(51 days)
The Interject Injection Therapy Needle Catheter is used for endoscopic injection into gastrointestinal mucosa and submucosa to: • introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system • aid in Endoscopic Mucosal Resection (EMR), Endoscopic Submucosal Dissection (ESD), or polypectomy procedures • control non-variceal hemorrhage
The Interiect™ Injection Therapy Needle Catheter that consists of a handle with a hub for injection, a catheter sheath, and a needle. It is available in a variety of configurations with varying needle lengths, gauges, and catheter lengths.
The provided document is a 510(k) premarket notification for a medical device called the "Interject Injection Therapy Needle Catheter." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics as might be found for novel devices or PMAs.
Therefore, the document does not contain the requested information regarding acceptance criteria, study details (sample size, data provenance, ground truth establishment, expert adjudication, MRMC studies, standalone performance), or training set information.
Instead, the document focuses on demonstrating that the new Interject Injection Therapy Needle Catheter is substantially equivalent to existing predicate devices.
Here's what can be extracted from the document conceptually related to performance and testing, though not in the format requested for acceptance criteria and a study proving those:
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Acceptance Criteria and Reported Device Performance: This information is not provided in a quantified, tabular format. The document states that the proposed device "meets the requirements of ISO 10993-1, ISO 11135, and ISO 10993-7." These are standards for biological evaluation of medical devices, sterilization, and ethylene oxide sterilization residuals, respectively. Meeting these standards is a form of acceptance criterion, but specific performance metrics (e.g., tensile strength, injection force, flow rate) are not detailed, nor are the actual measured performance values reported.
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Sample size used for the test set and the data provenance: Not applicable or not provided. The substantial equivalence argument relies on the fact that the proposed device is "identical" to one predicate (K012864) and has only "minor differences" (sheath outer diameter) from others, which are stated not to "alter the suitability of the proposed device for its intended use." This comparison suggests that new, extensive performance testing on a specific "test set" to establish entirely new performance metrics was not deemed necessary by the submitter beyond verifying compliance with the mentioned ISO standards.
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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): Not applicable. This type of information is relevant for studies involving human interpretation or clinical endpoints, which are not detailed in this 510(k) summary.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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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 therapy needle catheter, not an AI diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" in the context of clinical or diagnostic performance is not relevant for this type of device submission based on substantial equivalence to a physical instrument.
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The sample size for the training set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
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How the ground truth for the training set was established: Not applicable.
In summary, the document demonstrates substantial equivalence through:
- Stating "identical technological characteristics" to the predicate Interject Injection Therapy Needle Catheter (K012864).
- Acknowledging "similar technological characteristics" and "minor difference in sheath outer diameter" to Olympus InjectorForce Max (K902736) and Wilson-Cook Variable Length GI Injection Needle (K941305), but asserting this difference "does not alter the suitability of the proposed device for its intended use."
- Stating compliance with key ISO standards (10993-1, 11135, 10993-7) for biological evaluation and sterilization, noting that the "design and materials remain unchanged from that of the predicate Interject Injection Therapy Needle Catheter (K012864)."
The "study" here is implicitly the verification that the device maintains the same performance characteristics as the predicate through design and material equivalence and compliance with relevant industry standards for safety aspects (biocompatibility, sterilization). No specific clinical or comparative performance study with human readers or AI algorithms is described.
§ 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.