(251 days)
The EndoChoice Select injection needle is intended for endoscopic injection into the gastrointestinal mucosa.
The EndoChoice Select Injection Needle mainly consists of a cap, needle, boosting tube, and positioning ring, all made of 304 stainless steel. It also contains an outer tube and nut made of PTFE. The spring and spring tube are made of 302 stainless steel. The shell and injection handle are made of ABS. The bushing is made of TPE (SBS), the inner tube is made of nylon, and the color band indicator is made of CNBR.
The products are intended for single use; an individual device is packed in a sealed pouch following ETO sterilization. The device is used for local injection via endoscope, with the average contact time of the products and the mucosa of the human digestive tract of less than 1 hour.
The provided text describes a Special 510(k) Summary for the EndoChoice Select Injection Needle, which is a medical device. This type of submission is for modifications to a previously cleared device. The document primarily focuses on demonstrating "substantial equivalence" to a predicate device, rather than providing detailed acceptance criteria and a study to prove a device meets those criteria for a novel device.
Therefore, many of the requested data points (like specific performance metrics, sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, and detailed ground truth establishment) are generally not found in this type of submission. The focus is on showing the modified device performs as safely and effectively as the original, cleared device.
However, I can extract the information that is present and indicate where the requested information is not typically presented in a 510(k) summary focused on substantial equivalence.
1. Table of acceptance criteria and the reported device performance
For the modified EndoChoice Select Injection Needle, the "acceptance criteria" are predominantly related to the equivalence of its characteristics and safety to the predicate device. The "reported device performance" is essentially that it passed these equivalence-based tests.
| Acceptance Criteria (Demonstrated Equivalence to Predicate K132065) | Reported Device Performance (Result) |
|---|---|
| Material Equivalence: The new patient-contacting material must be safe and effective. | Biocompatibility testing for the new patient-contacting material passed. |
| Sterilization Equivalence: Sterilization method and efficacy must be equivalent. | Sterilization testing is unchanged from the predicate and passed. |
| Accelerated Aging Equivalence: Shelf life and stability characteristics must be equivalent. | Accelerated aging testing is unchanged from the predicate and passed. |
| Functional Equivalence: The modified device must perform identically to the predicate. | All test results passed, demonstrating safety and efficacy equivalent to the predicate device. |
| Design, Intended Use, Labeling Equivalence: Must be the same or similar as the predicate. | All characteristics (manufacturer, endoscope compatibility, sterility, sheath diameter, needle size, outer tubing, length, needle extension, indications for use, packaging) were found to be equivalent to the predicate. |
2. Sample sized used for the test set and the data provenance
The document does not specify sample sizes for individual tests. The "test set" here refers to the samples of the modified device used for the mentioned non-clinical tests (biocompatibility, accelerated aging, sterilization). The data provenance is internal to EndoChoice, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. Ground truth, in the context of device performance, would typically refer to established standards or verifiable performance metrics against which the device is measured. For a K151475 submission, the "ground truth" for "substantial equivalence" is the performance and safety profile of the predicate device (K132065).
4. Adjudication method for the test set
Not applicable/Not specified in this document. Adjudication methods are more relevant for human-read evaluations, not typically for non-clinical engineering tests of medical devices like injection needles.
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 device is an injection needle, not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI are not relevant.
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 substantial equivalence submission is the established safety and efficacy profile of the predicate device (EndoChoice Injection Needle K132065). The non-clinical tests conducted on the modified device (biocompatibility, sterilization, accelerated aging) were designed to demonstrate that the changes did not negatively impact these established characteristics of the predicate.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/machine learning model that would require a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical injection needle.
§ 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.