(126 days)
The Intuitive Surgical Endoscopic Instrument Control System Model IS4000) 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 laparoscopic surgical procedures, general thoracoscopical 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 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 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): Gastric Bypass (Roux-en-Y) and Gastric Sleeve. 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 softwarecontrolled, 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.
This document is a 510(k) summary for a labeling modification of the Intuitive Surgical da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200). It focuses on adding specific gastric procedures (Gastric Bypass and Gastric Sleeve) to the "general laparoscopic surgical procedures" indication for use. Therefore, the acceptance criteria and supporting studies are related to the safety and effectiveness of the device for these additional procedures, primarily against existing surgical methods (open and laparoscopic).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state formal "acceptance criteria" with specific numerical thresholds for performance metrics. Instead, it demonstrates substantial equivalence to predicate devices and established surgical practices (open and laparoscopic) by showing comparable or improved outcomes in various metrics. The acceptance is implicitly based on these comparisons showing non-inferiority or superiority in critical safety and effectiveness parameters.
| Metric (Acceptance Criteria implicitly: comparable or better than predicate/laparoscopic/open surgery) | Reported Device Performance (da Vinci-assisted vs. Open) | Reported Device Performance (da Vinci-assisted vs. Laparoscopic) |
|---|---|---|
| Mortality Rate (in-hospital or 30 days) | Comparable | Comparable |
| Lengths of Hospital Stay | Shorter | Comparable or Shorter |
| Intraoperative Complication Rates | Comparable | Comparable |
| Postoperative Complication Rates | Comparable or Lower | Comparable or Lower |
| Anastomotic Leak Rate | Comparable | Comparable or Lower (depending on anastomosis technique) |
| Anastomotic Stricture Rate | Comparable | Comparable or Lower (depending on anastomosis technique) |
| Reoperation Rate | Comparable or Lower | Comparable or Lower |
| Readmission Rate | Not reported for vs. Open | Comparable |
| Operative Time | Increased (but not associated with increased mortality/complication) | Increased (in N=7 publications) or Comparable/Shorter (in N=3 publications), not associated with increased mortality/complication |
| Estimated Blood Loss (EBL) | Not reported for vs. Open | Comparable |
| Conversion Rates | Not reported for vs. Open | Comparable or Lower |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The "test set" in this context refers to the published clinical data analyzed for Gastric Bypass (Roux-en-Y), which served as the "umbrella procedure" to support both Gastric Bypass and Gastric Sleeve.
- Sample Size (for Gastric Bypass umbrella procedure): The clinical data summarized in Table 1A involved 10 publications. The total number of patients included across these studies is:
- da Vinci (Robotic) Cohort: 172 + 61 + 100 + 100 + 100 + 125 + 100 + 65 + 388 + 143 = 1,354 patients
- Laparoscopic (Lap) Cohort: 173 + 46 + 100 + 100 + 100 + 121 + 100 + 54 + 389 + 323 = 1,506 patients
- Open Cohort: 95 + 524 = 619 patients
- Data Provenance: The data are from published clinical studies. The specific countries of origin are not mentioned, but clinical literature is generally international. The studies include both non-randomized, controlled, prospective studies (2 studies) and retrospective cohort studies (8 studies).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the given text. The "ground truth" for these clinical outcome studies is inherent in the reported patient outcomes and surgical metrics gathered and published by the original study authors. There is no mention of independent experts establishing a ground truth for a test set for the purpose of this 510(k) submission. The FDA's review process inherently involves medical experts, but they are assessing the submitted evidence, not establishing a new ground truth.
4. Adjudication Method for the Test Set
- This information is not provided. The text describes a review of published clinical data. Adjudication methods (like 2+1 or 3+1 consensus) are typically associated with image-based diagnostic studies or clinical trials where expert review of individual cases is part of the study design. For a meta-analysis or review of published literature on surgical outcomes, the "adjudication" is primarily how each original study defined and reported its outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. MRMC studies are typically used to evaluate the diagnostic performance of a device (often imaging-based AI) by comparing how multiple readers perform with and without the device. This submission is for a surgical system and its labeled indications, and the performance evaluation relies on real-world surgical outcomes and peer-reviewed literature, not diagnostic reader performance.
- Effect size of human readers improving with AI vs. without AI assistance: Not applicable, as it's not an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm-only) performance study was not done. The da Vinci system is a surgical assistance system, inherently involving a human surgeon (human-in-the-loop). Its "performance" is evaluated by the outcomes of surgeries performed with the system assisting the surgeon, compared to traditional methods.
7. The Type of Ground Truth Used
- The "ground truth" for the clinical performance evaluation is based on patient outcomes and surgical metrics reported in peer-reviewed clinical literature (e.g., mortality, complication rates, length of stay, operative time, reoperation rate, etc.). This is essentially outcomes data collected and documented in clinical studies.
8. The Sample Size for the Training Set
- This information is not applicable in the conventional sense for this type of submission. The da Vinci system is an electro-mechanical surgical system, not an AI/ML algorithm that undergoes a distinct "training" phase on a dataset of cases to learn to perform a task. The "experience" or "learning" of the system happens through engineering design, software development, preclinical testing, and extensive clinical validation over many years.
- However, if one were to consider the continuous development and refinement of the system's design and software, it would be based on an enormous "dataset" of engineering principles, surgical knowledge, user feedback, and prior clinical experience.
9. How the Ground Truth for the Training Set Was Established
- As explained above, a "training set" with established ground truth in the context of machine learning is not directly applicable here. The development of the surgical system relies on established surgical practices, engineering standards, and medical knowledge. Pre-clinical animal studies (mentioned as 6 evaluations in 24 animals) contribute to the developmental understanding and validation of the system's design, but this isn't a "training set" in the AI sense.
- The "ground truth" for surgical device development is rooted in the safety and effectiveness principles derived from surgical anatomy, physiology, surgical techniques, and clinical outcomes, primarily established by expert surgeons and medical researchers over decades.
§ 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.