(182 days)
This product is intended to be used in combination with an endoscope insertion into the body. Never use this product for any other purpose. This product is intended for use in medical professionals who are properly trained in using it as well as in endoscopic procedures and endoscopic treatments.
FUJILM Over-tube consists of an inserting through the body, a handle portion to be gripped by the operator, a water injection portion for injecting water onto the insertion part, a suction portion for suctioning air from the walls, thereby changing the rigidity of the insertion part, and a hook portion for the control part of the endoscope. The suction portion is formed by a three-way stopcock and can be connected to a suction machine and changing the position of the three-way stopcock lever, the insertion portion can be in the state of vacuum, thereby increasing the rigidty of the insertion portion. The rigid body of the insertion maintains the shape of Over-tube and allow the endoscope insertion to smoothly move back and forth and rotate while decreasing the adverse impact to the patient anatomy. In addition, when water is injected from the water inlet connected to the inside of Over-tube, water enters between the endoscope and Over-tube, reducing friction between the endoscope and the Over-tube.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called "Over-tube." It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not include information about studies involving human readers or AI assistance.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a structured table format. However, it lists various non-clinical tests performed and implies that the device "demonstrated that the design requirements" were met and that there were "no new concerns for the safety and efficacy."
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Bench Testing | Device meets design requirements for safety and efficacy. | Insertion force, working length, flexibility, shape retention portion, and outer diameter of the insertion portion were evaluated. No new safety/efficacy concerns identified. |
| Durability (Main Body) | No adverse effects on appearance, insertion force, attachability, and durability under tension. | Evaluated with accelerated-aged TR-1208A. No adverse effects reported. It was confirmed that "there were no adverse effects on the appearance, insertion force, attachable to the operating portion, and durability under tension." |
| Sterilized Packaging Safety | No adverse effects on appearance, seal strength, and dye penetration. | Evaluated with accelerated-aged TR-1507A. No adverse effects reported. It was confirmed that "there were no adverse effects on the appearance, seal strength, and dye penetration." |
| Biocompatibility | Device is biocompatible. | Testing performed; "There remains no new concern for the safety and efficacy." |
| Long-term Stability | Device maintains performance and safety over a 3-year shelf life. | Accelerated-aged testing supports the 3-year shelf life. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document mentions that Over-tube models TR-1208A and TR-1507A were used as representative models for bench testing. TR-1504A's performance was adopted from TR-1507A because it only differs in working length. For durability and packaging safety, accelerated-aged versions of TR-1208A and TR-1507A were used, respectively. The exact number of units tested for each model is not specified, but it's implied that "models" refers to individual devices. The document does not provide information about the country of origin or whether the data was retrospective or prospective. This is a premarket notification for a device, and the testing described is typically conducted in a controlled lab environment.
- Data Provenance: Not specified in terms of country of origin or retrospective/prospective. The tests conducted are non-clinical, likely laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to this document. The device is an "Over-tube" (an endoscope accessory), and the testing described is non-clinical performance and safety testing. It does not involve diagnostic interpretations by experts or the establishment of a "ground truth" for a test set in the way an AI-powered diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to this document. As mentioned above, the testing is non-clinical and does not involve adjudication of expert opinions.
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 to this document. The device is a physical endoscope accessory, not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable to this document. The device is a physical endoscope accessory, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable to this document. The "ground truth" for the non-clinical tests would be established through engineering specifications, material properties, and physical testing methodologies rather than clinical outcomes or expert consensus. For example, "insertion force" has a measurable target, not an expert consensus.
8. The sample size for the training set
This information is not applicable to this document. The device is a physical endoscope accessory and does not involve a "training set" in the context of machine learning or AI models.
9. How the ground truth for the training set was established
This information is not applicable to this document. There is no training set for this 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.