(65 days)
The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) is intended for use in minimally invasive surgical applications where soft tissue is being approximated with interrupted stitches.
ETHIBOND EXCEL Polyester Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) consists of the SEW E-Z Reload Unit, the SEW E-Z Suture Assistant, and the SEW-RIGHT Self Righting Needle Holder (see Instructions for Use for the ENDOPATH® SEW-RIGHT Self Righting Needle Holder).
The SEW E-Z Reload Unit is a sterile, single patient use device consisting of a knot/grasper element comprised of an ETHIBOND EXCEL polyester suture (in sizes 0 or 2-0) with a pre-tied knot and a curved needle attached. The knot/grasper element is contained inside a carrier for loading the SEW E-Z Suture Assistant.
The SEW E-Z Suture Assistant is a sterile, single patient use instrument designed to assist endoscopically in approximating tissue and in placing a suture and a secure knot intracorporeally. It is designed for use with a 5.4 mm trocar or a larger trocar with use of reducer cap.
The instrument has two levers: the control lever facilitates loading the instrument and opening and closing the grasper; the knot deployment lever contains a ratchet mechanism for controlled deployment of the pre-tied knot.
The instrument contains a shaft retractor button on both sides of the instrument for unloading and reloading knot/grasper elements.
The instrument may be reloaded during a single procedure. Do not reload the instrument for more than a total of eight knot deployments per instrument.
ETHIBOND EXCEL Polyester Suture is a nonabsorbable, braided, sterile, surgical suture composed of Poly (ethylene terephthalate). It is prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component. ETHIBOND EXCEL suture is uniformly coated with polybutilate or poly [oxy-1, 4 butanediyloxy 91, 6 hexanediyl)].
The highly adherent coating is a relatively nonreactive nonabsorbable compound which acts as a lubricant to mechanically improve the physical properties of the uncoated suture by improving ease of passage through tissues and by providing overall handling qualities as contrasted to the braided, uncoated fiber.
ETHIBOND EXCEL sutures are braided for optimal handling properties and, for good visibility in the surgical field, are dyed green. ETHIBOND EXCEL sutures meet all requirements established by the United States Pharmacopeia (U.S.P.) for nonabsorbable sutures.
The provided text describes the ENDOPATH® Endoscopic Tissue Fastening System (ETFS), but it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.
The document is a 510(k) Summary of Safety and Effectiveness, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance efficacy data against pre-defined acceptance criteria for a novel device.
Here's a breakdown of what is and is not present in relation to your questions:
Information Present in the Document:
- Device Description: Detailed description of the ETFS components (SEW E-Z Reload Unit, SEW E-Z Suture Assistant, SEW-RIGHT Self Righting Needle Holder) and the ETHIBOND EXCEL Polyester Suture.
- Intended Use/Indications: For approximation of soft tissues in minimally invasive surgical applications with interrupted stitches. ETHIBOND EXCEL Polyester Suture is for general soft tissue approximation and/or ligation.
- Technological Characteristics: States that they are "the same as the Predicate Devices."
- Performance Data (General Statement): "Bench testing and pre-clinical laboratory evaluations were performed to ensure that the device could be used as designed." It then provides qualitative observations: "The studies demonstrated that the ETFS system facilitated laparoscopic suturing, the ASD, together with the KEC, allowed for one-handed knot deployment, knot security appeared adequate, and the Self-Right Needleholder (Modified ENDOPATH® 5mm Reusable Needleholder) allowed for rapid needle orientation and facilitated needle management."
Information NOT Present in the Document (that you requested):
- A table of acceptance criteria and the reported device performance: This is explicitly missing. The document describes general findings from testing but doesn't quantify them against specific pass/fail criteria.
- Sample size used for the test set and the data provenance: Not mentioned. It only generically refers to "bench testing and pre-clinical laboratory evaluations."
- Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a surgical device, not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used: Not explicitly stated beyond "bench testing and pre-clinical laboratory evaluations." For a surgical device, this would typically involve biomechanical testing, animal studies, or cadaver studies, but the document doesn't detail the "ground truth" or how success was measured quantitatively.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
Conclusion based on the provided text:
The document serves as a 510(k) summary for a surgical device. Its primary purpose is to establish substantial equivalence, which it does by stating similar technological characteristics and providing general positive findings from "bench testing and pre-clinical laboratory evaluations." However, it does not provide the specific quantitative acceptance criteria or detailed study results (including sample sizes, expert involvement, or adjudication methods) that would be needed to fill out your requested table and answer many of your questions.
§ 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.