This guidance was written prior to the February 27, 1997 implementation of FDA's 
Good Guidance Practices, GGP's. It does not create or confer rights for or on any person 
and does not operate to bind FDA or the public. An alternative approach may be used if 
such approach satisfies the requirements of the applicable statute, regulations, or both. 
This guidance will be up dated in the next revision to include the standard elemnt s of GGP 's .  Guidance on 
Premarket Notification [5 10(k)] Submissions 
for 
Automated Endoscope Washers, WasherIDisinfectors, and Disinfectors 
Intended for Use in Health Care Facilities 
Infection Control Devices Branch 
Division of General and Restorative Devices 
August, 1993  Preface 
This guidance was developed by  the Infection Control Devices Branch, Division of General 
and Restorative Devices (DGRD), Office of Device Evaluation (ODE), Center for Devices 
and Radiological Health (CDRH), Food and Drug Administration (FDA). 
FDA regulates the introduction of medical devices into interstate commerce.  A person 
inicnding to mark&: an endoscope washerldisinfector must submit to FDA, and have clear&, 
a premarket notification [510(k)] submission prior to its introduction into interstate 
commerce.  Regulations governing the general content and format of 5 lo@) submissions are 
codified under 21 Code of Federal Regulations, Part 807.  These and other regulatory 
requirements pertaining to the marketing of a new medical device are discussed in guidance 
documents available from the CDRH Division of Small Manufacturers Assistance (DSMA). 
The intent of this guidance document is to provide 5100 applicants specific additional 
directions regarding information and data which should be submitted to FDA in a 510(k) 
submission for an endoscope washerldisinfector.  In this guidance, the term 
washerldisinfector will be used to refer to endoscope washers, washerldisinfectors, and 
disinfectors. 
A safe and effective system to disinfect endoscopes intended for use in other than normally 
sterile areas of the body is important in preventing nosocomial infections.  Comprehensive, 
scientifically sound criteria for the evaluation of endoscope washers, washerldisinfectors, and 
disinfectors is essential to help ensure that these devices are safe and effective for their 
intended use when used according to their labeling.  FDA recognizes the importance of 
providing applicants, and other interested parties, the agency's 510(k) submission criteria for 
endoscope washers, washerldisinfectors, and disinfectors in order to facilitate assembly of 
necessary data, to maintain consistency of review, and to provide for a more efficient 
regulatory process. 
The document expresses FDA's recommendations as of the date noted on the cover page. 
There is ongoing research and debate with regard to endoscope design and test methods. 
Despite this state of flux, FDA finds it necessary at this time to document its 5 1 0 0  
submission criteria in order to'expedite the availability of safe and effective 
washerldisinfectors.  FDA expects that this document will stimulate andlor accelerate 
development of test methods and specific validation procedures by the scientific community 
and regulated industry.  The document is not static but will be periodically revised to keep it 
current with state of the art developments in this area.  Comments on the document are 
welcome and should be sent to the address noted on page 17.  Advisory Concerning Accessories Used with Washer/Disinfectocs 
FDA regulates the accessories used with endoscope washerldisinfector~a s medical devices. 
These include detergents, enzyme cleaners, and liquid chemical germicides that are intended 
for reprocessing medical devices.  Liquid chemical germicides must be cleared under the 
510(k) process.  FDA is considering how to regulate the detergents and enzyme cleaners. 
The endoscope washerldisinfector, combined with legally marketed accessories, acts as a 
system tc, clmi and disinfect endoscopes safely and effectively. 
Since safe and effective cleaning and disinfection depends upon the combined performance of 
all elements in the system, FDA will not find an endoscope washerldisinfector substantially 
equivalent unless legally marketed, compatible accessories are identified in the 
washerldisinfector labeling, and the performance of the system is validated.  The guidance 
provides detail on the validation process. 
Manufacturers of products that are used in combination should work together to develop data 
to demonstrate that the products work as claimed in the system.  This minimizes costs and 
time expended in obtaining market clearance for a device used in the system. 
How does the washerldisinfector manufacturer have to address the accessories in their 510(k) 
notification?  It depends on (1) the marketing status and labeling for the accessory, (2) who 
markets the accessory, and (3) the labeling for the washerldisinfector. 
