(325 days)
For the administration of fluids from a container into the patient's vascular system through a vascular access device.
The proposed devices consist of IV Extension sets and IV set accessories. They are single use disposable devices intended for the administration of fluids from a container into the patient's vascular system. They are non-pyrogenic, sterile devices that can be used with or without a syringe. The extension sets consist of PVC tubing or polyethylene lined PVC tubing, a notch clamp, female luer, non-vented cap, male luer, and filter vented cap. They are used to administer solutions, drugs, antibiotics, lipids to the patient. The accessories consists of an anti-siphon valve, back check valve, and 1.2 µm Filter. They attach to the proposed sets to add a specific feature to facilitate the administration of fluid when used with a syringe. The anti-siphon valve reduces the risk of free flow from the syringe and backflow into the primary infusion line. The back check valve prevents backflow into the primary infusion line. The 1.2 um Filter prevents particulate matter and eliminates air bubbles.
The provided document is a 510(k) Summary for Baxter Healthcare Corporation's Intravascular Extension Sets and Accessories (K192366). It describes a Class II medical device intended for the administration of fluids into a patient's vascular system.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various tests conducted and generally states that "All tests met the acceptance criteria" without providing specific numeric results for each test. The acceptance criteria themselves are primarily referenced by external standards, not internal performance metrics.
| Test | Acceptance Criteria (Reference Standard) | Reported Device Performance |
|---|---|---|
| ISO 80369-7 Luer Tests on male Luer Lock Connector | BS EN ISO 80369-7:2016 (Clauses 6.1.2, 6.1.3, 6.2, 6.3, 6.4, 6.5, 6.6, 5), ISO 80369-20:2015 Annex E, ISO 594-1:1986 Clause 3, ISO 594-2:1998 Clause 3 (as applicable) | Met acceptance criteria |
| ISO 80369-7 Luer Tests on female Luer Lock Connector | BS EN ISO 80369-7:2016 (Clauses 6.1.2, 6.1.3, 6.2, 6.3, 6.4, 6.5, 6.6, 5), ISO 80369-20:2015 Annex E, ISO 594-1:1986 Clause 3, ISO 594-2:1998 Clause 3 (as applicable) | Met acceptance criteria |
| Tensile Strength Test | BS EN ISO 8536-9 Clause 5.3, BS EN ISO 8536-10 Clause 4.3, BS EN ISO 8536-11 Clause 5.3, BS EN ISO 8536-12 Clause 6.2 | Met acceptance criteria |
| Leak Test | BS EN ISO 8536-9:2015 Section A.4, BS EN ISO 8536-11:2015 Section A.4, ISO 8536-10:2015 Section A.4 | Met acceptance criteria |
| Counter Flow Test | ISO 8536-12:2007+A1:2013 Clause A.4 | Met acceptance criteria |
| Blocking Performance Test | ISO 8536-12:2007+A1:2013 Clause A.6 | Met acceptance criteria |
| Opening Pressure Test | ISO 8536-12:2007+A1:2013 Clause A.7.1 and per Baxter Test Method | Met acceptance criteria |
| Notch Clamp Activation Force Test | Per Baxter Test Method | Met acceptance criteria |
| Notch Clamp Shut-Off Test | ISO 8536-14:2015 | Met acceptance criteria |
| Filter Tests | EN ISO 8536-11 Clause 5.1 and per Baxter Test Method | Met acceptance criteria |
| Non-DEHP Claim Verification (. | Met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the individual performance tests (e.g., Luer tests, tensile strength, leak test, etc.). It only states that tests were conducted.
The data provenance is retrospective testing performed by Baxter Healthcare Corporation to verify the functional performance of the proposed devices. No information about the country of origin of the data is provided beyond the submitting company being U.S.-based (Illinois).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this type of device submission. The tests are bench tests verifying physical and chemical properties of the device, not clinical performance requiring expert medical review or ground truth establishment in a diagnostic context.
4. Adjudication Method for the Test Set
This section is not applicable. As mentioned above, the tests are primarily bench tests against engineering standards, not subjective assessments requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. The device in question is an intravenous extension set and accessories, which are physical medical components.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
For the performance tests, the "ground truth" or reference is established by the acceptance criteria outlined in various international standards (e.g., ISO, BS EN ISO) and Baxter's internal test methods. For biocompatibility, it's the biological response against established toxicology and biocompatibility standards. For sterility, it's the validation against a specified Sterility Assurance Level (SAL).
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical medical device. There is no "training set" in the context of an algorithm or AI system. The manufacturing process and quality control would involve ongoing sampling and testing, but not in the sense of a machine learning training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
§ 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.