Contains Nonbinding Recommendations 
 
Guidance for Industry and  
FDA Staff 
 
Intravascular Administration Sets 
Premarket Notification 
Submissions [510(k)]  
 
Document issued on: July 11, 2008 
 
This document supersedes Guidance for Industry and FDA Reviewers on 
the Guidance on Premarket Notifications for Intravascular Administration 
Sets, issued April 15, 2005. 
 
 
For questions regarding this document, please contact the chief of the General Hospital 
Devices Branch at 301-796-5580. 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug 
Administration 
Center for Devices and Radiological Health 
General Hospital Devices Branch 
Division of Dental, Infection Control, and General Hospital Devices 
Office of Device Evaluation 
  Contains Nonbinding Recommendations 
 
 
 
Preface 
 
 
Public Comment 
 
Written comments and suggestions may be submitted at any time for Agency consideration to 
the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, 
Room 1061, (HFA-305), Rockville, MD, 20852.  When submitting comments, please refer to 
the exact title of this guidance document.  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 at: 
http://www.fda.gov/cdrh/ode/guidance/1189.html.  You may also send an e-mail request to 
dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 
240-276-3151 to receive a hard copy.  Please use the document number (1189) to identify the 
guidance you are requesting. 
 
  ii Contains Nonbinding Recommendations 
 
Table of Contents 
 
1.  Introduction.......................................................................................................................1 
The Least Burdensome Approach.........................................................................................2 
 
2.  Background.......................................................................................................................2 
3.  The Content and Format of an Abbreviated 510(k) Submission......................................3 
Coversheet.............................................................................................................................3 
Proposed Labeling.................................................................................................................3 
Abbreviated 510(k) Summary Report...................................................................................4 
 
4.  Scope....................................................................................................................................5 
5.  Device Description..............................................................................................................7 
Material Composition............................................................................................................7 
Physical Specifications..........................................................................................................7 
Mechanical Specifications.....................................................................................................8 
Design Features.....................................................................................................................8 
 
6.  Risks to Health.....................................................................................................................8 
7.  Bench Testing......................................................................................................................9 
8.  Microbial Ingress Testing....................................................................................................9 
9.  Simulated Clinical Use Testing.........................................................................................10 
10. Sterilization.......................................................................................................................11 
11. Biocompatibility...............................................................................................................11 
12. Labeling............................................................................................................................11 
Intended Use........................................................................................................................11 
Description of the Device....................................................................................................11 
Directions for Use................................................................................................................12 
Precautions..........................................................................................................................12 
Warnings..............................................................................................................................13 
Labeling of Shelf Containers...............................................................................................13 
 
Appendix I.  Glossary of Terms..............................................................................................14 
Appendix II.  Abbreviations...................................................................................................16 
Appendix III. Recommended Submission Checklists for Intravascular Administration Sets 17 
 
  iii Contains Nonbinding Recommendations 
 
Guidance for Industry and FDA Staff 
 
Intravascular Administration Sets 
Premarket Notification Submissions 
[510(k)] 
 
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking 
on this topic.  It does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public.  You can use an alternative approach if the approach 
satisfies the requirements of the applicable statutes and regulations.  If you want to discuss 
an alternative approach, contact the FDA staff responsible for implementing this 
guidance.  If you cannot identify the appropriate FDA staff, call the appropriate number 
listed on the title page of this guidance.  
 
 
1.  Introduction 
FDA has developed this guidance document to assist industry in preparing premarket 
notification (510(k)s) submissions for intravascular (IV) administration sets and accessories.  
This revision of the document issued in 2005 updates the FDA-recognized standards and 
clarifies our recommendations for microbial ingress testing.  IV administration sets and 
accessories include:  
  extension sets  
  IV stopcocks and manifolds  
  in-line filters  
  flow regulators  
  fluid delivery tubing  
  vial adapters  
  IV transfer sets  
  subcutaneous administration sets  
  blood administration sets  
  transfusion filters.  
 
