This guidance was written prior to the February 27, 1997 implementation of FDAs Good
Guidance Practices, GGPs. 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 GGPs.
DRAFT GUIDANCE FOR THE PREPARATION OF
A PREMARKET NOTIFICATION FOR
EXTENDED LAPAROSCOPY DEVICES (ELD)
August 30, 1994
(reformatted 12/17/97)
This guidance document may contain references to addresses and telephone numbers that
are now obsolete.  The following contact information is to be used instead:
 While this guidance document represents a final document, comments and suggestions
may be submitted at any time for Agency consideration to the General Surgical Devices
Branch, 9200 Corporate Blvd., HFZ-410, Rockville, MD  20850.
 For questions regarding the use or interpretation of this guidance, contact the General
Surgical Devices Branch at 301- 594-1307.
 To contact the Division of Small Manufacturers Assistance (DSMA), call 800-638-2041
or 301-443-6597; fax 301-443-8818; email dsmo@cdrh.fda.gov; or write to DSMA
(HFZ-200), Food and Drug Administration, 1350 Piccard Drive, Rockville, Maryland
20850-4307.  FACTS-ON-DEMAND (800-899-0381 or 301-827-0111) and the World
Wide Web (CDRH home page: http://www.fda.gov/cdrh/index.html) also provide easy
access to the latest information and operating policies and procedures.
 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Center for Devices and Radiological Health
Rockville, MD  20850
page 1 I.  PURPOSE:
This guidance provides information for the preparation of a Premarket Notification
(510(k)) for an emerging group of devices that does have a readily identifiable predicate
with which to establish substantial equivalence, but does fall into a category of
laparoscopic accessories for which a discernible pattern of clinical and technological
progress is apparent, thus rendering them appropriate for 510(k) review.  These devices
will subsequently be referred to as Extended Laparoscopy Devices (ELD).  They are
Class II devices and, therefore, subject to special controls under  Section 513 of the
Federal Food, Drug, and Cosmetic Act.  Determination of substantial equivalence will be
made based upon analysis of data designed to establish that the new device is "as safe and
effective as a legally marketed device."  While the exact nature and extent of information
necessary to determine substantial equivalence for an ELD will be evaluated individually
based upon the specific device and labeling claims requested, it is our goal in this
communication to present an outline of what we would consider reasonable parameters
which would allow for comprehensive and expeditious review of your submission.
II.  DEFINITION:
An Extended Laparoscopy Device (ELD) is any device that provides extracorporeal
extension of pneumoperitoneum and/or permits the surgeon to perform tasks in a manner
normally ascribed to open surgery within the field of pneumoperitoneum, e.g., tactile
contact or use of standard manual surgical instruments.
III.  GENERAL INFORMATION:
1.  Product names; trade and usual
2.  Classification; Class II, 78GCJ
3.  Purpose of submission, CFR 807.81
4.  Predicate; may use combination of devices for intended use technical criteria
IV.  LABELING:
The proposed labeling should include labels and advertisements with descriptions,
intended use, directions for use and appropriate warnings and cautions.  A statement must
be included that advises the user to be adequately trained in each of the three approaches;
laparoscopic, laparoscopic-assisted, and open surgery.  Any claims related to enhanced
efficacy or ease of use relative to standard laparoscopic or open surgery must be
substantiated with appropriate clinical data.
V.  MATERIALS:
This section requires a complete listing of all materials used in fabricating the device.
We ask that you compare and contrast all materials with those of the predicate device and
that you provide biocompatibility data for those materials that are not identifiable in a
legally marketed predicate device according to the ISO 10993 standard.
page 2 VI. STERILITY:
For a device sold sterile, provide the following information as detailed in the ODE Blue
Book Memorandum #K90-1:
1. Sterilization method
2. Validation method
3. Sterility assurance level (SAL)- must be 10-6
4. Packaging information
VII.  PERFORMANCE DATA:
Due to the novel features displayed by these products and the relative paucity of
information concerning the devices themselves and the clinical applications for which
they are intended, FDA requires performance testing, including clinical evaluation.
1 . Bench testing must include evidence that each component of device and the
device itself possesses the strength to withstand the pressures normally associated
with laparoscopic surgery.  Integrity of valves and seals during different phases of
operation should be analyzed and documented.
2 . Animal testing should be designed to demonstrate compatibility of the device with
living tissues and to address to as great degree as possible whether or not the
design of the device allows the user to perform currently accepted laparoscopic
functions and/or procedures in a safe and effective manner.
3. Clinical studies should be designed to confirm the impressions reached in the first
two testing phases.  These studies may be undertaken in conjunction with a local
IRB without an FDA approved IDE; however, we would be happy to assist the
manufacturer in designing a suitable protocol or analyzing preliminary data.  In
general, we expect these studies to involve two phases:
a. an initial feasibility phase of 10-20 patients to establish basic product
viability and allow for design modifications; and
b. a second "pivotal" phase of 50-200 patients at sever sites with the goal of
developing comparative data for a single procedure with and without the
use of ELD to compare device performance to a recognized predicate
device and/or procedure.  Parameters of interest may include anesthesia
time, blood loss, complications, duration of intensive care and
hospitalization.
VIII.  CONCLUSION:
We hope that this guidance provides an insight to our current thinking regarding this new
group of devices.  Our goal is to clarify the review process to allow for rapid deployment
of this exciting new technology while maintaining the necessary quality standards that
physicians and patients deserve.
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