(182 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 in laparoscopic colorectal surgery 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 Surgical System is a console-based, multi-arm surgical system which enables a surgeon to remotely control surgical instrumentation during minimally invasive surgery in the lower abdomen and pelvis. The capital equipment is comprised of three main sub-systems as follows:
- Cockpit The station where the surgeon inputs information through hand and eye movements to direct the motion of the arms in the surgical field.
- Manipulator Arms Independent mechanized support arms that interface with the endoscope ● and surgical instruments. The manipulator arms produce output movements based on the instructions from the surgeon at the cockpit. The system is configurable with up to three arms.
- Node A relay unit which connects the cockpit inputs to the manipulator arms in the system as configured, and converts and transmits the video signals to the 2D/3D monitor on the cockpit console.
The document is a 510(k) summary for the Senhance Surgical System (K171120), comparing it to the predicate device, the Intuitive Surgical da Vinci Si Surgical System IS3000 (K081137). The device is an endoscopic instrument control system.
Here's an analysis of the acceptance criteria and the studies performed:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for specific metrics like sensitivity, specificity, or AUC, as would be typical for diagnostic AI devices. Instead, the substantial equivalence is determined by comparing procedural endpoints of the Senhance System's clinical data to published literature data of the predicate device. The general acceptance criterion seems to be that the Senhance System is "as safe and effective as the predicate device for its intended use" based on these comparisons.
Here's a summary of the performance data presented, compared implicitly to the predicate device's published literature:
| Metric (Procedural Endpoints) | Senhance - Gynecological Study (150 patients) | Senhance - Colorectal Study (45 patients) | Implicit Acceptance Criteria / Comparison to Predicate (via published literature) |
|---|---|---|---|
| Safety | |||
| Intraoperative Complications | 10 conversions to manual laparoscopy (2 associated with serious adverse events), no blood transfusions. Overall: 2 (Total Hysterectomy group) | 0 (all groups) | Similar or better than predicate |
| Post-operative Complications | 6 serious adverse events (4%), including wound dehiscence, infections, suspected pleurisy, rapid onset anemia. None device-related. | 2 (4.4%) serious complications (anastomotic leak, intraluminal bleed). None device-related. | Similar or better than predicate |
| Mortality | 0% (all groups) | 0% (all groups) | Similar or better than predicate |
| Conversion Rates (to open/manual) | 5 (3.3%) for Total Hysterectomy group | 1 (2.2%) for Right Hemicolectomy, 2 (4.4%) for Left Hemicolectomy. No conversions to laparotomy. | Similar or better than predicate |
| Reoperation Rates | 2 (1.3%) for Total Hysterectomy group | 0% (all groups) | Similar or better than predicate |
| Readmission Rates | 3 (2%) for Total Hysterectomy group | 1 (2.2%) for Right Hemicolectomy, 0% for others | Similar or better than predicate |
| Estimated Blood Loss |
§ 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.