IV administration sets with or without needleless access devices or systems are also 
addressed in this guidance. A needleless system may be incorporated as an integral  Contains Nonbinding Recommendations 
 
component (e.g., a Y-site connector), or may be marketed separately as an accessory (e.g., 
attached to other devices by the user at the point of use.)  
 
If your device contains a sharps injury prevention (safety) feature, we recommend that you 
consult the guidance entitled, Supplementary Guidance on Premarket Notifications for 
Medical Devices with Sharps Injury Prevention Features, 
http://www.fda.gov/cdrh/ode/guidance/934.html for information about simulated use testing 
of sharps injury prevention features.  
 
The Least Burdensome Approach 
The issues identified in this guidance document represent those that we believe should be 
addressed before your device can be marketed. In developing the guidance, we carefully 
considered the relevant statutory criteria for Agency decision-making. We also 
considered the burden that may be incurred in your attempt to follow the guidance and 
address the issues we have identified. We believe that we have considered the least 
burdensome approach to resolving the issues presented in the guidance document. If, 
however, you believe that there is a less burdensome way to address the issues, you 
should follow the procedures outlined in the document A Suggested Approach to 
Resolving Least Burdensome Issues. It is available on our Centers Web page at 
http://www.fda.gov/cdrh/modact/leastburdensome.html. 
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agency's 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.  
 
2.  Background 
A manufacturer who intends to market a device of this generic type must conform to the 
general controls of the Federal Food, Drug, and Cosmetic Act (the act), including the 
premarket notification requirements described in 21 CFR 807 Subpart E, and obtain a 
substantial equivalence determination from FDA prior to marketing the device. (See also 21 
CFR 807.81 and 807.87.) 
 
This guidance document identifies the classification regulation and product codes for 
hemodialysis blood tubing sets (refer to Section 4. Scope).  Other sections of this guidance 
document provide additional information to manufacturers on addressing risks related to 
these devices in premarket notifications (510(k)s).  
 
This document supplements other FDA documents regarding the specific content 
requirements of a premarket notification submission.  You should also refer to 21 CFR 
  2 Contains Nonbinding Recommendations 
 
807.87, the guidance, Format for Traditional and Abbreviated 510(k)s,1 and Premarket 
Notification 510(k) on CDRH Device Advice.2 
 
Under The New 510(k) Paradigm - Alternate Approaches to Demonstrating 
Substantial Equivalence in Premarket Notifications,3 a manufacturer may submit a 
Traditional 510(k) or has the option of submitting either an Abbreviated 510(k) or a Special 
510(k). FDA believes an Abbreviated 510(k) provides the least burdensome means of 
demonstrating substantial equivalence for a new device, particularly once FDA has issued a 
guidance document addressing that device. Manufacturers considering certain modifications 
to their own cleared devices may lessen the regulatory burden by submitting a Special 
510(k). 
 
3.  The Content and Format of an Abbreviated 510(k) 
Submission  
An Abbreviated 510(k) submission must include the required elements identified in 21 CFR 
807.87, including the proposed labeling for the device sufficient to describe the device, its 
intended use, and the directions for its use.  In an Abbreviated 510(k), we recommend that 
you include a descriptive summary report of appropriate supporting data within the meaning 
of 21 CFR 807.87(f) or (g).  The descriptive summary report should explain how this 
guidance document was used during the device development and testing, briefly describe the 
methods or tests used, and include a summary of the test data or description of the acceptance 
criteria applied to address the risks identified in this document and any other additional risks 
specific to your device.  This section suggests information to fulfill some of the requirements 
of section 21 CFR 807.87 and identifies other items that we recommend you include in an 
Abbreviated 510(k).  
 
Coversheet 
The coversheet should prominently identify the submission as an Abbreviated 510(k) and 
cite the title of this guidance document. 
 
Proposed Labeling 
Proposed labeling must be sufficient to describe the device, its intended use, and the 
directions for its use.  (21 CFR 807.87(e))  (Please refer to Section 11.  Labeling for 
specific information that should be included in the labeling for devices of the type 
covered by this guidance document.) 
 
