(63 days)
Connect™ for da Vinci® Surgical System(s) is an accessory intended for use by trained surgical proctors to (1) communicate and provide surgical advice to the operating surgeon when using da Vinci Surgical System(s) and (2) view surgical procedures related to the use of da Vinci Surgical System(s) using the Remote Proctor Interface. The wireless connectivity option provides a suitable alternative for the wired Ethernet connection between the da Vinci Surgical System(s) and the hospital's Internet Protocol (IP) infrastructure.
Connect is a software accessory, with a Remote Proctor Interface, intended for use by trained surgical proctors to communicate and provide surgical advice to operating surgeons when using the da Vinci Surgical System. By using the Remote Proctor Interface, proctors can also view da Vinci Surgical Procedures. Communication can be established through either a wired or wireless Ethernet connection between the da Vinci Surgical System(s) and the hospital's Internet Protocol (IP) infrastructure.
The modified Connect software developed by ISI has the following capabilities:
• Bi-directional audio
• Video from the OR to the RPI
• Enable/Disable connection on the da Vinci Touchscreen
• Image selection from RPI
• Remote Telestration
• Remote Pointer
The provided document, K123840, is a 510(k) summary for the "Connect for da Vinci Surgical System(s)," which is a software accessory. This submission is a Special 510(k), indicating modifications to an already cleared device. Special 510(k)s often rely on verification that changes do not adversely affect functionality, rather than extensive clinical studies.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Performance (General) | All test cases met requirements, demonstrating the subject device performed as expected. |
| Maintenance of Intended Use | The modified Connect accessory has the same Intended Use as the predicate devices. |
| Technological Characteristics | The fundamental technological characteristics are identical to the predicate device(s). Both encode audio/video for internet transport and utilize embedded da Vinci system software. |
| Safety and Effectiveness (Impact of Changes) | Risk analysis identified no new issues related to safety and effectiveness. Verification and validation results demonstrate the modified software performs as expected and in accordance with functional specifications. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "sample size" in terms of patient data or clinical cases for the testing. Instead, it refers to "Software Verification Testing and Validation Testing." This type of testing typically involves:
- Test Cases: The document states "All test cases met requirements." The number of specific test cases is not provided.
- Data Provenance: Not applicable in the context of software verification and validation testing, which focuses on device functionality rather than clinical data from patients. The testing would have been performed by Intuitive Surgical, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. Software verification and validation testing generally relies on predefined functional specifications, engineering standards, and test protocols to determine if the software performs as designed. It does not typically involve human experts establishing a "ground truth" for clinical outcomes in the same way a diagnostic AI might. Approval is based on functional equivalence to predicates.
4. Adjudication Method for the Test Set
Not applicable. As described above, the testing involved software verification and validation against specified requirements, not the adjudication of clinical outcomes by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a software accessory for communication and viewing surgical procedures, not a diagnostic or interventional AI that requires human reader comparisons for effectiveness. The submission focuses on functional equivalence and safety of software modifications.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense, a standalone evaluation of the software's performance was done through "Software Verification Testing and Validation Testing." This type of testing evaluates the algorithm and its interaction with the system's software independently of a human user's performance, ensuring the software features (bi-directional audio, video, remote telestration, etc.) function correctly. However, this is distinct from a standalone clinical performance study for a diagnostic AI.
7. The Type of Ground Truth Used
The "ground truth" in this context is the functional specification of the software. The testing verified that the modified software performed according to these engineering and functional specifications and that changes had no adverse impact on existing functionalities.
8. The Sample Size for the Training Set
Not applicable. The "Connect" device is a software accessory for communication and viewing surgical procedures. It is not an artificial intelligence/machine learning (AI/ML) device that would involve a "training set" of data to learn patterns or make predictions. The software operates based on deterministic programming and design specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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.