(166 days)
Vial access devices with SmartSite™ are standalone, single-vial use, disposable devices which provide access to a medication vial without the use of a needle during medication preparation. BD standalone vial access devices are not intended to be used on a patient.
Vial access devices with SmartSite™ are standalone, single-vial use, disposable devices which permit access to a medication vial without the use of a needle during medication preparation. Vial access devices with needle-free connectors are available in two configurations: 13 mm or 20 mm.
The provided text describes a 510(k) premarket notification for a medical device, the "BD SmartSite™ 13mm Vial Access Device" and "BD SmartSite™ 20mm Vial Access Device." This document focuses on demonstrating substantial equivalence to a predicate device rather than outright performance against specific acceptance criteria for a novel device or AI algorithm.
Therefore, the typical structure for acceptance criteria and human-in-the-loop studies for AI algorithms is not applicable to this document. This submission details the safety and performance testing to show that a new version of a device (subject device) is comparable to an already cleared device (predicate device).
Here's an analysis of the provided information, framed within the context of demonstrating substantial equivalence, and noting where the requested AI-specific information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of a specific table for acceptance criteria vs. device performance for a novel AI device, this document lists various bench and non-clinical tests performed according to recognized consensus standards. The "acceptance criteria" here implicitly refer to meeting the specifications of these standards to demonstrate safe and effective performance, thus supporting substantial equivalence.
| Acceptance Criteria (Implicitly, meeting standard specifications) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility: | Met applicable test specifications. |
| - Cytotoxicity (ISO 10993-5) | |
| - Genotoxicity (ISO 10993-3) | |
| - Sensitization (ISO 10993-10) | |
| - Irritation / Intracutaneous Reactivity (ISO 10993-23) | |
| - Acute Systemic Toxicity (ISO 10993-11) | |
| - Sub-acute/ Sub-chronic Toxicity (ISO 10993-11) | |
| - Material Mediated Pyrogenicity (ISO 10993-11) | |
| - Hemolysis Indirect (ISO 10993-4) | |
| - Chemical Requirements (ISO 8536-4) | |
| Physical/Functional Performance: | Met applicable test specifications. |
| - Conical fittings (ISO 594-1, ISO 594-2, ISO 80369-7) | |
| - Transfer set requirements (ISO 22413) | |
| - Particulate requirements (USP ) | Met particulate requirements. |
| - Microbial Ingress (FDA guidance, Harsh Infusates testing) | |
| - Packaging Integrity (ISO 11607-1, ISO 11607-2, ASTM F2096) | |
| Sterilization: | Met applicable test specifications. |
| - Radiation sterilization (ISO 11137-1, 11137-2, 11137-3) | |
| - Microbiological methods (ISO 11737-1, 11737-2) |
The document states: "All test results met their acceptance criteria and support that the BD SmartSite™ Vial Access Device is substantially equivalent to the predicate SmartSite Access Pin."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each non-clinical test. It lists the standards followed (e.g., ISO, ASTM, USP), which inherently define the methodologies and often the sample sizes for such tests.
Data provenance isn't described in terms of "country of origin" or "retrospective/prospective" as typical for clinical data or AI training data. Instead, the tests were conducted according to recognized international standards and FDA guidance documents.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device is not an AI algorithm requiring expert ground truth for image interpretation or similar tasks. The "ground truth" for these tests are the objective measurements against the specified performance parameters in the standards (e.g., proper fitting, no leaks, meeting particulate limits, etc.).
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as point 3. Testing involves objective measurements and adherence to specified standard protocols, not subjective expert adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is an intravenous administration set component, not an AI algorithm, and therefore no MRMC study or AI assistance evaluation was performed or required.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical and bench testing presented in this submission is based on objective measurements defined by the referenced national and international consensus standards (e.g., ISO, ASTM, USP). Examples include:
- Measurement of luer taper conformance.
- Detection of leaks using specific pressure tests.
- Counting particulate matter within specified limits.
- Assessment of biological responses in accordance with biocompatibility standards (e.g., cytotoxicity, sensitization).
- Validation of sterilization efficacy.
8. The Sample Size for the Training Set
This is not applicable as the device is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This 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.