(271 days)
The USGI Endoscopic Overtube is intended to be used with an endoscope to facilitate intubation, e.g., colonoscopy, change of endoscopes, removal of multiple polyps and/or foreign bodies.
The USGI Endoscopic Overtube is an endoscopic accessory designed to provide external support to an endoscope without hindering its flexibility or maneuverability. It is a shape locking tube with an atraumatic tip, a slip coated inner liner, a smooth outer skin, and a handle. The overtube is constructed from multiple nested links that are held together by four cables. Each link is bowl shaped, but without a bottom and has four equally spaced annular holes running longitudinally through the wall thickness. The purpose of the holes is to accommodate the tension wires which pass through each link. The wires are connected to the tip but slide freely through all other links. Applying tension to the wires squeezes the links together. The friction between links maintains their relative positions, allowing the practitioner to "lock in" a shape.
The provided document is a 510(k) summary for the USGI Endoscopic Overtube. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as typically seen for novel device performance or AI/software evaluations.
Based on the information available in the document:
1. Table of acceptance criteria and reported device performance:
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the USGI Endoscopic Overtube. Instead, it states that "Performance Data: All components that come in direct contact with the patient have a long history of use in medical devices and are biocompatible. This 510(k) notice includes mechanical and functional bench testing that demonstrate that the USGI Endoscopic Overtube performs as intended."
And for the "Basis for Determination of Substantial Equivalence," it states: "Bench testing demonstrates that the devices are functionally equivalent."
This phrasing indicates that the acceptance criteria were likely implicitly linked to the functional equivalence of the device to its predicates, ensuring it performs "as intended" and is "functionally equivalent." No specific quantitative metrics or target values for performance are provided.
2. Sample size used for the test set and the data provenance:
The document mentions "mechanical and functional bench testing" but does not specify the sample size for these tests (e.g., number of devices tested, number of test cycles). It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective nature) as these are not typically relevant to bench testing for mechanical devices in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a mechanical endoscopic overtube, not a diagnostic or AI device that requires expert-established ground truth for its performance evaluation in this 510(k) context. The evaluation relies on engineering principles and comparison to predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. As noted above, this is a mechanical device evaluation, not one involving expert adjudication of diagnostic outcomes.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the sense of clinical 'ground truth' for diagnostic performance. The "ground truth" for this device's performance would be its ability to mechanically function as designed and as demonstrated by its predicate devices, validated through mechanical and functional bench testing.
8. The sample size for the training set:
Not applicable. This is a mechanical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, no training set for an AI/machine learning model.
In summary, the provided document is a regulatory submission for a mechanical medical device (USGI Endoscopic Overtube) seeking clearance based on substantial equivalence to existing predicate devices. The performance evaluation relies on mechanical and functional bench testing to demonstrate that the new device performs "as intended" and is "functionally equivalent" to the predicates. It does not contain the detailed information on acceptance criteria, clinical study designs, expert reviews, or AI-specific evaluations that would be relevant for a typical AI/Software as a Medical Device (SaMD) submission.
§ 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.