Generally, if the accessory is already a legally marketed medical device, then supplemental 
data must be submitted to FDA on performance of the accessory in the system, and the 
machine must be labeled for use with that accessory.  If the accessory is not a legally 
marketed medical device, then comprehensive data must be submitted to establish substantial 
equivalence.  For example, if the washerldisinfector indicates the use of Germicide X with 
their washerldisinfector for high level disinfection, and Germicide X is a legally marketed 
device, then data must be submitted validating use of Germicide X with the 
washerldisinfector.  If Germicide X is not legally marketed, the data must meet all the 
relevant requirements of the FDA Guidance for Liquid Chemical Germicides, including 
performance in the washerldisinfector. 
Until such time that the liquid chemical germicides with sterilizationlhigh level disinfection 
claims are cleared for marketing by FDA, we are considering implementation of interim 
measures to facilitate the clearance of endoscope washerldisinfector~. FDA recommends that 
a person considering the submission of a 5 10(k) to FDA for an endoscope washerldisinfector 
should contact the Chief, Infection Control Devices Branch at (301) 594-1307 for the most 
up-to-date information concerning the status of our procedures.  CONTENTS 
I.  Introduction 
Page 
Scope  3 
Purpose  3  
Definitions  3 - 4  
Principles Regarding Presentation of Data  4 - 7  
Document Availability  7 
11.  Content and Organization of Information in a 5100 
Cover Letter 
Table of Contents 
Labels and Labeling 
1.  Proposed Labels and Labeling 
2.  Labeling Requirements 
3.  User's Manual 
4.  Service Manual 
Standards, Practices, Technical Reports 
General description oflhe endoscope washerldisinfector 
1.  Overview 
2.  Intended Use 
3.  Design, Construction, Components, & Accessories 
4.  Process Monitors 
5.  Process Parameters/Development 
Descriptive Comparison to a Legally Marketed Device  Page 
G.  Performance Data  13 -16 
1.  Process Parameter Tests 
2.  Simulated-use Tests 
3.  In-use Tests 
H.  Software Documentation 
I.  Toxicological Evaluation of Residues 
1.  Introduction 
2.  Hazard Evaluation 
J.  510(k) Summary or Statement 
K.  Comments 
L.  Reviewer's Checklist 
M.  Comparison Table  Guidance on Premarket Notification [510(k)] for Endoscope Washers, 
WasherIDisinfectors, and Disinfectors Used in Health Care Facilities 
I.  Introduction 
A.  Scope 
This document estzblishes the 510(kj review requiremcrlis for endoscope washers, 
washerldisinfectors intended for use in health care facilities, e.g.,  hospitals, clinics, 
health care professional offices.  The types of devices within this generic class are 
those washerldisinfectors which are electromechanical and may be microprocessor 
controlled.  They are used to process endoscopes which are not normally used in 
sterile areas of the body, which can not be processed by a terminal sterilization 
process, or in which the recognized professional standard of practice permits high- 
level disinfection, when sterilization is not practicable.  Some machines may not 
include a washing step. 
Exclusions 
This document does not include manual endoscopic cleaning accessories such as 
brushes, buckets, etc. 
B.  Purpose 
This guidance is intended to: 
1.  assist persons (manufacturers, distributors, or importers) in organizing 
premarket notifications for endoscope washerldisinfectors; 
2.  achieve consistency in meeting the requirements and in the presentation of 
information; and 
3.  guide FDA revkw staff in conducting and documenting the review of 
premarket notifications; 
. 
C.  Definitions 
1.  Bioburden:  The naturally occurring microbial contamination on a medical 
device prior to exposure to a microbicidal process. 
2.  Inorganic and Organic Load:  The naturally occumng or artificially placed 
inorganic (e.g., metal salts) or organic (e.g., proteins) contaminants on a 
medical device prior to exposure to a microbicidal process.  The naturally 
occurring organic load is also known as bioburden.  Process and Product Qualification:  Elements of the validation program 
consisting of selected engineering and microbiological demonstrations 
performed according to predefined protocols to show process reproducibility 
and product acceptability. 
Precleaning:  The removal of foreign material, e.g., organic or inorganic 
contaminants, from medical devices prior to a decontamination or disinfection 
process. 
Process Residue:  The microbicidal agent or by-products of the 
cleaning/disinfection process remaining on a medical device after completion 
of the cleaningfdisinfection process. 
