(107 days)
The indicated use of health Line International Corporation's IV Administration Sets and Extensions Sets is for administration of fluids from a container to the patents vascular system.
HLIC's IV Administration Sets covered by this submission are gravity feed Intravascular Administration Sets. They are to be used for administering fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
The provided text is a 510(K) summary for the Health Line International Corporation's (HLIC) IV Administration and Extension Sets. It explicitly states that this is a submission to establish substantial equivalence to predicate devices, not an independent study demonstrating novel performance criteria or the effectiveness of AI.
Therefore, many of the requested elements are not applicable to this document. The device is a physical medical device (IV administration set), not a software or AI-driven diagnostic tool.
Here's the analysis based on the provided text, while also noting the limitations due to the nature of the submission:
1. A table of acceptance criteria and the reported device performance
The submission focuses on substantial equivalence to predicate devices and compliance with existing standards rather than novel performance criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (Baxter K925126 & Baxter K89098) | HLIC IV Administration Sets and Extension Sets are substantially equivalent to Baxter K925126 and K89098. HLIC's spike dimensions are slightly different but more compliant to ISO 8536-4:2004 dimensions. |
| Compliance with ISO 8536-4:2004 (Infusion equipment for medical use - Infusion sets for single use, gravity feed) | HLIC's devices were all compliant with ISO 8536-4:2004. |
| Compliance with ISO 10993 (Biological evaluation of medical devices) | HLIC's devices were all compliant with ISO 10993 requirements. |
| DEHP Free | Product is DEHP free. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical trial data or algorithm evaluation. The "performance data and the safety data" mentioned refer to engineering and biocompatibility testing to demonstrate equivalence and standards compliance, not a clinical study on a patient cohort. Therefore, sample sizes for such tests are not described in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the context of expert consensus for AI or diagnostic performance is not relevant here. The evaluation relies on standardized tests and comparison to predicate devices, not expert interpretation of outputs.
4. Adjudication method for the test set
Not applicable. There is no human-interpreted "test set" 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 not an AI device, and no MRMC study was conducted or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
For the purpose of this 510(K) submission, the "ground truth" is established by:
- Predicate device characteristics: The established characteristics and performance of the Baxter IV Administration and Extension Sets.
- International standards: The specifications and requirements outlined in ISO 8536-4:2004 and ISO 10993.
- Engineering and materials testing: Physical, chemical, and biological tests to confirm the device meets predefined technical specifications and safety profiles, ensuring biological compatibility and functional integrity (e.g., flow rates, material strength, sterility).
8. The sample size for the training set
Not applicable. This is not an AI device, and there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or AI model involved.
§ 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.