(28 days)
This hood is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
This hood is intended to be used in compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
Principles of Operation: Align the objective lens of endoscope with the drain of the hood and attach the hood to the distal end of endoscope by pressing the hood until it stops. Securely attach the endoscope with sterile medical tape. Insert the endoscope equipped with the hood through the mouth. Perform the intended treatment. After completion of the examination, slowly withdraw the endoscope along with the attached hood. Peel the tape off the endoscope completely and remove the hood from the endoscope. Dispose of the hood and tape according to local laws and regulations.
The presented document is a 510(k) summary for the Hood (DH-083ST) by Fujifilm Corporation. It describes the device's intended use and performance testing conducted to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Specification | Reported Device Performance |
|---|---|
| Material composition | Unchanged from predicate device |
| Compatibility with endoscopes | Tested and listed in Operation Manuals |
| Dimensional accuracy | All dimensional measurements (Outer diameter, Maximum diameter of attaching endoscope, Total length, Inner diameter of distal end, Distance from the tip) were conducted and passed their respective test objectives. |
| Biocompatibility | Not explicitly mentioned in this summary, but implied that it's either equivalent to the predicate or addressed by unchanged materials. |
| Sterility | Not explicitly mentioned in this summary. |
| Functionality (maintaining field of view during mucosal resection) | Implied through testing against ISO 8600-1:2015 and comparison to predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "performance testing was conducted, and the passed all test objectives."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The testing described focuses on physical dimensions and compatibility with endoscopes, rather than a clinical evaluation requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the tests (dimensional measurements and compatibility), an adjudication method as typically used in clinical studies with human interpretation is unlikely and not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable and therefore not provided. The device is a physical hood for an endoscope, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and therefore not provided. The device is a physical component (an endoscope hood), not an algorithm.
7. The Type of Ground Truth Used
For the described tests, the "ground truth" would be the engineering specifications and measurements of the device's dimensions and its fit with compatible endoscopes, along with compliance with the ISO 8600-1:2015 standard. There is no mention of expert consensus, pathology, or outcomes data as these types of ground truth are more relevant for diagnostic or therapeutic devices with clinical interpretation.
8. The Sample Size for the Training Set
This information is not provided and not applicable as this is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and not applicable as this is not an AI/machine learning device.
§ 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.