Disinfection:  The process that kills a defined scope of pathogenic organisms, 
not necessarily all microbial forms (e.g., bacterial endospores). 
Disinfectant:  A chemical agent that eliminates a defined scope of pathogenic 
organisms, not necessarily all microbial forms (e.g., bacterial endospores). 
High Level Disinfectant:  A germicide that kills all microbial pathogens, 
except large number of bacterial endospores, when used according to labeling. 
Unit:  A specified substrate or carrier upon which a specified number of test 
organisms are inoculated.  A unit may be a specified volume, weight, or 
surface area.  For example a unit could be specified as an entire device or a 
component of a device, (if the device must be disassembled prior to 
disinfection), or a portion of a device. 
Validation:  A documented program which provides a high degree of assurance 
that a specific process will consistently meet its predetermined specifications 
and quality attributes. 
Intended Use:  It is the objective intent of the persons legally responsible for 
the labeling of the .device.  The intent is determined by their expressions or 
may be shown by the circumstances surrounding the distribution of the device. 
The objective intent may, for example, be shown by labeling claims, 
advertising matter, or oral or written statements by such representatives.  It 
may be shown by the offering or the using of the device, with the knowledge 
of such persons or their representatives, for a purpose for which it is neither 
labeled nor advertised (21 CFR 5801.4). 
D.  Principles Regarding Presentation of Data 
1.  Editorial Considerations:  The 510(k) should be carefully edited, as well as 
scientifically reviewed before it is submitted to FDA.  It should be proofread  to assure that all pagedsections are included and are properly indicated, 
consecutive, distinctly copied, and legible. 
2.  Abbreviations:  Standard abbreviations acceptable to a significant peer 
reviewed journal should be used wherever possible.  All other abbreviations 
should be identified at the beginning of each section in which they are used or 
in footnotes to tables and graphs. 
3.  Data Availability:  This document outlines typical circun~stanceso f data 
review.  It is not possible to anticipate all situations that may require FDA 
review.  Thus, those submitting applications should be aware that they may be 
asked to submit additional data, to present data in another format or to provide 
more detailed explanations of the information submitted, if required to 
establish equivalence. 
Applicants should keep data used for the 5 100 submission on file in a 
controlled and well organized format.  This will allow the applicant to 
expeditiously supply FDA with additional information or analysis if required. 
Errors in data that are identified by the applicant after submission to FDA 
should be brought to FDA's attention immediately. 
4.  Tables and Graphs:  Well-constructed tables are fundamental to the reporting 
and evaluation of data.  All tables should be clearly identified and captioned 
with symbols keyed to a footnote or accessible reference page which 
adequately indicates the nature of the data. 
Graphs should supplement, not replace, data tables.  They should be of 
publication quality. 
5.  Published Literature:  Published methods or data referenced in study reports 
should be appended to the study report.  Reprints of other referenced published 
reports or data should be appended to the section in which they are referenced. 
A11 referenced reports and data should be summarized including an explanation 
of how it .relates to: the current submission.  Reference citations should be 
complete (e.g., title, author, journal, volume, year). 
6.  Protocols and Data Analysis: 
Test reports must include the protocol (objectives, precise description of 
materials, experimental methods, controls, observations, statistical methods 
and analyses, conclusions and comments.  Do not submit raw data.  Additional 
specific directions on protocols are included in sections that follow.  7.  Reference to Submitted Data: 
The applicant may reference any information previously submitted to FDA in 
support of the 510(k).  If the applicant did not submit the referenced data, the 
applicant either must provide the referenced information, or have the original 
submitter provide a letter of authorization to FDA.  Often, if the data are not 
extensive, resubmitting data in the 510(k) will facilitate the review of the 
document. 
8.  Other Considerations 
a.  The 510(k) should include a response to all elements in Part I1 below or 
include an explanation of why data or information has not been 
supplied, or why alternative information is justified.  Original 5 10Qs 
that are grossly incomplete following a cursory review may be placed 
immediately on a hold status by notification to the applicant. 
b.  Under Section 807.87(h), the 510(k) must include any additional 
information regarding the device requested by FDA that is necessary to 
make a finding as to whether the device is substantially equivalent to a 
legally marketed device. 
During the review period FDA may identify deficiencies in the 
submission that cause FDA to be unable to determine whether the 
device is equivalent.  Notification of the existence and specifics of the 
deficiencies may be made either by telephone or in writing or both, 
depending upon the number and complexity of the deficiencies. 
