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510(k) Data Aggregation
(60 days)
Single Use Injection Needle
Single use injection needle is to be used in conjunction with an endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.
The Single Use Injection Needles are sterile, single-use devices. The Single Use Injection Needles can is expected 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 Single Use Injection Needle is designed to pass through the endoscope's forceps to mark the lesions of the digestive tract and use it for injection. Compatibility with endoscopes, working lengths are 1800mm, 2000mm, 2300mm, and the minimum working clamp channel is φ 2.8 mm.
The provided document is a 510(k) Summary for a Single Use Injection Needle, which is a medical device, not an AI/ML software. Therefore, the questions related to AI/ML software performance criteria, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the loop performance)," "training set," and "ground truth for the training set" are not applicable to this submission.
The document describes the non-clinical performance testing conducted to demonstrate the essential performance of the proposed device and confirm it works as intended and is substantially equivalent to a predicate device.
Here's the information extracted from the document regarding the acceptance criteria and study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" side-by-side with "reported device performance" in the format typically seen for AI/ML models (e.g., sensitivity, specificity thresholds). Instead, it lists the types of performance tests conducted and concludes that the results demonstrated substantial equivalence. The predicate device's characteristics serve as the de-facto acceptance criteria for equivalence.
Here's a summary of the non-clinical performance tests and the conclusion of equivalence:
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Functional Performance: | |
| A. Inserting into endoscope | Works as intended |
| B. Withdrawing from endoscope | Works as intended |
| C. Advance of tube | Works as intended |
| D. Retraction of tube | Works as intended |
| E. Smooth puncturing of the needle | Works as intended |
| F. Normal reaction force to needle puncturing | Works as intended |
| G. Patency of lumen | Works as intended |
| H. Needle retraction propriety | Works as intended |
| I. Luer lock connector | Works as intended |
| J. Dimension (e.g., outer sheath diameter, needle size, needle length, working length) | Similar to predicate, differences determined not to affect compatibility/function (e.g., minor sheath diameter difference does not affect compatibility with 2.8mm channel; needle sizes/lengths within predicate range) |
| Material/Processing Performance: | |
| Shelf-Life (3 years) | Demonstrated through accelerated aging test (ASTM F1980-16); 3-year aging will be performed to support results. |
| Sterilization Validation (SAL |
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