(110 days)
The product is a tamper evident, sterile seal used to cover opened pharmacy type drug containers. Such as vials, IV bottles, IV bags, etc.
The device is a seal used to cover and protect the septum surface of a previously opened vial, IV bottle or bag. The seal serves as a tamper resistant seal in that, once the seal is removed, it can not be reattached to the septum.
This document is a 510(k) premarket notification for the Steri-Tamp device, which is a tamper-evident, sterile seal for drug containers. The provided text is a regulatory submission to the FDA and does not contain a study proving that the device meets acceptance criteria in the way a clinical trial or performance study would for a diagnostic or therapeutic device.
The "study" here is essentially a comparison to a predicate device to establish substantial equivalence, which is the basis for 510(k) clearance. The acceptance criteria are implicit in the comparison to an already legally marketed device (IVA Seal II).
Based on the provided text, I cannot complete a table of acceptance criteria and reported device performance or answer most of your detailed questions because the document is a regulatory submission for a simple medical accessory, not a clinical study report.
Here's what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are implied to be "substantially equivalent" to the predicate device, IVA Seal II, in terms of materials, packaging, seals per roll, dispenser box, sterilization, reattach characteristic, coding, tampering evidence, and removal method. The performance is presented as direct comparison.
| Feature / Acceptance Criteria (Implicit: "Same as predicate") | Predicate Device (IVA Seal II) Performance | Steri-Tamp Device Performance |
|---|---|---|
| Materials: Top Layer | Metal | Metalized Polyester |
| Materials: Bottom Layer | Metal | Polypropylene |
| Packaging | Roll Stock on 3" core in a dispenser box | Roll Stock on 3" core in a dispenser box |
| Seals per roll | 1000 | 1000 |
| Dispenser Box | Sealed in a vented polypropylene bag | Sealed in a vented polypropylene bag |
| Sterilization | Gamma Radiation | ETO (Ethylene Oxide) |
| Reattach | Can not be reattached | Can not be reattached |
| Coding | Same (Implicit: Multi-color as described for Steri-Tamp) | Multi-color |
| Tampering | Tamper evident | Tamper evident |
| Removal | Pull Tab | Pull Tab |
Note on Differences: While metalized polyester and polypropylene for the top and bottom layers, respectively, and ETO sterilization are different from the predicate device's materials and sterilization method (metal for both layers, Gamma Radiation), the FDA's clearance indicates these differences were not considered to raise new questions of safety or effectiveness and therefore were deemed substantially equivalent. The key functional characteristics (e.g., tamper-evidence, inability to reattach, sterility) are preserved.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This is not a clinical study with a "test set" in the traditional sense. It's a device comparison.
- Data Provenance: Not applicable.
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)
- Not applicable. Ground truth for a clinical study is not relevant here. The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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 a simple sterile seal, not an AI-powered diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this regulatory submission is the predicate device's previously established safety and effectiveness. The argument is that Steri-Tamp is substantially equivalent to the predicate.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not applicable.
§ 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).