Telephone contact will be used to clarify minor deficiencies. 
The applicant may elect to do one of the following:  respond to the 
deficiencies, submit a premarket approval application under section 5 15 
of the act, formally withdraw the submission, or allow the submission 
to be administratively deleted if a response to the deficiencies is not 
received by.FDA within 30 days. 
Responses to the deficiency letters or telephone calls must be in writing 
and shall include a restatement of the deficiency (or copy of the 
deficiency letter) and the complete response.  A response to 
deficiencies that is on its face grossly incomplete may not be considered 
for reevaluation and FDA may place the file on hold once again after 
the applicant is notified. 
Amended information may raise additional significant questions, 
therefore, it is essential for the applicant to fully consider the 
deficiencies and provide a comprehensive response.  c.  Nonclinical laboratory studies that will be submitted as part of a 
premarket notification submission should be conducted according to 
FDA GLP regulations (21 CFR Part 58).  Compliance with these 
regulations supports the quality and integrity of the data submitted. 
Variances and the reason(s) for the variances from the GLP regulations 
should be noted in the submission. 
E.  Document Availability 
The following relevant FDA documents are available from Division of Small 
Manufacturers Assistance [(800)638-2041 or (301)443-6597]: 
Guidance on the Content and Format of Premarket Notification [510(k)] 
Submissions for Liquid Chemical Germicides 
Reviewer Guidance for Computer Controlled Medical Devices Undergoing 
5 lo@) Review 
11.  Content and Organization of Information in a 510(k) 
A.  Cover Letter 
The submission shall have a cover letter providing the following information 
described in 21 CFR 5807.87 (Information required in a premarket notification 
submission): 
1.  Trade or proprietary name of the device. 
2.  Common or usual name of the device - endoscope washer/disinfector. 
3.  Classification name of the device - endoscope, accessories, cleaning for 
endoscope. 
4.  The establishment registration number, if applicable, or the sponsor, owner or 
operator submitting the premarket notification. 
5.  Class in which the device has been put under section 513 of the act, and the 
appropriate panel, if known.  [78-FEB-11] 
6.  A statement explaining the purpose of the submission (e.g., new device, 
significant modification of device previously found equivalent (new intended 
use, material, or manufacturing process, etc.).  Refer to 21 CFR @07.87(g) 
for additional requirements.  The change may require some or all of the 
information needed for a new device.  7.  A brief statement indicating the device is similar to andlor different from other 
legally marketed products of comparable type in commercial distribution. 
Data supporting that statement must be included (see below for more detail on 
performance data comparisons).  It is important that the applicant provide 
specific descriptive information on the legally marketed devices(s) to which 
equivalence is claimed.  Such information shall be provided in a separate 
section and include labeling for the equivalent device(s), and reference to a 
510(k) notification or information indicating its pre-1576 status. 
8.  The name, address, and telephone number of the individual or individuals in 
the U.S.  that may be contacted regarding the submission. 
B.  Table of Contents 
The 510(k) shall include a table of contents noting section titles and pages.  Each 
section shall be separated and begin with a section contents page if the section 
consists of several parts. 
C.  Labels and Labeling 
1.  Proposed Labels and Labeling:  The submission should contain proposed 
labels, labeling, and advertisements sufficient to describe the device, its 
intended use, and the directions for use.  Labels include the information 
affixed directly to the device and its packaging.  Labeling also includes the 
users manual, service manual, and any other information that accompanies the 
device. 
2.  Labeling Reuuirements:  The labeling must meet the requirements of 21 CFR 
Part 801 as it relates to a determination of intended use.  ODE will concentrate 
on the following: 
Subpart A, Sections 801.4 and 801 -5, related to intended uses and adequate 
directions for ubse. 
Subpart B, Sections 80 1.109 and 80 1.1 16, related to prescription devices and 
commonly known directions. 
Other portions are deferred for review to CDRHiOffice of Compliance, 
Promotion and Advertising Policy Staff. 
