(38 days)
The neoClose device is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/ laparoscopic surgery.
The neoClose device is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/ laparoscopic surgery. There are two neoClose product codes, neoClose Hasson and neoClose Universal, each consisting of an AccuGuide and two AutoAnchors loaded onto two Drivers.
The neoClose Hasson is designed to provide sealed anchoring of a laparoscopic trocar and suture placement for subsequent soft tissue approximation. The neoClose Universal is equivalent to the neoClose Hasson design in its method of soft tissue approximation but does not provide for sealed anchoring of a trocar. Soft tissue approximation is facilitated by delivering two AutoAnchors, through an AccuGuide with a Driver. The AutoAnchors and Drivers for both the neoClose Hasson and Universal are identical but the AccuGuides differ in construction. The Hasson AccuGuide features Suture Locks, a flexible Sleeve, and two Guide Channels while the Universal AccuGuide features a Thumb Grip and one Guide Channel.
The provided text describes a 510(k) summary for a medical device called neoClose. This submission focuses on establishing substantially equivalent to a previously marketed predicate device (neoClose, K123280), rather than outlining acceptance criteria and a study to prove new performance claims for an innovative device.
Therefore, many of the requested categories for a study proving device performance against acceptance criteria cannot be directly extracted from this document. The document explicitly states that the technical characteristics of the applicant device are substantially equivalent to the predicate device, with the only change being an extension of shelf life. The "study" mentioned is primarily focused on demonstrating this equivalence rather than measuring new performance metrics against predefined acceptance criteria.
Here's an analysis of the information provided in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not available in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device, not on establishing and meeting new performance acceptance criteria for a novel device. The "performance" section states: "Design Verification bench testing support the use of the neoClose device and demonstrate that it is at least as safe and effective as the predicate device, neoClose (K123280)." This implies comparison to the predicate's performance, not to specific, new acceptance criteria.
Note: If specific performance criteria and results were provided for the predicate device (K123280) regarding the "delivery of absorbable AutoAnchors through soft tissues", then the bench testing for K131688 would have been compared against those. However, these details are absent from this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Design Verification bench testing" and a "GLP Animal Study completed with the predicate device." It does not specify sample sizes for these tests, nor the data provenance (e.g., country of origin, retrospective/prospective). The animal study was done with the predicate, not the present device, and is used to infer safety and effectiveness based on the very minor change to the current device (shelf life extension).
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not applicable/not available. The document describes a medical device for surgical procedures, not diagnostic software that requires expert-established ground truth. The equivalency is based on design, materials, and bench/animal testing, not expert consensus on interpretations.
4. Adjudication Method for the Test Set
This information is not applicable/not available. Adjudication methods like 2+1 or 3+1 are typically used for diagnostic studies involving human readers, not for demonstrating substantial equivalence of a surgical device through bench and animal testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not applicable/not available. MRMC studies are associated with diagnostic imaging or similar interpretation tasks, often involving AI assistance. This device is a surgical instrument, and the submission is for substantial equivalence, not a comparative effectiveness study involving human readers with and without AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable/not available. This is a physical surgical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
For the bench testing, the "ground truth" would implicitly be the performance characteristics of the predicate device (K123280), as the goal was to demonstrate that the modified device is "at least as safe and effective." For the GLP Animal Study, the "ground truth" would be the observed safety and effectiveness outcomes in the animal model for the predicate device.
8. The Sample Size for the Training Set
This information is not applicable/not available. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not available. As this is not an AI/ML algorithm, there is no training set or ground truth in that context.
§ 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.