GUIDANCE DOCUMENT
Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology February 1993
- Docket Number:
- FDA-2020-D-0957
- Issued by:
-
Guidance Issuing OfficeCenter for Devices and Radiological Health
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.
Biopsy devices for gastroenterology and urology are described in the FDA
regulations under three classifications. These classifications are 21 CFR
876.1075 (a) Gastroenterology-Urology Biopsy Instruments, 21 CFR 876.1500
(a) Endoscopes and Accessories, and 21 CFR 876.4300 (a) Endoscopic
Electrosurgical Unit and Accessories.
The classification 876.1075 (a), Gastroenterology-Urology Biopsy
Instruments, includes devices that are "used to remove, by cutting or
aspiration, a specimen of tissue for microscopic examination. This generic
type of device includes the biopsy punch, gastrointestinal mechanical
biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle
and needle set, and nonelectric biopsy forceps. This section does not
apply to biopsy instruments covered by classification regulations in other
parts of the device classification regulations." These are Class II
devices as stated in 21 CFR 876.1075 (b) and their procodes are: 78 FFF -
cover, biopsy forceps; 78 FCL - forceps, biopsy, non-electric; 78 KNW -
instrument, biopsy; 78 FCF - instrument, biopsy, mechanical,
gastrointestinal; 78 FCK - instrument, biopsy, suction; 78 FCI - punch,
biopsy; and 78 FCG - set, biopsy needle and needle, gastro-urology.
The classification 876.1500 (a), Endoscopes and Accessories, includes a
"device ... to allow observation and manipulation of body cavities, hollow
organs, and canals." Cytology brushes, as endoscopic accessories, are
covered under this classification, are Class II devices as stated in 21 CFR
876.1500 (b), and have the procode 78 FDX - brush, cytology, for
endoscopes.
The classification 876.4300, Endoscopic Electrosurgical Unit and
Accessories, includes a "device used to perform electrosurgical procedures
through an endoscope. This generic type of device includes ... electric
biopsy forceps, ... flexible snare, ... self-opening rigid snare, ... "
These are Class II devices as stated in 21 CFR 876.4300 (b) and their
procodes are 78 KGE - forceps, biopsy, electric; 78 FDI - snare, flexible;
and 78 FDJ - snare, rigid self-opening.
The primary reference for the information required to be in a premarket
notification (510(k)) for a medical device is set forth in 21 CFR 807.87.
The purpose of this regulation is to provide adequate documented
information to determine substantial equivalence to a device in commercial
distribution. Substantial equivalence is to be established with respect
to, but not limited to, intended use, design, energy used/delivered,
materials, performance, safety, effectiveness, labeling, and other
applicable characteristics.
FDA recommends that each premarket notification for a biopsy device include
the following information in order to ensure that the submission is
complete and will permit a determination of substantial equivalence:
I. The device name, including both the trade or proprietary name and the
classification name (Gastroenterology-Urology Biopsy Instrument,
Endoscopes and Accessories for cytology brushes, or Endoscopic
Electrosurgical Unit and Accessories for electric biopsy forceps) of
the device as described in 21 CFR 807.87 (a).
II. The establishment registration number, if applicable, of the owner or
operator submitting the premarket notification as described in 21 CFR
807.87 (b).
III.The class (Class II) in which the device has been placed under section
513 of the act and the appropriate panel (78 Gastroenterology/Urology)
as described in 21 CFR 807.87 (c).
IV. Action taken by the person required to register to comply with the
requirements of the act under section 513 for Special Controls. Note
that Special Controls are not currently required for biopsy devices
under section 513 of the act.
V. The Safe Medical Devices Act of 1990 (SMDA) requires all persons
submitting a premarket notification submission to include either (1) a
summary of the safety and effectiveness information in the premarket
notification submission upon which an equivalence determination could
be based (510(k) summary), OR (2) a statement that safety and
effectiveness information will be made available to interested persons
upon request (510(k) statement). Safety and effectiveness information
refers to information in the premarket notification submission,
including adverse safety and effectiveness information, that is
relevant to an assessment of substantial equivalence. The information
could be descriptive information about the new and predicate device(s),
or performance or clinical testing information.
