... 5 
(1)  Testing to Demonstrate Compliance with Special Controls ......................................... 6 
a.  Final Finished Tissue Containment System Testing ................................................. 7 
i.  Final Finished Tissue Containment System Integrity Testing .............................. 7 
ii.  Final Finished Tissue Containment System Strength Testing .............................. 8 
(a)  Tissue Containment System Pull Force Test......................................................... 8 
(b)  Tissue Containment System Burst Strength Test .................................................. 9 
iii.  Insufflation Pressure Control Testing ................................................................. 10 
iv.  Clinical Simulation Study ................................................................................... 11 
(2)  Additional Testing Recommendations ....................................................................... 13 
a.  Thickness/Material Composition ............................................................................ 13 
b.  Material Permeability Testing ................................................................................. 14 
c.  Mechanical Strength ............................................................................................... 15 
i.  Tensile Strength Testing...................................................................................... 15 
ii.  Puncture Testing .................................................................................................. 16 
iii.  Partial Puncture Followed by Material Permeability Testing ............................. 16 
 
   
  Contains Nonbinding Recommendations 
 
 
Non-Clinical Performance Assessment 
of Tissue Containment Systems Used 
During Power Morcellation 
Procedures 
 
 
Guidance for Industry and 
Food and Drug Administration Staff 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on 
FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
or Office responsible for this guidance as listed on the title page.  
 
 
I.  Introduction 
 
This guidance document provides recommendations that may help manufacturers comply with 
the special controls related to non-clinical performance data for gynecologic and general 
laparoscopic power morcellation containment systems (tissue containment systems). Tissue 
containment systems are used to enable isolation and containment of tissue during a power 
morcellation procedure performed following a laparoscopic procedure for the excision of benign 
tissue that is not suspected to contain malignancy. These devices are class II (special controls) 
and subject to premarket notification (510(k)) requirements. Throughout this guidance, the terms 
FDA, the Agency, we, and us refer to the Food and Drug Administration and the terms 
you and yours refer to medical device manufacturers. 
 
For the current edition of the FDA-recognized consensus standard(s) referenced in this 
document, see the FDA Recognized Consensus Standards Database.1 For more information 
regarding use of consensus standards in regulatory submissions, please refer to the FDA 
guidance titled Appropriate Use of Voluntary Consensus Standards in Premarket Submissions 
for Medical Devices.2  
 
 
1 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.  
2 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices. 
1  Contains Nonbinding Recommendations 
 
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited. The use of 
the word should in Agency guidances means that something is suggested or recommended, but 
not required. 
 
II.  Background 
Laparoscopic power morcellators (LPMs)3 have been associated with the spread of tissue. There 
is a risk of spreading unsuspected cancerous tissue beyond the uterus when LPMs are used 
during gynecologic surgeries intended to treat benign fibroids. Unsuspected cancerous tissue 
may also be spread in the abdomen during use of a LPM during general surgical procedures. This 
may have a negative impact on survival.4 In addition, there is a risk of spreading benign uterine 
tissue beyond the uterus that may result in additional surgery due to symptoms such as 
abdominal pain and distension which are related to adhesions resulting in response to the 
devitalized tissue.5,6,7 Benign tissue may also be spread in the abdomen during use of a LPM 
during surgical procedures, which can lead to abscess or infection. Tissue containment systems 
used during laparoscopic power morcellation are intended to isolate and contain tissue that is 
considered benign, which may prevent the peritoneal spread of cancerous tissue in cases of an 
occult cancer. While a tissue containment system cannot prevent all cases of tissue spread, as 
some cases may occur without morcellation or due to manipulation of the tissue before it is 
placed into the tissue containment system, it can provide an important mitigation for this risk. 
Tissue containment systems should only be used with compatible LPMs that have received FDA 
marketing authorization. For more information, refer to the FDA guidance document Product 
Labeling for Laparoscopic Power Morcellators.8 
A laparoscopic power morcellation containment system, for gynecologic or general use, is a 
prescription device consisting of an instrument port and tissue containment method that creates a 
working space allowing for direct visualization during a power morcellation procedure following 
 
3 This guidance uses the term laparoscopic power morcellators or LPMs in lieu of laparoscopic 
electromechanical morcellators. FDA believes this terminology is understood and recognized both by clinicians and 
non-clinicians (e.g., American College of Obstetricians and Gynecologists Special Report: Power Morcellation and 
Occult Malignancy in Gynecologic Surgery May 2014, available at: https://www.sgo.org/wp-
content/uploads/2014/04/ACOG_Statement.pdf and Society of Gynecologic Oncology Position Statement: 
Morcellation December 2013, available at: https://www.sgo.org/resources/morcellation/). 
4 https://wayback.archive-
it.org/7993/20170404182209/https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm. 
5 Tan-Kim J, Hartzell KA, Reinsch CS, ODay CH, Kennedy JS, Menefee SA, and Harrison TA. Uterine sarcomas 
and parasitic myomas after laparoscopic hysterectomy with power morcellation. Am J Obstet Gynecol. 2015; 
212:594.e1-10. 
6 Van der Meulen JF, Pijnenborg JMA, Boonuma CM, Verberg MFG, Geomini PMAJ, and Bongers MY. Parasitic 
myoma after laparoscopic morcellation: a systematic review of the literature. BJOG. 2016; 123:69-75. 
7 Lete I, Gonzalez J, Ugarte L, Barbadillo N, Lapuente O, and Alvarez-Sala J. Parasitic leiomyomas: a systematic 
review. Eur J Obstet Gynecol Repro Biol. 2016; 203:250-259. 
8 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/product-labeling-
laparoscopic-power-morcellators. The FDA guidance document Product Labeling for Laparoscopic Power 
Morcellators applies to LPMs with either a general indication or a specific gynecologic indication but not LPMs 
specifically indicated only for non-gynecologic surgery. 
2  Contains Nonbinding Recommendations 
 
