Guidance for the Preparation of a Premarket Notification for Extended Laparoscopy Devices (ELD)
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.
August 30, 1994
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 email@example.com; 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
III. GENERAL INFORMATION:
- Product names; trade and usual
- Classification; Class II, 78GCJ
- Purpose of submission, CFR 807.81
- Predicate; may use combination of devices for intended use technical criteria
For a device sold sterile, provide the following information as detailed in the ODE Blue Book Memorandum #K90-1:
- Sterilization method
- Validation method
- Sterility assurance level (SAL)- must be 10-6
- 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.
- 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.
- 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.
- 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.