VI. Proposed labels, labeling, and advertisements sufficient to describe
the biopsy device, its intended use, and the directions for use should
be provided with a specific intended use statement and any warnings,
contraindications, or limitations clearly displayed as described in 21
CFR 807.87 (e). The label of the device must bear the caution
statement as outlined in 21 CFR 801.109 (b) (1): "CAUTION: Federal
law restricts this device to sale by or on the order of a physician."
A. A label includes any identification on the biopsy device and on
the package in which it is stored and shipped. The package
device label should include the device name, U.S. point of
contact, corporation name, address, and phone number. The package
label should also include all of the above, as well as sterility
status, expiration date, disposable/single use, quantity enclosed,
size (diameter and length), energy used/delivered, etc.
B. Device labeling for the biopsy device includes the intended use, a
description of the device, and directions for use.
1. The intended use statement should include specific
indications. The anatomical sites, i.e. target organs, and the
target population should be defined.
2. The directions for use should contain comprehensive
instructions to include, but not necessarily be limited to, how to
prepare the biopsy device for use, how to operate the biopsy
device, how to stop operation and retrieve the sample, any special
instructions for specimen processing, a description of which parts
are single use/disposable or reusable, and a description of the
functional test procedures which should be performed for the
biopsy device prior to use. Maintenance and troubleshooting
procedures should be outlined with instructions on how to perform
the maintenance, the frequency of the maintenance, and a
corporation contact point if troubleshooting procedures fail.
3. Contraindications (e.g. excluded population), precautions
(e.g. needle advancement/penetration depth), and warnings should
be included in the labeling of the device.
C. Advertisements or promotional literature for the biopsy device
that will accompany the device should be provided. Literature or
labeling may not imply approval by FDA in any manner. Guidance on
labeling issues is described in Bluebook Memo G91-1 "Device
Labeling Guidance (3/8/91)" and a copy may be obtained from the
Center for Devices and Radiological Health's Division of Small
Manufacturers Assistance at (800) 638-3041 or (301) 443-6597.
VII. A Summary of Equivalence comparing similar devices legally in
commercial distribution in the United States must be provided. This
includes devices in commercial distribution prior to May 28, 1976, the
enactment date of the Medical Devices Amendments, and any new devices
introduced subsequently. A Summary of Equivalence includes similarities
and differences between the device and the device to which it is compared.
The biopsy device should be compared with a legally marketed biopsy device,
including, but not limited to, the following:
intended use including specific target organs;
design
needle, cannula(s), and stylet size: diameter and
gauge;
needle advancement/penetration depth;
sample notch size;
number of samples;
jaw size;
brush size: diameter and length;
mechanics of action (automatic, manual, spring
operated, electrically operated, etc.);
mode of action (single puncture and sample, single
puncture and multiple samples, brush rotation,
suction, scraping: side-to-side or up-and-down,
etc.);
electrical compatibility;
safety features; and
other applicable specifications
energy used/delivered for electric biopsy forceps and
biopsy guns;
materials of all components identifying those that come
into patient contact;
performance;
anatomical sites (i.e. target organs);
target population justifying any new population cited;
visualization techniques;
method of placement; and
other related information.
State whether the substantially equivalent device is a pre-amendment device
or a device which has been through the 510(k) process, providing the 510(k)
document control number if known. The summary of equivalence information
should be provided in a manner that is clear and comprehensible, e.g.
tabular form.
VIII. For a device that has undergone a change or modification that could
significantly affect the safety or effectiveness of the device, or the
device is to be marketed for a new or different indication for use, the
510(k) must include appropriate supporting data to show that the
manufacturer has considered what consequences and effects the change or
modification or new use might have on the safety and effectiveness of the
device, as described in 21 CFR 807.87 (g).
