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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 updated in the next revision to include the standard elements of GGP’s.
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GUIDANCE ON THE CONTENT OF PREMARKET NOTIFICATION [510(K)] SUBMISSIONS FOR EXTERNAL INFUSION PUMPS |
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March 1993
GUIDANCE ON THE CONTENT OF PREMARKET NOTIFICATION [510(K)]
SUBMISSIONS FOR EXTERNAL INFUSION PUMPS
I. Introductory Information
A. Scope
This document establishes the 510(k) review requirements for external
infusion pumps. The external infusion pump may be electrically powered,
mechanically powered, or use an alternate energy source. Examples of
devices within this generic type include peristaltic, piston,
spring-driven, syringe, and elastomeric types of pumps. Accessory devices,
such as carrying cases, are also included within this type of device.
Disposable functional components such as infusion sets or cassettes,
provided or specifically recommended for use with these devices, must be
identified and demonstrated to be either: 1) substantially equivalent, or
2) legally marketed medical devices. If these functional components are
included for evaluation in this submission they should meet all other
applicable guidance.
EXCLUSIONS
This document does not address submissions for implantable infusion
pumps or closed-loop devices, which both require premarket approval. This
document also does not cover pressure infusors for I.V. bags (as described
in 21 CFR 880.5420).
B. Purpose
This guidance is intended to:
1. assist persons (manufacturers, distributors, or
importers) in organizing premarket notifications for
external infusion pumps;
2. achieve consistency in meeting of requirements and in
the presentation of information; and
3. guide FDA review staff in conducting and documenting
the review of premarket notifications for external
infusion pumps.
C. Definitions
1. Infusion Pump: described in FDA regulation, 21 CFR
880.5725, as "a device used in a health care facility
to pump fluids into a patient in a controlled manner.
The device may use a piston pump, a roller pump, or a
peristaltic pump and may be powered electrically or
mechanically. The device may also operate using a
constant force to propel fluid through a narrow tube
which determines the flow rate. The device may include
means to detect a fault condition, such as air in, or
blockage of, the infusion line and to activate an
alarm."
2. Cassette: a specially designed disposable
component/accessory that mates with the infusion pump
to complete the pumping or controlling mechanism.
3. Elastomeric Pump: an infusion pump which utilizes the
energy in an elastic membrane to provide the force for
fluid delivery.
4. Flow Profile: a graph or table representing
numerically the flow rate versus time over the course
of an infusion.
5. Fluid Pathway: all portions of the device or any
accessories which contact the fluid being infused.
6. Patient Controlled Analgesia (PCA) Pump: an infusion
pump, intended for the delivery of analgesics, which is
equipped with a component which allows for additional
limited delivery upon patient demand.
7. Syringe Pump: an external infusion pump which utilizes
a piston syringe as the fluid reservoir and to control
fluid delivery.
8. Intended Use: 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 ( 801.4). Some use conditions
for infusion pumps may include single use only, home
use, reusable, intravenous and intra-arterial delivery.
9. Abbreviations:
AAMI - Association for the Advancement of Medical
Instrumentation
ANSI - American National Standards Institute
CBER - Center for Biologics Evaluation and Research
CDER - Center for Drug Evaluation and Research
CDRH - Center for Devices and Radiological Health
CFR - Code of Federal Regulations
DSMA - Division of Small Manufacturers Assistance
FDA - Food and Drug Administration
FR - Federal Register
IEC - International Electrotechnical Commission
ISO - International Organization for Standardization
OCS - Office of Compliance and Surveillance
ODE - Office of Device Evaluation
SMDA - Safe Medical Devices Act of 1990
UL - Underwriters Laboratory
D. General 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 pages/sections 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
circumstances of 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 510(k)
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 that adequately indicates the nature of
the data.
Graphs should supplement, not replace, data tables.
They should be of a high 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. All referenced reports and
data should be summarized including an explanation how
it relates to the current submission. Reference
citations should be complete (e.g., title, author,
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: In support of the 510(k)
the applicant may reference any information previously
submitted to FDA. If the applicant did not submit the
referenced data he must provide, or have the submitter
provide to FDA, a letter of authorization. Often, if
the data are not extensive, resubmitting data in the
510(k) will facilitate the review of the document.
E. Document Availability
The following documents are available from DSMA [(800)638-2041 or
(301)443-6597]:
Tripartite Biocompatibility Guidance for Medical Devices ODE Blue
Book Memorandum #K90-1: 510(k) Sterility Review Guidance Reviewer
Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review.
