(87 days)
The Sterile Auto-Disable syringes with/without needle for single use is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.
The Sterile Auto-Disable syringes with/without needle for single use is a syringe with or without needle, sterile, single use hypodermic syringe with a 6% (Luer) male connector/lock fitting in various sizes. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The main principle of the syringe is that after the injection is completed, the plunger can be locked for self-locking.
The provided text describes a 510(k) premarket notification for a medical device: Sterile Auto-Disable Syringes with/without Needle for Single Use. The FDA clearance letter indicates that the device has been reviewed and determined to be substantially equivalent to a legally marketed predicate device (Safety Auto-Disable Syringe with Needle (Auto-Lock), K143497).
However, the provided document does not contain information related to a study proving the device meets acceptance criteria for an AI/ML-driven medical device. The document is a regulatory submission for a physical medical device (syringes) and details its physical, material, and performance characteristics compared to a predicate device.
Specifically, the document discusses:
- Device Description: The physical components and mechanism of the auto-disable syringe.
- Indications for Use: Aspiration of fluids and fluid injections.
- Comparison to Predicate Device: Detailed table comparing features like indications for use, product code, regulation number, class, principle of operation, safety features, intended user, environment of use, syringe volume, nozzle type, lubricant, barrel transparency, graduations legibility, needle length, needle gauge, configuration of the tip, needle hub, single use, performance specifications, sterilization, SAL, materials, pyrogenicity, biocompatibility, and labeling.
- Performance Data: Lists various tests conducted to demonstrate the physical device's safety and bio-compatibility, such as biocompatibility testing (Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogens, Hemolysis, Particulate Matter), sterilization validation, shipping and shelf-life testing, and performance testing against ISO standards (ISO 7864, ISO 9626, ISO 80369-7, ISO 7886-4, ISO 7886-1).
None of the information requested in your prompt regarding acceptance criteria and studies for an AI/ML device is present in this documentation. The questions about sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment are relevant to AI/ML device evaluations, but not to the type of device described in this 510(k) submission.
Therefore, I cannot populate the table or answer the specific questions about AI/ML device performance and validation using the provided text. The document is about the substantial equivalence of a physical syringe, not a software or AI/ML product.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).