(85 days)
The Genyx Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure.
The Genyx Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure. The Genyx Injection Needle materials are similar to those used in the predicate device. The Genyx Injection Needle is substantially equivalent to both predicate devices in that they all contain a stainless steel shaft and a luer lock hub where a standard syringe can be attached for injection of materials through the lumen of the needle into tissue.
The provided text describes a 510(k) premarket notification for the Genyx Injection Needle, seeking substantial equivalence to predicate devices. It does not contain details about specific acceptance criteria, a study design with test sets, expert involvement, or performance metrics in the way that would typically be described for software or AI/ML device evaluations.
Based on the nature of this submission (a 510(k) for an injection needle), the "acceptance criteria" are compliance with safety standards and equivalent performance to a predicate device in terms of "injection performance." The "study" is a nonclinical test comparing the new device to a predicate device.
Here's an attempt to structure the information based on your request, highlighting what is present and what is absent:
Acceptance Criteria and Device Performance Study for Genyx Injection Needle
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Safety Standards | Adherence to applicable safety standards | "Designed and will be tested to applicable safety standards." | This implies compliance is expected/achieved, but specific test results are not detailed in this summary. |
| Equivalence to Predicate Device | Perform equivalently to the predicate device, the Richard Wolf Aspiration/ Injection Needle, with respect to injection performance. | "Genyx Injection Needle was found to perform equivalently to the predicate device... with respect to injection performance." | This is a qualitative statement of equivalence. No specific quantitative measures of "injection performance" are provided. |
| Technological Changes | Technological changes do not raise any new issues of safety, effectiveness, or performance. | "Thus, the technological changes in the Genyx Injection Needle do not raise any new issues of safety, effectiveness or performance of the product." | This is a conclusion based on the comparison, not a direct measurement. |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified. The document refers to "nonclinical tests" and states the device "will be tested" and "was found to perform equivalently." This suggests some testing was done, but the number of units or test repetitions is not provided.
- Data Provenance: Not applicable in the context of this device. This is a physical medical device (an injection needle), not a data-driven AI/ML system. The "testing" refers to physical performance assessment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The evaluation is a technical/engineering assessment of a physical device's performance against a predicate, not an expert-driven ground truth establishment for diagnostic accuracy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept is for resolving disagreements in expert opinions for diagnostic tasks, which is not relevant to the evaluation of this physical medical device.
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:
- Not applicable. This is not an AI/ML device, and no human-reader study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's evaluation is essentially the established performance and safety profile of the predicate device. The performance of the Genyx Injection Needle was compared directly against the predicate device to establish equivalence.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device that requires a training set.
§ 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.