                                                           
1 http://www.fda.gov/cdrh/ode/guidance/1567.html 
2 http://www.fda.gov/cdrh/devadvice/314.html  
3 http://www.fda.gov/cdrh/ode/parad510.html  
  3 Contains Nonbinding Recommendations 
 
4
Abbreviated 510(k) Summary Report  
In accordance with 21 CFR 807.87, your summary report should contain the following:  
 
Description of the device and its intended use   
Please describe the device and include an explanation of how the device functions 
and the specific physical and performance characteristics of the device.  Refer to 
Section 5.  Device Description for specific information to include in the device 
description for devices of the type covered by this guidance document.  You should 
also submit an indications for use enclosure.5   
 
Description of device design  
You must include a brief description of the device design requirements. (21 CFR 
807.87(f)) 
 
Identification of the risk analysis method 
We recommend that you identify the risk analysis method(s) you used to assess the 
risk profile, in general, as well as the risk profile of the specific devices design and 
the results of this analysis. Please refer to Section 6.  Risks to Health for the risks to 
health generally associated with the use of this device that FDA has identified. 
 
Discussion of the device characteristics  
We recommend that you discuss the device characteristics that address the risks 
identified in this guidance document and any additional risks identified in your risk 
analysis.   
 
Description of the performance aspects 
You should describe the nonclinical tests submitted, referenced, or relied on in your 
submission.  See Sections 7-10 of this guidance for specific performance aspects.    If 
you follow a suggested test method, you may cite the method rather than describing 
it.  If you modify a suggested test method, you may cite the method but should 
provide sufficient information to explain the nature of and reason for the 
modification.  For each test, you may either (1) briefly present the data resulting from 
the test in clear and concise form, such as a table, or (2) describe the acceptance 
criteria that you will apply to your test results.6  (See also 21 CFR 820.30, Subpart C 
- Design Controls for the Quality System Regulation.) 
                                                           
4 This is not the report described in 21 CFR 807.92, which may be submitted to satisfy 21 
CFR 807.87(h). 
5 Refer to http://www.fda.gov/cdrh/ode/indicate.html for the recommended format. 
6 If FDA makes a substantial equivalence determination based on acceptance criteria, the 
subject device should be tested and shown to meet these acceptance criteria before being 
introduced into interstate commerce.  If the finished device does not meet the acceptance 
  4 Contains Nonbinding Recommendations 
 
 
Reliance on standards 
If you choose to rely on a recognized standard for any part of the device design or 
testing, you may include either a:  
 
  statement that testing will be conducted and meet specified acceptance criteria 
before the device is marketed; or  
 
  declaration of conformity to the standard.7   
 
Because a declaration of conformity is based on results from testing, you cannot 
properly submit a declaration of conformity until you have completed the testing the 
standard describes.  For more information, please refer to section 514(c)(1)(B) of the 
act and the FDA guidance, Use of Standards in Substantial Equivalence 
Determinations.8  
 
If it is not clear how you have addressed the risks identified by FDA or additional risks 
identified through your risk analysis, we may request additional information about aspects of 
the devices performance characteristics.  We may also request additional information if we 
need it to assess the adequacy of your acceptance criteria.  Under 21 CFR 807.87(l), you 
must submit any additional information that is necessary to reach a determination regarding 
substantial equivalence.  
 
As an alternative to submitting an Abbreviated 510(k), you can submit a Traditional 510(k) 
that provides all of the information and data required under 21 CFR 807.87 and described in 
this guidance.  A Traditional 510(k) should include all of your methods, data, acceptance 
criteria, and conclusions.  Manufacturers considering certain modifications to their own 
cleared devices should consider submitting Special 510(k)s.  
 
The following is a specific discussion of how you should apply this guidance document to a 
premarket notification submission for IV administration sets and accessories.  
 
