(177 days)
The Disposable Injection Needle is intended to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.
The Disposable Injection Needle is a sterile, single-use device as a kind of accessories for digestive endoscopy. The Disposable Injection Needle is intended to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.
The Disposable Injection Needle is designed to insert through the suitable endoscope's forceps to inject harden agent to target lesion in treatment for bleeding of esopha-gastric varix or to mark the lesions of the digestive tract.
The Disposable Injection Needle has different model specifications depending on different working length and the needle size.
This document is a 510(k) summary for a Disposable Injection Needle. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria for a complex AI/software-driven medical device. Therefore, the requested information, which pertains to such a study (sample sizes, expert adjudication, MRMC studies, ground truth establishment for AI/ML models), is not present in the provided text.
The document discusses non-clinical bench testing to demonstrate that the Disposable Injection Needle meets design specifications and performs comparably to a predicate device. This is a physical device, not an AI/ML-driven one.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a direct "acceptance criteria" table in the sense of performance metrics for an AI/ML model (e.g., sensitivity, specificity, AUC). Instead, it lists various physical and chemical performance tests for the medical device. The "acceptance criteria" for these tests would be meeting the specified thresholds or demonstrating equivalence to the predicate device. The "reported device performance" is that the tests were carried out and demonstrated substantial equivalence.
Non-Clinical Performance Tests Performed:
| Test Category | Specific Tests Performed | Reported Performance |
|---|---|---|
| Material/Device Safety | Biocompatibility (Cytotoxicity, Skin Sensitization, Skin Irritation, Acute/Subacute Systemic Toxicity, Pyrogen Test) | Complies with ISO 10993 standards and FDA guidance. |
| Sterilization | EO sterilization validation (ISO 11135, ISO 11737-2, ISO 10993-7, USP ) | Validated according to applicable standards. |
| Shelf Life & Packaging | Accelerated Aging (ASTM F1980), Packaging Requirements (ISO11607-1, ISO11607-2), Seal Leaks (ASTM F 1929, ASTM D 3078), Microbial Barrier (DIN 58593-6), Seal Strength (ASTM F88/F88M), Shipping Performance (ASTM D4169) | Validated according to applicable standards. |
| Bench Performance | Appearance, Dimension, Bond Strength, Operational performance, Puncture Performance, Liquid leakage, Injection connector (Luer connector), Patency of lumen, Corrosion Property, Chemical performance | Tests carried out, demonstrated substantial equivalence to predicate. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for specific tests. The document mentions tests were performed on "both the subject device (Alton Disposable Injection Needle) and the predicate device (Anrei Single Use Injection Needle)." It doesn't specify the number of units tested for each.
- Data Provenance: Not applicable in the context of clinical or image data. The "data" here refers to the results of bench testing. There is no mention of country of origin of data, nor whether it's retrospective or prospective, as these terms apply to clinical studies.
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):
Not applicable. This device is a physical medical instrument, not an AI/ML system that requires expert annotation for ground truth. The "ground truth" for these tests would be established by validated test methods and reference standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a study involving human readers or interpretation.
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-assisted device. The document explicitly states: "N/A, no clinical studies are available for the subject device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth for this device's performance is based on established engineering and materials testing standards (e.g., ISO, ASTM, USP) and the performance of the legally marketed predicate device. For example, for biocompatibility, the ground truth is compliance with ISO 10993. For mechanical performance, it's demonstrating equivalence to the predicate and meeting specified functional requirements.
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.
In summary: The provided FDA 510(k) summary is for a physical medical device (Disposable Injection Needle) and demonstrates substantial equivalence through non-clinical bench testing against a predicate device and adherence to recognized standards. It does not contain the information requested regarding AI/ML device performance studies, as those types of studies (MRMC, standalone algorithm performance, expert adjudication, ground truth for training/test sets) are not relevant to this specific device submission.
§ 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.