(92 days)
The Port Access Infusion Set with Antineedle Stick Protector is a safety intravascular administration set with a non-coring Huber needle that is used to access an implanted medication port for solution infusion and blood sampling. The port access infusion sets are designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the needle is activated during removal from the patient's implanted medication port.
The Port Access Infusion Set with Antineedle Stick Protector is sterile, single use device with a non-coring Huber needle (90 degree), non-DEHP polyvinyl chloride tubing with or without Y connector or a needleless access connector which incorporates an integral antineedle stick protector used to prevent accidental needlestick injuries. The device is used for accessing an implanted medication port by puncturing the septum of the medication port and is used for the delivery of medication and for blood sampling. Fluid administration through the non-DEHP polyvinyl chloride fluid pathway of the port access infusion set are those generally used in hospitals and for delivery of chemotherapy. The device includes an integral antineedle stick device that when used prevent clinician's needle stick injuries.
This document is a 510(k) premarket notification for the Kawasumi Laboratories Port Access Infusion Set with Antineedle Stick Protector (K060580). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than independently proving safety and effectiveness through extensive clinical trials. Therefore, the information provided for acceptance criteria and studies is limited and different from what would be expected for a novel device requiring a PMA (Premarket Approval).
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Biocompatibility requirements | "The device meets all the biocompatibility... test requirements." |
| Pyrogenicity test requirements | "The device meets all the... pyrogenicity test requirements." |
| Minimize accidental needlestick injuries (efficacy of antineedle stick protector) | "Kawasumi Laboratories has conducted a successful simulated use study to determine the acceptability of this device for use to minimize accidental needlestick injuries." |
| "The Antineedle stick protector has successfully been clinically evaluated." | |
| Conclusion: "...Antineedle stick protector... performs as well as the predicate device" for preventing accidental needle stick injuries. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for simulated use study or clinical evaluation.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to have been conducted by Kawasumi Laboratories. Given they are based in Japan with a U.S. agent, the studies could have been conducted in either region. The studies were likely prospective as they were specifically conducted for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The "simulated use study" and "clinically evaluated" phrases do not detail the methodology for expert involvement or ground truth establishment.
4. Adjudication method for the test set:
This information is not provided in the document.
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:
- No MRMC study or AI component: This device is a physical medical device (infusion set with a safety mechanism), not an AI/software device. Therefore, an MRMC study or AI-related effectiveness is not applicable and was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable: As noted above, this is a physical device, not an algorithm.
7. The type of ground truth used:
- For Biocompatibility and Pyrogenicity: Established by laboratory test standards and methodologies for these specific tests (e.g., ISO standards for biocompatibility).
- For Antineedle Stick Protector Efficacy: Based on the results of the "simulated use study" and "clinical evaluation." The specific "ground truth" for these would likely be defined by the study protocols themselves, such as absence of needlestick injuries in the simulated tasks or real-world use for the clinical evaluation. The document states the device was found "acceptable for use to minimize accidental needlestick injuries" and that it "successfully been clinically evaluated." The ultimate ground truth is implied to be actual prevention of needlestick injuries.
8. The sample size for the training set:
- Not Applicable: There is no "training set" in the context of this physical device.
9. How the ground truth for the training set was established:
- Not Applicable: As there is no training set, this question is not applicable.
§ 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.