(38 days)
The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pickups, needle holders, endoscopic retractors, stabilizers, 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 ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, general noncardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system is indicated for adult and pediatric use. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. It is intended for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.
The da Vinci S Surgical System, Model IS2000 V1.1, consists of three integrated sub-systems as follows: Intuitive Surgical Endoscopic Instrument Control System: The Endoscopic Instrument Control System is comprised of two sub-systems - the Surgeon Console, Model SS2000, and Patient Side Cart, Model PS2000. While seated at the Surgeon Console, the surgeon controls critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within the operative field. Endoscopic instrument and camera movements are controlled by the surgeon through use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The endoscopic instruments are held in a fixed position (with respect to the patient) by either two (or optionally three) unique manipulators known as Patient Side Manipulators (PSM), which are located on the Patient Side Cart (PSC, Model PS2000). The endoscope is also held in a fixed position (with respect to the patient) by another manipulator. similar to the PSM, known as the Endoscope Camera Manipulator (ECM) and also located on the PSC. The PSM and ECM are attached to surgical arms on the PSC known as Set-up Joint (SUJ) arms. Commands from the Surgeon Console are relayed to the PSC, which is located immediately adjacent to the patient, via a cable. Instrument and endoscope changes are performed by another provider positioned adjacent to the PSC. Intuitive Surgical Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci Surgical System, also known as Intuitive Surgical Insite® Vision System, Model VS2000, consists of a stereo endoscope, endoscopic camera, and various accessories, including a light source and light guides. The Insite Vision System provides two independent images that are relayed to the viewer located in the Surgeon Console, where they are fused to form a 3-D (or alternatively a 2-D image) image of the surgical field.
This document is a 510(k) summary for the Intuitive Surgical® da Vinci® S™ Surgical System (Model IS2000, V1.1) and EndoWrist® Endoscopic Instruments. It describes modifications to an already legally marketed device. As such, the submission focuses on demonstrating substantial equivalence to the predicate device rather than presenting new clinical study data with acceptance criteria for device performance.
Therefore, many of the requested sections below are not applicable or cannot be extracted from the provided text.
1. A table of acceptance criteria and the reported device performance
Not applicable. The submission is for design modifications to an already cleared surgical system and focuses on demonstrating substantial equivalence to the predicate device. It does not present specific performance acceptance criteria for new clinical efficacy or safety endpoints, but rather confirms that the modifications do not negatively impact the existing performance and safety.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The submission refers to "bench testing and risk analysis activities" and "design analysis and comparison" rather than a clinical test set. No sample size, country of origin, or study design (retrospective/prospective) for a test set is mentioned.
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)
Not applicable. No direct "ground truth" establishment by experts for a test set is described. The assessment is based on demonstrating that the modified device's technological characteristics and performance are essentially the same as the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication is described.
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
Not applicable. This device is a surgical system, not an AI-assisted diagnostic tool. Therefore, an MRMC study and effects on human readers are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a surgical system that requires a human surgeon for operation. "Algorithm only" performance is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. As a modification submission, the "ground truth" for substantial equivalence is derived from the established safety and effectiveness of the predicate device, confirmed through engineering analysis, bench testing, and risk analysis to ensure the modifications do not introduce new safety or efficacy concerns.
8. The sample size for the training set
Not applicable. This document does not describe the development or training of an AI algorithm; it details modifications to a surgical system.
9. How the ground truth for the training set was established
Not applicable. No AI algorithm development or training set is described in the provided text.
§ 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.