4.  Scope 
The scope of this document is limited to the device defined in 21 CFR 880.5440, class II, and 
assigned the product codes described in the table below. 
                                                                                                                                                                                    
criteria and, thus, differs from the device described in the cleared 510(k), FDA recommends 
that submitters apply the same criteria used to assess modifications to legally marketed 
devices (21 CFR 807.81(a)(3)) to determine whether marketing of the finished device 
requires clearance of a new 510(k). 
7 See http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3654.pdf 
8 See http://www.fda.gov/cdrh/ode/guidance/1131.html 
  5 Contains Nonbinding Recommendations 
 
Procod
Common Name 
e 
FMG  IV Set Stopcock  
(includes manifolds) 
FPA  Intravascular Administration Set  
(includes needleless access devices/systems and blood flow 
regulator) 
BRZ  Blood Transfusion Set 
FPB  Infusion Line (In-Line) Filter 
CAK  Blood Transfusion Microfilter 
FPK  Fluid Delivery Tubing 
LHI  IV Fluid Transfer Set  
(includes vial adapter) 
Pharmacy compounding systems (procode NEP) classified in the intravascular administration 
set identification are exempt from the premarket notification procedures, subject to the 
limitations in 21 CFR 880.9. 
 
Section 880.5440 Intravascular Administration Set  
An intravascular administration set is a device used to administer fluids from a container 
to a patients vascular system through a needle or catheter inserted into a vein. The 
device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an 
infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts 
of the set, a side tube with a cap to serve as an injection site, and a hollow spike to 
penetrate and connect the tubing to an I.V. bag or other infusion fluid container.  
 
IV administration sets administer fluids to a patients vascular system by various means, 
gravity flow, via a pump, subcutaneously, or through implanted vascular ports. These IV sets 
may include Diethylhexylphthalate (DEHP) and non-DEHP PVC tubing, co-extruded tubing, 
calibrated burettes, filters, standard and needle free Y-injection sites (swabbable and non-
swabbable), anti-siphon valves, and check valves to prevent retrograde fluid flow.  
 
  6 Contains Nonbinding Recommendations 
 
5.  Device Description 
We recommend that you identify your device by regulation and product code described in 
Section 4. Scope, and include the following information:   
  indications for use 
  design features; i.e., materials, configurations, size, safety features  
  specifications and dimensions  
  materials, including chemical formulation  
  conformance with standards.  
 
Side by side comparisons of the information described below, whenever possible, in tabular 
format are desirable.  We recommend that you describe how any differences may affect the 
comparative safety and effectiveness of the new device.  
 
Material Composition 
We recommend that you provide a complete listing of all device materials (trade name 
and chemical formula) and identify any metallic components. Metallic components may 
affect the safety of the device in an MRI environment. We also recommend that you 
identify any polyvinylchloride (PVC) plasticizers, lubricants, bonding agents, or other 
additives (e.g., color additives, ink, dyes, markings, radiopaque materials) and provide 
their amounts. 
 
It is helpful to present the information in the form of a listing, noting the component 
name followed by specific material identifier. We believe stating only a generic class 
(e.g., PVC) is not adequate because there are many formulations of material 
compositions.  
 
Physical Specifications 
When describing physical specifications, we recommend that you include: 
  dimensions: inner diameter (ID), outer diameter (OD), length, width  
  types of configurations  
  priming volume  
  residual volume in needleless access ports  
  dimensions of other features  
  proximal and distal end configuration: shape, location, and diameter of outlets 
and side ports  
  connector types: e.g., Luer lock, slip fit  
  the color of all components  
  any other unique physical features and specifications of the device.  
  7 Contains Nonbinding Recommendations 
 
 
Mechanical Specifications 
When providing mechanical specifications, we recommend that you provide: 
  strength of materials (tensile, flexural)  
  strength of joints, bonds, connections, hinges, valves, locking mechanisms, etc.  
  tubing elongation  
  connector performance criteria; e.g., to prevent leakage  
  burst pressure  
  puncture/reseal limits of septa  
  flow characteristics  
  material hardness  
  crimping/flexion when intended for use with infusion pumps.  
 
