(30 days)
The NIS-5 Is a needle-less device intended as an intravascular administration set accessory for the delivery of drugs and fluids. The NIS-5 device may aid in the prevention of needle stick injuries.
Not Found
This FDA letter (K053129) indicates a "substantial equivalence" determination for the NexusTKO Needleless Access Device, Model NIS-5. Historically, 510(k) clearances, especially for devices like this from 2005, primarily relied on demonstrating substantial equivalence to a predicate device already on the market, rather than extensive direct clinical outcome studies or established acceptance criteria with detailed statistical performance metrics in the same manner as a pre-market approval (PMA) application.
Therefore, the requested information regarding detailed acceptance criteria, specific study designs, sample sizes, and expert validation for this specific 510(k) clearance (K053129) will likely not be explicitly detailed in the provided documents. The letter primarily confirms the administrative clearance based on equivalence.
However, I can provide a general interpretation based on typical 510(k) requirements for similar devices during that period and what can be inferred from the "Indications for Use" stating "may aid in the prevention of needle stick injuries."
General Interpretation based on typical 510(k) process for Needleless Access Devices:
For a device like the NIS-5, demonstrating substantial equivalence typically involves showing that the device is as safe and effective as a legally marketed predicate device. This often involves:
- Performance Testing: Bench testing for fluid flow rates, leak integrity, pressure resistance, connection integrity, and potentially microbiology (e.g., bacterial ingress/egress).
- Biocompatibility: Tests according to ISO 10993 for materials in contact with fluids/blood.
- Sterilization Validation: Ensuring the device can be sterilized effectively.
- Human Factors/Usability: To ensure the device can be used safely and effectively by healthcare professionals.
Regarding the "prevention of needle stick injuries" claim: This specific claim would have likely been supported by either:
1. Design features explicitly eliminating needles or
2. Comparative bench testing or simulated use studies demonstrating reduced risk compared to traditional methods requiring needles (e.g., during IV line access or drug administration).
Unable to Fulfill Specific Data Request from Provided Documents:
Based solely on the provided FDA letter and "Indications for Use," the following information cannot be extracted or inferred:
- A table of acceptance criteria and the reported device performance: This detail is not part of an FDA clearance letter.
- Sample sizes used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not provided.
- Adjudication method for the test set: Not provided.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: Highly unlikely for this type of device and 510(k) submission from 2005. MRMC studies are typical for imaging AI.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is a mechanical device, not an AI algorithm.
- The type of ground truth used: Not explicitly stated, but for a mechanical device, ground truth would be based on engineering specifications, validated test methods (e.g., flow rate measurements, leak tests), and potentially microbiological culture results.
- The sample size for the training set: Not applicable as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
Conclusion:
The provided FDA letter for K053129 is an administrative document confirming "substantial equivalence." It does not contain the detailed technical specifications, acceptance criteria, or study results that would be part of the actual 510(k) submission. To obtain the specific data you're asking for, one would need to access the full 510(k) submission (if publicly available, often summarized, or through a Freedom of Information Act request), which would contain the performance data, test reports, and rationale for demonstrating substantial equivalence.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.