3.  User's Manual:  The user's manual shall contain, where applicable, at a 
minimum, the following information: 
a.  the intended use of the washer/disinfector, such as cleaning and high-  level disinfection of endoscopes; a list of all brands and models of 
endoscopes which are compatible with the washerldisinfector; if generic 
descriptions, such as submersible, flexible, or rigid endoscopes, 
sigmoidoscopes, colonoscopes, etc. are used to describe endoscopes 
which are compatible with the endoscope washerldisinfector,-the 
manufacturer will require to provide the rationale as to why generic 
descriptions are adequate; 
limitations of use, that is, any special characteristics of certain types of 
endoscopes or their accessories which require special handling or which 
may not be adequately disinfected by  the washerldisinfector; 
name and address of the manufacturer; 
type and model designation; 
installation instructions; 
detailed operating or use instructions for all modes; the instructions 
should identify when various default or optional modes are applicable; 
the cleaning and disinfection instructions in the manual for the 
endoscope washerldisinfector must compliment the cleaning and 
disinfection instructions provided by  the endoscope manufacturer. 
how the detergent and disinfectant are prepared, added to the machine, 
reused, if applicable; and a description of how the disinfectant is added 
to the cycle; 
if the detergent or disinfectant are reused, detailed instructions on 
monitoring the effectiveness of each; the instructions must state that test 
strips, which are labeled for use with the specific brand of chemical 
germicide, must be used on a regular basis, i.e., daily, to monitor the 
effective concentration of the germicide; 
identification of the dilution factor of the disinfectant per machine cycle 
if the disinfectant is reused; 
a description of any cycle counter used to monitor the disinfectant's 
reuse life; and how to set the disinfectant change warning light, i.e., 
when and how the cycle counter is reset; 
a list of all detergents, enzyme cleaners, and disinfectants which are 
compatible with the washerldisinfector;  the manual should include a 
warning that the user must follow the labeling for the detergent,  enzyme cleaner, and germicide regarding conditions of preparation and 
use; 
m.  pre- and post-processing recommendation including precleaning 
recommendations and final alcohol rinse or air drying, if applicable. 
(If the recommendation for the precleaning of endoscopes is not 
included in the manual, then the firm must provide justification with 
supporting data why precleaning is not necessary.)  Also note in 
labeling that a sterile water final rinse is ideal, when practicable, but a 
water rinse of a determined low contamination quality followed by a 
70% alcohol rinse may be acceptable when medically necessary; 
n.  error or fault indications, their causes, and response; 
o.  interpretation and use of indicator gauges, if applicable; 
p.  instructions for disinfecting the machine itself, unless convincing data 
are provided showing that such a process is not needed, aid the 
frequency that the self-disinfection cycle should be done; 
q.  any applicable warnings, hazards, and precautions; 
r.  other relevant information regarding the use of the washerldisinfector 
such as input water quality, water pressure, air pressure, use of sterile 
water for the rinses, alcohol rinses, etc. and a source of additional 
information should the user have a question; and 
s.  if the device is not a washer, precautions indicating the need for 
thorough precleaning and rinsing of the scope before placement into the 
machine. 
4.  Service Manual:  Submit the service manual for the device which includes: 
a.  a detailed description of all the tasks that must be accomplished to 
maintain the washerldisinfector in proper operating condition, e.g., 
routine maintenance and inspections instructions, calibration, periodic 
microbiological sampling of all fluid paths and other communicating 
passages; etc. 
b.  the schedule for these tasks, and; 
c.  who is responsible for the tasks (user or authorized service personnel). 
D.  Standards, Practices, Technical Reports  Appropriate or relevant industry or regulatory standards and recognized standards of 
practice, which the device meets, should be referenced including the year of standards 
publication.  The applicant may certify that the device meets the stated standard.  The 
applicant then is obliged to meet the standard and maintain documentation of testing 
showing that the device meets the standard.  The UL 544 standard may be applicable 
for the automated endoscope washerldisinfectors.  The following organizations have 
guidelines which also may be applicable to automatic endoscope washerldisinfectors: 
AAMI, ISO, AORN, SGNA, ASGE, APIC.  This list is not all inclusive. 
E.  Description of the Endoscope Washerldisinfector 
1.  Overview 
a.  Provide a complete overview of the endoscope washerldisinfector. 
