(95 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 a funnel shaped 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. This 510(k) notice adds an additional model of the device.
The provided text does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria. Instead, it describes a 510(k) summary for the JetPrep Flushing Device, a medical device for endoscopic irrigation.
The "Performance Data" section states generally that: "The JetPrep Flushing Device has been subjected to extensive safety and performance validations prior to release. 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." It then concludes: "Performance data demonstrates that the modified JetPrep Flushing Device is as safe and effective as the cleared JetPrep Flushing Device."
This statement indicates that performance data was gathered, but it does not provide specific acceptance criteria, numerical results from a study, or details about the study design. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (K111274), implying that its performance is considered acceptable because it is similar to an already cleared device.
Therefore, I cannot populate the requested table or answer most of the questions because the necessary detailed information on acceptance criteria and study particulars is not present in the provided text.
However, I can extract the following relevant information:
- Device Name: JetPrep Flushing Device
- Purpose of filing: A modification to a previously cleared device (K111274). This is a "special 510(k)" notice.
- Intended Use: "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."
- Predicate Device: JetPrep Flushing Device (K111274) from JetPrep, Ltd.
Missing Information:
All of the following information is not present in the provided text:
- A table of acceptance criteria and reported device performance.
- Sample size for the test set and data provenance.
- Number of experts and their qualifications used to establish ground truth for the test set.
- Adjudication method for the test set.
- Details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study (effect size, if human readers improve with AI).
- Details of a standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any studies.
- Sample size for the training set.
- How the ground truth for the training set was established.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence, not a detailed technical report of a performance study 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.