Significant modifications should be supported by a rationale for the
modification with supporting documentation, including clinical or other
valid scientific studies which demonstrate that these differences do not
affect safety and effectiveness, as described in 21 CFR 807.87 (f).
The description of all biopsy devices should include any significant
changes or modifications from the predicate device that could affect
safety, effectiveness, or intended use. Provide any bench, animal,
clinical, functional, in vitro, and/or any other testing data to support
your claims. Provide certification regarding any compliance with voluntary
standards, if applicable.
IX. The physical description of each biopsy device to be marketed should
be provided in the form of a labeled diagram, photograph/picture,
schematic, etc., which includes all internal/external,
assembled/unassembled, etc. parts of the biopsy device. The physical
description should include the specifications (length, width, height,
diameter, power requirements, other applicable information) of the biopsy
device. The description should also identify any parts which are
disposable (i.e., needles, sheath, cannula, etc.). The labeled diagram,
photograph/picture, schematic, etc., should address the name and function
of all parts of the biopsy device. This is especially important for
automated biopsy guns and electric biopsy forceps where part of the
mechanics of action is performed without operator intervention.
If the biopsy device is sold in a set that includes accessories, these
accessories need to be identified and reviewed along with the biopsy device
and require the same types of information as stated above. These
accessories might include cannulas, handles/holders, introducer, spacers,
stylets, syringes, trocar, etc. Labeling must state whether the accessory
is intended for single use and whether it is reusable or disposable.
X. An exact identification of all materials used to fabricate the biopsy
device should be provided and a statement regarding any material
differences from the pre-amendment or substantially equivalent biopsy
device should be explicitly stated. If the materials are identical to the
pre-amendment or substantially equivalent device and are identically
processed and sterilized, then this should be explicitly stated. The
sponsor will need to provide biocompatibility testing data on any material
changes that have been implemented or justify why this data is not needed,
i.e. the material does not come into patient contact. Biopsy devices are
considered to be a short-term implants, with the type of tissue it comes in
contact dependent on the indications for use. At a minimum,
biocompatibility data should be provided for the following tests:
irritation, sensitization, cytotoxicity, acute systemic toxicity, and
implantation. Guidance for the testing is provided in the document
entitled "Tripartite Biocompatibility Guidance for Medical Devices" and a
copy may be obtained from the Center for Devices and Radiological Health's
Division of Small Manufacturers Assistance at (800) 638-2041 or (301)
443-6597.
An exact identification of all colors (ink, dyes, markings, radiopaque
material, etc.) used to fabricate the biopsy device should be provided and
a statement regarding any colorant changes from the pre-amendment or
substantially equivalent biopsy device should be included. If the colors
are identical to the pre-amendment or substantially equivalent device then
this should be explicitly stated. The sponsor will need to provide
biocompatibility testing data on any colorant changes that have been
implemented; state how the markings are processed (etched, bands, in
material, etc.) and whether the color contacts skin, mucosa, etc.
XI. The following data should be provided to demonstrate substantial
equivalence of your biopsy device with respect to functional performance.
These tests should be conducted in a manner as similar as possible to how
the biopsy device will be used in a medical procedure. A statistically
valid number of biopsy devices should be tested to establish the
performance of each size. A sampling of biopsy devices representative of
the product line, e.g. largest, smallest, longest, and shortest, should be
tested. Testing should be conducted in accordance with accepted industry
standards and explicitly stated as such, or a description and analysis of
the test procedures used should be provided justifying their validity. If
the applicant believes that functional testing is not appropriate for the
type of biopsy device to be marketed, justification should be provided.
Functional data for a cytology brush (manual or electric) must include, if
applicable, testing demonstrating electrical compatibility with other
gastroenterology-urology electrical devices; animal, bench, or other
testing that defines the appropriate specifications for motor speeds, brush
rotation, suction pressures, timing, possible electrical hazards to
patient, etc.; how the tip, if applicable, is attached to the rod and the
force needed to detach the tip, and brush/bristle attachment and strength.
