Radionics 22-March-99 Xknife Stereotactic Radiosurgery System
1. Failure to establish and maintain procedures to ensure that formal documented
reviews of the design results are planned and conducted at appropriate stages of the device’s design development, that appropriate representatives are included, and that the results of a design review, including identification of the design, the date, and the individual(s) performing the verification, are documented in the design history file as required by 21 CFR 820.30(e). For example:
a. Procedures were not established to ensure that formal and systematic design
reviews were conducted for the “Xknife 4” treatment planning software change.
While design reviews were allegedly conducted, the results of those reviews,
including identification of the design, the date, and individuals performing the
review were not documented.
b. There is no documentation to show that the results of in-house verification testing underwent a design review prior to transfer of the design to production.
2. Failure to establish and maintain procedures for the identification, documentation,
validation or where appropriate, verification, review and approval of design changes before their implementation as required by 21 CFR 820.30(i). For example:
The Design Control Changes Procedure, QS3-04-0006 Rev. A (approved 3/6/97)
lacks necessary detail in many areas:
a) It does not contain, nor does it cross reference to any other procedures regarding required verification, validation and reviews of design changes.
b) It implies that validation of design changes may be optional, but it does not
address any criteria whereby verification of design changes could be determined
sufficient in lieu of an otherwise mandatory validation requirement for design
changes.
c) It does not specify how design changes to be made to existing marketed
products/software are to be initiated, approved, documented and controlled.
3. Failure to establish and maintain design input procedures that ensure that design
requirements relating to the device are appropriate, address intended use of the
device, and the needs of the user and patient; failure to include a mechanism for
addressing incomplete, ambiguous, or conflicting design requirements, as required
by 21 CFR 820.30(c). For example:
Design input procedures were not established for the “Xknife 4” treatment planning
software change and there was no documented mechanism for addressing
incomplete, ambiguous, or conflicting design requirements.
4. Failure to establish and maintain procedures for validating the device design;
failure to document the results of the design validation, including identification of
the design, method(s), the date, and the individual(s) performing the validation in
the design history file, as required by 21 CFR 820.30(g). For example:
Procedures were not established for validating the “Xknife 4” treatment planning
software change.
5. Failure to establish and maintain procedures for verifying the device design, to
confirm that the design output meets the design input requirements, as required by
21 CFR 820.30(f). For example:
The results of testing show that the design/system requirements were not met for the Auto Contour/Contour procedures on page 5 and 8, the Jaws procedure on page 20, and the Autoplan procedure on page 22 of the test plan. There is no documented justification for accepting the design with these discrepancies left unresolved.
6. Failure to establish and maintain procedures to ensure that the device design is
correctly translated into production specifications as required by 21 CFR 820.30(h).
For example:
There was no established procedure for transferring the “Xknife 4” treatment
planning software to production.
