SAB · Table Mounted Miniaturized Electromechanical Surgical System

General, Plastic Surgery · 21 CFR 878.4962 · Class 2

Overview

Identification

The MIRA Surgical System is a miniaturized robotic assisted surgery device indicated for the mobilization of the colon in adults at least 5'0" (1.52 m) tall and having a weight of at least 100 lbs (45.36 kg) who are undergoing minimally invasive colectomy procedures. It is intended to assist in the visualization of tissues and provide accurate and precise control of surgical instruments to grasp, retract, and dissect while maintaining hemostasis with electrocautery during manipulation of tissues.

Classification Rationale

FDA concludes that this device should be classified into Class II. This order, therefore, classifies the MIRA Surgical System, and substantially equivalent devices of this generic type, into Class II under the generic name table mounted miniaturized electromechanical surgical system. FDA has determined that, for the previously stated indications for use, the MIRA Surgical System can be classified in class II with the establishment of special controls for class II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.

Special Controls

In combination with the general controls of the FD&C Act, the table mounted miniaturized electromechanical surgical system is subject to the following special controls: (1) Data obtained from premarket clinical performance validation testing and postmarket surveillance acquired under anticipated conditions of use must demonstrate that the device performs as intended in the intended patient population, unless FDA determines based on the totality of the information provided for premarket review that data from postmarket surveillance is not required. (i) Data provided from (1) must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in a variety of disease etiologies relevant to the device intended use. The test data set must include data acquired from a patient population that is representative of the intended patient population. (ii) Objective performance measures (i.e., rate and number of conversions to open surgery, rate of device related adverse events and their severity, cause, and outcomes) must be reported with relevant descriptive or developmental performance measures. (2) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must evaluate: (i) All surgical tasks pertinent to the device’s intended use, demonstrating the device can accurately and precisely control attached surgical instruments without excess of adverse events, device and not-device related. (ii) Acute and chronic histopathology and gross examination of the affected organs and surrounding tissue. (3) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. (4) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (5) Human factors validation testing must be performed and must demonstrate that the device/user interfaces of the system support safe use in all use environments. (6) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness of the device has not been evaluated for outcomes related to the treatment or prevention of cancer, including but not limited to risk reduction, overall survival, disease-free survival and local recurrence, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A detailed summary of the post-market surveillance data collected under paragraph (1) of this section and any necessary modifications to the labeling to accurately reflect outcomes based upon the post-market surveillance data collected under paragraph (1) of this section. (7) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and precision; (ii) System testing; A. Instrument reliability; B. Thermal effects on tissue; C. User-device interface performance; D. Workspace access testing; and E. Performance testing with compatible devices. (8) Software verification, validation, and hazard analysis must be performed. (9) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (10) Performance data must demonstrate the sterility of all patient-contacting device components. (11) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (12) Performance data must validate the reprocessing instructions for the reusable components of the device. (13) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (14) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (15) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device-specific use training program, which did not require submission of a premarket notification during the reporting period.

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