(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 and retraction. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures and laparoscopic gynecological surgery. 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 Senhance Articulating platform (internally named Articulating Be4) is intended as an addition to the suite of adapters, couplers and instruments previously cleared for use with the Senhance Surgical System ("Senhance System") most recently cleared under K212054 which is being used as the predicate. This submission requests clearance for one (1) new Articulating Adapter and two (2) Articulating Couplers to be used with the existing articulating instruments.
The provided text describes the acceptance criteria for the Senhance Articulating Platform, an addition to the Senhance Surgical System, and summarizes various studies conducted to demonstrate its substantial equivalence to a predicate device (Senhance Surgical System K212054).
Here's a breakdown of the requested information based on the text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a formal "acceptance criteria" table with specific pass/fail metrics. Instead, it describes performance testing categories and their summaries, demonstrating that the device met expectations or performed as intended. The overarching acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to the predicate device, meaning it is as safe and effective and performs similarly.
| Test Category | Acceptance Criteria (Implied by Summary) | Reported Device Performance (Summary from Text) |
|---|---|---|
| Bench Testing | Articulating instruments perform as intended after mechanical integrity tests; Senhance system performs as intended with the articulating platform. | "The following tests confirmed that the articulating instruments perform as intended after tests of mechanical integrity under conditions of simulated use and that the Senhance system performs as intended when used with the subject Senhance Articulating platform: Sterile Drape Reliability, Cantilever Bending Reliability, Jaw Actuation Reliability, Coupler Use Life." |
| Reprocessing/Cleaning | Cleaning procedures ensure effective cleaning based on protocols for previously cleared couplers. | "The test results demonstrated that the cleaning procedures for the modified articulating couplers allow them to be effectively cleaned according to the processing instructions provided in the labeling." |
| Sterilization | Steam sterilization process achieves a Sterility Assurance Level (SAL) of at least 10⁻⁶. | "A validation of the steam sterilization process for the modified articulating couplers was conducted to demonstrate a Sterility Assurance Level (SAL) of at least 10⁻⁶." |
| Electrical Safety & Compatibility | Compliance with relevant IEC standards (60601-1, 60601-1-2, 60601-2-18, 60601-2-2). | "The Senhance Articulating platform used in conjunction with the Senhance system comply with current versions of IEC 60601-1 (Basic safety and essential performance), IEC 60601-1-2 (Electromagnetic disturbances), IEC 60601-2-18 (Endoscopic equipment interactions), and IEC 60601-2-2 (High frequency surgical equipment)." |
| Software | Senhance system software continues to reliably operate as designed with the new adapter and couplers. | "Software testing was conducted to demonstrate that the Senhance system software continues to reliably operate as designed with the addition of the new adapter and couplers." |
| Design Validation | Devices perform as intended according to defined user needs and intended uses in a simulated use environment; applicable user-level requirements are met. | "A single-center, un-blinded, observational, simulated use design validation evaluation... was conducted with users who represented the intended primary user population... All applicable user level requirements were assessed and found to be met." |
| Usability Testing | Surgical teams can independently perform all critical tasks without use errors leading to harm; overall residual risk of use errors is mitigated to an acceptable level. | "In a simulated use environment, the surgical teams were able to independently perform all critical tasks without use errors that would lead to harm. This study demonstrated that the overall residual risk of use errors with the Senhance Articulating platform have been mitigated to an acceptable level." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify a numerical sample size for any of the individual tests. It uses terms like "comprehensive set of testing," "single-center," and "surgical teams."
- Data Provenance: The document generally indicates prospective assessment through various forms of testing (bench, validation, usability). It doesn't specify the country of origin, but given it's an FDA submission for a US company (Asensus Surgical, Inc. in Durham, NC), it's highly likely the data was generated in the United States.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document mentions "users who represented the intended primary user population" for the "Design Validation" and "surgical teams" for "Usability Testing." However, it does not specify the number of experts or their qualifications (e.g., "radiologist with 10 years of experience"). This is a common characteristic of device submissions focusing on mechanical function and usability rather than diagnostic accuracy.
4. Adjudication Method for the Test Set:
- The document states the design validation was "un-blinded, observational." It does not mention any explicit adjudication method like "2+1" or "3+1" for conflict resolution, as would be common in studies involving subjective assessment. Given the nature of the tests (mechanical performance, cleaning effectiveness, usability of surgical tools), direct adjudication as seen in image interpretation might not be applicable or described in this summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
- No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating the safety and effectiveness of the new articulating platform itself and its compatibility with the existing Senhance Surgical System, primarily through technical and simulated-use testing. It does not evaluate the improvement of human readers (surgical teams) with or without AI assistance, as this is a surgical system, not a diagnostic AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable in the context of the Senhance Articulating Platform. This device is a component of a robotic surgical system that assists human surgeons; it is not a standalone algorithm performing a task without human interaction (like image analysis AI). The "Software" testing confirmed the system's software reliability with the new components, but this is about the system's control functionality, not an AI algorithm performing a task in isolation.
7. Type of Ground Truth Used:
The ground truth or reference standard for this type of device (surgical instrument/platform) is primarily established by:
- Performance Specifications/Engineering Standards: For bench testing (e.g., "perform as intended after tests of mechanical integrity," "Sterility Assurance Level (SAL) of at least 10⁻⁶," compliance with IEC standards).
- Defined User Needs and Intended Uses: For design validation and usability testing (e.g., "according to defined user needs," "independently perform all critical tasks without use errors that would lead to harm").
- Established Reprocessing Protocols: For cleaning effectiveness.
There isn't a "pathology" or "outcomes data" ground truth in the typical diagnostic sense, as this isn't a diagnostic device.
8. Sample Size for the Training Set:
- The document does not mention a training set sample size. This is because the submission is for a hardware addition to a robotic surgical system, not a machine learning or AI model that requires a dedicated training set. The "Software" testing is about verifying the existing system's software functions correctly with the new components, not training a new algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no mention of a training set for an AI/ML model in this submission.
§ 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.