 
a laparoscopic procedure for the excision of benign tissue that is not suspected to contain 
malignancy. FDA classified both laparoscopic power morcellation containment systems for 
gynecologic and general uses into class II (special controls), subject to 510(k) requirements, 
under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA 
determined the special controls that are necessary, in conjunction with the general controls of the 
FD&C Act, to provide reasonable assurance of safety and effectiveness for these devices. The 
special controls for laparoscopic power morcellation containment systems for gynecologic and 
general use are codified in 21 CFR 884.4050(b) and 21 CFR 878.4825(b), respectively.  
 
This guidance recommends non-clinical test methods that may help manufacturers meet the non-
clinical performance data requirements identified in the special controls codified in 21 CFR 
884.4050(b)(4) (for gynecologic use) and 21 CFR 878.4825(b)(4) (for general use), and also 
includes other non-clinical testing recommendations to support a 510(k) submission/substantial 
equivalence determination. The recommendations in this guidance are based on FDAs 
experience evaluating the safety and effectiveness of tissue containment systems. However, 
manufacturers may use alternative approaches and provide different documentation so long as 
their approach and documentation satisfy premarket submission requirements in applicable 
statutory provisions and regulations. 
 
For more information about the specific content requirements of and recommendations for a 
510(k) submission, refer to 21 CFR 807.87 and FDAs guidance document, Format for 
Traditional and Abbreviated 510(k)s.9 
 
III.  Scope 
 
The scope of this guidance document is limited to the tissue containment systems used during a 
power morcellation procedure for gynecologic use (product code PMU) classified under 21 CFR 
884.4050 and for general use (product code PZQ) classified under 21 CFR 878.4825.  
 
The guidance document provides recommendations on (1) test methods, (2) test parameters, and 
(3) test acceptance criteria to support a 510(k) submission/substantial equivalence determination 
and demonstrate compliance with the special controls requiring non-clinical performance data 
identified in 21 CFR 884.4050(b)(4) and 21 CFR 878.4825(b)(4): 
  
21 CFR 884.4050(b)(4) states (for gynecologic use):  
 
Non-clinical performance data must demonstrate that the device meets all design 
specifications and performance requirements. The following performance characteristics 
must be tested: 
 
(i) Demonstration of the device impermeability to tissue, cells, and fluids; 
 
 
9 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditional-and-
abbreviated-510ks. 
3  Contains Nonbinding Recommendations 
 
 
(ii) Demonstration that the device allows for the insertion and withdrawal of 
laparoscopic instruments while maintaining pneumoperitoneum; 
 
(iii) Demonstration that the containment system provides adequate space to perform 
morcellation and adequate visualization of the laparoscopic instruments and tissue 
specimen relative to the external viscera; 
 
(iv) Demonstration that intended laparoscopic instruments and morcellators do not 
compromise the integrity of the containment system; and 
 
(v) Demonstration that intended users can adequately deploy the device, morcellate a 
specimen without compromising the integrity of the device, and remove the device 
without spillage of contents. 
 
21 CFR 878.4825(b)(4) states (for general use):  
 
Non-clinical performance data must demonstrate that the device performs as intended under 
anticipated conditions of use. The following performance characteristics must be tested: 
 
(i) Demonstration of the device impermeability to tissue, cells, and fluids; 
 
(ii) Demonstration that the device allows for the insertion/withdrawal of laparoscopic 
instruments while maintaining pneumoperitoneum;  
 
(iii) Demonstration that the containment system provides adequate space to perform 
morcellation and adequate visualization of the laparoscopic instruments and tissue 
specimen relative to the external viscera;  
 
(iv) Demonstration that compatible laparoscopic instruments and morcellators do not 
compromise the integrity of the containment system; and  
 
(v) Demonstration that users can adequately deploy the device, morcellate a specimen 
without compromising the integrity of the device, and remove the device without spillage 
of contents. 
 
This guidance document is focused on non-clinical performance testing. Note that additional 
information, such as clinical data, may be needed to demonstrate substantial equivalence.
  
