(152 days)
The Intuitive Surgical Endoscopic Instrument Control System, Model 184000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, 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 laparosopic 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 Surgical System, Model 184200) 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 laparosopic 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 the following additional representative, specific procedures under the cleared "general laparoscopic surgical procedures" Indication for Use of the da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294): Pancreatectomy (partial, distal, segmental), Pancreaticoduodenectomy (Whipple Procedure), Splenectomy and Cholecystectomy. 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 text describes a 510(k) premarket notification for a labeling modification of the da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200. This modification adds specific representative procedures (Pancreatectomy, Pancreaticoduodenectomy, Splenectomy, and Cholecystectomy) under the existing "general laparoscopic surgical procedures" indication for use.
Crucially, the submission states that there are no changes to the technological characteristics of the device. Therefore, the "device" in question (the da Vinci surgical system itself) is already cleared, and the performance data presented is to establish substantial equivalence for the expanded indications for use, not to prove the fundamental performance of the surgical robot. The acceptance criteria and "device performance" in this context refer to the clinical outcomes of procedures performed using the da Vinci system compared to traditional open or laparoscopic methods, demonstrating that the new indications are safe and effective.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the document. Instead, the study aims to demonstrate that da Vinci Xi/X-assisted procedures for the newly added indications are comparable or superior to existing open or laparoscopic surgical procedures across a range of clinical outcomes.
The "reported device performance" is derived from the clinical literature review for the "umbrella procedures" (Pancreatectomy and Pancreaticoduodenectomy), which are considered representative of the more complex/higher-risk operations. The less complex/lower-risk "covered procedures" (Splenectomy and Cholecystectomy) were supported by inference from the umbrella procedures.
Below is a summary of the findings, which implicitly serve as the "acceptance criteria" and "reported performance" through comparative equivalence:
| Performance Metric | Da Vinci-assisted vs. Open/Laparoscopic Pancreatectomy (Umbrella Procedure #1) | Da Vinci-assisted vs. Open/Laparoscopic Pancreaticoduodenectomy (Umbrella Procedure #2) |
|---|---|---|
| Mortality | Comparable mortality rates. | Comparable mortality rates. |
| Estimated Blood Loss (EBL) / Transfusion Rates | Comparable or lower blood transfusion rates and/or EBL volumes. | Comparable EBL volumes. |
| Length of Hospital Stay | Comparable or shorter length of hospital stay as compared to laparoscopy and open surgery. | Comparable length of hospital stay as compared to laparoscopy and comparable or shorter length of hospital stay as compared to open surgery. |
| Complication Rates | Comparable or lower complication rates. | Comparable or lower complication rates. |
| Spleen Preservation Rates | Higher or comparable spleen preservation rates. (Specific to pancreatectomy) | Not applicable / Not reported in the context of this procedure. |
| Gastric Emptying Rates | Lower or comparable delayed gastric emptying rates. | Lower or comparable delayed gastric emptying rates. |
| Reoperation Rates | Comparable reoperation rates. | Comparable reoperation rates. |
| Readmission Rates | Comparable or higher readmission rates. | Not explicitly summarized as "comparable or higher" but individual studies show variations (e.g., Orti-Rodriguez not reported, Zhang not reported). Needs closer interpretation of Tables 2A/2B. |
| Pancreatic Fistula Rates | Comparable pancreatic fistula rates as compared to both open and laparoscopic surgical procedures. | Comparable pancreatic fistula rates as compared to both open and laparoscopic surgical procedures. |
| Operative Time | Increased operative times were associated with da Vinci procedures as compared to open and laparoscopic procedures. (Not associated with increased mortality/complications). | Increased operative times were associated with da Vinci procedures as compared to open and laparoscopic procedures. (Not associated with increased mortality/complications). |
| Conversion Rates | Comparable or lower conversion rates reported for da Vinci-assisted procedures as compared to laparoscopic procedures. | Comparable or lower conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures. |
2. Sample Size Used for the Test Set and Data Provenance
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Sample Size for Clinical Studies (Test Set):
- Pancreatectomy (Umbrella Procedure #1): Eleven (11) publications were identified. The sample sizes within these publications varied significantly. For example, in Table 1A, individual study cohorts ranged from 22 to 3743 patients for da Vinci, laparoscopic, and open procedures. The largest single cohort for da Vinci was 258 (Zureikat, 2017) and for open was 3743 (Zureikat, 2017).
- Pancreaticoduodenectomy (Umbrella Procedure #2): Eight (8) publications were identified. Individual study cohorts ranged from 102 to 3743 patients. The largest single cohort for da Vinci was 476 (Pedziwiatr, 2017) and for open was 3743 (Zureikat, 2017).
- Covered Procedures (Splenectomy and Cholecystectomy): No specific clinical studies were provided for these procedures; their clearance was supported by the data from the umbrella procedures.
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Data Provenance: The data are derived from published clinical literature, including:
- Prospective randomized controlled trials
- Meta-analyses
- Systematic reviews
- Large database comparative studies
The specific countries of origin are not specified, but peer-reviewed medical literature typically encompasses international data. The studies are retrospective and prospective, depending on the nature of the individual publications included in the literature review.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable in the traditional sense for this submission. The "ground truth" for the clinical effectiveness and safety of the da Vinci system for these procedures is established by the peer-reviewed published clinical literature, which is generated by numerous clinical researchers and practicing surgeons. The FDA review process itself involves experts (e.g., "Director, Division of Surgical Devices, Office of Device Evaluation") who evaluate the scientific rigor and conclusions of the submitted literature review.
4. Adjudication Method for the Test Set
Not directly applicable in the terms of human reader adjudication of images. The "adjudication" in this context is the consensus reached through the scientific and statistical analysis presented in the peer-reviewed meta-analyses, systematic reviews, and comparative studies. The FDA then adjudicates the strength of this evidence for the purpose of granting substantial equivalence.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The submission relies on a literature review comparing clinical outcomes of different surgical approaches (da Vinci, laparoscopic, open).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This question is not applicable. The da Vinci Surgical System is a human-in-the-loop device; it is controlled by a surgeon. The "performance" being evaluated is the outcome of surgical procedures when performed using the da Vinci system (with a human surgeon operating it), compared to other surgical methods. This is not an AI algorithm performing a task autonomously.
7. The Type of Ground Truth Used
The "ground truth" for the clinical performance claims is based on patient outcomes data reported in published clinical trials and studies. These outcomes include:
- Mortality rates
- Estimated blood loss
- Length of hospital stay
- Postoperative complication rates
- Spleen preservation rates (for pancreatectomy)
- Gastric emptying rates
- Reoperation rates
- Readmission rates
- Pancreatic fistula rates
- Operative time
- Conversion rates
- R0/R1 resection rates
- Lymph node yield
8. The Sample Size for the Training Set
No explicit "training set" for an AI algorithm is mentioned as this device is not presented as an AI-driven autonomous system in this submission. The performance data is for the surgical system itself. The publications reviewed in the submission can be considered the evidence base that informs the regulatory decision, rather than a training set for an AI model.
9. How the Ground Truth for the Training Set Was Established
As no training set for an AI algorithm is mentioned, this question is not applicable. The clinical "ground truth" for the effectiveness of the surgical system is established through the standard methodologies of clinical research (e.g., prospective trials, retrospective analyses, meta-analyses) that generated the published literature.
§ 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.