Design Features 
We recommend that you describe the design features of your device and any similarities 
or differences between those features and features of similar legally marketed devices of 
the same type, which may affect safety and effectiveness. 
 
6.  Risks to Health 
In the table below, FDA has identified the risks to health generally associated with the use 
of intravascular administration sets and accessories addressed in this document. The 
information we recommend you include in your 510(k) to address these identified risks are 
given in this guidance document, as shown in the table below. We recommend that you 
conduct a risk analysis to identify any other risks specific to your device and submit the 
results of this analysis. If you elect to use an alternative approach to address a particular risk 
identified in this document or have identified risks additional to those in this document, you 
should provide sufficient detail to support the approach you have used to address that risk. 
 
Identified risk  Recommended mitigation measures 
Device malfunction  Section 7. Bench Testing  
Adverse tissue reaction  Section 11. Biocompatibility 
Infection  Section 8. Microbial Ingress Testing 
Section 9. Simulated Clinical Use Testing 
Section 10. Sterilization 
Improper use  Section 12. Labeling 
 
  8 Contains Nonbinding Recommendations 
 
7.  Bench Testing 
We recommend that you conduct all testing under both a dry test condition and a wet 
environment simulating body fluids or fluids being administered. We recommend that you 
evaluate your device compared with a similar legally marketed device, using worst case 
simulated static and dynamic forces to the failure point of the components. We also 
recommend that you describe how you determined the worst case conditions used. Testing 
should assess: 
  the force to attach and detach connections  
  the force to activate and deactivate any safety features present  
  the number of injection port accesses to failure for needleless port with valves, 
diaphragms, or membranes  
  the pressure and leak tolerance for pre-slit septa under extreme conditions of use.  
 
In addition, when your device is intended for use with other manufacturers blunt cannulae, 
we recommend that you conduct the pressure and leak tolerance testing for pre-slit septa 
under extreme conditions of use with those blunt cannulae. 
 
Where appropriate to your devices intended use or design, we recommend that you follow 
the standards listed below or equivalent measures, in addition to the testing described above.  
  ISO 8536-4: 2004, Infusion Equipment for Medical Use, Part 4  
  ANSI/AAMI BF7:  R2002, American National Standard for Blood Transfusion Micro 
Filters  
  ISO 1135-4: 2004, Transfusion Equipment for Medical Use  
  ISO 594, Conical Fittings with a 6 % (Luer) Taper for Syringes, Needles, and Certain 
Other Equipment.  
 
8.  Microbial Ingress Testing 
A needleless device that facilitates bi-directional fluid flow may increase the patients risk of 
infection because these features allow the entry of microorganisms into the sterile fluid path. 
We recommend that you conduct microbial ingress testing of these devices. This testing is 
intended to simulate repeated access. 
 
We recommend that you provide results from a simulated use test for microbial ingress in 
your device. Testing should simulate the use of the device in a clinical setting, i.e., the 
number of microbial challenges in the study should approximate the number of user 
interactions with the access site that would be expected clinically. The testing should 
demonstrate that the disinfection procedures you use are effective. We recommend that you 
provide an analysis of the study results and a summary of the results and conclusions.  
 
  9 Contains Nonbinding Recommendations 
 
We recommend that you provide a detailed protocol for your study, which describes the: 
  study procedure for the subject device  
  amount and identity of challenge organisms  
  methods used to prepare the challenge organisms commonly associated with 
contaminated needleless access devices, i.e. 2 gram negative and 2 gram positive 
organisms. 
  method of device contamination/inoculation for all sites of device inoculated  
  access procedure  
  time and culture procedures  
  rationale for the challenge microorganisms used as inoculum (minimum of 103 per 
device)  
  type of environment in which the study was conducted  
  positive (non-disinfected device) and negative controls used in the study  
  rationale for the sample size used in the study 
  validation (using microbiological techniques) of the disinfecting procedures for 
insertion and reinsertion into the needleless access site.  
 
