(126 days)
The Anovo™ Instrument ARM Curved Scissors is indicated for use for tissue manipulation including cutting, dissecting, and coagulating and cutting using monopolar energy.
The Anovo™ Instrument ARM Hook Electrode is indicated for use for tissue manipulation including dissecting, and coagulating and cutting using monopolar energy.
The Anovo™ Instrument ARM Curved Scissors and the Anovo™ Instrument ARM Hook Electrode are intended for use with the Anovo™ Surgical System.
The Anovo™ Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMs during single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures listed below.
The Anovo™ Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment. The representative uses of the Anovo™ Surgical System are indicated for the following benign procedures:
- · Total Benign Hysterectomy with Salpingo-Oophorectomy
- · Total Benign Hysterectomy with Salpingectomy
- · Total Benign Hysterectomy
- · Salpingectomy
- · Oophorectomy
- · Adnexectomy
- · Ovarian cyst removal
The Anovo™ Instrument ARM Curved Scissors and Anovo™ Instrument ARM Hook Electrode are optional instruments for the Anovo™ Surgical System Model 6N. The Anovo™ Surgical System Model 6N with Instrument ARM Grasper end-effector ("Predicate Device") was the subject of a De Novo request (DEN190022) for transvaginal access to gynecological procedures and was granted a marketing authorization in February 2021. Both the Anovo™ Instrument ARM Curved Scissors and Hook Electrode are intended to be used with the Anovo™ Surgical System. The Anovo™ Surgical System comprises the Anovo™ Surgeon Console operated by a nonsterile surgeon, two sterile instruments (Instrument ARMS) actuated by the non-sterile, Anovo™ Robotic Control Unit (RCU). The system allows the physician to operate the Instrument ARMS from the Anovo™ Surgeon Console by manipulating the ARMS Controllers under visual guidance. No changes were made to the Anovo™ Surgical System for the scope of this submission.
The provided text describes a 510(k) premarket notification for new surgical instruments (Anovo™ Instrument ARM Curved Scissors and Anovo™ Instrument ARM Hook Electrode) intended for use with an existing surgical system (Anovo™ Surgical System Model 6N). The submission aims to demonstrate substantial equivalence to a predicate device (Anovo™ Instrument ARM Grasper end-effector).
However, the document does not describe the acceptance criteria and the study that proves a device meets the acceptance criteria in the context of an AI/ML medical device. Instead, it focuses on the substantial equivalence of surgical instruments to a predicate device through bench testing, pre-clinical animal studies, thermal damage testing, and biocompatibility testing.
Therefore, I cannot fulfill the request to describe the acceptance criteria and study for an AI/ML device based on the provided text. The information requested (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance) is relevant to AI/ML device evaluations and is not present in this 510(k) summary for surgical instruments.
§ 878.4961 Mountable electromechanical surgical system for transluminal approaches.
(a)
Identification. A mountable electromechanical surgical system for transluminal approaches is a software-controlled, patient bed- and/or operating table-mounted electromechanical surgical system with human/device interfaces that allows a qualified user to perform transluminal endoscopic or laparoscopic surgical procedures using surgical instruments attached to an electromechanical arm.(b)
Classification. Class II (special controls). The special controls for this device are:(1) 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.
(2) 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.
(3) The device manufacturer must conduct and complete post-market surveillance, including an impact of the training program on user learning, behavior, and performance, in accordance with an FDA-agreed-upon protocol. The device manufacturer must submit post-market surveillance reports that contain current data and findings in accordance with the FDA-agreed-upon protocol.
(4) The device manufacturer must submit a report to 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.
(5) 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 (b)(3) of this section and any necessary modifications to the labeling to accurately reflect outcomes based upon the post-market surveillance data collected under paragraph (b)(3) of this section.
(6) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use.
(7) Human factors validation testing must be performed and must demonstrate that the user interfaces of the system support safe use in an operating room environment.
(8) 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;
(iii) Instrument reliability;
(iv) Thermal effects on tissue;
(v) Human-device interface;
(vi) Mounting hardware testing;
(vii) Workspace access testing; and
(viii) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed. Software documentation must include an assessment of the impact of threats and vulnerabilities on device functionality and end users/patients as part of cybersecurity review.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) 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.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.