This description can consist of detailed drawings, photographs, and 
brochures.  The description should include the method in which 
endoscopes are connected to the endoscope washerldisinfector.  The 
interior dimensions and locations of all components should be indicated. 
b.  Provide a labeled, blocked colored schematic of each cycle of the 
endoscope washerldisinfector including water, air and disinfectant lines, 
and all detergent, disinfectant, and water reservoirs. 
c.  Provide a labeled, blocked colored schematic of the fluid pathway from 
the washerldisinfector through all compatible endoscopes. 
d.  Describe all accessories, such as the adaptor hook-ups for endoscopes, 
which are compatible with the endoscope washerldisinfector. 
2.  Intended Use(s):  Provide a clear description of the intended use(s) of the 
device (refer to the definition of intended use). 
3.  Design, Constniction, Components, & Accessories 
a.  Describe the materials used to construct all major components of the 
device.  Provide the rationale for their selection. 
b.  Indicate the device installation requirements such as electrical, 
plumbing, venting to the outside, etc. 
c.  Describe the input requirements for the endoscope washerldisinfector 
such as water quality, water pressure through the lines of the 
washerldisinfector and the channels of the endoscopes, electrical 
requirements, the pressures required to move fluids or air through the 
lines of the washerldisinfector and channels of the endoscopes,  compressed air quality, etc.  Provide the rationale for each of the input 
requirements. 
d.  Describe all manual or automatic controls, instrumentation, recorders, 
vents inputs, outlets, filters, and safety features. Provide the rationale 
for each. 
e.  Describe the delivery system(s) for the detergent(s) and the liquid 
chemical germicide(s), i.e. pumps, tubing, nozzle heads, connectors, 
etc.  Provide the rationale for the design of the delivery system(s). 
f.  Describe all accessories marketed with the washerldisinfector such as 
endoscope hook-up adapters.  Provide the rationale for the accessories. 
4.  Process Monitors 
a.  Provide a complete description of the components used to monitor the 
process.  Include information on specifications of the instruments and 
sensors (accuracy, precision, range, specificity, sensitivity). 
b.  Certify that all monitors reflect actual process conditions. 
5.  Process ParameterdDevelopment  
a.  Describe all process parameters.  Parameters may include time, 
temperature, hardness of the water, preprocessing conditions, 
postprocessing conditions, etc.  Identify the factors that affect the 
effectiveness of the processes and state how they are controlled. 
b.  Provide the specifications and basis for each process parameter.  The 
process parameters must be based  upon sound scientific studies, such as 
those describe in Section G and I, which show that each phase of the 
processLachievesi ts stated purpose. 
c.  Describe all fault conditions related to each of the process parameters, 
including under what conditions a fault is detected and how the 
washerldisinfector will respond.  Provide the rationale for each. 
F.  Descriptive Comparison to a Legally Marketed Device 
Identify a legally marketed device to which substantial equivalence is claimed.  More 
than one device can be listed, but the device(s) chosen should be as close in intended 
use and technology to the new device as possible.  Provide the information noted 
below to show how the new device is both similar to and different than the legally 
marketed device.  This information canbe provided in a comparison table (re  Attachment 1).  This information may be identical to that provided under Parts C and 
E.  The applicant may wish to combine some or all of Parts C and E.  Indicate how 
the differences may affect safety and effectiveness. 
1.  Provide labeling (labels, instructions for use, promotional material)-for the 
legally marketed device(s) to which substantial equivalence is claimed.  To 
facilitate comparison, also include clear photographs, or other representations 
of the legally marketed devicc(s3;-uniess the labeling has ample information. 
2.  Compare and contrast the intended use of the new device to the predicate. 
3.  Compare all materials that come into contact with the fluid pathways of the 
device, for example endoscopes, wash chamber, tubing, etc. The precise 
materials of the new device, and if possible, the predicate should be identified 
to the extent possible. 
4.  Compare the operational principles. 
5.  Compare design, construction, components, accessories, process monitors, 
process parameters, etc. 
G.  Performance Data 
In general, endoscope washerldisinfectors work in combination with detergents, 
enzyme cleaners, and liquid chemical germicides to eliminate scope contamination. 
The electromechanical aspects of an endoscope washerldisinfector can be evaluated on 
the basis of engineering specifications and tests.  However, since the device must 
work in combination with other products as a system to achieve its intended use, FDA 
believes that test data must be produced showing the ability of the device to produce a 
disinfected scope. 
1.  Process Parameter Tests:  Provide a summary of the data from tests which 
demonstrate that the machine achieves and maintains the specified physical 
process parameters,  These data should be from repeated runs using 
representative types of endoscopes (at least 3 runsltype) identified in the 
labeling as being compatible with the washer, i.e. gastroscopes, colonoscopes, 
sigrnoidoscopes, etc. 