9.  Simulated Clinical Use Testing 
For devices that include sharps injury prevention features, we recommend that you conduct 
simulated clinical use testing; provide an analysis of the results; and a summary of the results 
and conclusions.  For information about this kind of testing, see Training for Development of 
Innovative Technologies Project,9 and the guidance entitled, Supplementary Guidance on 
Premarket Notifications for Medical Devices with Sharps Injury Prevention Features.10  
 
We recommend that you provide a detailed protocol for your study that addresses variables 
in the patient and health care professional user populations. If the device will be exposed to 
many conditions of use, we recommend that you assess the variables to accurately judge the 
performance of the device under these conditions. These variables include, but are not 
limited to training, learning curve, and the experience of users. For information about device 
design and human factors, see ANSI/AAMI HE48-1993: Human factors engineering 
guidelines and preferred practices for the design of medical devices and the FDA guidance 
entitled, Do It By Design - An Introduction to Human Factors in Medical Devices.11 
 
                                                           
9 http://www.tdict.org 
10 http://www.fda.gov/cdrh/ode/guidance/934.html 
11 http://www.fda.gov/cdrh/humfac/doit.html 
  10 Contains Nonbinding Recommendations 
 
We recommend that you devise protocols, whenever possible, based on statistical 
considerations, such as sample size, response variables, pass-or-fail criteria, comprehensive 
report forms, proper controls, and appropriate statistical test methods. (This guidance does 
not provide a detailed discussion of statistical considerations).  
 
10. Sterilization 
FDA recommends that you provide sterilization information as described in the guidance, 
Updated 510(k) Sterility Review Guidance K90-1.12  The device should be sterile, with a 
sterility assurance level (SAL) of 1 x 10-6 using a sterilization cycle that has been validated 
in accordance with the Quality Systems (QS). 21 CFR 820.30. 
 
11. Biocompatibility 
We recommend that you conduct biocompatibility testing for your device as a prolonged 
duration, indirect blood path contacting device as described in the guidance entitled, Use of 
International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: 
Evaluation and Testing.13  You should select the tests appropriate for the duration and level 
of contact and submit your pass/fail criteria.  We also recommend that you document the 
results in your design history file as a part of the QS (21 CFR 820.30).  If identical materials 
are used in a predicate device with the same type and duration of contact, you may identify 
the predicate device in lieu of performing biocompatibility testing. 
 
12. Labeling 
Labeling must provide sufficient detail to satisfy the requirements of 21 CFR 807.87(e).  The 
following information will assist you in meeting the requirements of 21 CFR Part 801.14 
 
Intended Use 
We recommend that you clearly state the intended use of your device and include the 
indications for use and include the intended (target) population, e.g., pediatric patients. If 
your device is intended for use with a specific blunt cannula, infusion pump, or other 
device, we recommend that you identify that device.  
 
Description of the Device 
                                                           
12 http://www.fda.gov/cdrh/ode/guidance/361.html 
13 http://www.fda.gov/cdrh/g951.html 
14 Although final labeling is not required for 510(k) clearance, final labeling must comply 
with the requirements of 21 CFR 801 before a medical device is introduced into interstate 
commerce.  In addition, final labeling for prescription medical devices must comply with 21 
CFR 801.109.  Labeling recommendations in this guidance are consistent with the 
requirements of part 801. 
  11 Contains Nonbinding Recommendations 
 
We recommend that the description of the device include: 
  type  
  set length, in inches and millimeters  
  inner diameter (ID)  
  outer diameter (OD)  
  drops/ml  
  priming volume  
  filter  
  needle gauge and length  
  single use only, nontoxic, non-pyrogenic fluid path, where applicable  
  sterile, if package is intact, undamaged, and protective caps are secure.  
 