 
IV.  510(k) Submission Recommendations 
 
The sections below provide recommendations on how to comply with the special controls 
requiring non-clinical performance data codified in 21 CFR 884.4050(b)(4) and 21 CFR 
878.4825(b)(4), and describe what information is recommended for submission to FDA in a 
510(k) to demonstrate that the special controls have been met. In addition to compliance with 
special controls requiring non-clinical performance data, manufacturers must comply with all of 
the other special controls identified in 21 CFR 884.4050(b) and 21 CFR 878.4825(b) and should 
4  Contains Nonbinding Recommendations 
 
 
include information to demonstrate that these special controls have been met in a 510(k) 
submission for a tissue containment system. The other special controls relate to biocompatibility, 
sterility, shelf life, training, and labeling, which includes a boxed warning. Manufacturers are 
also expected to meet applicable 510(k) requirements.10 The sections below also provide 
recommendations for other non-clinical testing to support a 510(k) submission/substantial 
equivalence determination. Please note that where the guidance references final, finished device 
testing, this testing should be conducted on the tissue containment system that includes all 
manufacturing processes for the to-be-marketed tissue containment system including 
sterilization. 
 
  Device Description and Predicate Comparison 
The device description in the 510(k) submission should include a labeled diagram for each model 
included in the submission. The device description should include: 
 
  A description of the overall device system including accessories, pictures, samples (if 
practical), and engineering diagrams; 
  A description of the principle of operation accompanied by labeled diagrams, as 
applicable, to show the insertion, deployment and removal steps; 
  Specifications for the system overall as well as individual components; and  
  A description of the compatible LPMs. 
 
510(k) submissions include a comparison of the new device to a legally marketed device, 
commonly referred to as the predicate device. FDA recommends that all comparisons be 
provided in a manner that is clear and comprehensible, such as in tabular form that lists the 
similarities and differences between the new and predicate device. For more information, refer to 
the FDA guidance Format for Traditional and Abbreviated 510(k)s: Guidance for Industry and 
FDA Staff.11 
 
In addition to the non-clinical performance testing required by the special controls, differences in 
technological characteristics between the new and predicate devices may necessitate additional 
testing to demonstrate substantial equivalence. For input on additional testing to support a 
510(k), we recommend that you seek FDAs feedback through the Q-Submission process. For 
more information, see the FDA guidance document Requests for Feedback and Meetings for 
Medical Device Submissions: The Q-Submission Program.12 
  
  Non-Clinical Performance Testing 
The following sections provide non-clinical performance testing recommendations. Section B(1) 
provides recommendations on testing to comply with the special controls requiring non-clinical 
 
10 See 21 CFR 807.87. 
11 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditional-and-
abbreviated-510ks). 
12 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-
meetings-medical-device-submissions-q-submission-program.  
5  Contains Nonbinding Recommendations 
 
 
performance data (see 21 CFR 884.4050(b)(4) and 21 CFR 878.4825(b)(4)). Section B(2) 
provides additional testing recommendations for the 510(k) submission that are not associated 
with the special controls. 
 
For information on the recommended content and format of test reports for the testing described 
in this section, refer to FDAs guidance document, Recommended Content and Format of Non-
Clinical Bench Performance Testing Information in Premarket Submissions.13  
 
(1) Testing to Demonstrate Compliance with Special Controls 
 
In order to demonstrate that the device meets the non-clinical performance characteristics 
identified in 21 CFR 884.4050(b)(4) and 878.4825(b)(4), as applicable, non-clinical performance 
testing information should be provided in the 510(k) submission. FDAs recommendations on 
the non-clinical test methods to help comply with each special control are identified in Table 1. 
 
Table 1: Special Controls and Recommended Test Methods.  
 
Special Control   Recommended Test Methods  
21 CFR 884.4050(b)(4)(i)    Final Finished Tissue Containment System integrity testing 
21 CFR 878.4825(b)(4)(i)  (see Section IV.B(1)(a)(i)) 
21 CFR 884.4050(b)(4)(ii)    Insufflation pressure control testing (see Section 
21 CFR 878.4825(b)(4)(ii)  IV.B(1)(a)(iii)) 
  Clinical simulation study (see Section IV.B(1)(a)(iv)) 
21 CFR 884.4050(b)(4)(iii)    Clinical simulation study (see Section IV.B(1)(a)(iv)) 
21 CFR 878.4825(b)(4)(iii) 
21 CFR 884.4050(b)(4)(iv)    Clinical simulation study (see Section IV.B(1)(a)(iv)) 
21 CFR 878.4825(b)(4)(iv)    Final Finished Tissue Containment System testing (see Section 
IV.B(1)(a)) 
21 CFR 884.4050(b)(4)(v)    Clinical simulation study (see Section IV. B(1)(a)(iv)) 
21 CFR 878.4825(b)(4)(v)    Final Finished Tissue Containment System testing (see Section 
IV.B(1)(a)) 
   
 
13 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-
and-format-non-clinical-bench-performance-testing-information-premarket. 
6  Contains Nonbinding Recommendations 
 
 
 
a.  Final Finished Tissue Containment System Testing 
 
This section provides recommendations on test methods for evaluating the mechanical strength 
and integrity of the final finished tissue containment system. For the purposes of this testing, we 
recommend the use of samples at the end of their proposed shelf life as this is the least 
burdensome approach to addressing the requirements identified in 21 CFR 884.4050(b)(4) and 
21 CFR 878.4825(b)(4) as well as the requirements identified in 21 CFR 884.4050(b)(3) and 21 
CFR 878.4825(b)(3) for demonstrating device functionality over the intended shelf life. Note that 
samples can either undergo accelerated or real time aging. If there are multiple device sizes, you 
should incorporate test samples that are representative of all sizes which could be assessed using 
the worst-case size sample(s). You should provide a justification for the choice of worst-case 
size sample(s) in your submission. In addition, each test should include a statistically significant 
sample size to provide confidence that the results are representative of the final finished device.  
 
