(183 days)
An empty container with sterile fluid path used to hold an admixture of compatible fluids for administration to a patient. Medication transfer is done using aseptic technique.
The subject device is an empty two-port style EVA container available in sizes ranging from 50 mL to 4000 mL. The devices are provided sterile and packaged in multi-pack kits. The intended use is to hold an admixture of compatible fluids for administration to the patient. Medication transfer is done using aseptic technique.
The provided document is a 510(k) Pre-Market Notification from the FDA regarding the "HCT Empty EVA Container Pack." This document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing a clinical study with acceptance criteria for a novel AI/Ml medical device.
Therefore, the information requested in your prompt regarding acceptance criteria, study design, sample sizes for test and training sets, ground truth establishment, expert involvement, and MRMC studies is not present in this regulatory document. These types of details are typically found in validation studies for AI/ML devices, not premarket notifications for substantially equivalent medical containers.
The document does include details about performance testing, which serves a similar purpose of demonstrating the device meets certain specifications or thresholds. Here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes performance testing that was conducted to ensure the device's safety and effectiveness, particularly addressing the differences in packaging from the predicate device. While explicit "acceptance criteria" values are not listed in a quantifiable table, the tests implicitly aim to demonstrate performance meeting internal specifications and relevant ISO/ASTM standards. The "Reported Device Performance" is stated by the declaration that the tests were conducted "to confirm that the differences in packaging do not affect the safety or effectiveness of the device."
| Performance Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Hanger Hold Performance Tests | Meets internal specification | Confirmed to not affect safety or effectiveness |
| Bag Volume Capacity | Meets internal specification | Confirmed to not affect safety or effectiveness |
| Resistance to Dropping (per ISO 15747 Section 4.1.3 & A. 4) | Complies with ISO 15747 | Confirmed to not affect safety or effectiveness |
| Administration Port Leak Tests | Meets internal specification | Confirmed to not affect safety or effectiveness |
| Performance of Injection Site (per ISO 15747 Section 4.1.10 & A. 10) | Complies with ISO 15747 | Confirmed to not affect safety or effectiveness |
| Integrity (Strength of Joints) Testing | Meets internal specification | Confirmed to not affect safety or effectiveness |
| Particulate Testing (per USP ) | Complies with USP | Confirmed to not affect safety or effectiveness |
| Sterilization (ISO 11137-1:2006, ISO 11137-2:2013) | Meets ISO 11137 standards for radiation sterilization | Complies with relevant standards |
| Shipping Containers (ASTM D4169) | Complies with ASTM D4169 | Complies with relevant standards |
| Bacterial Endotoxins (ANSI/AAMI ST72:2011) | Complies with ANSI/AAMI ST72 | Complies with relevant standards |
| Gross Leaks in Packaging (ASTM F2096-11) | Complies with ASTM F2096-11 | Complies with relevant standards |
| Integrity of Seals (ASTM F1886/F1886M-16) | Complies with ASTM F1886/F1886M-16 | Complies with relevant standards |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only lists the types of tests performed.
- Data Provenance: Not specified, but generally implies in-house testing by the manufacturer (Health Care Technologies) or contracted labs. The tests are non-clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI/ML device requiring clinical expert adjudication for "ground truth." The tests are physical and chemical property evaluations.
4. Adjudication method for the test set:
- Not applicable. This is not a clinical study requiring adjudication. Test results are based on objective measurements against specified standards or internal criteria.
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 device is an empty container, not an AI/ML algorithm.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an empty container, not an AI/ML algorithm.
7. The type of ground truth used:
- Not applicable in the context of AI/ML. For this device, "ground truth" refers to the objective physical and chemical properties and performance characteristics measured against established industry standards (ISO, ASTM, USP) and the manufacturer's internal specifications.
8. The sample size for the training set:
- Not applicable. As this is not an AI/ML device, there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As this is not an AI/ML device, there is no "training set" or ground truth for its establishment.
Summary for the provided document:
The regulatory submission for the HCT Empty EVA Container Pack is a substantial equivalence determination (510(k)) for a medical device container. The document details non-clinical performance testing to demonstrate that the device, despite minor packaging differences, maintains the same safety and effectiveness as its predicate device. This involves physical and chemical tests against industry standards and internal specifications, not clinical or AI/ML-specific validation studies. Therefore, many of the questions asked, which are highly relevant to AI/ML device evaluation, are not applicable to this type of medical device and regulatory submission.
§ 880.5025 I.V. container.
(a)
Identification. An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.(b)
Classification. Class II (performance standards).