(441 days)
The BD Alaris™ Pump Epidural Infusion Set is indicated for use by trained healthcare professionals within healthcare facilities through the epidural route for adults, pediatrics and neonates.
The BD Alaris™ Pump Epidural Infusion Set is an administration set consisting primarily of bag spike, vent cap, drip chamber, tubing (including pump segment), safety clamp, roller clamp, male NRFit™ connector, and male NRFit™ cap. The drip chamber cap located at the proximal end of the administration set, and the male NRFit™ cap, located at the distal end of the administration set, maintain sterility of the fluid path prior to usage. The spike located on the proximal end of the drip chamber is inserted into a prepared fluid container. The male NRFit™ connector enables connection of the administration set to a compatible female NRFit™ connector on the patient's epidural catheter. The BD Alaris™ Pump Epidural Infusion Set is intended to interface with the BD Alaris™ Pump Module. The device is supplied fluid-path sterile using gamma irradiation, in a perforated pouch, is non-pyrogenic, and is for single-use only. The device tubing is color-coded with a yellow stripe to signify administration of medication intended for an epidural route of administration. The BD Alaris™ Pump Epidural Infusion Set is not intended for gravity administration. The device is intended for prescription use only. DEHP or natural rubber latex are not part of the material formulation.
The BD Alaris™ Pump Epidural Infusion Set is designed to deliver medications intended for the epidural route of administration. The NRFit™ connector conforms to ISO 80369-6, Small-bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The NRFit™ connector is not compatible with the standard luer connector commonly used for intravenous infusion. The addition of the NRFit™ connector eliminates the risk of misconnection that may result in infusion of medications not intended for an epidural route of administration.
The provided document is a 510(k) summary for the BD Alaris™ Pump Epidural Infusion Set. It describes non-clinical safety and performance testing to demonstrate substantial equivalence to a predicate device, rather than a study proving that an AI device meets acceptance criteria. Therefore, most of the requested information regarding AI device evaluation is not applicable or available in this document.
However, I can extract information related to the general acceptance criteria and studies performed for this medical device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "All testing met pre-established acceptance criteria and successfully demonstrated that the device... is safe for its intended use and performs as intended." However, it does not provide a specific table with detailed numerical acceptance criteria for each test and the corresponding device performance results. The testing was conducted according to various FDA recognized and internal consensus standards, implying that the acceptance criteria are inherent within these standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample sizes used for the various non-clinical safety and performance tests. It also does not mention data provenance in terms of country of origin or whether the tests were retrospective or prospective since these are non-clinical bench and lab tests.
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. This is a submission for a mechanical medical device (infusion set), not an AI device that requires expert-established ground truth for performance evaluation such as image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically relevant for clinical studies involving human interpretation or decision-making, which is not the case for this non-clinical submission.
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:
This information is not applicable. An MRMC study is relevant for AI devices assisting human readers/interpreters, which is not what the BD Alaris™ Pump Epidural Infusion Set is.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this device, "ground truth" would correspond to the established physical and chemical properties, functionality, and safety requirements defined by international standards (e.g., ISO, AAMI, ASTM) and FDA guidance documents. The device's performance was measured against these predefined specifications. For example, for biocompatibility, the ground truth is defined by the passing criteria of ISO 10993 tests.
8. The sample size for the training set:
This information is not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable. This is not an AI device that requires a training set or its associated ground truth establishment.
Summary of relevant information from the document (focused on device evaluation):
- Acceptance Criteria: Implicitly defined by the numerous FDA recognized and internal consensus standards followed, including:
- Human Factors: ANSI/AAMI HE75: 2009 (R2013), IEC 62366-1: Edition 1.0 2015.
- Functional/Bench/System Testing: ISO 8536-4: 2010/Amd1: 2013(E), ISO 8536-8: 2015, ISO 80369-1: 2018, ISO 80369-6: 2016, ISO 80369-20: 2015. Specific tests listed: Flow Rate Accuracy, Bolus Accuracy, Air-in-Line, Upstream Occlusion Time-to-Alarm, Post Occlusion Bolus & Downstream Occlusion Time to Alarm.
- Biocompatibility: ISO 10993-1, ISO 10994-5, ISO 10993-10, ISO 10993-23, ISO 10993-11, ASTM F756-2017, ISO 10993-4, USP 41 General Chapter , ISO 10993-3, ISO 10993-12, ISO 10993-17, ISO 10993-18.
- Sterilization and Shelf Life/Packaging: ISO 11137-1, ISO 11137-2, ISO 11737-1, ANSI/AAMI ST72, ASTM D4728-17, ASTM D4169-16, ASTM D5276-19, ASTM F1980-16, USP 41 General Chapter , USP 41 General Chapter .
- Studies Performed: Non-clinical safety and performance testing were conducted to demonstrate substantial equivalence to the predicate device. These included:
- Human factors testing.
- Functional, bench, and system testing (e.g., flow rate accuracy, air-in-line, occlusion time-to-alarm).
- Biocompatibility testing.
- Sterilization and shelf life/packaging testing.
- Device Performance: All testing met pre-established acceptance criteria, demonstrating that the device is safe for its intended use and performs as intended. Specific quantitative results are not provided in this summary.
- Ground Truth: For non-clinical tests, the "ground truth" is defined by the pass/fail criteria and specifications outlined in the referenced national and international standards.
- Clinical Data: No clinical data were included in the submission.
§ 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.