i.  Final Finished Tissue Containment System Integrity Testing  
 
Significance: During the surgical procedure, the integrity of the tissue containment system could 
be compromised due to contact with surgical instruments, including the power morcellator, 
and/or due to use issues. The tissue containment system could also be leak prone without any 
direct contact with instruments for reasons such as design and manufacturing issues. An 
evaluation of the integrity of the tissue containment system following power morcellation with a 
leakage test is recommended to demonstrate the robustness of the device to withstand the 
intended clinical use. Therefore, it is important to demonstrate device system integrity post-
morcellation.  
  
Recommendations: We recommend conducting microbial leakage testing that incorporates the 
following: 
 
  Samples should include the final finished tissue containment system post-clinical 
simulation study. (See Section IV.B(1)(a)(iv) below.)  
  The entire device (including seams) should be used to demonstrate that the device is 
capable of retaining all of the patients cells/fluids during the morcellation procedure.  
  If there are multiple device models made of the same material and you are using the same 
sealing method (if applicable), in lieu of testing each device model, you should conduct 
testing on a worst-case sample (e.g., the bag with the largest surface area). You should 
provide adequate justification for the worst-case sample in your submission.  
  A quantitative method should be used to test for the presence of leaks and/or the size of 
the leaks. 
  You should ensure the device is subjected to worst-case quantitative testing during 
leakage testing. You should consider the worst-case conditions for duration of testing 
consistent with the device labeling and clinically relevant pressure.  
  You should ensure that during the leakage testing, the bag is sufficiently filled to 
adequately distend the bag and prevent any folds or creases from forming in the bag, 
which in turn may prevent a hole in the bag from being detected. You should provide 
adequate justification for the volume used to fill the bag. 
7  Contains Nonbinding Recommendations 
 
 
  Validation of the detection limit of your assay and justification as to how it is sufficiently 
sensitive to detect the passage of a single cancer cell should be provided. You should 
ensure that the acceptance criteria of the assay are sufficiently sensitive to detect a single 
cancer cell crossing the device barrier.  
  Validation data that evaluates the ability of your test method to detect leaks using tissue 
containment systems with known hole sizes in a volume similar to the tissue containment 
system test volume should be provided. You should use positive and negative controls for 
leakage tests to help verify the sensitivity of the test protocol. 
  While performing leakage testing, you should pressurize the inside of the bag with the 
worst-case pressure expected during the surgical procedure for the following scenarios, 
including a safety factor, and should include an adequate description for: 
  When the hole size is greater than the size of cancer cells and the ability of the 
cancer cells to permeate through the holes depends on the pressure differential 
across the barrier. Under clinically relevant pressures, the contents (i.e., tissue, 
cells, including blood and cancer cells, and fluids) could leak outside the tissue 
containment system. 
  When the surgical instruments, while damaging the tissue containment system, 
may create a flap instead of a complete opening. Under clinically relevant 
pressures, the flap might open and leak the contents outside the tissue 
containment system. Consequently, if the pressure applied during the leakage 
testing is lower than the clinically relevant pressure levels, the tissue containment 
system might pass the leakage test (because the differential pressure is low or 
the flap is closed without tissue containment system pressure) even though cancer 
cells would have leaked out of the tissue containment system under appropriate 
pressure conditions. You should use clinically relevant pressure for leakage 
testing and provide appropriate justification for the chosen pressure. 
  After the clinical simulation study, but prior to conducting the microbial leakage testing, 
the test samples should be subjected to cleaning and/or sterilization. You should describe 
and justify these processes and ensure that any residuals from cleaning and sterilization 
processes are effectively removed or neutralized. You should validate the neutralization 
step to demonstrate that the results have not been confounded by cleaning and/or 
sterilization residuals. As part of the consideration of worst-case conditions, you should 
choose a microbial species size that is significantly smaller than cancer cells (e.g., 
Brevundimonas diminuta) and a large microbial concentration (i.e., >106-107 CFU/mL) 
and you should immerse the entire device in the growth media. 
  To ensure that the acceptance criteria of the assay is sufficiently sensitive to detect a 
single cancer cell crossing the device barrier, you should perform filtration of the entire 
volume of fluid. 
  If you choose to conduct an alternate test to the microbial method, you should evaluate 
the entire bag surface for leaks and provide validation of the detection limit of your assay. 
If applicable, provide a justification/rationale for not testing leaks on certain areas of the 
tissue containment system.  
 
ii.  Final Finished Tissue Containment System Strength Testing 
 
(a)  Tissue Containment System Pull Force Test 
8  Contains Nonbinding Recommendations 
 
 
 
Significance: Tissue containment devices are generally subjected to tensile loads during 
laparoscopic surgery (e.g., during insertion and removal of the tissue containment system). An 
evaluation of the tensile strength of the tissue containment system as a final finished device is 
important to ensure that when used as intended, the device can withstand clinical forces during 
insertion and removal and not fail.  
  