Functional data for automatic biopsy devices, needles and needle sets must
include testing demonstrating needle advancement and penetration. Accurate
needle advancement is important to ensure the sample is obtained from the
intended tissue site with minimal trauma to that site and the surrounding
tissue sites. If claiming that the device will take multiple samples at
one site, bench testing data must be presented demonstrating that the gun
and needle assembly of the biopsy device are capable of being fired and are
able to obtain the claimed amount of samples without damage to the interior
mechanisms, and that the quality and size of the biopsy sample taken with
the later shots are equivalent for the types of tissues and/or tumors for
which the device is indicated. If the biopsy device uses electricity,
electrical safety (isolation) must be demonstrated.
Functional data for electric biopsy forceps must include testing
demonstrating electrical compatibility with the gastroenterology-urology
electrosurgical devices recommended in the labeling, electrical safety
(isolation), and that the device can withstand the maximum currents
generated without device damage or patient and user (operator) injury.
XII. Complete information regarding biopsy devices that are sold sterile
must be provided and must include sterilization method; validation method;
packaging materials and a description of the packaging to ensure sterility
is maintained; sterility assurance level (SAL), and radiation dose or the
maximum levels of residuals of ethylene oxide, ethylene chlorohydrin, and
ethylene glycol which remain on the device, whichever applicable. If the
device will be labeled as pyrogen free, or non-pyrogenic, provide a
description of the method used to make that determination (LAL or Rabbit
test). If the entire biopsy device is not sold sterile, labeling must
clearly identify which parts are sterile and non-pyrogenic. Guidance on
sterility issues is described in ODE Bluebook Memo K90-1 510(k) "Sterility
Review Guidance (2/12/90)" and a copy may be obtained from the Center for
Devices and Radiological Health's Division of Small Manufacturers
Assistance at (800) 638-2041 or (301) 443-6597.
If the biopsy device is sold and labeled nonsterile or can be reprocessed,
instructions on disassembly, cleaning, disinfection, and/or sterilization
should be provided, if applicable. If appropriate, a statement that the
biopsy device requires high level disinfection should be provided and
compatible solutions and/or procedures for high level disinfection and/or
sterilization need to be identified. Accessories that are disposable
should be labeled as single use.
The Association for Practitioners in Infection Control (APIC) and the
Center for Disease Control (CDC) have established definitions and
guidelines for the selection and use of disinfectants, which depend on the
site(s) of device contact. The applicant's recommendations must be based
on the target organs stated in their labeling.
XIII. If this device is to be marketed as a kit, identify all components
and provide the certification stated below:
I certify that the following components of my kit are either (1)
legally marketed pre-amendments devices, (2) exempt from premarket
notification (consistent with the exemption criteria described in
the classification regulation(s) and the limitations of exemptions
from Section 510(k) of the act (e.g., 862.9), or (3) have been
found to be substantially equivalent through the premarket
notification process for the use(s) for which the kit is to be
intended (i.e., I am not claiming or causing a new use for the
component(s)).
I further certify that these components are not purchased in
"bulk", but are purchased in finished form, i.e., they are
packaged, labeled, etc., consistent with their pre-amendments,
exemption, or premarket notification criteria and status.
If you cannot make the above referenced certification statement
(first paragraph) for each component of your kit, you must itemize
the components without a pre-amendments, exemption, or premarket
notification status. In this case we will continue our premarket
notification review of these components of your kit.
If you cannot make the above referenced certification statement
(second paragraph) for each component of your kit, you must
itemize these components, state whether they are pre-amendments,
exempt, or have been found substantially equivalent through the
premarket notification process, and describe how you further
process them (e.g., sterile, package/repackage, label/relabel,
etc.).
If the device kit contains components which are subject to
regulation as drugs, a substantially equivalent determination will
not apply to the drug component(s) of the device. For information
on applicable Agency requirements for marketing the drug
component(s) in the kit, it is suggested that you contact the
Center for Drug evaluation and Research's Division of Drug
Labeling Compliance at (301) 295-8063.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-0957.