(335 days)
The JetPrep Flushing Device is intended for use as a flexible endoscopic accessory to apply legally marketed solutions for washing mucosal tissue in the gastrointestinal tract.
The JetPrep Flushing Device is a sterile, disposable, single use device, intended for use as flexible endoscopic accessory to apply legally marketed solutions for washing mucosal tissue in the gastrointestinal tract. The device is composed of a catheter with a spray tip on its distal tip. During operation, the catheter should be inserted into the endoscope working channel. The spray tip location can be manually controlled by the user to be positioned on the distal end of the endoscope working channel, and thus apply 360 degree irrigation spray pattern. The device does not impede aspiration of debris and fluids through the endoscope working channel while it remains within the endoscope. For providing irrigation fluids, the device should be connected to legally marketed irrigation pumps or manual syringe for endoscopy.
The provided text is a 510(k) summary for the JetPrep Flushing Device. It describes the device, its intended use, and states that it has been subjected to "extensive safety and performance validations prior to release." However, it does not contain specific acceptance criteria or detailed results of a study demonstrating the device meets such criteria.
The document primarily focuses on establishing substantial equivalence to a predicate device (Hobbs Mistifier Spray Catheter) based on indications for use, design, and operation principles, rather than presenting a formal performance study with predefined acceptance criteria. This is common for 510(k) submissions where substantial equivalence is demonstrated through comparison to an already cleared device, potentially relying on non-clinical performance data (e.g., biocompatibility) and design similarities rather than extensive clinical efficacy trials.
Therefore, most of the requested information cannot be extracted from this document, as it is not present.
Here's what can be addressed based on the provided text:
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1. A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document states "The JetPrep Flushing Device has been subjected to extensive safety and performance validations prior to release" and "The device parts that come in contact with the irrigation fluids and/or the patient's tissue are composed of materials that were tested for biocompatibility." However, it does not specify what those performance validations were, what their acceptance criteria were, or the quantitative results.
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2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not provided in the document. No specific test set or study details are mentioned.
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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 provided in the document. No ground truth establishment is described.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided in the document.
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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 provided in the document. This device is a flushing device, not an AI-assisted diagnostic tool, so such a study would not be applicable.
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6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This information is not provided in the document. This device is a physical medical device, not an algorithm.
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7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): This information is not provided in the document.
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8. The sample size for the training set: This information is not provided in the document, as no training set is mentioned.
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9. How the ground truth for the training set was established: This information is not provided in the document, as no training set or ground truth establishment is mentioned.
In summary, the provided 510(k) summary focuses on substantial equivalence and general safety/biocompatibility, rather than detailed performance study data with explicit acceptance criteria.
§ 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.