(262 days)
The device is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract.
The device is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract.The Disposable Injection Needles are consist of needle tube, inner tube, outer tube, protective sleeve, booster tube, handle, limitation ring, buckle and conical connector. The needle tube and booster tube are made of 06Cr19Ni10. The inner tube are made of PP.The handle, limitation ring, buckle and connector are made of ABS. The diameter of the outer tube is available in two specifications, respectively are 1.8mm and 2.3mm. There are five specifications for the working length of the outer tube, respectively are 1200mm,1800mm,2000mm and 2300mm. There are three specifications for outer diameters of needle tube, respectively are 21G, 23G and 25G. Five specifications for lengths of needle tube, respectively are 4mm, 5mm, 7mm and 8mm.
The device is sterilized by ethylene oxide. The shelf life is 3 years.
The inner, middle and transportation packaging ways respectively are sealed pouch, box and carton.The corresponding product quantities is 1 pc per bag, 10 pcs per box and 5 boxes per carton.
This is a 510(k) premarket notification for a medical device (Disposable Injection Needles), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than complex performance criteria for AI/ML devices. Therefore, many of the requested categories for AI/ML device performance are not applicable to this submission.
Based on the provided document, here's an analysis of the acceptance criteria and supporting studies:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of "acceptance criteria" in the way one might expect for a digital health or AI device (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly defined by compliance with established medical device standards and demonstrating performance comparable to the predicate device. The Reported Device Performance is stated as meeting the requirements of these standards.
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit in Document) | Reported Device Performance |
|---|---|---|
| Biocompatibility | No cytotoxicity (ISO 10993-5:2009) | No cytotoxicity |
| No intracutaneous reactivity (ISO 10993-23:2021) | No intracutaneous reactivity | |
| No skin sensitization (ISO 10993-10:2021) | No skin sensitization | |
| No systemic toxicity (ISO 10993-11:2017) | No systemic toxicity | |
| No Pyrogen (no specific standard cited, but general requirement) | No Pyrogen | |
| No Hemolysis (ASTM F756-17) | No Hemolysis | |
| Assessment of circulating blood-contacting materials on Partial Thromboplastin Time (PTT) (ASTM F2382-18) | Test performed (results imply acceptance) | |
| Platelet Leukocyte Count (ASTM F2888-19) | Test performed (results imply acceptance) | |
| Performance Bench Testing | Tensile strength (ISO 20695:2020) | Test performed (results imply acceptance) |
| Fracture force (ISO 20695:2020) | Test performed (results imply acceptance) | |
| Stainless steel needle tubing requirements (ISO 9626:2016) | Test performed (results imply acceptance) | |
| Resistance against autoclaving, corrosion, thermal exposure (ISO 13402:1995) | Test performed (results imply acceptance) | |
| Small-bore connectors for liquids and gases (ISO 80369-7:2021) | Test performed (results imply acceptance) | |
| Sterile hypodermic needles requirements (ISO 7864:2016) | Test performed (results imply acceptance) | |
| Patency | Performance tested | |
| Injection residue | Performance tested | |
| Needle retraction suitability | Performance tested | |
| Sterilization | EO Sterilized | EO Sterilized |
| SAL (Sterility Assurance Level) | 10^-6 | |
| Endotoxin Limit | 20 EU per device |
The document concludes that "The conclusions drawn from the non-clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device Injection Needle (K213914)." This general statement serves as the overall reported device performance and proof that it meets the implicit acceptance criteria of substantial equivalence.
The following information is not applicable to this traditional medical device submission, as it pertains to AI/ML device evaluations:
- Sample size used for the test set and the data provenance: Not applicable. The tests are physical and chemical bench tests on the device materials and functional aspects, not AI performance on data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML device often involves expert annotation. For this physical device, "ground truth" is measured by adherence to established engineering and biocompatibility standards.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML ground truth. For this device, the "ground truth" is adherence to performance specifications outlined in the referenced ISO and ASTM standards.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.