(93 days)
The Tidal High-Flow Non-coring Needle is intended for the access of totally implantable vascular access ports (VAPs) to administer I.V. fluids, infusions drugs, and other fluids, and for the administration of blood products, and/or withdrawal of blood as part of the therapy regimen
The 16Ga and 18Ga Tidal High-Flow Non-coring Needles are an extension of our 19, 20, and 22 gauge non-coring (Huber) Needle line used to access our line of totally implantable access devices. These large gauge non-coring needles incorporate a stylet to render them non-coring. The needle is made from 304 series stainless steel and the hubs are molded from K-Resin and LDPE. All materials are certified USP Class VI and are the exact same materials used to manufacture the products approved under K863721 and K111101. The needles are a disposable product that will be packaged sterile and non-pyrogenic in a single use peel pouch. ETO sterilization will be used. The sterilization will be done in-house using a validated sterilization procedure that is identical to the sterilization method used in previous 510(k) clearances.
The provided text describes a 510(k) summary for a medical device called the Tidal High-Flow Non-coring Needle. This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study to prove the device meets specific acceptance criteria in the manner that an AI/ML device would be evaluated.
Therefore, many of the requested details about acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment are not applicable to this type of regulatory submission and device.
However, I can extract information related to the closest equivalents to "acceptance criteria" and "performance data" as presented in this document.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in the format typically seen for AI/ML device evaluations. Instead, it states that "The Tidal High-Flow Non-coring Needles have met all predetermined acceptance criteria of design verification evaluations through testing examination." The tests performed are listed as:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance with 16Ga high-flow, noncoring needles for septum puncture / port leak to failure (worst case scenario) using a representative sample of ports found in the marketplace. | The data collected from the non-clinical tests demonstrated that the functionality and performance characteristics of the Tidal High-Flow Non-coring Needles are comparable to the currently marketed needles based on available literature. |
| Performance following 25 punctures with the 16Ga high-flow needle for septum puncture / port leak to failure with a 19Ga Huber point needle using a representative sample of ports found in the marketplace. | The data collected from the non-clinical tests demonstrated that the functionality and performance characteristics of the Tidal High-Flow Non-coring Needles are comparable to the currently marketed needles based on available literature. (This is a general statement. Specific numerical results are not provided in this summary.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: The document mentions "a representative sample of ports found in the marketplace" was used for the septum puncture/port leak tests. No specific number is provided.
- Data provenance: Not explicitly stated, however, the testing was conducted by Norfolk Medical, a US-based company, and the FDA guidance referenced is US-based. It is implied to be prospective bench testing.
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)
Not applicable. This is a physical device being evaluated via bench testing for mechanical properties and biocompatibility, not an AI/ML device requiring expert consensus for ground truth. The "ground truth" here is the physical performance as observed in the tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an image review or interpretative task requiring adjudication.
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
Not applicable. This is a physical medical device (needle), not an AI/ML diagnostic or assistive device for human readers.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is a physical medical device. The "standalone" performance refers to the device's inherent mechanical and material properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance evaluation in this context is based on bench testing results (septum puncture/port leak to failure) and material characterization against established standards (e.g., ISO, USP Class VI for biocompatibility).
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of 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).