System Design Validation of Stryker Digital Capture and it’s Accessories for use in Endoscopic Surgeries

Abstract

An endoscopy is a procedure where a surgeon uses a special instrument called an endoscope to examine the inside of a human body. It can also be used for biopsy purposes where a small sample of tissue is removed from the body for analysis. Endoscopic surgeries are also known as Minimally Invasive surgery. In this technique, the surgeon makes small incisions in patient’s body and introduces an instrument called an endoscope onto which a camera is inserted which enables the surgeon to visualize during the intervention. The current study reports the System design validation of Stryker Digital Capture and its accessories intended to be used in endoscopic surgeries. The Stryker Digital Capture (also referred to as SDC) is a comprehensive OR documentation system. It is a network-compatible hardware platform on which software functionality can be added to tailor the product features to the customer needs. In the present study, the production equivalent units of SDC along with other devices and accessories to be required for the system design validation were obtained from the Production unit in San Jose, USA which were then assembled in the iSuite lab in SGTC, Gurgaon where the validation cycles were performed. The company’s Design Controls were followed for the purpose to ensure that the resulting product is safe and effective for its intended use. The device and relevant accessory packages were used as intended within a simulated use environment for two different scenarios: laparoscopic surgery design validation and arthroscopic surgery design validation and for two different software versions. These were 1.2.0 and 1.2.1 i.e Cart Limited release and Cart Full release respectively. Cart Limited release refers to the release of the SDC along with the Base package, Voice package, Device package and whereas the Cart full release refers to the release of the SDC along with all the required packages, 1688 Camera and L11 Light source. The simulated environments were set up as similarly as possible to the real use environment. The validation consisted of testing in a simulated cart where the SDC was placed on a surgical cart with all the relevant devices used for endoscopic surgeries. All products within scope of this system design validation were production or production equivalent, with appropriate measures of traceability to the manufacturing process. The system design validation for both the releases was performed in multiple evaluations until the product passed almost all the defined user needs. The product was then released (limited launch) in the market and following this, the User data was obtained from the surgeons regarding the feedback of the product