(17 days)
The USGI TransPort Endoscopic Guide is intended to be used with an endoscope to facilitate intubation of the endoscope and as a guide for various flexible endoscopic instruments.
The TransPort Endoscopic Access Device is comprised of a flexible shaft that can be rigidized and locked into position, a steerable tip and multiple lumens that allow insertion and exchange of flexible instruments. It is supplied as two separately packaged components, i.e., a reusable, metal body and a strerile, single use disposable sheath.
The provided text describes a 510(k) summary for the USGI TransPort™ Endoscopic Access Device. This device is an "Endoscopic Overtube" and its submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria and performance studies is not directly available in this document.
Here's a breakdown of what can be extracted and what is not applicable:
1. Table of acceptance criteria and the reported device performance
This information is not present in the provided 510(k) summary. The summary states: "Bench testing was conducted to ensure that the device performs as intended when used according to its instructions for use." However, it does not detail specific acceptance criteria or the reported performance metrics from this bench testing.
2. Sample size used for the test set and the data provenance
No test set data for performance evaluation (e.g., in a clinical study) is described in this 510(k) submission. The "bench testing" mentioned suggests in-vitro or simulated use, not a human-based test set from a specific country or retrospective/prospective data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the summary does not describe a clinical study requiring ground truth establishment by experts.
4. Adjudication method for the test set
This information is not applicable as the summary does not describe a clinical study requiring adjudication.
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 an endoscopic access device, not an AI-powered diagnostic tool. Therefore, MRMC studies or AI assistance are not relevant.
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 not an algorithm or AI-powered.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable as the summary describes functional "bench testing" for a physical device, not a diagnostic or AI algorithm requiring ground truth.
8. The sample size for the training set
This information is not applicable as the device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI algorithm requiring a training set and ground truth establishment.
Summary of available information from the K072405 document:
- Device Name: USGI TransPort™ Endoscopic Access Device
- Intended Use: To be used with an endoscope to facilitate intubation of the endoscope and as a guide for various flexible endoscopic instruments.
- Comparison Basis: Substantially equivalent to predicate devices (USGI Medical TransPort™ Endoscopic Access Device K061216 and ShapeLock™ Endoscopic Access Device K033954) in terms of intended use, technology, and materials.
- Performance Claim: "Bench testing was conducted to ensure that the device performs as intended when used according to its instructions for use." (No specific criteria or results provided in this summary).
In conclusion, the provided 510(k) summary for K072405 focuses on demonstrating substantial equivalence through comparison and general bench testing, not on providing detailed acceptance criteria and performance data from a clinical or AI-centric study. Therefore, most of the requested fields are not applicable to the content of this specific 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.