(441 days)
The BD Alaris™ Pump Infusion Set is indicated for use by trained healthcare professionals within healthcare facilities through intravenous, intra-arterial and subcutaneous routes for adults, pediatrics and neonates or irrigation of fluid spaces for adults.
The BD Alaris™ Pump Infusion Set is designed to interface with the BD Alaris™ Pump Module or to be used for gravity infusion. The BD Alaris™ Pump Infusion Set is a single-use infusion set that is available in various configurations of the following components: fluid container spike, vent cap, drip chamber, pump segment assembly, roller clamp and/or pinch clamp, SmartSite™ Y-sites, check valve and male luer lock connector. The drip chamber cap located at the proximal end of the infusion set and the male luer lock cap located at the distal end of the infusion set maintain sterility of the fluid path prior to use. The spike located on the proximal end of the drip chamber is inserted into a fluid container. The infusion set is supplied fluid-path sterile using gamma irradiation and is non-pyrogenic.
The BD Alaris™ Pump Infusion Sets are infusion sets used by healthcare professionals for administering fluids and medications. The device's performance was evaluated through non-clinical design verification testing, including functional, bench, system, and biocompatibility tests. No clinical data was included in the submission.
Here is a summary of the acceptance criteria and the study results:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Testing | All functional tests were required to demonstrate equivalent performance to the predicate device and safe and effective design for intended use. Specific acceptance criteria are implied to be derived from referenced standards (e.g., ISO 8536-4, AAMI TIR101:2021). | All test results met their acceptance criteria. |
| Microbial Ingress | Acceptance criteria as per FDA guidance document, Intravascular Administration Sets Premarket Notification Submissions [510(k)] and internal protocol for Aerosol Challenge. | Met acceptance criteria. |
| Human Factors/Usability Engineering | Compliance with IEC 62366-1:2015, IEC 62366-2:2016, ANSI/AAMI HE75:2009/(R 2018), AAMI TIR 101:2021, AAMI TIR17:2008, IEC 60601-1-6: 2013, and relevant FDA guidance documents. | Met acceptance criteria. |
| Flow Rate Accuracy | Compliance with AAMI TIR101:2021 and FDA guidance document, Infusion Pumps Total Product Life Cycle. | Met acceptance criteria. |
| Bolus Accuracy | Compliance with AAMI TIR101:2021 and FDA guidance document, Infusion Pumps Total Product Life Cycle. | Met acceptance criteria. |
| Air-in-Line | Specific criteria not detailed, but implied to demonstrate safe operation. | Met acceptance criteria. |
| Upstream Occlusion Time-to-Alarm | Specific criteria not detailed, but implied to demonstrate safe operation and timely alarm. | Met acceptance criteria. |
| Post Occlusion Bolus & Downstream Occlusion Time to Alarm | Specific criteria not detailed, but implied to demonstrate safe operation and timely alarm. | Met acceptance criteria. |
| Biocompatibility | Acceptance criteria as per ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-23:2021, ISO 10993-10:2021, ISO 10993-11:2017, ISO 10993-4:2017, ISO 10993-3:2014, USP , and relevant FDA guidance documents. | All tests (Cytotoxicity, Irritation, Sensitization, Material Mediated Pyrogenicity, System Toxicity, Hemolysis, Genotoxicity, Particulates) met acceptance criteria. |
| Sterilization | Compliance with ISO 11137-1:2006/AMD 1:2013, ISO 11137-2:2013, USP , USP , and ANSI/AAMI ST72:2011 R:2016. | Met acceptance criteria. |
| Shelf-Life | 3 years shelf-life claim, established through compliance with ASTM D642-15, ASTM D4169-16, ASTM D4332-14, ASTM D4728-06, ISO 11607-1, and ISO 11607-2. | Achieved 3-year shelf-life claim. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes for each non-clinical test performed. It generally refers to "Design verification testing" and "Performance testing completed on the subject device." The testing would have been conducted internally by CareFusion/BD.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as this was a non-clinical premarket notification (510(k)) for a medical device (infusion set), not an AI/software device requiring expert interpretation of results for ground truth establishment. The "ground truth" here is defined by engineering standards, physical measurements, and biological compatibility test results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this was not a study involving human reader interpretation or clinical 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. No MRMC study was conducted as this device is an infusion set, not an AI or imaging device requiring human-in-the-loop performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device, not a software algorithm. The "standalone performance" would be the device functioning according to its specifications, which was evaluated through the functional and performance tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical testing was based on:
- Established engineering and performance standards: e.g., ISO 8536-4 for gravity flow rate, AAMI TIR101:2021 for flow rate and bolus accuracy.
- Biocompatibility standards: e.g., ISO 10993 series and USP .
- Sterilization and shelf-life standards: e.g., ISO 11137 series and ASTM standards.
- FDA guidance documents: for various aspects like microbial ingress and general infusion pump lifecycle.
- Internal protocols: where specific external standards might not cover all aspects.
8. The sample size for the training set:
Not applicable. This is a medical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there was no 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.