(285 days)
B Recon Line is intended for transfer of solvent from IV bag to a vial with powder drug to be reconstituted, through the APOTECAbag automated system.
B Double Filling Line is intended for the transfer of solvent from a bag and liquid drug from a vial to a bag through the APOTECAbag automated system.
B Filling Line is intended for transfer of drug from a vial to a bag through the APOTECAbag automated system.
B Recon Line with needle is intended for transfer of solvent from a bag to a vial with powder drug to be reconstituted, through the APOTECAbag automated system.
B Double Filling Line with vial needle is intended for the transfer of solvent from a bag and liquid drug from a bottle to a bag through the APOTECAbag automated system.
B Filling Line for bag is intended for transfer of drug from a bag to another bag through the APOTECAbag automated system.
B Dispensing Line devices are only to be used with APOTECAbag pharmacy compounding device. These devices are not to be used for the compounding of chemotherapy and oncology drugs.
B Dispensing Line is a disposable medical device used for the transfer of liquids from an initial container to a final one, by means of the action of a peristaltic pump. It is a sterile tube, with sections designed to be inserted in peristaltic pump and with specific terminal connectors for the connection of the device with the different containers.
The tube section to be inserted in the peristaltic pump presents a larger diameter than the other sections of tube.
The device is intended to be used with the purpose of pharmacy compounding in the automated system APOTECAbag.
The device is manufactured with biocompatible materials and it is provided sterile by EO sterilization method.
This document describes the regulatory submission for the "B Dispensing Line" device (K203674). This device is an IV fluid transfer set designed for use with the APOTECAbag automated pharmacy compounding system. The provided information focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device, the KIRO Set (K152441).
No AI/ML device is mentioned in this documentation. The device is a physical medical device (IV fluid transfer set). Therefore, questions related to AI/ML specific studies, such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable.
Here's the information regarding the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria / Standard | Reported Performance |
|---|---|---|
| Performance Testing | ||
| Performance test (in APOTECAbag) | Acceptable dosage time and accuracy, No leakage, Right disconnection (no ruptures), Ability to maintain acceptable performances after prolonged used, Dosage accuracy | PASS |
| Dose accuracy and repeatability | Acceptable dosage accuracy, mean and maximum error in the limits imposed by US Pharmacopoeia, Ability to maintain performances after prolonged use | PASS |
| Leakage test | ISO 8536-9 | PASS |
| Tensile stress test | ISO 8536-9 | PASS |
| Test for transparency | ISO 8536-9 | PASS |
| Drug Compatibility | No adverse compatibility effects | PASS |
| Biocompatibility Testing | ||
| Cytotoxicity MEM Elution | ISO 10993-5:2009, ISO 10993-12:2012 | PASS |
| Acute Systemic Toxicity | ISO 10993-11:2017, ISO 10993-12:2012 | PASS |
| Guinea Pig Sensitization Test | ISO 10993-10:2010, ISO 10993-12:2012 | PASS |
| Haemolysis test direct and indirect contact | ISO 10993-4:2017, ISO 10993-12:2012 | PASS |
| Pyrogen Test on rabbits | USP 41-NF36:2018 Pyrogen Test (USP Rabbit Test) | PASS |
| Rabbit Intracutaneous injection test | ISO 10993-10:2010, ISO 10993-12:2012 | PASS |
| Bacterial Endotoxins Test | USP 41-NF36:2019 Bacterial Endotoxins Test | PASS |
| Particulate contamination | ISO 8536-4 | PASS |
| Chemical characterization | ISO 8536-4 | PASS |
| Particulate Matter for Injections | USP (Method 1 Light Obscuration Particle Count Test) | PASS |
| Sterilization and Shelf Life Testing | ||
| Packaging Validation | Effective microbiological barrier, product sterility and integrity preservation | PASS |
| Sterilization Validation | ISO 11135:2014 | PASS |
| Shelf life, Real time | Sterility and product integrity maintained over the entire shelf life | Ongoing |
| Labelling validation | Correctness and completeness of labeling | PASS |
2. Sample size used for the test set and the data provenance
The document states that "AEA srl has performed the following non-clinical/design verification testing." This refers to laboratory-based testing on the physical device itself, not a dataset in the context of an AI/ML model. Therefore, "sample size" and "data provenance" (country of origin, retrospective/prospective) as concepts related to data analysis for AI/ML are not applicable here. The tests were performed on physical samples of the B Dispensing Line.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as this is a physical medical device and no AI/ML model requiring expert-established ground truth data is involved. The ground truth for the performance tests would be established by measuring the physical properties and functionality of the device against predefined engineering and quality standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical medical device's non-clinical performance testing. The "adjudication method" traditionally refers to how conflicting expert opinions are resolved in establishing ground truth for evaluating diagnostic or prognostic algorithms.
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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" is defined by established engineering standards, regulatory guidelines (e.g., ISO, USP), and documented performance specifications for the device. For example:
- Performance tests: Measured physical accuracy, absence of leakage, structural integrity.
- Biocompatibility tests: Absence of adverse biological reactions as defined by ISO 10993 standards.
- Sterilization tests: Validation against ISO 11135.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device, so there is no training set or ground truth for it.
In summary, the provided document details the non-clinical performance and safety testing of a physical medical device, the B Dispensing Line. It does not involve any AI/ML components, and therefore, many of the requested specific details related to AI/ML study design are not relevant to this 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.