(71 days)
The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with Coated VICRYL® is intended for use in minimally invasive surgical applications where soft tissue is being approximated with interrupted stitches
The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with Coated VICRYL® is a single patient use reloadable instrument that is intended for the use in minimally invasive surgical applications where soft tissue is being approximate with interrupted stitches. It is designed for use with a 5 mm trocar. The instrument is design for eight-knot deployments.
This document describes the 510(k) Summary of Safety and Effectiveness for the Ethicon Endo-Surgery, Inc. ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with Coated VICRYL®. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study report of device performance against those criteria.
Therefore, much of the requested information regarding detailed acceptance criteria, specific reported device performance metrics (e.g., in a table), sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within the provided text.
The document primarily states that "Pre-clinical laboratory evaluations were performed to ensure that the device performs as intended." and "The bench data and the animal studies demonstrated that the ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with Coated VICRYL® facilitated laparoscopic suturing, allowed one-handed knot deployment, and provided a secured knot in soft tissue with interrupted stitches." This is a high-level summary of performance, not detailed acceptance criteria and results.
Based on the provided text, here is what can be extracted and what is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device performs as intended | Facilitated laparoscopic suturing |
| Allowed one-handed knot deployment | |
| Provided a secured knot in soft tissue with interrupted stitches |
Note: The document does not provide specific quantitative acceptance criteria (e.g., minimum knot tensile strength, duration of one-handed deployment, success rate of knot deployment) nor does it provide specific quantitative results against such criteria. The reported performance is qualitative.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "bench data and the animal studies" but does not give sample sizes for either.
- Data Provenance: Not specified. It's likely from Ethicon's internal labs (Cincinnati, Ohio, USA) but not explicitly stated. The studies are pre-clinical.
- Retrospective or Prospective: These were "pre-clinical laboratory evaluations" and "animal studies," which are inherently prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
Note: For a surgical tool, "ground truth" might refer to expert assessment of the quality of the suturing/knotting or physiological outcomes in animal models, but the document does not elaborate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, this is a surgical device, not an AI/imaging diagnostic device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable/not described. This is a manual surgical instrument where human interaction is integral.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Implied to be based on observations during "bench data and animal studies" to assess "facilitated laparoscopic suturing," "one-handed knot deployment," and "secured knot in soft tissue." This would likely involve direct observation and potentially measurement of knot parameters (e.g., tensile strength testing in bench studies, possibly histological evaluation or healing outcomes in animal studies), but the exact "type of ground truth" (e.g., a specific measurement or a panel of surgical experts' consensus) is not detailed.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/not specified. The device is a mechanical surgical instrument, not an algorithm that requires a "training set" in the machine learning sense. The "training" here would be iterative design and testing.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. See point 8.
§ 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.