Recommendations: We recommend you conduct a pull force test on the tissue containment 
system that incorporates the following: 
 
  Samples of final finished tissue containment system at the end of their proposed shelf life 
should be used for testing. The test samples do not need to be preconditioned (i.e., 
subjected to clinical simulation) before testing. Note that either accelerated aged or real 
time aged samples can be used.  
  You should perform the pull test in a test fixture that mimics the clinical use conditions. 
The following are general recommendations for the test fixture. You should: 
  Ensure that the spatial and physical properties of the test fixture mimic the 
abdominal wall. 
  Create the smallest possible incision (or cavity) as per the instructions for use for 
your device. You should include a specific wound retractor or other accessories 
intended to be used with the tissue containment system in the test setup.  
  Include a tissue specimen that represents the worst-case scenario with respect to 
shape, size, and weight of tissue relative to the incision size. See also Section 
IV.B(1)(a)(iv) for additional considerations for the tissue specimen. 
  To measure the applied force, you should use either a hand-held force gauge or a tensile 
testing machine attached to the part(s) of the tissue containment system that is intended to 
help pull the tissue containment system out of the abdominal cavity.  
  For a tissue containment system with multiple openings, you should pull and measure the 
forces for all the openings.  If applicable, you should provide a justification/rationale for 
omitting pull testing and measuring the forces on certain openings of the tissue 
containment system.  
  The measured forces to the pre-defined acceptance criteria should be compared. 
 
(b)  Tissue Containment System Burst Strength Test 
 
Significance: It is important to evaluate the burst strength of the tissue containment system as a 
final finished device, since the tissue containment system may be made of various components 
such as straps, tethers, and opening rings attached to the tissue containment system. An 
evaluation of the burst strength of the tissue containment system as a final finished device is 
important to ensure that when used as intended, the device can withstand clinical forces during 
use and not fail. 
 
Recommendations: We recommend you conduct a burst strength test that incorporates the 
following: 
 
9  Contains Nonbinding Recommendations 
 
 
  Samples of final finished tissue containment system at the end of their proposed shelf life 
should be used for testing. The test samples do not need to be preconditioned (i.e., 
subjected to clinical simulation) before testing. Note that either accelerated aged or real 
time aged samples can be used. 
  You should test the device specimens to failure and compare the measured pressure-to-
failure to the pre-defined acceptance criteria. 
  You should provide the following results and analyses from the burst testing14 in your 
submission: 
  Pressure-time curve; 
  Burst pressure (i.e., the maximum pressure prior to failure); 
  Factor of safety, which compares the burst pressure to radial forces imparted on 
the device during the surgical procedure (e.g., insufflation pressure, external 
pressure of the tissue from the abdomen); and 
  Failure locations, if any, based on the tissue containment system design and 
composition. 
 
iii. Insufflation Pressure Control Testing  
 
Significance: Insertion and withdrawal of laparoscopic instruments into the tissue containment 
system should not significantly impact the ability to maintain insufflation within the tissue 
containment system. Inability to maintain the insufflation pressure could cause the power 
morcellator and/or other surgical instruments to contact and damage the tissue containment 
system. Any damage to the tissue containment system may cause leakage of its contents. 
 
Recommendations: We recommend you conduct insufflation pressure control testing that 
incorporates the following:  
 
  Samples of final finished tissue containment system at the end of their proposed shelf life 
should be used for testing. The test samples do not need to be preconditioned (i.e., 
subjected to clinical simulation) before testing. Note that either accelerated aged or real 
time aged samples can be used.  
  In order to ensure adequate distension within the tissue containment system, you should 
perform tests to examine the limits of insufflation pressure losses during laparoscopic 
instrument insertion/removal that would still ensure that there is adequate space within 
the tissue containment system for surgical instruments. You should test devices to ensure 
that they are within the acceptance criteria.  
  For devices that include valves as part of the design, you should conduct testing on the 
component that includes the valve(s). For devices that rely on passage through an 
accessory that includes the valve(s), you should conduct testing on the complete device 
usage set-up.  
 
 
 
14 Herman A, Duraiswamy N, Nandy P, Myers MR, Price V, Gibeily G, and Hariharan P. In Vitro Leakage Testing 
of Tissue Containment Bags When Subjected to Power Morcellation Forces. J Minim Invasive Gynecol, Mar-Apr 
2020;27(3):655-664. 
10  Contains Nonbinding Recommendations 
 
 
iv. Clinical Simulation Study  
 
Significance: The clinical simulation study is important to evaluate the ability of the tissue 
containment system to maintain its structural integrity and impermeability when users perform 
power morcellation of resected tissue. Inability to use the tissue containment system 
appropriately could cause damage to the tissue containment system while operating the power 
morcellator and other surgical instruments. Any damage to the tissue containment system may 
cause leakage of bag contents. 
 
