(60 days)
The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.
The purpose of this submission is to seek clearance for an alternate Node component called the Smart Node (to be marketed as the Intelligent Surgical Unit (ISU)), which introduces enhanced image processing features and augments the endoscope movement capabilities of the TransEnterix® Senhance® Surgical System. The Smart Node adds three new methods of camera control for the surgeon operating at the Senhance Cockpit.
The provided text describes a 510(k) submission for the TransEnterix Senhance Surgical System with an alternate Node component called the Smart Node (marketed as the Intelligent Surgical Unit or ISU). This submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K192877).
However, the document does not contain the following information regarding acceptance criteria and a study proving the device meets those criteria:
- A table of acceptance criteria and the reported device performance: The document lists types of testing performed (Bench Testing, Electrical Safety and Compatibility, Software Verification and Validation, Pre-Clinical Design Validation, Usability Testing) and states that performance was evaluated and requirements were met, but it does not provide specific quantitative acceptance criteria or detailed reported performance values in a table.
- Sample size used for the test set and the data provenance: For the pre-clinical design validation and usability testing, it mentions "a single-center" and "users who represented the intended primary user population," but specific sample sizes for the test set are not provided. Data provenance is not explicitly mentioned beyond the type of model used (live porcine model for pre-clinical, simulated use for usability).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
- Adjudication method: This information is not provided.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is not mentioned. The device is a surgical system, not an AI diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable in this context.
- Standalone performance: The document focuses on the integrated performance of the "Senhance Surgical System with Smart Node" and its comparison to the predicate device. It does not describe a standalone performance study of the Smart Node component in isolation, outside of specific functional tests.
- Type of ground truth used: For the pre-clinical design validation, it states it was conducted in a live porcine model, which "most closely represents the human anatomy," implying the physiological outcomes in this model served as validation. For usability, "user level requirements were assessed and found to be met," suggesting user feedback and task completion were the ground truth.
- Sample size for the training set: The document describes performance testing to support substantial equivalence for a new component (Smart Node) of an existing surgical system. It does not mention a "training set" in the context of machine learning model development. The software verification and validation are for "software modifications to support the subject Smart Node," not the training of a new AI model with a distinct training set.
- How the ground truth for the training set was established: As no training set is described for a machine learning model, this information is not applicable.
Summary of available information related to performance testing:
- Device: TransEnterix® Senhance® Surgical System with Smart Node (Intelligent Surgical Unit (ISU))
- Purpose of Submission: Seek clearance for an alternate Node component (Smart Node) that introduces enhanced image processing features and augments endoscope movement capabilities.
- Performance Tests Conducted:
- Bench Testing: Evaluated the performance of the Smart Node and the overall system, confirming compatibility, reliability, functionality, safety, and efficacy. (Specific criteria/results not provided).
- Electrical Safety and Compatibility: Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-18. (No specific numerical results/acceptance criteria given, just compliance statement).
- Software Verification and Validation Testing: Conducted on software modifications for the Smart Node, following FDA guidance for "major" level of concern software. (No specific test results/acceptance criteria given).
- Pre-Clinical Design Validation:
- Environment: Single-center, un-blinded, observational, simulated use design validation.
- Model: Live porcine model.
- Users: Users representing the intended primary user population.
- Ground Truth: Assessed user-level requirements; all found to be met.
- Sample Size/Provenance: Not specified beyond "single-center" and "live porcine model."
- Usability Testing:
- Modifications: Based on new Smart Node features.
- Study Type: Confirmatory summative study.
- Users: Performed by users in a simulated use environment.
- Ground Truth: Users were able to independently perform all critical tasks without use errors that would lead to harm.
- Sample Size/Provenance: Not specified.
Conclusion stated by the submitter: The performance testing supported the safety and functionality of the device and demonstrated that the device is substantially equivalent to the predicate device.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.