(186 days)
The Nipro Blood Collection Needle are intended to be used to collect blood for various blood tests.
The Nipro Blood collection needles that we intend to market include gauges 18, 20, 21, and 22. Each gauge is available in various lengths from 20 to 40 mm. Blood Collection Needles are described in hypodermic single lumen needle (21 CFR 880.5570). The materials used for the components include stainless steel SUS 304 (SS), synthetic rubber, and polypropylene (PP). Epoxy resin as an adhesive and silicone oil as a lubricant are also used.
The provided document is a 510(k) summary for the Nipro® Blood Collection Needle. It establishes substantial equivalence to a predicate device (Exel International Blood collection needle, K861152A).
However, a 510(k) submission generally does not include detailed studies demonstrating device performance against specific acceptance criteria for a new, novel device, especially for a well-established product type like a blood collection needle. Instead, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Therefore, many of the requested details about acceptance criteria and a study proving the device meets them will not be explicitly present in this type of document because the type of study conducted for a 510(k) for a blood collection needle is primarily a comparison to a predicate, not a de novo clinical trial with new performance metrics.
Here's an analysis based on the provided text, highlighting what can be answered and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness (equivalent to predicate) | "The Nipro and Exel devices are exactly the same devices, therefore, all technical characteristics are identical." This implies equivalent safety and effectiveness based on identical design to a legally marketed predicate. |
| Material Composition (equivalent to predicate) | Materials include stainless steel SUS 304, synthetic rubber, polypropylene, epoxy resin, and silicone oil, matching common materials for such devices and presumably matching the predicate. |
| Indications for Use (equivalent to predicate) | "Intended to be used to collect blood for various blood tests." This matches the intended use of the predicate. |
| Gauge and Length Availability (equivalent to predicate) | Available in gauges 18, 20, 21, 22 and lengths 20 to 40 mm, consistent with standard blood collection needles and likely the predicate. |
Explanation: The document's core statement is that the Nipro and Exel devices "are exactly the same devices, therefore, all technical characteristics are identical." This is the primary "performance" metric accepted for a 510(k) for this type of device – proving substantial equivalence by demonstrating identical characteristics to a predicate. There are no explicit quantitative performance acceptance criteria (e.g., "blood flow rate must exceed X ml/min") or detailed test results presented in this summary, as the nature of a 510(k) for a Class II device like this relies heavily on comparison rather than novel performance data.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For a device like a blood collection needle seeking substantial equivalence, a formal "test set" in the context of clinical studies with specific sample sizes might not be required if the technical characteristics are deemed identical to a predicate. The "data provenance" would likely refer to manufacturing and design specifications rather than clinical study data.
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)
This information is not applicable and not provided. This type of detail is typical for diagnostic algorithms or subjective interpretation studies, not for a hardware device like a blood collection needle demonstrating substantial equivalence through technical comparison.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are relevant for studies where expert consensus is needed to establish ground truth from subjective observations (e.g., image interpretation), which is not the case for this 510(k) submission.
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
This is not applicable and not provided. This type of study is specific to AI or diagnostic imaging devices where human interpretation is involved. The Nipro Blood Collection Needle is a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable and not provided. This refers to AI algorithm performance, which is irrelevant for a blood collection needle.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the Nipro Blood Collection Needle in the context of this 510(k) is implicitly the technical specifications and performance of the legally marketed predicate device (Exel International Blood collection needle K861152A). The claim is that the Nipro device is "exactly the same" as the predicate in all technical characteristics, therefore it is substantially equivalent in safety and effectiveness.
8. The sample size for the training set
This is not applicable and not provided. This concept relates to machine learning models, not a physical medical device like a blood collection needle.
9. How the ground truth for the training set was established
This is not applicable and not provided. As above, this applies to machine learning, not this device.
In summary:
This 510(k) submission for the Nipro Blood Collection Needle demonstrates substantial equivalence primarily by stating that its technical characteristics, materials, and intended use are "exactly the same" as a legally marketed predicate device (Exel International Blood collection needle, K861152A). The "study" proving this amounts to the submission of design specifications, material compositions, and intended use statements that were reviewed and accepted by the FDA as being identical to the predicate. The document does not contain information about clinical trials, expert consensus, or AI performance metrics because such studies are not typically required for a 510(k) for this class and type of device when substantial equivalence to a predicate is established by identical technical characteristics.
§ 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).