Recommendations: We recommend you conduct a clinical simulation study that incorporates the 
following: 
 
Study Design Recommendations 
  You should describe the scope of the study and the list of pass/fail criteria. 
  While choosing the people who will use the device during the study, you should consider 
the clinical specialties associated with the intended use of the device and select people 
with varying levels of surgical experience with different surgical specialties and clinical 
settings. 
  You should ensure that the test setup reflects the clinical settings where the device may 
be used and the intended users, including the surgical team.  
  You should ensure that the simulation study design closely mimics clinical use, which 
may include a bench model, animal model or cadaver, with an appropriate rationale. For 
the chosen model, the test setup should have the following features that are important to 
simulate clinical use:  
  Mimics the spatial and physical properties of the abdominal wall. 
  Simulates the presence of other organs in the abdomen and their relationship with 
the morcellator and the tissue containment system.  
  Distends the bag to the same level and volume as expected during clinical use.  
  Replicates forces encountered by the clinician while inserting the bag, insufflating 
the bag, and inserting the instruments into the laparoscopic environment and 
while performing the surgery.  
  Includes a tissue surrogate that can mimic the weight, dimensions, rigidity, 
elasticity, volume, density, and other relevant physical properties of human tissue 
that will be subjected to power morcellation. If ex vivo tissue is selected for 
simulation, it should mimic the true compliance of the tissue in vivo.  
  Provides comparable visibility inside the bag.  
  You should use blood or blood analog fluid inside the tissue containment 
system to mimic the same level of visibility as expected clinically.  
  If ex vivo tissue is used and contains blood, separate use of blood or blood 
analog fluid is not needed. 
  If your device is intended to also be used for human tissue that may contain stones 
(e.g., kidney stones), you should use tissue or tissue surrogate containing stones. 
  As part of this simulation, we recommend that you only consider the surgical steps 
related to the contained power morcellation and tissue extraction. The initial surgical 
steps for organ excision (e.g., hysterectomy, myomectomy, splenectomy, partial 
11  Contains Nonbinding Recommendations 
 
 
hepatectomy, nephrectomy) can be omitted from the study. As mentioned above, the 
surrogate tissue can be placed in the abdomen and used for the simulation in lieu of ex 
vivo organs/tissue.  
 
Simulation Procedure Recommendations 
  You should select the morcellators for testing based on the proposed indications for use.  
  All the laparoscopic instruments (e.g., trocars, graspers, tenaculum, insufflator, 
laparoscope) intended for use with the tissue containment system should be used. 
  Before morcellating the tissue specimen, you should observe and describe if the viscera 
and bowel are retracted sufficiently to allow for safe morcellation of the tissue in the 
tissue containment system.  
  You should track and describe the rate of leakage of CO  from the tissue containment 
2
system and/or the change in pressure in the device while performing the surgery (see 
Section IV.B(1)(a)(iii)). This information is relevant for assessing the ability of the tissue 
containment system to maintain a distended state during the procedure and prevent 
aerosol spread of cancer cells at tissue extraction sites and within the abdomen. In the 
event of loss of working space within the tissue containment system, you should assess 
the ability and ease of re-insufflation of the tissue containment system to regain working 
space. 
  After the procedure, you should: 
  Perform a visual assessment of the tissue containment system for tears and 
perforations.  
  Perform a qualitative leak test, which may include the use of dye to identify leaks.  
  Conduct quantitative final finished tissue containment system integrity testing 
(see Section IV.B(1)(a)(i)). 
  You should include the following information in the test report: 
  Morcellator details; 
  Incision size; 
  Tissue specimen type, size and weight; 
  Surgical instruments used; 
  Ability of the user to develop and maintain distension of the tissue 
containment system; 
  Ability of the user to insert and remove surgical instruments; 
  Ability of the user to introduce the tissue containment system correctly; 
  Ability of the user to place the specimen in the tissue containment system 
correctly; 
  Ability of the user to morcellate the tissue and maintain visual contact 
with the tissue and morcellator; 
  Ability of the user to remove the tissue containment system following 
morcellation;  
  Any additional input received from the users;  
  Documentation that the study met all pre-defined acceptance criteria; and 
  Detailed description of any protocol deviations and why they are not 
expected to impact the outcome of the study. 
 
12  Contains Nonbinding Recommendations 
 
 
For additional information on conducting this clinical simulation study, refer to the FDA 
guidance document titled Applying Human Factors and Usability Engineering to Medical 
Devices.15  
 
(2)  Additional Testing Recommendations 
 
While not required in the special controls in 21 CFR 884.4050(b)(4) and 21 CFR 878.4825(b)(4), 
we recommend that you conduct the following additional tests to aid in demonstrating substantial 
equivalence of the new tissue containment system. We recommend that you provide the results 
from testing that demonstrate that all device specifications have been met. We recommend that 
you consider evaluating the design specifications for individual device components (as discussed 
above, for the final finished device, non-clinical performance data must demonstrate that the 
device meets all design specifications (21 CFR 884.4050(b)(4) and 21 CFR 878.4825(b)(4)). 
 
For each test method, we recommend that you conduct comparative testing using a predicate 
device with similarities in device design and material composition (e.g., homogeneous versus 
composite materials) to your device. If you determine that the following tests are not warranted, 
such as because these device properties were assessed through other tests, we recommend that 
you state this in your submission and provide a rationale. 
 
a.  Thickness/Material Composition 
 
Significance: Thickness and material composition are important design parameters as they 
impact the physical strength and impermeability of the device. Tests that evaluate thickness and 
material composition generally help to ensure that any local defects and irregularities in the 
material that may cause decreased strength or increased permeability are identified.  
 
