(96 days)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) shall 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 and general thoracoscopic surgical procedures. The system is indicated for adult 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.
Contraindication:
Use of the force feedback needle driver is contraindicated in hysterectomy and myomectomy due to the risk of vaginal bleeding requiring hospital readmission and/or the need for additional procedures. The use of non-force feedback needle drivers is recommended for suturing in these procedures.
The da Vinci Surgical System, Model IS5000 (da Vinci 5) is a software-controlled, electro-mechanical system designed to enable complex surgery using a minimally invasive approach. The system consists of a Console, Robot, and Tower and is used with an endoscope, instruments, and accessories.
The basis for this submission is a modification to the da Vinci Surgical System, Model IS5000, cleared under K232610. The device software has been modified to include a new "force gauge" graphical user interface element, which provides a visual representation of forces applied while completing tasks with the da Vinci Force Feedback instruments.¹ The modification also includes changes to the device labeling.
The provided FDA 510(k) clearance letter and summary for the Da Vinci Surgical System (IS5000) focuses on a software modification, specifically the addition of a "force gauge" graphical user interface (GUI) element. The document does not provide detailed information about clinical performance studies with acceptance criteria in the sense of diagnostic accuracy or clinical outcomes directly tied to the new GUI feature.
Instead, the performance data presented is related to software verification and validation and human factors. This is typical for device modifications where the core functionality of the device remains unchanged, and the modification primarily affects the user interface or internal software operations.
Here's a breakdown of the requested information based only on the provided text, recognizing the limitations of this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
Since the primary modification is a software change and the addition of a GUI element, the acceptance criteria are not clinical performance metrics but relate to the software's adherence to design specifications and usability.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Software Verification & Validation | All testing passed; continues to meet design specifications and user needs. Software documentation provided according to FDA guidance. |
| Human Factors Validation | Based on Comparative Task Analysis (CTA) and Use-Related Risk Analysis (URRA), human factors validation conducted for impacted critical tasks. All testing passed. |
2. Sample Size Used for the Test Set and Data Provenance
- Software Verification & Validation: The document states "unit, subsystem integration, and system level" testing. This typically involves internal testing by engineers. It does not specify a "sample size" in terms of patient data or clinical cases. The provenance is internal development and testing.
- Human Factors Validation: While a "human factors validation" was conducted, the document does not specify the number of users (the "test set" in this context) involved in these studies. The provenance would be from internal usability testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable in the context of this software modification submission. The "ground truth" for software verification is adherence to design specifications and functional requirements. For human factors, it relates to usability and safety of interaction, which is assessed through user testing and expert review of the interface. The document does not specify the number or qualifications of "experts" involved in establishing this ground truth.
4. Adjudication Method for the Test Set
Not applicable for the types of testing described. Adjudication methods like "2+1" typically apply to diagnostic studies where multiple readers interpret cases and a consensus or tie-breaker is needed to establish ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not explicitly mentioned or implied to be done for this submission. The submission focuses on verification of the software change and human factors, not on comparing clinical effectiveness with and without the AI assistance (which the force gauge isn't explicitly defined as, but rather a new GUI element for an existing force feedback instrument).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. The force gauge is a graphical user interface element that provides visual feedback to the human operator using the Da Vinci Surgical System. It inherently functions "with human-in-the-loop."
7. The Type of Ground Truth Used
- Software Verification & Validation: The "ground truth" is the design specifications and functional requirements of the software. The tests verify that the software performs as designed.
- Human Factors Validation: The "ground truth" is adherence to usability principles and mitigation of use-related risks, assessed through task analysis and user studies against established human factors engineering principles.
8. The Sample Size for the Training Set
Not applicable. This submission concerns a modification to an existing surgical system's software GUI. It does not describe an AI/ML algorithm that requires a "training set" in the conventional sense for model development. The "force gauge" is a visual representation of existing force feedback data, not a new predictive or analytical algorithm trained on data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a "training set" for an AI/ML model.
Summary of Device and Study Context:
The Da Vinci Surgical System (IS5000) submission (K251213) is a Traditional 510(k) for a software modification to an already cleared device (K232610). The modification adds a "force gauge" graphical user interface (GUI) element that visually represents forces applied by existing Da Vinci Force Feedback instruments.
The study described is not a clinical effectiveness trial but rather a set of engineering verification and validation activities to ensure the software modification is safe and functions as intended, and that the new GUI element does not introduce new use-related risks. The FDA's clearance is based on the determination that the modified device is substantially equivalent to its predicate device, and the performance data provided (software V&V, human factors) supports this equivalence for the specific modification.
§ 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.