(198 days)
The injection needle is intended for endoscopic injection into the gastrointestinal mucosa.
The 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), and the inner tube is made of nylon. 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 product and the mucosa of the human digestive tract of less than 1 hour.
The provided text describes a 510(k) submission for an "Injection Needle" and focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria for the new device.
Therefore, many of the requested sections (Table of acceptance criteria, Sample size for test set, Number of experts, Adjudication method, MRMC study, Standalone study, Type and establishment of ground truth for test and training sets) cannot be fulfilled from the provided text, as this information is not present. The submission focuses on comparing the characteristics of the new device to a predicate device to claim substantial equivalence, which is a different type of evaluation than a direct performance study against defined acceptance criteria.
However, based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of a formal study with quantitative results against pre-defined thresholds. Instead, it presents a comparison of the new device's characteristics against a predicate device to demonstrate substantial equivalence. The "performance" described is in terms of similar technical characteristics and capabilities to the predicate.
| Characteristic | Acceptance (Substantial Equivalence) | Reported Device Performance (EndoChoice Injection Needle) | Predicate Device (Medi-Globe Injectra Injection Needle) |
|---|---|---|---|
| Compatible with currently available endoscopes | Yes | Yes | Yes |
| Supplied Sterile | Yes | Yes | Yes |
| Sheath diameter | Similar | 2.3 mm | 2.5 mm |
| Needle size | Similar | 22 – 25 gauge | 22 – 25 gauge |
| Outer tubing | Similar | Thermoplastic polymer - PTFE | Thermoplastic Polymer |
| Length | Similar | 240 cm | 230 cm |
| Needle Length | Similar | 5 mm | 4 mm |
| Indications for use | Similar | Intended for endoscopic injection into the gastrointestinal mucosa. | Used for endoscopic injection of solutions into tissues of the digestive system and injection of saline as a procedural aid in endoscopic polypectomy procedures. |
| Packaging | Similar | Single-use EO sterilized tyvek pouch with one device per pouch. | Single-use EO sterilized steam sealed pouch with one device per pouch. |
2. Sample sized used for the test set and the data provenance
Not applicable. The submission describes a comparison of technical characteristics and an assessment of safety and effectiveness based on biocompatibility, accelerated aging, performance, and sterilization validation testing. There is no "test set" in the context of a clinical performance study with human data or a labeled dataset for AI evaluation. The data provenance simply refers to these internal engineering and biological safety tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication is mentioned.
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 device or a diagnostic device where MRMC studies would typically be performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (an injection needle), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. Ground truth, in this context, would relate to a clinical diagnostic or AI performance study, which is not what this submission describes. The "truth" considered here is that the device, through various engineering and biological tests, meets safety and performance requirements that are substantially equivalent to a legally marketed predicate.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI model.
9. How the ground truth for the training set was established
Not applicable. This is a medical device, not an AI model.
§ 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.