(253 days)
The Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Models IS1200, IS3000) are intended to assist in the accurate control of Intuitive Surgiçal Endoscopic EndoWrist Instruments and Accessories including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic/harmonic 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 ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2. 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 (except for transoral otolaryngology surgical procedures). 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 510(k) is being submitted to request an expansion of the Indications for Use to include transoral otolaryngology surgical procedures. There are no changes in the design, technology, materials, manufacturing, performance, specifications, or method of use for the da Vinci Surgical Systems, EndoWrist Instruments and Accessories associated with this pre-market notification. The da Vinci Surgical Systems (Models IS1200, IS2000, IS3000) consists of two integrated sub-systems as follows: A Surgeon Console and a 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. The 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), which is 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 individual positioned adjacent to the PSC.
Intuitive Surgical Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci Surgical Systems, 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 surgeon located at 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 (K090993) is for an expansion of the Indications for Use for the Intuitive Surgical da Vinci Surgical Systems to include transoral otolaryngology surgical procedures. Since this is an expansion of indication for an existing device, the study is focused on demonstrating substantial equivalence rather than meeting specific performance criteria.
Therefore, the structure for acceptance criteria and device performance table, and sections related to algorithm performance, training data, ground truth establishment, and MRMC studies are not directly applicable in the conventional sense for this submission. The 510(k) summary focuses on comparing the surgical tasks involved in the new indication to those already cleared for the device.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
As this 510(k) is for an expansion of indications for an already cleared device (Intuitive Surgical da Vinci Surgical Systems), the acceptance criteria are not in the form of numerical performance metrics for an AI algorithm. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to existing treatment methods and the lack of new safety or effectiveness issues.
| Acceptance Criterion (Implied) | Reported Device Performance/Justification |
|---|---|
| Feasibility of use for Transoral Otolaryngology Surgical Procedures | A multicenter retrospective clinical study confirmed the feasibility of the device for transoral otolaryngology surgical procedures. |
| Efficacy in Transoral Otolaryngology Surgical Procedures | The multicenter retrospective clinical study confirmed the efficacy of the device in these procedures. Historical controls demonstrated substantial equivalence of robotic-assisted transoral procedures to alternative methods (Open surgery, transoral surgery, chemoradiation). |
| Safety in Transoral Otolaryngology Surgical Procedures | The multicenter retrospective clinical study confirmed the safety of the device for this indication. The submitter concludes no new issues of safety or effectiveness are raised. |
| Functional Assessment for Transoral Otolaryngology Surgical Procedures | The multicenter retrospective clinical study included functional assessment of patients undergoing these procedures. |
| Equivalence of Surgical Tasks with Existing Indications | A comparison of surgical tasks involved in transoral otolaryngology procedures confirmed "there are no new tasks above and beyond those for which the da Vinci Surgical System... is currently used." |
| No Changes to Device Design/Technology | Stated that "There are no changes in the design, technology, materials, manufacturing, performance, specifications, or method of use for the Intuitive Surgical Endoscopic Instrument Control Systems." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a numerical value within the 510(k) summary. It refers to a "multicenter retrospective clinical study" that included "transoral otolaryngology surgical patients." The exact number of patients or cases is not provided.
- Data Provenance:
- Country of Origin: Not specified in the summary.
- Retrospective or Prospective: Retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This submission does not involve an AI algorithm with a defined "ground truth" established by experts in the typical sense. The clinical study's "ground truth" would be derived from patient outcomes, surgical observations, and comparison to standard treatments.
- Number of Experts: Not applicable/not specified. The study involved a clinical assessment implicitly by the treating physicians and researchers.
- Qualifications of Experts: The study was conducted by "trained physicians in an operating room environment," as indicated in the Intended Use statement common to the da Vinci system.
4. Adjudication Method for the Test Set
Not applicable as this is a clinical outcomes study for an existing surgical device's indication expansion, not a diagnostic or AI performance study requiring expert adjudication of image annotations or classifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a study measuring the effectiveness of human readers with or without AI assistance. It's a clinical study to support an expanded indication for a surgical robot.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The da Vinci Surgical System is a human-controlled robotic surgical system; it's not an autonomous algorithm. The study assesses the system's performance with a human surgeon.
7. Type of Ground Truth Used
The "ground truth" in this context refers to the clinical outcomes and observations from the surgical procedures performed using the da Vinci system.
- Type of Ground Truth: Clinical outcomes (feasibility, efficacy, safety, functional assessment) from actual patient surgeries, compared to historical controls for alternative treatment methods (Open surgery, transoral surgery, and chemoradiation treatment).
8. Sample Size for the Training Set
Not applicable. The da Vinci Surgical System is a physical device, and this submission is for an expanded indication, not an AI algorithm that requires a training set in the machine learning sense. The device itself has been developed and refined over many years and multiple previous 510(k) clearances.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reasons stated above.
§ 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.