(241 days)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi Surgical System Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically- assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Model IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
This 510(k) is for a labeling modification only, to include "Ventral Hernia Repair" (VHR) procedures under the cleared "general laparoscopic surgical procedures" Indication for Use of the da Vinci Xi Surgical System, Model IS4000 and the da Vinci X Surgical System, Model IS4200. There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (Models IS4000 and IS4200) proposed in this submission. The da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200, are software-controlled, electro-mechanical systems designed for surgeons to perform minimally invasive surgery. The Model IS4000 and Model IS4200 Surgical Systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and Accessories.
The provided document, K173585, describes the a 510(k) premarket notification for a labeling modification to include "Ventral Hernia Repair" (VHR) procedures under the cleared "general laparoscopic surgical procedures" Indication for Use of the da Vinci Xi Surgical System (Model IS4000) and the da Vinci X Surgical System (Model IS4200). The document does not describe the acceptance criteria and study proving a device's performance against acceptance criteria in the manner typically seen for AI/ML-enabled devices. Instead, it focuses on demonstrating the substantial equivalence of adding VHR procedures to the existing robotic surgical systems by comparing the outcomes of robotic-assisted VHR to traditional open and laparoscopic VHR.
Therefore, many of the specific questions about acceptance criteria for an AI/ML device's performance, sample sizes for test sets, establishment of ground truth by experts, MRMC studies, and standalone algorithm performance, as requested in the prompt, are not applicable or directly addressed by this document. This document is about a surgical system, not an AI/ML diagnostic or prognostic tool.
However, I can extract information related to the clinical study data used to support the labeling modification, which serves a similar purpose to a performance study for a new indication.
Here's the information as it relates to the provided document:
1. A table of acceptance criteria and the reported device performance:
The document doesn't define explicit numerical "acceptance criteria" in the way one would for an AI/ML device (e.g., "sensitivity must be >X%"). Instead, it demonstrates comparability and, in some cases, superiority of the robotic-assisted VHR to existing surgical methods across several clinical outcomes and measures. The "acceptance" for this 510(k) is based on demonstrating substantial equivalence and safety and effectiveness for the new indication compared to existing methods.
The tables provided (Tables 1, 2, 3, and 4a) present the "reported device performance" in terms of clinical outcomes for robotic-assisted VHR procedures compared to open and laparoscopic VHR. Below is a summary of the key findings, which serve as the "performance" data used to support the new indication.
Summary of Device Performance (Robotic-Assisted VHR vs. Comparators)
| Outcome/Measure | Robotic-Assisted vs. Open (Non-Complex VHR) | Robotic-Assisted vs. Laparoscopic (Non-Complex VHR) | Robotic-Assisted vs. Open (Complex VHR) | Robotic-Assisted vs. Laparoscopic (Complex VHR) - Unmatched AHSQC Data & Published Literature |
|---|---|---|---|---|
| Length of Stay | Comparable (2 ± 7 days vs. 2 ± 14 days) | Shorter (2 ± 7 days vs. 4 ± 13 days) | Shorter (2 ± 3 days vs. 5 ± 7 days) | Shorter in AHSQC data (2 ± 3 days vs. 4 ± 3 days). Published literature varies (1-9.2 days). |
| Intraoperative Complications | Comparable | Comparable | Comparable | Comparable in AHSQC data (2% vs. 11%). Published literature (0-1.5%). |
| Transfusions (Intra/Post-op) | Comparable | Comparable | Comparable | Comparable (0% across all AHSQC cohorts). Published literature (0 or 51-91.7ml EBL). |
| Postoperative Complications (through 30 days) | Comparable (9% vs. 11%) | Comparable (10% vs. 11%) | Comparable (24% vs. 20%) | Mixed: Robotic-assisted (24%) vs. AHSQC Laparoscopic (11%). Published literature (0-60%). |
| Readmission Rates (through 30 days) | Comparable (2% vs. 3%) | Comparable (2% vs. 3%) | Comparable (7% vs. 4%) | Comparable in AHSQC data (7% vs. 7%). Published literature (0-13%). |
| Re-encounter Rates (through 30 days) | Lower clinic re-encounter for robotic-assisted (29% vs. 41%). Comparable ER. | Comparable | Lower clinic re-encounter for robotic-assisted (16% vs. 27%). Comparable ER. | Mixed: Robotic-assisted (17% Clinic, 5% ER) vs. AHSQC Laparoscopic (22% Clinic, 15% ER). Published literature (0). |
| Reoperation Rates (through 30 days) | Comparable ( |
§ 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.