2.  Simulated-use Tests:  The applicant must provide microbiological and chemical 
test data to demonstrate that the machine can deliver a high level disinfectant 
for the contact conditions necessary for high-level disinfection for all 
endoscopes identified in the labeling, when used  in accordance with the 
directions for use.  The simulated-use testing must evaluate the worst case 
conditions for the washerldisinfector, the disinfectant, and the endoscopes. 
For example, worst case conditions for the washerldisinfector could be  prolonged use at its minimum performance standards and just prior to any 
scheduled maintenance such as filter changes.  The worst case conditions of 
the disinfectant could be an organically stressed disinfectant which is tested at 
the end of its shelf-life and reuse life against a resistant organism (e.g., a 
mycobacterium test species).  The worst case conditions for an endoscope 
would be testing with an old scope as opposed to a new scope.  The simulated- 
use testing must include the following: 
a.  the protocols for the methods of inoculating and handling of the 
endoscopes prior to processing and the protocols for validating the 
recovery methods (the draft IS0 standard "Sterilization of health care 
products - Validation and routine control - Microbiological methods 
contains examples of acceptable validation methods); 
b.  replicate runs with representative types of endoscopes (at least 3 
mnsltype) as indicated by the labeling claims including a pediatric 
endoscope, if appropriate; 
c.  a separate evaluation of the effectiveness of each process step (washing, 
disinfection, rinsing, etc) over time either based upon the maximum 
number of days of reuse as stated upon the labeling for the disinfectant 
or as directed by the machine's labeling if the number of days of reuse 
is less than that stated on the labeling for the disinfectant.  For 
example, microbiological and chemical testing would be done after the 
first cycle on day 0, at intervals during the testing period, and after the 
final cycle on the last day of the testing period as determined by either 
the germicide labeling or machine labeling.  Reduced testing which 
concentrates on the initial and longest process days (e-g., day 0 and 14 
day) must be justified such as demonstrating the linearity of the 
variables and performance. 
(1)  an evaluation of the washing parameters to demonstrate the 
effectiveness of the washing step, including a fiberoptic 
examination of the endoscopes before and after washing to show 
that the washing cycle removes all visible organic soil; 
(2)  determination of the effectiveness of disinfection phase of the 
washerldisinfector separate from the washing phase; this would 
require inoculation of the endoscopes at the start of the 
disinfection phase;  refer to the FDA's Guidance for Liquid 
Chemical Germicides for the requirements for high level 
disinfection; 
(3)  an evaluation of the rinse phase(s) to show that the 
washer/disinfector-r educes any disinfectant residues to safe  levels and that the rinse cycles reduce any detergent residues to 
levels that do not interfere with the effectiveness of the 
disinfectant (see the discussion on Toxicological Evaluation of 
Residues); 
(4)  evaluation of any other parameters, i.e., alcohol rinse, air 
drying, self-disinfection process, etc. to demonstrate that they 
.  achieve their intended use, and; 
(5)  evaluation of the combined process including the effectiveness of 
the self-disinfection stage for the washerldisinfector, if 
applicable, to demonstrate that the washerldisinfector achieves 
its intended use; the testing protocol should reflect the use 
conditions that a washerldisinfector would experience in an 
endoscopy setting such as multiple cycles over the period of 
time recommended between selfdisinfection or after the 
machine has set over the period of time recommended between 
self-disinfection; microbiologically evaluate the condition of all 
areas which could be a source of contamination before and after 
the self-disinfection cycle. 
3.  In-use Testine;:  Because of the increasing public health concern about the 
transmission of diseases such as AIDS, hepatitis, and tuberculosis, and due to 
the lack of correlation of simulations to actual use, FDA is requiring not only 
simulated-use testing but also in-use testing data. 
