(13 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, vacuum 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, general non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with mediastinotomy to perform coronary anastomosis during cardiac adjunctive 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 a design modification to the Intuitive Surgical Endoscopic and EndoWrist Instruments to incorporate the functionality of the Everest / Gyrus Bipolar Lyons Dissecting Forceps (a Class II, Electrosurgical cutting and coagulation device and accessories) Product Code GEI, under CFR Section 878.4400.
The Intuitive Surgical EndoWrist PK Dissecting Forceps (P/N 400214 for the da Vinci Surgical System - Model IS1200, and P/N 420214 for the da Vinci S Surgical System - Model IS2000) is an endoscopic instrument with a grasping end effector (or grips) to be used in conjunction with the Intuitive Surgical Endoscopic Instrument Control Systems (Model IS1200 and IS2000) and a external electrosurgical unit (ESU) provided by Gyrus Medical. The instrument is a reposable bipolar electrosurgical instrument connected to the ESU via a bipolar electrosurgical cable. The ESU can be activated by a foot pedal attached to the ESU itself, and controls the current flow to the grasping end effector of the device. A current passes from the ESU between the grip jaws then back to the generator, allowing for precise tissue coagulation. The instrument end effectors (or grips) are identical to the Everest Bipolar Lyons Dissecting Forceps, and the identical Gyrus connection cable, Gyrus ESU's and Footswitch are used with the EndoWrist PK Dissecting Forceps.
There are no changes to the Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci Surgical System, Model IS1200 and da Vinci S Surgical System, Model IS2000) associated with this pre-market notification. The da Vinci and da Vinci S Surgical Systems consists of two integrated sub-systems as follows:
Intuitive Surgical Endoscopic Instrument Control System: This subsystem is comprised of the Surgeon Console (SSC) and Patient Side Cart (PSC). 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 PSC. 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 PCS 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 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 Intuitive Surgical Endoscopic Instrument Control 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.
This 510(k) submission describes a design modification to an existing device, the Intuitive Surgical EndoWrist PK Dissecting Forceps. Therefore, the study presented focuses on demonstrating substantial equivalence to predicate devices rather than establishing and meeting specific, quantitative acceptance criteria for a novel device performance. The details provided in the submission are typical for such modifications, emphasizing equivalence through risk analysis and bench testing without a separate clinical study involving human readers or extensive ground truth adjudication as might be seen for a new diagnostic AI device.
Here's a breakdown of the requested information based on the provided text, highlighting what is and isn't applicable:
Acceptance Criteria and Device Performance
Since this is a design modification submission focused on demonstrating substantial equivalence, specific quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) are not explicitly stated in the document. Instead, the acceptance criterion implicitly is "substantially equivalent" to the predicate devices without introducing new safety or effectiveness issues.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantially equivalent to predicate device without introducing new issues of safety or effectiveness. | "Design and risk analysis and assessment has been conducted to confirm that basic functional characteristics are substantially equivalent to the predicate device without introducing any new issues of safety or effectiveness, and a 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." |
| Design input meets design output requirements. | "The results of the design control process confirm that the design input meets the design output requirements." |
Study Details
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated. The study involved "bench testing" which implies testing of device units/components. The number of units tested is not provided.
- Data Provenance: Not applicable in the traditional sense for a medical image or diagnostic AI device. This is a physical electrosurgical instrument. The testing would be conducted in a lab environment.
- Retrospective/Prospective: Not applicable. Bench testing is typically performed in a controlled, prospective manner on manufactured devices or components.
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)
- Number of Experts: Not applicable. For a device like this, ground truth is established through engineering specifications, performance standards, and comparison to predicate device characteristics, not through expert human interpretation of data in the same way it would be for a diagnostic AI. The "design and risk analysis and assessment" would be performed by qualified engineers and regulatory specialists.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This type of testing does not involve subjective human interpretation necessitating adjudication. Performance is assessed against measurable engineering specifications and the characteristics of the predicate devices.
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
- MRMC Study: No. This is not an AI diagnostic device and does not involve human readers for diagnostic interpretation. Therefore, no MRMC study was conducted.
- Effect Size of AI Improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the context of an AI algorithm. The device itself (the EndoWrist PK Dissecting Forceps) is a standalone instrument that functions in conjunction with the da Vinci Surgical System and an external ESU. Its performance is evaluated through bench testing against its design specifications and predicate device characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For this type of device modification, the "ground truth" or reference standard would be the engineering specifications, performance characteristics of the predicate devices (Intuitive Surgical EndoWrist Bipolar Forceps and Everest / Gyrus Bipolar Lyons Dissecting Forceps), accepted industry standards for electrosurgical instruments, and the design input requirements. This is not a pathology-based or outcomes-based ground truth.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
§ 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.