This benchtop test provides empirical evidence for the continued structural integrity of the lead and helix, screw or tined attachment devices when subjected to mechanical flex and bending replicating in vivo conditions. The test is accelerated to obtain results in less time than physiological rates would allow. The test may be conducted under simulated physiological conditions at 37°C in air or a PBS bath.
The testing objective is to meet the appropriate standard requirements, as identified by the device manufacturer and may include FDA guidance Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions and Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. The test demonstrates the device integrity when subjected to flex fatigue (and distal tip buckling) for an appropriate post-implantation time period. Fatigue tests may be conducted for a minimum of 10 years post-implantation while feasibility or strength characterization tests may be shorter. A device failure is defined by the device manufacturer (for example any visibly cracked/broken lead, change in conductivity/DC resistance, tip leaking or dislodgement). The device manufacturer will also examine the devices post-testing against the acceptance and/or failure criteria.
The test system utilizes a special frame and fixture designed by MDT that is integrated with a 9120 Bose Stent Graft Durability Test Instrument. The Bose SGT system operates using linear motors rated at 445N (100 lbs). The SGT motors integrate with the lead fixture assembly in a vertical orientation to provide a linear axial displacement that imparts a bend/flex motion to the leads. The dual motor configuration increases overall system stability and doubles stroke capacity.
|Lead OD||Testing Stations||Displacement||Frequency*|
|4F - 10F||24||0mm- 24mm||30Hz - 70Hz|
*Test frequency is strain dependent
MDT tests are conducted in accordance with ANSI/ISO/IEC 17025-2005. Testing schedules and resource needs are determined during project kickoff meetings with MDT engineers and the customer. Services are performed in accordance with standard operating procedures and test protocols specific to the project. Standard tests do not begin without a protocol signed by both the customer and an MDT representative. For feasibility or non-standard tests, MDT will develop a method and protocol with customer input and will review the final process with the customer prior to initiation of the test.
The test equipment software monitors the cycle count and displacement throughout the duration of the test. MDT engineers monitor the test daily and record the temperature and pressure for the system, as well as the outside radial strain at predetermined positions for each device being tested. MDT sends weekly updates to ensure customers are apprised of the status of their test. Updates include raw data collected throughout the week for the customer's analysis.
MDT offers several inspection and monitoring methods including:
Tests are conducted in accordance with ANSI/ISO/IEC 17025-2005. In compliance with this standard, MDT test reports include comprehensive documentation and summary of the test protocol and results. Any test method deviations, additions, or exclusions are documented and reviewed with the customer prior to beginning the test. Information within the report includes the specific test conditions, statements of compliance with test protocol, and the estimated measurement uncertainty. The reported results only relate to the items tested. Any opinions and interpretations provided by MDT are clearly marked as such. Any additional information required by customer-specific methods will also be noted. At the conclusion of the test, MDT provides the customer with a Microsoft Windows formatted CD containing copies of all raw data, inspection results, and other information collected during the test (see example test reports).
Please take a few moments to tell us more about your device and test requirements in our short questionnaire, and we will be happy to provide you with a quote.