(29 days)
The dedicated Q Core administration sets for the Sapphire pump are intended for single-patient use and single-use only.
The dedicated Q Core Administration Sets for the Sapphire infusion pump are provided sterile and are for single-use and single-patient use only. Components from the previously cleared administration sets were used to make a set with new configuration, all within the parameters (e.g. length, diameters, materials) of the sets cleared with the Sapphire Infusion Pump. This new configuration is substantially equivalent to the administration sets that were cleared under K123049, having identical indications for use and technological characteristics. In addition, this set includes a pressure activated back check valve ("PAV") that has the same cracking pressure as the back check valve that was cleared with administration sets under K031749 (Bodyguard Infusion System). The PAV valve has been added to make it consistent with other sets on the market.
The provided text is a 510(k) summary for the Q Core Administration Set, indicating device clearance based on substantial equivalence to predicate devices. It describes the device, its intended use, and pre-clinical testing performed. However, it does not contain the specific acceptance criteria or the detailed results of a study designed to prove the device meets those criteria, as typically presented in a scientific publication.
The document states that "Preclinical testing included in the submission to demonstrate that the new administration set is safe and performs as intended involved the following: Visual tests, Dimensional testing, Physical requirements, Flow accuracy." It then concludes that the new administration set "is substantially equivalent... with respect to the indications for use, technological characteristics and materials."
Therefore, based only on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and a study demonstrating compliance. The document is a regulatory approval letter and summary, not a detailed scientific study report.
However, I can extract the information that is present and indicate what is missing based on your request:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not Explicitly Stated for Performance, but Implied by "Substantially Equivalent") | Reported Device Performance (Summary from Preclinical Testing) |
|---|---|
| (Not explicitly defined in the document for specific performance metrics) However, the implicit acceptance criteria is Substantial Equivalence to predicate devices (K123049 and K031749) for: |
- Indications for Use
- Technological Characteristics
- Materials
- Cracking pressure of the back check valve | - Passed Visual tests
- Passed Dimensional testing
- Passed Physical requirements
- Passed Flow accuracy
Conclusion: The new administration set is "substantially equivalent" to predicate devices K123049 (primary predicate) and K031749 (for back check valve cracking pressure). |
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 used for the test set: Not specified in the provided document. The document only mentions "Preclinical testing" but does not detail the number of units tested for Visual, Dimensional, Physical, or Flow accuracy.
- Data provenance: Not specified. The document indicates Q Core Medical Ltd. is located in Netanya, ISRAEL, but does not state where the testing was conducted or the origin of the data.
- Retrospective or prospective: Not specified.
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 present in the document. The testing described (Visual, Dimensional, Physical, Flow accuracy) for an administration set does not typically involve expert review for "ground truth" establishment in the manner of medical image analysis or clinical diagnosis. These are engineering and performance tests against specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods like "2+1" are typically used in clinical studies or expert reviews to resolve discrepancies, which isn't described for the preclinical engineering tests mentioned.
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 document describes a medical device (infusion administration set) that does not involve "human readers" or "AI assistance" in its direct function. It is a physical medical component, not a diagnostic or AI-powered system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the preclinical testing mentioned (Visual, Dimensional, Physical, Flow accuracy), the "ground truth" would be the engineering specifications and performance standards for the device, and compliance with these standards (or equivalence to predicate device performance) would be the measure. No expert consensus, pathology, or outcomes data is mentioned as ground truth for these tests.
8. The sample size for the training set
- Not applicable. This device does not use a "training set" in the context of machine learning or AI development.
9. How the ground truth for the training set was established
- Not applicable. This device does not use a "training set."
§ 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.