§ 888.3600 Implantable post-surgical kinematic measurement knee device.

(a) Identification. An implantable post-surgical kinematic measurement knee device is a device that provides objective kinematic data after total knee arthroplasty surgery. The kinematic data provided by the device are used as an adjunct to other physiological parameter measurement tools utilized during the course of patient monitoring and treatment post surgery. (b) Classification. Class II (special controls). The special controls for this device are: (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following tests must be conducted: (i) Mechanical testing must evaluate the mechanical function (mechanical fatigue, static mechanical strength) and durability of the implant. (ii) Simulated use testing must evaluate the ability of the device to be sized, inserted, and sufficiently secured to any compatible components. (iii) Testing must demonstrate the accuracy, reliability, and reproducibility of kinematic measurements. (iv) Testing must demonstrate diagnostic and therapeutic ultrasound conditions for safe use. (v) Testing must demonstrate that the device performs as intended under anticipated conditions of use demonstrating the following performance characteristics, if applicable: (A) Magnetic pulse output testing; (B) Magnetic and electrical field testing; and (C) Testing of the safety features built into the device. (vi) Testing must demonstrate hermeticity of any electronic component enclosures. (2) Performance testing must evaluate the compatibility of the device in a magnetic resonance (MR) environment. (3) Human factors testing must demonstrate that the intended user(s) can correctly use the device for its intended use, including for implantation and post-procedure data access. (4) Performance data must demonstrate the sterility of the device implant and patient-contacting components. (5) Performance data must validate the reprocessing instructions for the reusable components of the device. (6) The patient-contacting components of the device must be demonstrated to be biocompatible. (7) Design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (8) Performance testing must demonstrate the electromagnetic compatibility/interference, (EMC/EMI), electrical safety, thermal safety, battery safety, and wireless performance of the device. (9) Software verification, validation, and hazard analysis must be performed. (10) The labeling must include the following: (i) A shelf life; (ii) Physician and patient instructions for use, including images that demonstrate how to interact with the device; (iii) Detailed instruction of the surgical technique; (iv) Hardware and software requirements for interacting with the device; (v) A clear description of the technological features of the device including identification of the device materials, compatible components, and the principles of operation; (vi) Identification of magnetic resonance (MR) compatibility status; (vii) Validated methods and instructions for reprocessing of any reusable components; and (viii) A statement regarding the limitations of the clinical significance of the kinematic data.