(10 days)
QUICKPIN is a Luer-lock spike used in manual or automated pharmacy compounding for addition and / or extraction of IV substances, including antineoplastics and substances for chemotherapy, from rubber-stoppered containers including multidose vials. It is equipped with a 0.2 micron hydrophobic air-filter that minimizes the formation of aerosols when preparing and dispensing the substances. This device is intended to be used by trained healthcare personnel. It is restricted to sale by or on the order of a physician.
QUICKPIN is a Luer-lock spike used in manual or automated pharmacy compounding for addition and/or extraction of IV substances, including antineoplastics and substances for chemotherapy, from rubber-stoppered containers including multi-dose vials. It is equipped with a 0.2 micron hydrophobic air-filter that minimizes the formation of aerosols when preparing and dispensing the substances.
The provided document is a 510(k) summary for a medical device (QUICKPIN), focusing on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and detailed study results in the format requested. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, and MRMC studies, is not present.
However, I can extract information related to the device's functional validation, which serves as a form of acceptance in the context of a 510(k) submission.
1. Table of Acceptance Criteria (Implied) and Reported Device Performance
| Acceptance Criteria (Implied from Functional Testing) | Reported Device Performance |
|---|---|
| Materials meet USP physicochemical and ISO 10993-1 biological tests. | All materials comply. |
| Correct operation of the device in foreseeable operating conditions. | Correct operation demonstrated. |
| No adverse influence on safety and performance due to technological differences (filter materials, air-inlet dimensions). | Verified by bench-testing. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided document. The text mentions "bench tests performed on the proposed QUICKPIN device" and "Functional laboratory testing."
- Data Provenance: The document implies in-house laboratory testing conducted by Grifols or a contracted lab. The exact country of origin and whether it was retrospective or prospective is not specified, but typically bench testing for device validation is prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This type of information is typically related to clinical studies or performance evaluations where human judgment forms the ground truth, which is not the primary focus of this 510(k) summary (which relies on bench testing for substantial equivalence).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which are not detailed here.
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 was done/reported. The device is a Luer-lock spike, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical medical device, not an algorithm. However, its "standalone" performance in terms of functionality was evaluated via bench testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For materials: Conformance to established standards (USP physicochemical tests, ISO 10993-1 biological tests) serves as the "ground truth."
- For functional performance: The "ground truth" is the device operating correctly according to its intended use in simulated or laboratory conditions. This would be based on predefined engineering specifications and functional requirements.
8. The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI/machine learning model.
§ 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.