(88 days)
The USGI Shape Locking 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 Shape Locking Endoscopic Overtube is an endoscopic accessory designed to provide external support to an endoscope without hindering its flexibility and maneuverability. It is an overtube guide that can conform to any bend configuration of the scope and then be shape locked in that form. In the "shape locked" configuration, the scope can be further advanced or withdrawn repeatedly. The USGI Shape Locking Endoscopic Overtube is a shape locking tube with an atraumatic tip, a slip coated inner liner, a smooth outer skin, and a handle. The Shape Locking Tube is constructed from multiple nested links that are held together by four cables. Applying tension to the cables 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) premarket notification letter from the FDA to USGI Medical, Inc. regarding their Endoscopic Sheath. It primarily focuses on the device's substantial equivalence to a previously cleared predicate device (K023902).
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device | Bench testing demonstrates that the devices are functionally equivalent. |
| Biocompatibility of Patient-Contacting Materials | All components that come in direct contact with the patient have a long history of use in medical devices and are biocompatible. |
| Performance as Intended (Mechanical & Functional) | Mechanical and functional bench testing demonstrate that the USGI Shape Locking Endoscopic Overtube performs as intended. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of an AI/algorithm-based device. The testing described is bench testing of the physical device. Therefore, information regarding sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable in this context. The document refers to the device itself and its components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document describes a physical medical device and its mechanical/functional performance, not an AI or algorithm-based diagnostic tool requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated in point 3.
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
This information is not applicable. The device is a physical endoscopic overtube, not an AI or algorithm that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as the device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
For the biocompatibility aspect, the ground truth is established by the "long history of use in medical devices" of the materials, implying a track record of safety and acceptance as biocompatible.
For the mechanical and functional performance, the ground truth is based on the device's ability to "perform as intended" as demonstrated by bench testing. This refers to engineering and design specifications rather than clinical ground truth (like pathology or outcomes data).
8. The Sample Size for the Training Set
This information is not applicable as the document describes a physical medical device, not an AI or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
In summary, the provided document describes a 510(k) submission for a physical medical device, the USGI Endoscopic Sheath. The acceptance criteria and testing focus on the device's physical and functional performance, as well as the biocompatibility of its materials, by demonstrating substantial equivalence to a predicate device through bench testing. The concepts of AI/algorithm performance, training/test sets, expert ground truth, and MRMC studies are not relevant to this document.
§ 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.