Directions for Use 
We recommend that your directions for use include: 
  a step-by-step procedure for use of the device  
  a step-by-step procedure for the use of needleless access components, where 
applicable  
  special patient instructions (including instructions for contacting the healthcare 
provider if indicated for home use)  
  the recommended frequency of replacing the IV set or needless access device, as 
appropriate, for example per CDC guidelines or facility protocol  
  the duration of use and frequency of replacing IV sets when used for the 
administration of lipids, blood, or blood products according to their labeling  
  directions for replacing the sterile cap (needleless access devices without pre-slit 
septa only) with each use unless a mechanism is in place to keep the cap sterile  
  instructions for cleaning and disinfecting y-sites  
  instructions for cleaning and disinfecting pre-slit septa, where applicable  
  instructions for discarding a used device.  
 
We also recommend that you include illustrations, pictures, posters, cards, and other 
visual aids that clarify and reinforce the directions for use.  
 
Precautions 
We recommend that labeling include any special limitations related to opacity or the type 
of solutions used with the device (e.g., light sensitive solutions, fat emulsions, lipids, 
blood, and blood products). We also recommend that labeling identify the presence of the 
  12 Contains Nonbinding Recommendations 
 
plasticizer DEHP in the fluid pathway of PVC tubing, because leaching of the plasticizer 
is possible on contact with lipids. 
 
Warnings  
We recommend that labeling warn against use with high-pressure infusion systems, 
where applicable. 
 
For administration sets that may be used with infusion pumps with no restricted flow 
feature, labeling should include warnings related to unrestricted flow and instructions for 
use with gravity flow. 
 
Labeling of Shelf Containers 
For labeling a multi-unit or shelf container, we recommend that you include: 
  a description of the contents, in words and/or pictures  
  the number of infusion sets or accessories  
  instructions for use in each shelf container  
  terms describing whether the units are sterile and single use  
  the year and month of sterilization  
  the recommended storage conditions, if any.  
  13 Contains Nonbinding Recommendations 
 
Appendix I.  Glossary of Terms 
The terms here are defined for the purpose of this guidance document only, unless otherwise 
noted. 
 
Anti-Siphon Valve. An accessory to an IV administration set that protects against 
unregulated gravity fluid infusion or blood. 
Backcheck Valve. An accessory to an IV administration set that allows for uni-directional 
fluid flow and serves as a multiple access site for the injection of fluids.  
Blood Administration Set. A device used as part of a system to administer and filter blood 
and/or blood components to a patient. 
Capped Luer Connector. A needleless system that is the same as those commonly used at 
the catheter end of IV sets. The mating Luer fitting of a syringe or secondary set can be 
aseptically connected directly to the Luer port. A manual clamp is included on the tubing 
above the Y-site to prevent fluid flow while attaching or detaching a connection; when the 
port is not in use, it is capped to maintain a closed system. Alternately, a pre-pierced septum 
injection adapter, recessed needle injection adapter, or valved connector can be aseptically 
placed on the Luer connector of the capped Luer Y-site to provide a self-sealing site. See 
also p.328, Needlestick-prevention Devices, ECRI Health Devices. 23: (89) Aug./Sept. 
1994. 
Filter. An accessory to or component of an IV administration set; a device that is designed to 
eliminate entrapped air or inadvertent particulates and microbial contaminants from solutions 
prior to patient administration.  
Intravascular Administration Set. A device used to administer fluids from a container to a 
patients vascular system through a needle or catheter inserted into a vein. The device may 
include a needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, 
an IV set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube 
with a cap to serve as an injection site, and a hollow spike to penetrate and connect the 
tubing to an IV bag or other infusion fluid container (21 CFR 880.5440).  
IV Flow Regulator. An accessory (to an IV administration set) that controls the flow of 
intravenous solutions. 
IV Manifold. An accessory to an IV administration set that provides multiple access ports 
and regulates the directional flow of fluids for simultaneous/alternate intravenous therapy. 
IV Stopcock. An accessory to an IV administration set that regulates the directional flow to a 
patient's vascular system and provides an access port(s) for the administration of solutions.  
  14 Contains Nonbinding Recommendations 
 
Needleless System. Components of a device that provide repeated access to a patients 
vascular system without the use of sharps. Fluid flow through the system may be uni-
directional or bi-directional, with the latter enabling the user to administer or withdraw fluids 
or medication. Needleless mechanisms include three types: pre-pierced septum and blunt 
cannula; valved connector (also called reflux valve); and capped Luer connector. 
Prepierced Septum and Blunt Cannula. A needleless system in which a blunt cannula is 
placed on the syringe or secondary set. It can be aseptically inserted into a pre-pierced 
septum on a Y-site, injection adapter, or extension set. 
 
