(316 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, scalpels, ultrasonic shears, 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 and cryogenic ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, general cardiovascular and 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. The system is indicated for adult and pediatric use. 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.
This special 510(k) is being submitted for an additional EndoWrist® instrument, the Cardiac Probe Grasper, to be utilized with probes and catheters used endoscopically during cardiac ablation procedures. This submission also includes the related minor labeling changes / clarifications on the da Vinci® Surgical Systems and EndoWrist Instruments. There are no changes in the technology, materials, manufacturing, performance, design, specifications or method of use for the da Vinci Surgical System or the CryoCath SurgiFrost Surgical CryoAblation System.
The da Vinci Surgical Systems consist of two integrated subsystems as follows: Intuitive Surgical® Endoscopic Instrument Control System: This sub-system is comprised of the Surgeon Console and Patient Side Cart. While seated at the Surgeon Console, the surgeon is able to view the surgical field and control critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within that field. Movements are controlled by the surgeon through use of Master Tool Manipulators (MTMs), two hand-operated mechanisms residing within the Surgeon Console. The EndoWrist® endoscopic instruments, stereo endoscope and camera attach to surgical arms located on the Patient Side Cart (PSC). The endoscopic instruments attach to arms known as Patient Side Manipulators (PSM). Another arm, known as the Endoscope Camera Manipulator (ECM), holds the stereo endoscope and camera. Commands from the Surgeon Console are relayed to the PSC, located adjacent to the patient, via various cables. Instrument and endoscope insertions, removals and exchanges are performed by another member of the surgical team 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 the InSite® Vision System, consists of a stereo endoscope, endoscopic camera, and 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 of the surgical field. Additional monitors may be supplied by the user to allow other members of the surgical team to view the procedure.
Here's a breakdown of the acceptance criteria and the study details for the Intuitive Surgical® da Vinci® Surgical System and Endoscopic Instruments and the Intuitive Surgical® EndoWrist® Cardiac Probe Grasper, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" aspect is addressed by confirming that the new instrument maintains the basic functional characteristics of existing, cleared instruments within the da Vinci system.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence: The Cardiac Probe Grasper must maintain the basic functional characteristics of existing EndoWrist instruments. | "Design analysis and comparison, as well as bench testing, have been conducted to confirm that basic functional characteristics of the subject devices are substantially equivalent to the predicate devices cited, and that design output meets the design input requirements." The document states the Cardiac Probe Grasper will be used to "position and hold probes used during ablative cardiac procedures, and will also facilitate precise and delicate blunt dissection of the pericardial reflections at the superior vena cava (SVC) and inferior vena cava (IVC)," which aligns with the general functions of EndoWrist instruments (grasping, blunt dissection). It also clarifies that "there are no changes in the instrument technology, materials, manufacturing or sterilization processes, requirements or compatibility with the da Vinci Surgical Systems." This implies the performance is consistent with the established system. Additionally, the da Vinci Surgical System itself receives a minor labeling change to include "delivery and placement of microwave and cryogenic ablation probes and accessories," and it's stated that "The use of the da Vinci Surgical System to deliver and place the SurgiFrost probe is equivalent to the currently cleared practice of using conventional minimally invasive surgical instruments." This suggests the system's performance in this new specific use case is also deemed equivalent. |
| Safety and Effectiveness: No new safety or effectiveness concerns should be introduced by the new instrument or labeling changes. | The 510(k) submission aims to demonstrate substantial equivalence, which inherently means the device is as safe and effective as the predicate device(s). The fact that the FDA cleared the device implies they found no new safety or effectiveness concerns preventing market entry. |
2. Sample Size Used for the Test Set and Data Provenance
The document only mentions "bench testing" and "design analysis and comparison." It does not provide specific details about a "test set" with a defined sample size for clinical or real-world performance evaluation.
- Sample Size: Not specified.
- Data Provenance: Not specified, but likely laboratory-based (bench testing). The regulatory submission is for a medical device in the US, so the "country of origin" of the data is implicitly internal to the manufacturer's testing or US-based contract labs. The study is presumed to be prospective as it's part of a pre-market submission, involving new tests on the Cardiac Probe Grasper.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The document does not describe the establishment of a "ground truth" using experts in the context of the bench testing or design analysis mentioned. The evaluation is based on engineering principles and comparison to existing products.
4. Adjudication Method for the Test Set
Not applicable, as no expert-based ground truth establishment or adjudication process is described for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study is not mentioned in the document. The device is a surgical instrument and system, not an imaging AI or diagnostic algorithm that would typically undergo an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical instrument and system that inherently requires human-in-the-loop operation. It is not an algorithm that operates autonomously.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic AI algorithms (e.g., pathology, outcomes data) is not directly applicable here. For this surgical instrument, the "ground truth" for its performance is derived from its ability to meet design input requirements and demonstrate functional equivalence and compatibility with the existing da Vinci Surgical System, which is already legally marketed and established as safe and effective for its intended uses. This is verified through:
- Design analysis and comparison: Engineering review against predicate devices.
- Bench testing: Laboratory tests to confirm functional characteristics.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical surgical instrument and system, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
§ 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.