XZeal Technologies, Inc.
Product: XZeal Dental X-Ray Unit Z70
1. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). For example:
b. Your firm has not established and maintained documentation in support of Section 4.6 – Design Validation of the Product – Conception and Development, PR0-04.01, Ver. 00, concerning software validation of the embedded software for the device. Specifically, you stated to our investigator that your firm is not responsible for the software because your firm does not manufacture it. You also stated to our investigator your firm did not know what, if any, validation activities were performed by your firm?s Chinese supplier for this software.
In addition, your firm?s Risk Analysis Report ? Software, Ver. 00, Technical File, does not adequately access the risk presented by the software controlling the XZeal Dental X-Ray Unit Z70 as a moderate risk to users and patients. For example, the report indicates a ?No? to the questions: ?Could a malfunction of, or a latent design flaw in the Software Device lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Moderate Injury? and ?Does the Software Device control the delivery of potentially harmful energy that could result in death or serious injury, such as radiation treatment systems, defibrillators and ablation generators.?
Your firm?s October 7, 2014 response includes reference to assembly operational checks or functional (Black-box) testing of the XZeal Dental X-Ray Unit Z70. Adequate software validation of the XZeal Dental X-Ray Unit Z70 software would require more than functional testing, including but not limited to a description of software (i.e.: Title, Manufacturer, Version Level, Release Date, etc.); control of capabilities of end user; reliability of functionality; maintenance and control of software versions; and adequate software hazard analysis.
FDA District Office: Florida District