(204 days)
The Intuitive Surgical® da Vinci® Site™ Instruments and Accessories used with the da Vinci® Si Surgical System (153000) 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 hysterectorny and salpingo- oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the Single-Site Port.
The da Vinci Single-Site Instruments and Accessories consist of semi-rigid shaft instruments, two fixed-shape curved cannulae sets (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), a rigid 10 mm Blunt Obturator, and a Single-Site Port (with insufflation adapter 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, clipligation, 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 pertains to a modification of the Intuitive Surgical® da Vinci® Single-Site™ Instruments and Accessories, specifically a change in the material formulation of the Single-Site Port. The core of the submission argues for substantial equivalence to the predicate device due to this material change.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a formal table of "acceptance criteria" with numerical targets and corresponding "reported device performance" values for all tests. Instead, it describes general categories of verification and validation testing, with the implicit acceptance criterion being that the new material formulation performs equivalently to the predicate.
| Category | Test Description | Test Methods | Implicit Acceptance Criteria | Reported Device Performance (Summary) |
|---|---|---|---|---|
| Biocompatibility | Biocompatibility | ISO 10993 (Parts 1-12), FDA's 510(k) Memorandum #G95-1 | The new silicone material must meet biological safety standards for "limited duration contact ( |
§ 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.