Prucka 30-June-99 Multi-channel electrocardiographic amplifiers, CardioLab EP System and CardioCath Catheterization Lab System software
2. Failure to establish and maintain procedures for validation of the device design, including software validation, and documentation of the validation, as required by 21 CFR 820.30(g). For example:
a. Standard operating procedures have not been established for software validation.
b. Review of the validation records for CardioLab Cath version 1.1 revealed:
i. The module entitled, “CO Worksheet” lacked complete documentation of testing in that the actual values under Section V. corresponding to the expected values of _____ [Hemoglobin] and _____ [02 capacity] were not documented.
ii. The module entitled “Measurements” does not identify test inputs and outputs.
c. Review of the validation records for CardioLab EP version 4.11 revealed:
i.The test record entitled, “Acquisition w/ Amps, HLT-CLAB II amp, 48 channels” under the Section entitled, “Testing sampling rates: _____ and _____ documented that surface ECG channels 4, 5 and 6 were not available which is contrary to expected results.
ii. The test record entitled, “Stimset/Detect-Clab II amps (32 channels)” documented various instances in which the actual values generated did not meet established specifications.
7. Failure to maintain complete device specifications, including software specifications in the Device Master Record, as required by 21 CFR 820.181(a).
a. Complete Device Master Records have not been established for the CardioLab EP, CardioLab Cath, or CardioMapp software systems which include software specifications.
b. The document entitled “CardioCath Specifications” is incomplete in that the following parameters are not identified:
i. A description of all files to be created/accessed as well as all reports and or visual displays to be generated.
ii. A description of all limits and parameters to be measured, the frequency of measurement, and the points at which the user is to be alerted and/or data is to be rejected.
iii. A description of all error messages, their cause, and the corrective actions required.
8. Failure of the Device Master Record to include or refer to the location of quality assurance procedures and specification including acceptance criteria, as required by 21 CFR 820.181(c). For example, standard operating procedures have not been established for software quality assurance and acceptance activities.