Recommendations: We recommend you conduct testing that evaluates the thickness and material 
composition that incorporates the following:  
 
  You should provide complete information on the methodology used to measure thickness 
and identify the total thickness of the tissue containment system material. If the tissue 
containment system under consideration is a composite material with multiple layers 
(e.g., polymer and fabric material), you should describe the process used to manufacture 
the layered-composite. 
  Measurements of thickness for the different layers (e.g., as averages with standard 
deviations), and if applicable, for the entire system should be included.  
  You should provide details about the material homogeneity of the system. You should 
observe and describe the presence of voids or defects in the polymer layer and at the 
intersection of polymer and fabric layers for a composite tissue containment system. The 
resolution of the measurement technique should be fine enough to delineate the presence 
of manufacturing defects such as voids that may be on the order of the size of cancer cells 
 
15 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-
factors-and-usability-engineering-medical-devices.  
13  Contains Nonbinding Recommendations 
 
 
or smaller. We recommend using imaging techniques such as high resolution optical or 
electron microscopy.16 
  For homogeneity and void testing, you should consider evaluating material specimens 
from multiple locations, including weak spots such as seams and straps.  
 
 
b.  Material Permeability Testing 
 
Manufacturers can elect to conduct initial testing on the containment system material itself as 
part of the design development process to ensure that the selected materials, when subjected to 
processing, are impermeable to tissue, cells and fluids. This section is intended to provide 
recommendations on tissue containment system material permeability testing, if the 
manufacturer elects to conduct this test; it does not address the final finished device testing. Final 
finished device testing as described in Section IV.B(1)(a) is a recommended method to address 
certain special controls identified in Table 1 above.   
 
Significance: If the device material, following manufacturing and additional processing, 
including sterilization, is not adequately robust to ensure that the tissue containment system is 
impermeable to tissues, cells, and fluids, cancerous and non-cancerous blood cells, tissue cells, 
and fluids can leak from the tissue containment system into the abdomen.  
 
Recommendations: We recommend conducting material permeability testing that incorporates 
the following: 
 
  You should use an appropriate marker for material permeability testing (e.g., viral or 
bacteriophage marker) and provide a detailed methodology for the testing similar to the 
American Society of Testing and Materials (ASTM) F1671/F1671M-13 standard.17 You 
should consider the worst-case scenario for the surrogate marker by using a marker size 
less than or equal to the size of cancer cells.  
  If you are considering an alternative to the microbial leak testing methodology described 
in ASTM F1671/F1671M-13, you should provide validation of the detection limit of your 
assay and the justification as to how it is sufficiently sensitive to detect the passage of a 
single cancer cell. The method of leakage detection should be sensitive enough to detect 
the tissue containment system material without and with defects (e.g., defects could be 
holes that are smaller than cancer cells). In addition to leakage testing of the tissue 
containment system material under consideration, you should include positive and 
negative controls for leakage tests to verify the sensitivity of the test protocol.  
  If you are conducting microbial leakage testing, you should provide evidence that the 
method is sensitive enough to identify holes smaller than cancer cells.  
  While performing any type of leakage testing, you should challenge the tissue 
containment system material to pressures that are clinically relevant as these devices are 
 
16 Herman A, Duraiswamy N, Nandy P, Myers MR, Price V, Gibeily G, and Hariharan P. In Vitro Leakage Testing 
of Tissue Containment Bags When Subjected to Power Morcellation Forces. J Minim Invasive Gynecol, Mar-Apr 
2020;27(3):655-664.  
17 ASTM F1671/F1671M-13: Standard Test Method For Resistance of Materials Used in Protective Clothing To 
Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System.  
14  Contains Nonbinding Recommendations 
 
 
subjected to insufflation and additional localized pressures during the power morcellation 
procedure.18 You should test the material to a pressure above the insufflation pressure 
using a safety factor,19 and should provide a detailed scientific rationale for the 
designated safety factor. 
 
It is important to evaluate the material permeability of critical sections of the tissue containment 
system such as straps, tethers, and opening rings that are bonded/attached since these sections 
undergo additional processing steps that may impact material permeability. You should provide a 
detailed justification for the selection of both tested and untested sections of the device. 
 
c.  Mechanical Strength 
 
The tests recommended in this section are intended to evaluate the mechanical strength of the 
tissue containment system material. They do not address the final finished device testing. 
Manufacturers should refer to Section IV.B(1)(a)(ii) above for FDAs recommendations on 
mechanical strength testing of the final finished device.  
 
It is important to evaluate the mechanical strength of critical sections of the tissue containment 
system such as straps, tethers, and opening rings that are bonded/attached since these sections 
undergo additional processing steps that may impact mechanical strength. You should provide a 
detailed justification for the selection of both tested and untested sections of the device.  
 