II. Content and Organization of Information in a 510(k) for an
External Infusion Pump
A. Cover Letter
The submission shall have a signed cover letter providing the
following information described in 807.87 (Information required in a
premarket notification submission):
1. The infusion pump's trade or proprietary name.
2. Common Name: Syringe Pump, Elastomeric Pump, etc.
3. Classification name: Infusion Pump
4. The establishment registration number, if applicable,
of the sponsor, owner or operator submitting the
premarket notification
5. Class: II
Panel: 80
Procodes: list all the following that apply
FRN - Infusion Pump
MEA - PCA External Infusion Pump
MEB - Elastomeric External Infusion Pump
LZG - External Insulin Infusion Pump
LZH - External Enteral Infusion Pump
FPA - Intravascular (IV) Administration Set
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
807.87(g) for additional information regarding changes
to devices. The change may require some or all of the
information needed for a new device. Please supply the
previous 510(k) number(s), if applicable.
7. A brief statement indicating the device is similar to
and/or different from other products of comparable type
in commercial distribution.
8. Name, address, and phone number of a U.S. contact
person, if available.
B. Labels and Labeling
1. The submission shall 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
or its container or packaging. Labeling also includes
professional or patient package inserts, and any other
information that accompanies the device.
2. 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 portion of Part
801:
Subpart A, 801.4 and 801.5, related to intended
uses and adequate directions for use; and
Subpart B, 801.109 and 801.116, related to
prescription devices and commonly known
directions.
Other provisions of Part 801 are deferred for review to
CDRH/OCS Device Labeling Compliance Branch.
3. Labeling for an infusion pump should include:
a. a list of device specifications including, but not
limited to: reservoir volume, flow rates and
profiles (if applicable), accuracy, residual
volume, and the operational conditions (e.g.,
temperature, pressure, fluid viscosity) under
which these are valid;
b. route(s) of administration as indicated in the
statement of intended use (see section D.2.);
c. the fluid(s) to be administered by the pump as
indicated in the statement of intended use (see
section D.2.);
d. comprehensive directions for preparation and use
for all possible functions of the device;
e. a description of all warning and alarm features;
f. a copy of patient instructions for use if the
device is intended for home use, or would
reasonably be expected to be used in a home
setting;
g. the prescription statement found under
801.109(b)(1);
h. instructions for cleaning and maintenance which is
to be done by the user; and
i. an identification of any dedicated administration
set or the specifications and/or specific models
of infusion sets which are appropriate for use
with this pump.
C. Standards
Listed are some, but not all, of the standards related to infusion
pumps:
1. AAMI, Draft Infusion Device Standard
2. UL 544 Standards for safety, medical and dental
equipment
3. IEC 601-1/ANSI ES1-1985 Safe Current Limits for
Electromedical Apparatus
The applicant may certify that the device meets a standard. The
applicant then is obliged to comply with the standard and maintain
documentation of tests showing that the device meets the standard.
Certification of meeting a specific standard and reference to standards in
the 510(k) may reduce the documentation needed in the 510(k) submission.
This is noted in pertinent sections.
D. Device Description
The applicant must submit a complete description of the device,
including all models and variations.
1. State the type of infusion pump (e.g., peristaltic,
piston, syringe). Provide a labeled representation of
the device in sufficient detail to facilitate the
evaluation of the nature and operation of the device
(e.g., photographs, detailed drawings, or engineering
drawings). If the labeling already includes sufficient
illustrations of the device, refer to the labeling.
2. Provide a clear statement of the intended use(s) of the
infusion pump.
a. Specify the route(s) of administration.
b. If the infusion pump is labeled for use with a
specific drug/biologic, the applicant must supply
information demonstrating that use of the
drug/biologic with the device is consistent with
the approved drug/biologic labeling.
c. Identify any specific uses for the pump. For
example, PCA is a generally accepted specific use
for a pump used to deliver analgesics.
d. State whether the infusion pump is indicated for
the delivery of blood or blood products.
3. Provide the following information for the device. The
applicant may refer to relevant standards.
a. Physical Specifications and Descriptions
(1) Components: Identify and describe all major
components or component groups (i.e., not
individual electronic or mechanical components)
and give dimensions. Each component/component
group should be identified as reusable or
disposable. Identify any component/component
group which contacts the fluid path.
(2) Pumping Mechanism (Fluid Control Mechanism):
Describe the physical method used to generate and
control fluid flow. Identify and provide
specifications for all major components involved
in this process.
(3) Administration Sets & Drug Reservoir: Identify
sets appropriate for use with the pump.
Peristaltic and piston devices often have
specialized administration sets which must be used
with the individual pump. Describe the drug
reservoir. Indicate if these are currently
legally marketed devices or if they are included
for evaluation in this submission.
(4) Power Requirements: Describe the energy/power
requirements and characteristics. Indicate if
device meets UL 544 (if applicable). If not,
describe how it deviates from the standard.
