(212 days)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi Surgical System, Model IS4000 and 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, 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 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 modifications to the da Vinci Xi and X Surgical Systems adds a hardware component called the Advanced Processor (AP4000) as well software components, both on the Advanced Processor and a separate iOS app, to the surgical system.
These modifications enable the following functionality: Video recording/Image capture, WiFi pairing of iOS devices with the Advanced Processor, an iOS app to view live endoscopic video once the iOS device has been paired and data logging on the AP4000 hard disk (stereo endoscopic video, kinematics and real time events). This allows surgeons to initiate and control video recordings as well as capture endoscopic images. These modifications also allow OR staff and others present in the OR to pair their iOS mobile devices with the Advanced Processor in order to view the live endoscopic video.
This FDA 510(k) summary describes modifications to the da Vinci Xi and X Surgical Systems, not a new AI/ML medical device. Therefore, much of the requested information regarding AI/ML device studies and acceptance criteria is not applicable to this document. The document focuses on regulatory clearance for hardware and software modifications that enhance existing functionalities of a robotic surgical system, rather than an AI-driven diagnostic or treatment recommendation system requiring clinical performance studies against a ground truth.
Specifically, the modifications enable:
- Video recording/Image capture.
- WiFi pairing of iOS devices with an Advanced Processor.
- An iOS app to view live endoscopic video.
- Data logging (stereo endoscopic video, kinematics, real-time events).
The submission asserts that these modifications do not affect the substantial equivalence of the device to its predicate because "verification and validation testing have established there are no new issues of safety or effectiveness."
Here's an attempt to answer the questions based on the provided document, highlighting what is not applicable due to the nature of the submission:
1. A table of acceptance criteria and the reported device performance
Since this is a submission for modifications to an existing device, and not a new diagnostic or prognostic AI/ML device, there are no specific clinical performance acceptance criteria (e.g., sensitivity, specificity, accuracy) reported in this document. The "acceptance criteria" for these modifications appear to be successful completion of verification and validation testing, and compliance with relevant standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| All required specifications met | "The subject device met all required specifications and functioned as intended." |
| Functioned as intended | "The modifications enable the following functionality: Video recording/Image capture, WiFi pairing of iOS devices with the Advanced Processor, an iOS app to view live endoscopic video once the iOS device has been paired and data logging on the AP4000 hard disk (stereo endoscopic video, kinematics and real time events)." and "These modifications do not affect the substantial equivalence of the subject device to the predicate as verification and validation testing have established there are no new issues of safety or effectiveness." |
| Safety and performance evaluated/verified | "Safety and performance of the da Vinci Xi/X Surgical System has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing." |
| Compliance with IEC 62304:2006/AC:2015 | "software validation activities were performed in accordance with IEC 62304:2006/AC: 2015- Medical device software - Software life cycle processes" |
| Compliance with FDA Guidance for Software in Medical Devices | "in addition to the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices."" |
| Compliance with EMC, Electrical Safety, and Wireless Coexistence | "electromagnetic compatibility testing (in accordance with ISO 60601-1-2:2015 / IEC 60601-1-2:2014), electrical safety testing (in accordance with IEC 60601-1: 2012) and wireless coexistence testing were performed." |
| No new questions of safety or effectiveness | "The da Vinci Xi/X Surgical System raises no new questions of safety or effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes verification and validation testing of software and hardware modifications for a robotic surgical system, not a clinical study involving a test set of patient data for an AI/ML diagnostic or prognostic algorithm. The testing would involve engineering and software validation tests, not clinical data sets in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. Ground truth establishment by experts is relevant for AI/ML algorithms performing tasks like diagnosis or detection. The current submission focuses on verifying the functionality and safety of video recording, streaming, and data logging features.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as #3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device provides tools for surgeons (video recording, streaming), but it is not an AI assistant meant to improve human reader performance in interpreting medical images or data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The modifications are for a human-controlled surgical system, enhancing its capabilities rather than introducing a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. The "ground truth" for the verification and validation of these modifications would be the functional specifications and safety requirements met through engineering and software testing.
8. The sample size for the training set
This information is not applicable. This document does not pertain to the development or validation of an AI/ML algorithm that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable. As no AI/ML training set is mentioned or implied, the method for establishing its ground truth is irrelevant to this submission.
§ 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.