The following are general recommendations for mechanical strength characterization testing:  
 
  When establishing the acceptance criteria, you should consider the forces applied to the 
tissue containment system during clinical use and include a safety factor by comparing 
the clinical forces to force-to-failure. We recommend that you provide a rationale for 
each acceptance criterion. 
  We recommend that you test the specimens to failure or provide a justification for the test 
endpoint (e.g., choosing the maximum test withstand pressure/force in a pull test). 
 
i.  Tensile Strength Testing  
 
Significance: Similar to the concerns associated with evaluating the tensile strength of the final, 
finished tissue containment system, as described in Section IV.B(1)(a)(ii)(a), if the device 
material does not have enough mechanical strength to withstand these loads, the device may fail 
and result in leakage of the device contents. 
 
Recommendations: We recommend you conduct tensile testing and describe the results and 
analyses from the tensile testing by including the following information: 
 
18 Herman A, Duraiswamy N, Nandy P, Myers MR, Price V, Gibeily G, and Hariharan P. In Vitro Leakage Testing 
of Tissue Containment Bags When Subjected to Power Morcellation Forces. J Minim Invasive Gynecol, Mar-Apr 
2020;27(3):655-664.  
19 Herman A, Duraiswamy N, Nandy P, Myers MR, Price V, Gibeily G, and Hariharan P. In Vitro Leakage Testing 
of Tissue Containment Bags When Subjected to Power Morcellation Forces. J Minim Invasive Gynecol, Mar-Apr 
2020;27(3):655-664.  
15  Contains Nonbinding Recommendations 
 
 
  Stress-strain curve; 
  Ultimate tensile strength (UTS) and its comparison to the tensile forces imparted 
on the device during a worst-case surgical scenario; 
  Elongation or strain at break; 
  Toughness; and 
  Failure locations, if any, based on device design and composition. 
 
ii.  Puncture Testing 
 
Significance: The tissue containment system may be subjected to puncture forces from surgical 
instruments (e.g., graspers). It is critical for the device material to be able to withstand these 
forces without resulting in leakage. 
 
Recommendations: We recommend you conduct puncture testing that incorporates the following:  
 
  You should use surgical instruments (e.g., graspers and trocars) that are typically used in 
the clinical procedure. You should test worst-case scenario(s) in terms of instrument 
sharpness and contact area. 
  You should apply the load to the side of the device that is in contact with the instrument. 
For composite tissue containment system with multiple layers, the force at which the tip 
of the instrument pierces all the layers is considered the puncture force.  
  The following results and analyses from puncture testing should be provided: 
  Instrument force-displacement curve; 
  Puncture force; and 
  Safety factor analysis, comparing the measured puncture forceto forces imparted 
 
on the device during the surgical procedure. 
 
iii. Partial Puncture Followed by Material Permeability Testing 
 
Significance: For a composite tissue containment system, surgical instruments could damage one 
of the layers while leaving the other layers intact. For example, the layer that offers leak 
resistance could be damaged while the other layers remain intact.20 The force at which a layer of 
the tissue containment system is damaged and causes leakage of the contents from inside is 
referred to as the partial puncture force. A combination of instrument puncture testing followed 
by leakage testing helps estimate the partial puncture force.  
 
Recommendations: The test methodology for this test is similar to puncture testing and material 
permeability testing discussed in Sections IV.B(2)(c)(ii) and IV.B(2)(b) above, respectively. We 
recommend you conduct insufflation pressure control testing that incorporates the following:  
 
  You should use information from the puncture testing (in Section IV.B(2)(c)(ii) above) to 
determine the range of applied forces for partial puncture. For a composite tissue 
 
20 Herman A, Duraiswamy N, Nandy P, Myers MR, Price V, Gibeily G, and Hariharan P. In Vitro Leakage Testing 
of Tissue Containment Bags When Subjected to Power Morcellation Forces. J Minim Invasive Gynecol, Mar-Apr 
2020;27(3):655-664.  
16  Contains Nonbinding Recommendations 
 
 
containment system, the puncture forces used to partially puncture the device and to 
cause leakage can be much lower than the complete puncture forces. 
  Force should be applied the same way as for puncture testing (with the applied force less 
than puncture force) followed by leakage testing with dye for detection. Alternatively, a 
microbial leakage test may also be used for confidence and robustness in the leakage 
detection study. After partial puncture testing, you should perform material permeability 
testing (similar to Section IV.B(2)(b) above) with a predetermined pressure of 2 psi.21 
Alternatively, you should provide a justification for using a different pressure for leakage 
testing.  
  You should use surgical instruments that are typically used in the clinical procedure. You 
should consider testing a worst-case scenario in terms of instrument sharpness, contact 
area, and probability of contact with the tissue containment system during use. 
  You should apply the partial load to the side of the tissue containment system that is in 
contact with the instrument. Information from the puncture testing can be used to 
determine the range of partial loads that can be imparted on the device and you should 
include this information in your submission.  
  The following results from the partial puncture and leakage testing should be provided: 
  Partial puncture force-displacement curve; 
  Partial puncture force that created enough damage to the device to cause leakage 
during leakage testing; and 
  Failure locations with respect to puncture and leakage, if any, based on device 
design and composition. 
 
 
 
 
21 Herman A, Duraiswamy N, Nandy P, Myers MR, Price V, Gibeily G, and Hariharan P. In Vitro Leakage Testing 
of Tissue Containment Bags When Subjected to Power Morcellation Forces. J Minim Invasive Gynecol, Mar-Apr 
2020;27(3):655-664.  
 
17