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510(k) Data Aggregation
(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 |
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