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The Intuitive Surgical" Endoscopic Instrument Control System (hereinafter referred to as the " da Vinci System") 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, 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 general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. 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 special 510(k) is being submitted for a minor labeling change / clarification on the da Vinci® Surgical System. There are no changes in the design, technology, materials, manufacturing, performance, specifications, and method of use for the da Vinci Surgical System or the Guidant Flex 10 ablation probe and Microwave Ablation System. The only change is an updated indication statement and addendum user manual sheet for the da Vinci® Surgical System.

The da Vinci® Surgical System consists of two integrated sub-systems as follows:

Intuitive Surgical® Endoscopic Instrument Control System: This subsystem is comprised of the Surgeon Console and Patient Side Cart. 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 arms known as Patient Side Manipulators (PSM), which are located on the Patient Side Cart (PSC). The endoscope is also held in a fixed position (with respect to the patient) by another arm, similar to the PSM, known as the Endoscope Camera Manipulator (ECM) and also located on the PSC. Commands from the Surgeon Console are relayed to the PSC. which is located immediately adjacent to the patient, via cables. 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, 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.

The provided 510(k) summary (K043153) describes a "Special 510(k)" for a minor labeling change/clarification for the Intuitive Surgical® da Vinci® Surgical System. Crucially, this submission explicitly states that there are no changes in the device's design, technology, materials, manufacturing, performance, specifications, and method of use.

Therefore, there is no new study or performance data presented in this specific 510(k) to prove the device meets acceptance criteria related to its performance. Instead, the submission relies on the substantial equivalence to previously cleared predicate devices (K990144, K002489, K011002, K013416, K021036, K022574, K040237 for the da Vinci® system itself, and K013946, K041340 for the Guidant Microwave Ablation System).

Here's an analysis based on the document's content:

1. Table of acceptance criteria and the reported device performance:

Since this is a special 510(k) for a labeling change, no new specific performance acceptance criteria or reported device performance for the device itself is presented. The document asserts that "design analysis and comparison, as well as bench testing, has been conducted to confirm that basic functional characteristics are substantially equivalent to the predicate devices cited, and that design output meets the design input requirements." However, the exact acceptance criteria for these past tests are not detailed in this document.

2. Sample size used for the test set and the data provenance:

Not applicable. No new test set data is presented for performance evaluation of the device. The "bench testing" mentioned is to confirm substantial equivalence, not to demonstrate new performance metrics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No new test set requiring expert ground truth is described.

4. Adjudication method for the test set:

Not applicable. No new 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 not an AI/CAD device for image interpretation, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a surgical system with human-in-the-loop control, not a standalone algorithm.

7. The type of ground truth used:

Not applicable. No new performance study requiring ground truth is described in this document. For previous clearances, the ground truth would have been established through a combination of engineering specifications, clinical outcomes, and expert assessment for safety and effectiveness in surgical procedures.

8. The sample size for the training set:

Not applicable. This document pertains to a labeling change for an existing device, not the development or training of a new algorithm.

9. How the ground truth for the training set was established:

Not applicable.

In summary, for K043153:

The "acceptance criteria" for this specific submission relate to the administrative requirements of a Special 510(k) – specifically, demonstrating that the labeling update and the intended use clarification do not alter the fundamental safety and effectiveness of the device as previously cleared. The "study that proves the device meets the acceptance criteria" is the assertion of substantial equivalence to previously cleared predicate devices and the internal checks (design analysis and comparison, bench testing) to confirm that the labeling change has no impact on the underlying device performance. The performance of the da Vinci® Surgical System itself was established in prior 510(k) submissions, which are not detailed in this document.

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