(21 days)
Indicated for use in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varicies and for submucosal dye marking in the upper GI tract. The Enteryx® Injection Catheter is also a component of the Enteryx® Procedure Kit.
The Enteryx® Injection Catheter is an injection needle consisting of a needle, catheter shaft and a handle. The handle incorporates a luer for injection capabilities and offers a locking mechanism to lock the needle in place with respect to the catheter shaft.
The provided text is a 510(k) summary for the Enteryx® Injection Catheter. It outlines the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain the detailed performance study information typically found in algorithms or AI/ML device submissions.
Therefore, for most of the requested points, the answer will be that the information is not present in the provided document. This document focuses on demonstrating substantial equivalence through physical comparison and functional testing, not through rigorous clinical trials with acceptance criteria for a specific performance metric.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified as performance metrics (e.g., sensitivity, specificity, accuracy) would be for an AI/ML device. | "results of physical comparison and functional testing support a determination of substantial equivalence" |
| Not applicable (device is an injection catheter, not an AI/ML diagnostic tool). | "substantially equivalent to the currently marketed Boston Scientific Enteryx® Injection Catheter in terms of performance characteristics, biocompatibility, and intended use." |
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: Not applicable/Not provided. The submission relies on "physical comparison and functional testing" rather than a clinical test set with human or imaging data.
- Data provenance: Not applicable/Not provided.
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)
- Number of experts: Not applicable/Not provided. Ground truth establishment by experts is not described for this type of device submission.
- Qualifications of experts: Not applicable/Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable/Not provided. No test set requiring expert adjudication is described.
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
- MRMC study: No. This submission is for an injection catheter, not an AI/ML-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of ground truth: Not applicable. The device's performance is assessed through "physical comparison and functional testing" against a predicate device, not against a clinical "ground truth" as would be established for a diagnostic or AI device.
8. The sample size for the training set
- Sample size for training set: Not applicable. This is not an AI/ML product that would have a training set.
9. How the ground truth for the training set was established
- How ground truth for training set was established: Not applicable.
§ 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.