(5) Materials: Identify the basic materials of
construction. Provide the chemical formulation of
all materials which contact the fluid path.
b. Operational Specifications and Descriptions
(1) Flow Rates and Profiles: State the accuracy for
the device. Describe all possible delivery rates
and flow profiles, and the operational conditions
(e.g., temperature, pressure, fluid viscosity)
under which the device will meet the stated
accuracy figure. List the reservoir volume and
residual volume.
(2) Safety/Alarm Functions: For electronic pumps
describe all of the various alarm, warning and
safety functions, both hardware and software, of
the device. For mechanical devices describe any
safety mechanisms built into the device.
(3) Other Capabilities: Describe any other
capabilities the device may possess.
c. Biological Specifications
State the biocompatibility category for all
components and materials in the fluid pathway per
the draft ISO 194 Biocompatibility Standard or the
Tripartite Biocompatibility Guidance.
d. Chemical Specifications
(1) State the compatibility requirements for the
device with any specific drug or biologic
referenced in the device labeling.
(2) State the stability requirements for storage of
any specific drug or biologic referenced in the
device labeling.
E. Descriptive Comparison to a Legally Marketed Device
Identify a legally marketed infusion pump to which substantial
equivalence is claimed. (If possible, identify the 510(k) number(s).)
More than one infusion pump 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 or different from the legally marketed device. Side by side
comparisons, whenever possible are desirable (see Attachment 2). This
information may be identical to that provided under Part D and the
applicant may wish to combine some or all of Parts D and E information.
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
representations of the legally marketed device(s),
unless the labeling has ample information.
2. Compare and contrast the intended use for the new
device to the predicate device(s).
3. Compare materials used to fabricate fluid path
components. The precise materials of the fluid path of
the new device, and if possible, the predicate
device(s) should be identified to the extent possible.
4. Compare the operational principles including mode of
action.
5. Compare physical, operational, biological, and chemical
specifications.
F. Performance Data Supporting Substantial Equivalence
Provide the protocols and results of the tests indicated below. If
the stated test is taken from a standard that specifically addresses the
performance criterion, then the applicant should reference the standard and
certify that the device will meet the criterion. Data need not be
submitted in this instance.
The studies should be well-designed to meet the stated objectives.
This will include rigorous attention to: statistical elements (hypotheses,
test statistics, analyses, sample size and sampling, power, etc.),
inclusion/exclusion criteria, controls, minimization of bias, test
parameters (endpoints), follow-up, evaluation criteria, etc. Some of the
above points may overlap. Ample reference material exists on study design
and methods upon which the applicant may rely (e.g., biocompatibility).
1. Bench Data
The following bench data is generally necessary for a
non-electronic pump or any pump with a unique design
unless the sponsor can completely address all of the
following issues using device specifications.
a. For a pump intended only to maintain a constant
set flow rate, this data should demonstrate that
the device can maintain a set flow rate over the
complete course of the infusion within the
designated accuracy. The testing should
demonstrate adherence to specifications at the
limits of the operational parameters.
b. For a pump which does not maintain a constant flow
rate, testing results should be used to generate a
representative flow profile. This representative
flow profile must be included in the device
labeling.
c. Testing should also demonstrate that the device
can maintain the specified flow characteristics
despite changes in ambient temperature, pressure,
or fluid viscosity, which would reasonably be
expected to be encountered according to the
intended use of the device. If significant, the
effects of these factors should be discussed
quantitatively in the labeling so the user is made
aware of the effects of these factors.
2. Comparative Claims
Additional data may be needed to support comparative
claims.
3. Unique Designs
Additional data may be needed to support designs that
are significantly different from typical designs.
4. Biocompatibility Data
For all fluid path materials certify that the identical
materials have been used in other legally marketed
devices under the same use conditions, or provide
documentation attesting to the biocompatibility of the
component materials in the finished product according
to the 1987 Tripartite Biocompatibility Guidance for
Medical Devices and 1992 draft ISO 194 standard
(Biological testing of medical and dental materials and
devices). With regard to metals, the applicant may
simply identify device components made of an ASTM grade
of metal that ASTM certifies is biocompatible, e.g.,
ASTM 316 stainless steel.
Biocompatibility test data may be required for colors
that are not listed in FDA regulations or are not used
in other legally marketed devices for a similar
intended use.
5. Drug/Biologic and Device Compatibility
Data demonstrating drug or biologic and material
compatibility is required if a specific drug or
biologic is referenced in the device labeling.
6. Drug/Biologic Stability
If the device labeling indicates that the drug or
biologic is to be stored in the reservoir, stability
data for the recommended storage period and conditions
is required.
G. Software
The sponsor must indicate the level of concern (see p.16 of the
document indicated below) for pumps which are software controlled and
provide appropriate software information according to the "Reviewer
Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review."
