(37 days)
neoClose is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/laparoscopic surgery.
The neoClose AutoAnchor Pack consists of absorbable AutoAnchors and neoClose Drivers. The neoClose AutoAnchor consists of an absorbable suture attached to an absorbable polymeric anchor. There are two distinct product codes: the neoClose 2 AutoAnchor Pack (NCAA2-U) and the neoClose 4 AutoAnchor Pack (NCAA4-U). The neoClose AutoAnchors and Drivers are provided sterile (EtO). Each neoClose AutoAnchor is pre-loaded on a neoClose Driver. The neoClose Driver is used to deliver an AutoAnchor through the abdominal wall layers into the abdominal cavity for subsequent soft tissue approximation. The neoClose AutoAnchor and Driver are to be used in conjunction with a neoClose Guide.
This document (K142903) is a 510(k) premarket notification for the neoClose AutoAnchor Pack. It establishes substantial equivalence to previous neoClose devices. The document does not contain the detailed study information requested. It states that "Performance Data" was provided, but only lists "Biocompatibility" and "Bench Testing" at a high level, without any specific acceptance criteria, reported performance, sample sizes, ground truth details, or information about human reader studies.
Therefore, most of the requested information cannot be extracted from this document.
Here's what can be extracted based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document states: "Bench Testing was conducted for the neoClose AutoAnchor Pack to demonstrate that it is at least as safe and effective as the predicate device." However, no specific acceptance criteria or reported device performance metrics are provided in this document.
2. Sample sized used for the test set and the data provenance
Not provided in this document. The document only mentions "Bench Testing" was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. The document does not describe studies involving expert interpretation or ground truth establishment for a test set.
4. Adjudication method for the test set
Not applicable/Not provided.
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
Not applicable. This device is a surgical instrument (suture passer), not an AI-powered diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
Not applicable/Not provided. The document refers to "Bench Testing" and "Biocompatibility" without specifying a ground truth in the context of diagnostic performance.
8. The sample size for the training set
Not applicable/Not provided. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable/Not provided. This device is not an AI/ML algorithm.
§ 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.