(94 days)
The Ethicon Endo Surgery® Endoscopic Suturing System (ESS) is indicated for endoscopic placement of suture(s) and approximation of soft tissue.
The Ethicon Endo Surgery® Endoscopic Suturing System (ESS) is a sterile, single-use, disposable suturing system for use in gastrointestinal procedures. It consists of the following components:
- Endoscopic suturing device (ESD)
- ESD mounting tool
- Four (4) needle/ suture packs each in a needle-loading tool
- Endoscopic knotting element device (KED)
- Four (4) knotting element implants
- KED handle stop
- KED threading tool
The endoscopic suturing device (ESD) is the suturing component of the system. The ESD is mounted on commercially available flexible gastrointestinal endoscopes with 9.9-10.5 mm outer diameter and minimum 2.8 mm working channel such as the Olympus GIF-100 or GIF-140. Under endoscopic visualization, the ESD enables the physician to create continuous or interrupted suture lines in soft tissue. The ESD consists of a suturing assembly activated through a flexible control shaft terminating in an ergonomic handle. The suture assembly consists of a tissue recess and needle/suture assembly. The needle/suture assembly is loaded in the ESD prior to use with the supplied needle-loading tool. The suturing assembly of the ESD contains a tissue recess, which allows access to an amount of tissue necessary to achieve tissue bites. After tissue is located in the recess of the suturing assembly, the handle is squeezed. The handle is connected to a control cable, which actuates the needle/suture assembly, causing a circular needle, with suture attached, to be partially rotated within the suturing assembly. Following a full revolution (approximately 4 strokes), the needle returns to a stored position within the suturing assembly. The device is repositioned to perform another tissue bite or stitch. Following completion of the last stitch, the endoscope and ESD are removed. By spacing the stitches appropriately and then tightening the suture line, tissue approximation will be achieved.
The knotting element device (KED) is the suture terminating and cutting component of the system. The KED is used for the endoscopic termination of two ends of suture. The KED consists of an end-effector (a suture cutter and a two-piece knotting element implant) activated through a flexible control shaft terminating in an ergonomic handle. The knotting element implant consists of a mating polymer inner lock and outer washer sleeve, which is threaded with suture and crimped together through the actuation of the device. The two ends of the suture are threaded through the knotting element with the assistance of the KED threading tool and, while external tension is held on the ends of the suture lines, the device is passed through the working channel, over the suture to the termination location inside the body. The suture line is tightened, and the handle is activated to release the knotting element implant and to cut the suture line leaving approximately 1 cm of suture material and the knotting element implant. The mating parts of the knotting element implant secure the two ends of the suture. This fixation replaces the knot component of suture. The device and scope are then free of the suture line and can be removed.
The device is available with a variety of suture materials. The materials are described in the following table.
Trade Name: Pronova®, Material Type: Poly (hexafluoropropylene-VDF), Brief Description: Nonabsorbable, monofilament
Trade Name: Prolene®, Material Type: Polypropylene, Brief Description: Nonabsorbable, monofilament
Trade Name: Coated Vicryl®, Coated Vicryl® Plus Antibacterial, Material Type: Polyglactin 910, Brief Description: Absorbable, braided with and without antibacterial coating
Trade Name: PDS® II, Material Type: Polydioxanone, Brief Description: Absorbable, monofilament
Trade Name: Monocryl®, Monocryl® Plus Antibacterial, Material Type: Poliglecaprone 25, Brief Description: Absorbable, monofilament with and without antibacterial coating
The Ethicon Endo Surgery® Endoscopic Suturing System (ESS) is packaged sterile for single patient use. This system is commonly referred to by the product code EES01. Ethicon Endo Surgery also intends to market the ESD and KED separately. These product codes are yet to be determined.
The provided text (K061770) describes the Ethicon Endo Surgery Endoscopic Suturing System (ESS) and its 510(k) summary for FDA clearance. However, it does not contain details about specific acceptance criteria, device performance metrics, or the study design that would include information on sample size, data provenance, expert qualifications, or adjudication methods.
The document only states:
"Performance Data. Bench testing was performed to demonstrate that the new device performs as intended. A clinical literature search was also conducted and the literature supports the intended use of the new device."
This is a very high-level statement and lacks the specificity required to answer most of your detailed questions.
Therefore, I cannot populate the table or provide the requested information from the given text. The text does not elaborate on:
- Acceptance Criteria and Reported Device Performance: No specific metrics (e.g., success rate, tissue approximation strength, time to suture) or criteria are mentioned, nor are specific performance results reported from the bench testing.
- Sample Size and Data Provenance: No numbers for samples (test or training set), nor information on whether the data was from a specific country or if it was retrospective/prospective.
- Number of Experts and Qualifications: No mention of experts for ground truth establishment.
- Adjudication Method: Not applicable as no expert review process is described.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No mention of such a study, or human reader improvement with/without AI. This device is a surgical tool, not an AI diagnostic system.
- Standalone Performance Study: The document refers only to "bench testing" and "clinical literature search," not a standalone algorithm performance study. As it's a physical device, the concept of "standalone algorithm performance" (without human-in-the-loop) isn't directly applicable in the same way as an AI diagnostic device.
- Type of Ground Truth: Not applicable, as no ground truth for a diagnostic task is mentioned.
- Training Set Sample Size: No training set mentioned.
- Ground Truth for Training Set: Not applicable.
In summary, the provided 510(k) summary focuses on device description, indications for use, technological characteristics compared to predicate devices, and a general statement about performance data, but it does not provide the detailed study design and results typically found for AI/imaging device clearances related to performance metrics and clinical studies.
§ 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.