(81 days)
The Intuitive Surgical® da Vincio Single-Site™ Instruments and Accessories used with the da Vinci® Si Surgical System (1S3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.
The da Vinci Single-Site Instruments and Accessories consist of semi-rigid shaft instruments, two fixed-shape curved cannulae (250 mm and 300 mm lengths), an accessory cannula for insertion of manual laparoscopic instruments, a semi-rigid blunt obturator (250 mm and 300 mm lengths), and a Single-Site Port (with insufflation tubing and stopcock) for the placement and insertion of multiple cannulae/instruments through a single incision.
The da Vinci Single-Site Instruments and Accessories include instruments to perform manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing. The da Vinci Single-Site Instruments and Accessories are intended to be used with the existing da Vinci Si Surgical System (IS3000).
This submission describes a Special 510(k) for the Intuitive Surgical da Vinci Single-Site Instruments and Accessories, specifically focusing on the addition of a Single-Site Permanent Cautery Hook. The filing asserts substantial equivalence to a predicate device, rather than providing a new study demonstrating performance against specific acceptance criteria for a new clinical indication.
Therefore, many of the requested elements (e.g., acceptance criteria, detailed study design, sample sizes, ground truth establishment, expert qualifications, MRMC study, standalone performance) are not provided in this 510(k) summary as they are not typically required for a Special 510(k) where the primary claim is substantial equivalence to a previously cleared device with minor modifications.
Here's an analysis based on the provided text, indicating where information is not applicable or not provided:
1. Table of Acceptance Criteria and Reported Device Performance
No specific numerical acceptance criteria or quantitative performance metrics are provided in this 510(k) summary. The submission relies on the concept of "substantial equivalence" to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined as numerical targets. The underlying acceptance criterion is "substantial equivalence" to the predicate device. | "Bench and animal testing demonstrated that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements." |
| "The differences [between the subject and predicate devices] do not raise any different issues of safety or effectiveness as compared to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "bench and animal testing" but does not specify the sample sizes (e.g., number of tests, number of animals) or the provenance (e.g., country of origin, retrospective/prospective) for these tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The study involved bench and animal testing, not human expert evaluations for ground truth establishment in a diagnostic context.
4. Adjudication Method for the Test Set
Not applicable. This type of study does not involve expert adjudication as typically seen in image analysis or diagnostic device studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done; Effect Size of Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is not a study involving AI or human reader performance in a diagnostic or interpretive context. It relates to a surgical instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This refers to a surgical instrument, not an algorithm.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically understood in diagnostic device evaluation (e.g., pathology, clinical outcome) is not directly applicable here. The "truth" or validation was established through:
- Bench testing: Likely involved mechanical, electrical, and functional tests against engineering specifications and predicate device performance.
- Animal testing: Involved surgical procedures in animals to demonstrate functionality, safety, and performance in a live tissue environment.
8. The Sample Size for the 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
Not applicable, as there is no training set for this type of 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.