(28 days)
The SteriCap™ Mini Needle and standard needles are intended for use with a luer-tip syringe (e.g. luer-lock or slip-ip luer syringe) for the administration of drugs.
The SteriCap® Mini Needle ("SteriCap®") and Needles ("Needles") are devices intended to provide a means of fluid injection and aspiration to and from the body. The devices are a single lumen needle. For SteriCap® Mini Needle, the needle has a spring-actuated sliding cap, which protects the needle prior to use. For Needles, the needle is covered by a removable clear cap.
The additional gauges and lengths of the product family included in this submission are 30G/31G/33Gx 6mm and 31G / 33G x 4 mm. The additional gauges and lengths of the Needle included in this submission are 29G/30G/31G x 13 mm and 33G x 8 mm.
The provided text describes the submission of a medical device, the SteriCap™ Mini Needle and Standard Needles, for 510(k) premarket notification. The FDA's decision is that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain information about:
- A table of acceptance criteria and reported device performance related to an AI/ML or diagnostic imaging device.
- Sample sizes for test sets (beyond general mention of performance testing).
- Data provenance (country of origin, retrospective/prospective).
- Number of experts or their qualifications for ground truth establishment.
- Adjudication methods for test sets.
- Whether an MRMC comparative effectiveness study was done, or its effect size.
- Whether a standalone (algorithm only) performance was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
The text focuses on the physical characteristics and performance testing of a hypodermic needle, demonstrating its substantial equivalence to a predicate device. The performance data mentioned relates to:
- Dimensional and Physical Properties Verification (ISO 9626:2016, ISO 7864:2016)
- Needle quality (ISO 9626:2016, ISO 7864:2016)
- Color coding (ISO 6009:2016, ISO 7864:2016)
- Biocompatibility (ISO 10993-1, cytotoxicity, sensitization, irritation, acute systemic toxicity, materials mediated pyrogenicity)
- Sterility/Shipping and Shelf-life (ISO 11135:2014, ISO 10993-7, ASTM F1980-16, ASTM D4169-16, ASTM F2096-11, ASTM F88/F88M-15)
These are standard tests for medical devices, particularly those involving materials, sterility, and physical properties, and are not related to AI/ML device performance or diagnostic accuracy.
Therefore, I cannot provide the requested information based on the given input, as it describes a physical medical device (hypodermic needle) and not an AI/ML-based diagnostic device.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).