Valved Connector (also called reflux valve). A needleless system in which a valved 
connector prevents the flow through the connector until a mating Luer connector is 
aseptically inserted; the valve then opens.  
Vial Adapter. A device designed to facilitate the withdrawal of drugs or solutions from a 
vial and may have a needleless device component as part of its design.  
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Appendix II.  Abbreviations 
 
AAMI  Association for the Advancement of Medical Instrumentation 
ANSI  American National Standards Institute 
ASTM  American Society for Testing and Materials 
CDC  Centers for Disease Control and Prevention 
CDRH  Center for Devices and Radiological Health 
CFR  Code of Federal Regulations 
Division of Anesthesiology, General Hospital, Infection Control, and Dental 
DAGID 
Devices 
DEHP  Diethylhexylphthalate 
DSMICA  Division of Small Manufacturers, International, and Consumer Assistance 
ECRI  Emergency Care Research Institute 
FDA  Food and Drug Administration 
ID  Inner Diameter 
IRB  Institutional Review Board 
ISO  International Organization for Standardization 
IV  Intravascular 
OD  Outer Diameter 
ODE  Office of Device Evaluation 
 
 
 
  16 Contains Nonbinding Recommendations 
 
Appendix III. Recommended Submission Checklists for 
Intravascular Administration Sets 
Device Description 
Item Included  Yes  No  Comments 
Narrative description          
Photographs or labeled 
        
diagrams 
Insertion tube, if 
        
applicable 
Sample provided          
Physical Specifications 
Item Included  Yes  No  Comments 
Dimensions and volumes          
Proximal and distal end 
        
configurations 
Connector type          
Color (purpose)          
Opacity          
Markings and scales          
Special features          
Mechanical Specifications 
Item Included  Yes  No  Comments 
Strength of materials          
Stress characteristics          
Fluid flow rate          
Lubricant identified (if 
        
applicable) 
Material Specifications (cont.) 
Item Included  Yes  No  Comments 
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Tensile strength          
Burst test          
Leakage test          
Security of attachments          
Hardness          
Percentage tubing elongation          
Crimping or flexing with 
        
clamp 
Cyclic performance with  
        
pump 
Labeling 
Item Included  Yes  No  Comments 
Device name          
Intended use          
Type          
Size, set length          
Inner diameter          
Outer diameter          
Drops/ml          
Priming volume          
Filter          
Needle gauge and length          
Quantity          
Single use only          
Sterile, non-toxic          
Non-pyrogenic fluid path          
Directions for use          
Promotional materials          
Plasticizer          
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Sterilization 
Item Included  Yes  No  Comments 
Method (EtO/Gamma)          
Validation Method          
SAL          
Dosage (if gamma 
        
irraditated) 
Residues (if ethylene 
        
oxide) 
Pyrogen-free method          
Packaging materials          
Tabular Comparison to a Legally Marketed Device 
Item Included  Yes  No  Comments 
Identified as appropriate 
        
legally marketed device 
Side-by-side comparison          
Features          
Intended use(s)          
Labeling          
All materials          
Specifications (as above)          
Performance data          
Technological aspects          
How differences may 
affect safety and          
effectiveness 
 
Biocompatibility Tests 
Item Included  Yes  No  Comments 
Cytotoxicity          
  19 Contains Nonbinding Recommendations 
 
Sensitization          
Intracutaneous          
Systemic toxicity          
Hemocompatibility          
Other          
Performance Studies 
Item Included  Yes  No  Comments 
Risk analysis, if 
        
appropriate 
Microbial challenge, if 
        
appropriate 
Simulated use study          
Actual use study, if 
        
appropriate 
 
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