The in-use (clinical) testing data must include an evaluation of the 
washerldisinfector to clean and high level disinfect various scopes taken from 
actual patient use.  The test report must include: 
a.  the complete protocol indicating sampling, pretreatment @recleaning), 
handling, posttreatment (type of rinse), etc.; 
b.  evaluation of the major types of scopes indicated in labeling for the 
washerldisinfector; 
c.  a statistically derived sample size for each of the major types of scopes; 
d.  control and treated scopes for each of the major types of scopes; 
e.  colle&on  of specific data on the scope including, but not necessarily 
limited to, scope type and condition of scope; 
f.  microbiological information such as the bioburden loads on the control 
and treated scopes prior to use, immediately after use, and just prior to  placement in the machine, and the extraction method; 
g.  a rigorous statistical evaluation, including explanation of any skips in 
the data (residual growth); and 
h.  comparative data on equivalent machines, if claims are made. 
H.  Software Documentation 
Describe the validation of any software (or firmware).  Refer to the FDA Software 
Reviewers Guide (available from FDA Division of Small Manufacturers Assistance) 
for 510(k) software documentation recommendations.  Unless otherwise directed by 
FDA, automated endoscope washers are considered in the "major" risk category 
described in the software guidance. 
I.  Toxicological Evaluation of Residues 
1.  Introduction 
The 510(k) submission must include an assessment of the level of any 
residues, (e.g. detergents, germicides) remaining on the endoscope after 
processing in the endoscope washerldisinfector and a toxicological evaluation 
of these residues.  This can be satisfied by reviewing the available toxicity 
data of the particular residual chemical from animal toxicity studies sponsored 
by the manufacturer of the chemical or from published literature.  This 
evaluation is needed to determine the potential health risk of the residues 
remaining on the endoscope to the patient and the user. 
2.  Hazard Evaluation 
In ensuring safe conditions of use of the endoscope, the applicant must present 
data which defionstrate that there are no residues remaining on the endoscope 
or that the process .cycle removes the residues to a nontoxic level.  The 
applicant must also present data which demonstrate that there is no 
accumulation of residues over the use-life of the endoscope which could 
present a health risk to the patient and the user. 
J.  Summary of Information Regarding Safety and Effectiveness or Statement of 
Availability of Such Information 
Under the Safe Medical Device Act of 1990, the 5 10(k) shall include either (1) an 
adequate summary of any information respecting safety and effectiveness on which 
equivalence is based, or (2) a statement that information regarding safety and 
effectiveness will be made available upon request to any person.  A summary shall be in a separate section and be clearly indicated as the summary 
respecting safety and effectiveness as required by the amended act. 
Implementing regulations establishing the requirements for the summary and statement 
are forthcoming and will supersede this section.  Notification of the requirements will 
be published in the Federal Register. 
K.  Comments 
General questions regarding the submission of premarket applications should be 
directed to the Division of Small Manufacturers Assistance at (800) 638-2041. 
Questions or comments regarding this guidance should be directed to the following 
address: 
FDA 
Division of General and Restorative Devices, (HFZ-4 10) 
Infection Control Devices Branch 
1390 Piccard Drive 
Rockville, MD 20850-4308  L.  Checklist 
510(k) #:  Sponsor: 
Date:  Reviewer: 
#  YIN  Element 
1.  Cover Letter 
proprietary name 
common or usual name 
classification name 
establishment registration number 
purpose of the submission 
statement that the device is similar to andlor different 
from other products 
previous files referenced 
contact person 
Labeling 
proposed labels and labelings 
labeling requirements 
user's  manual 
service manual 
Standards, Practices, Technical Reports 
Description of the Endoscope Washerldisinfector 
overview of the endoscope washerldisinfector  intended use(s) 
design, construction, components, accessories 
process monitors 
process parameters/development 
Descriptive Comparison to a Predicate 
Performance Data 
physical tests 
simulated-use tests 
in-use tests 
Software Documentation 
Toxicclogical Evaluation of Residues 
residue evaluation 
hazard evaluation 
5 10(k) summary or statement  Attachment 1 
Comparison Table 
Feature  New Device  Predicate 
Labeling 
Intended use  I 
Identification of materials 
that come in contact with 
the fluid pathways 
Operational Principles 
I  I 
Design, constructions, 
I 
components 
Process Monitors: 
recorders, gauges, 
printouts, etc 
Process Parameters: 
time, temperature, input 
1  I 
water quality, pressure, etc 
II  
Softwarelfirmware controls 
I  I 
Cycle comparisons  I 
11  II  
Accessories indicated in 
labeling: 
germicides 
detergents 
I 
enzyme cleaners 
other 
This table illustrates the types of comparisons that should be made, not necessarily the 
amount of information.  It is not all inclusive.