H. Sterilization Information
See Attachment 1
I. SMDA Information
Summary or Statement of Safety and Effectiveness
All persons submitting a 510(k) must include either a summary of
safety and effectiveness information in the 510(k) upon which an
equivalence determination could be based OR a statement that safety and
effectiveness information about the [device name] will be made available to
any interested person upon request. Safety and effectiveness information
refers to adverse safety and effectiveness information, descriptive
information about the new and predicate devices, and performance/clinical
testing information.
If the summary option is selected, it should be included on a separate
page and identified as the Summary of Safety and Effectiveness for [device
name].
If the statement option is selected, do not include the word "summary"
in the statement.
The content and format of this information is specified in 57FR No.
82, Tuesday, April 28, 1992, page 18062.
III. COMMENTS
Address any comments regarding this guidance to:
Chief, General Hospital Devices Branch
HFZ-412
1390 Piccard Drive
Rockville, MD 20850-4308
Attachments
ATTACHMENT 1
STERILITY INFORMATION
For a device sold sterile, provide the following information as
detailed in the ODE Blue Book Memorandum #K90-1.
1. Sterilization method that will be used.
2. A description of the method that will be used to
validate the sterilization cycle, but not the
validation data itself. Reference to a standard method
(e.g., AAMI Radiation Standard) usually is sufficient.
3. The sterility assurance level (SAL) for the device
which the firm intends to meet. An SAL of 10-6 is
required for devices which contact normally sterile
areas of the body.
4. A description of the packaging to maintain the device's
sterility (this is not to include packaging integrity
testing data).
5. If sterilization involves EtO, the maximum levels of
residues of ethylene oxide, ethylene chlorohydrin, and
ethylene glycol which remain on the device. The levels
should be consistent with the draft Federal Register
Notice on EtO limits.1
6. Whether the product is "pyrogen free" and an
identification of the method used to make that
determination.2
7. The radiation dose, if radiation sterilization will be
used, and if it has been determined. Otherwise, amend
the 510(k) file at FDA when the dose has been
determined.
References
1. FDA Proposed Rule, 43 FR 27482 (June 23, 1978), Maximum
Residue Limits for Ethylene Oxide, Ethylene Chlorohydrin,
and Ethylene Glycol.
2. FDA Guidelines on Validation of the Limulus Amebocyte Lysate
(LAL) Test as an End-Product Endotoxin Test for Human and
Animal Parenteral Drugs, Biological Products, and Medical
Devices.
| ELEMENT OF COMPARISON | SUBJECT DEVICE | CLAIMED SE DEVICE #1 | (CLAIMED SE DEVICE (#2) |
| pump type | |||
| intended use(s) | |||
| specific drug.biologic use | |||
| labeling | |||
| components | |||
| pumping mechanism | |||
| administrative sets & reservoir | |||
| power requirements | |||
| materials | |||
| flow rates and profiles | |||
| safety/alarm functions | |||
| other capabilities |
ATTACHMENT 3 EXTERNAL INFUSION PUMP REVIEW CHECKLIST 510(k)#:____________ Sponsor:___________ Date:______________ Reviewer:__________ ELEMENT ADEQUATE COMMENTS (e.g., N/A, page #, 30ml, YES NO 18g, PVC, EtO, 10-6, ¾: ") Cover Letter
trade name
common name
classification name
establishment reg. #
procode(s)
purpose of submission
previous files referenced
statement that device is similar to and/or different from other products
Labeling
specifications
reservoir volume
flow rates
flow profiles
accuracy
operational conditions
statements route of administration fluids to be administered directions for preparation and use for all possible functions of the device description of all warning and alarm features prescription statement dedicated administration set or compatible sets
patient instructions
cleaning/maintenance instructions
Description of Device
type
basic description
photograph/drawing
Intended Use(s)
clear statement
route of administration
specific drug/biologic
other specific use(s)
blood or blood products
Physical Specifications
components/component group
reusable/disposable
fluid path contact
pump mechanism (fluid control mechanism)
administration sets & drug reservoir
power requirements
materials identification
Operational Specifications
flow rates
flow profiles
accuracy
operational conditions
reservoir volume
residual volume
safety/alarm functions
other capabilities
Biological Specifications
biocompatibility require- ments for all components and materials in fluid pathway
Chemical Specifications
compatibility requirements specific drug/biologic
stability requirements drug/biologic storage
Descriptive Comparison to Legally Marketed Device
identified appropriate legally marketed device(s)
labeling
description
intended use(s)
materials
operational principles
physical specifications
operational specifications
biological specifications
chemical specifications
side by side comparison
discussion of how differences may affect safety and effectiveness
Performance Data Supporting Equivalence
bench data
flow rate
flow profile
maintain flow
despite changes in
environment or fluid
comparative claims
unique designs
biocompatibility
compatibility
stability
Software Information
level of concern
documentation
Sterilization Information
method
validation method
SAL
packaging description
EtO residuals
pyrogen free method
radiation dose
SMDA Information
summary
statement
Updated September 5, 1997
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