(305 days)
The da Vinci Wireless Connectivity Option is intended to provide a suitable alternative for the wired Ethernet connection between the da Vinci Surgical System and the hospital's Internet Protocol (IP) infrastructure.
The Intuitive Surgical Endoscopic Instrument Control System (IS2000 da Vinci S Surgical System with da Vinci Connect™, da Vinci OnSite) 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/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, includina 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 suraical procedures, fransoral otolarynaology suraical procedures restricted to benlan and malignant tumors classified as T1 and T2, general cardiovascular and noncardlovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardlotomy procedures. The system is indicated for adult and pediatric use. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardlac revascularization. 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.
The da Vinci Wireless Connectivity Option for the da Vinci S Surgical System Model IS2000 with da Vinci Connect™ and da Vinci OnSite, is a minor modification that will provide an alternative to the wired Ethernet connection in the existing device. Specifically, the Wireless Connectivity Option will provide IEEE 802.11 wireless connectivity between the da Vinci S Surgical System and the hospital's Internet Protocol (IP) infrastructure.
The da Vinci Wireless Connectivity Option is a modification to the da Vinci S Surgical System, providing an alternative to the wired Ethernet connection.
Here's an analysis based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to Design Controls (ensuring the design meets regulatory and internal requirements) | "Performance tests (bench tests) were conducted to demonstrate conformance to Design Controls..." |
| Design output meets design input requirements (the as-built device functions as intended from the initial specifications) | "...and that the design output meets the design input requirements." |
| Does not raise any new issues of safety or efficacy compared to the predicate device | "The results of the testing do not raise any new issues of safety or efficacy." |
| Equivalent in safety, efficacy, and performance to the predicate device (K081207: Intuitive Surgical® da Vinci S™ Surgical System, Model IS2000, with da Vinci Connect™ and da Vinci OnSite™) | "Based on the technical characteristics, intended use and performance test data, the Intuitive Surgical® da Vinci® S™ Surgical System, Model IS2000, with da Vinci Connect™, da Vinci OnSite™ and Wireless Connectivity Option has been determined to be equivalent in safety, efficacy, and performance to the predicate device." |
2. Sample Size and Data Provenance
The study described is focused on "Performance tests (bench tests)" of the wireless connectivity option. The text does not provide specific details on the sample size for these bench tests, nor does it mention any human subject data, countries of data origin, or whether it was retrospective or prospective. Given the nature of a wireless connectivity option, the "sample" would likely refer to the number of test scenarios, data transfer attempts, and various network configurations tested.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. This submission concerns a technical modification (wireless connectivity) and not a diagnostic or treatment device requiring clinical interpretation by experts to establish ground truth for patient outcomes or disease states.
4. Adjudication Method for the Test Set
Not applicable. The study involves bench testing of a technical modification, not interpretation of clinical data that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states that "Performance tests (bench tests) were conducted." There is no mention of a human-in-the-loop study, MRMC study, or any assessment of human reader improvement with or without AI assistance. This device is an infrastructure component, not an AI diagnostic tool.
6. Standalone Performance Study
Yes, a standalone study was performed in the form of "bench tests" to evaluate the performance of the wireless connectivity option. The "algorithm" here refers to the functional implementation of the wireless connectivity. The reported performance implies that the device (the wireless connectivity option itself, without human intervention for its core function) met the specified technical and safety requirements.
7. Type of Ground Truth Used
The ground truth for this device modification was technical specifications and design input requirements. The bench tests demonstrated conformance to these predefined technical and performance standards for wireless communication.
8. Sample Size for the Training Set
Not applicable. This device is a hardware modification for connectivity, not a machine learning or AI model that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set was used.
§ 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.