(54 days)
The EndoGuide is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and removal of multiple polyps and/or foreign bodies.
The EndoGuide fits over a pediatric colonoscope and can be converted from a flexible to a rigid configuration on demand. The EndoGuide is back loaded onto the shaft of the colonoscope before the instrument is inserted into the patient. The device was designed to be activated by a vacuum source and needs to be connected to the existing vacuum line in the endoscopy suite. Application of vacuum causes the device to become rigid. In this "active" mode (vacuum on) the rigid insertion tube facilitates the passing of the colonoscope thru the insertion tube and resists colonoscope looping. In the "passive" mode (vacuum off) the insertion tube is very flexible and can be advanced deeper into the colon.
The provided text is a 510(k) summary for the EndoGuide device and does not contain detailed information about specific acceptance criteria or a comprehensive study report with quantitative performance data. The document states that the device is "substantially equivalent" to a predicate device, focusing on its functional characteristics and intended use.
Here's a breakdown of the available information and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states: "To support the substantial equivalence determination, a summary of the in-vitro testing to confirm the performance characteristics in comparison with the predicate device has been submitted." However, the actual table of acceptance criteria and the reported device performance from this in-vitro testing is NOT included in the provided text.
The document only notes the functional differences from the predicate device:
- The EndoGuide differs in that it is capable of becoming rigid when required by the physician. When rigid the device facilitates the passing of the endoscope thru the insertion tube and resists endoscopic looping. But when in its flexible state, the insertion tube is can be advanced into the colon.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document. It only mentions "in-vitro testing" without details on sample size, or whether the data was retrospective or prospective, or country of origin.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided. The 510(k) summary does not mention any expert review or ground truth establishment related to clinical performance metrics. The focus is on device function compared to a predicate.
4. Adjudication Method:
This information is not provided. Given that no expert review or ground truth establishment relevant to clinical performance is mentioned, an adjudication method would not be applicable in the provided context.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not conducted or reported in this 510(k) summary. The device is a medical instrument (an overtube), not an AI or imaging diagnostic tool that would typically involve human reader performance comparisons.
6. Standalone Performance Study (Algorithm Only):
A standalone performance study was not conducted or reported. As mentioned, this is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
The document refers to "in-vitro testing to confirm the performance characteristics in comparison with the predicate device." This implies that the "ground truth" for the device's technical performance would be defined by engineering specifications and comparative functional assessments against the predicate device's established performance. There is no mention of clinical outcomes data, pathology, or expert consensus being used as ground truth for this type of device in the provided summary.
8. Sample Size for the Training Set:
This information is not applicable and not provided. There is no "training set" as this device is a physical instrument, not an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided as there is no training set for this type of device.
In summary, the provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence of a physical medical device (EndoGuide) to a predicate device (Guardus™ Overtube) based on its operational characteristics and intended use. It explicitly mentions "in-vitro testing" for performance comparison but does not detail the specific acceptance criteria, test results, or methodology (like sample sizes, expert involvement, or ground truth establishment). It does not involve AI or diagnostic imaging algorithms, hence no MRMC or standalone algorithm performance studies are relevant or reported.
§ 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.