(224 days)
The BD Secondary Set is indicated for continuous or intermittent delivery of IV fluids, medications, including lipids, through intravascular routes of administration. The BD Secondary Set may be used with any patient with consideration given to the procedure being performed and fluids being infused.
The BD Secondary Infusion Set is an administration set consisting primarily of a bag spike, drip chamber, tubing, roller clamp, micro luer lock connector, and a hanger. The drip chamber cap is located at the proximal end of the administration set, and the micro luer lock cap is located at the distal end of the administration set. The bag spike, located on the proximal end of the drip chamber is inserted into a prepared fluid container. The BD Secondary Infusion Set is supplied as fluid-path sterile using gamma irradiation in a perforated pouch, is non-pyrogenic, and is for single-use only. The BD Secondary Infusion Set is for gravity administration. The device is intended for prescription use (RX) only. DEHP or natural rubber latex are not part of the material formulation. The set can be used for up to 7 days (168 hours) provided the set is continuously attached to the primary administration set.
This request is about a medical device, not an AI/ML powered device. The document describes a 510(k) premarket notification for a medical device called the "BD Secondary Infusion Set." It does not involve any AI or machine learning components. Therefore, the questions related to acceptance criteria and studies for AI/ML performance (such as sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.
The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical safety and performance testing, and biocompatibility testing. It explicitly states: "Not Applicable. There are no clinical data included in this submission."
Here's the relevant information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists several FDA-recognized consensus standards that the device met. It states: "The subject device met the applicable test specifications and acceptance criteria as described in the submission." However, it does not provide a table with specific numerical acceptance criteria and reported performance values. It only lists the standards themselves:
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| ISO 594-1:1986 (Conical fittings with a 6% (Luer) taper) | Met applicable test specifications and acceptance criteria |
| ISO 594-2:1998 (Conical fittings with a 6% (Luer) taper - Lock fittings) | Met applicable test specifications and acceptance criteria |
| ISO 8536-4:2019 (Infusion sets for single use, gravity feed) | Met applicable test specifications and acceptance criteria |
| ISO 8536-14:2016 (Clamps and flow regulators) | Met applicable test specifications and acceptance criteria |
| USP 41, National Formulary 36 (USP), General Chapter (Particulate Matter In Injections) | Met applicable test specifications and acceptance criteria |
| ISO 11137-1:2006 (Sterilization - Radiation - Requirements) | Met applicable test specifications and acceptance criteria |
| ISO 11137-2:2013 (Sterilization - Radiation - Establishing sterilization dose) | Met applicable test specifications and acceptance criteria |
| ISO 11737-1:2018 (Microbiological methods - Determination of a population of microorganisms) | Met applicable test specifications and acceptance criteria |
| ISO 11607-1:2019 (Packaging for terminally sterilized medical devices) | Met applicable test specifications and acceptance criteria |
| ISO 10993-1, -4, -5, -10, -11 (Biocompatibility) | Met applicable test specifications and acceptance criteria |
| ASTM F756 (Hemocompatibility) | Met applicable test specifications and acceptance criteria |
| Specific functional characteristics mentioned in comparison table: | |
| Priming Volume (10016073: 11 mL; 72215N: 13 mL) | Verification testing completed |
| Drip Rate (10016073: 20/mL; 72215N: 15/mL) | Verification testing conducted to confirm performance |
| Device Duration (Up to 7 days (168 hours)) | Verification testing was conducted to show performance |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document states "bench and nonclinical testing" was conducted according to various standards, but does not detail the sample sizes for these tests.
- Data provenance: Not explicitly stated, but assumed to be internal laboratory testing conducted by CareFusion/BD, as is typical for non-clinical device testing for 510(k) submissions. There is no mention of country of origin of data in a research context. It's retrospective in the sense that the testing was completed before the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. For non-AI/ML medical device testing like this, "ground truth" is typically established by physical measurements, chemical analysis, and adherence to established engineering and biological standards, rather than expert consensus on data interpretation.
4. Adjudication method for the test set:
This is not applicable. Device performance is assessed against predefined specifications and standard test methods (e.g., fluid flow rates, material compatibility, sterility checks), not through human adjudication of interpretations.
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 is not applicable. This device is not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. This device does not have an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical and biocompatibility testing, the "ground truth" is based on:
- Adherence to recognized consensus standards (e.g., ISO, USP, ASTM).
- Physical and chemical measurements meeting predefined engineering specifications (e.g., priming volume, drip rate accuracy, material properties).
- Biological responses in controlled laboratory tests (e.g., cytotoxicity, sensitization, hemocompatibility).
8. The sample size for the training set:
This is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
This is not applicable. There is no "training set" as this is not an AI/ML device.
§ 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.