Search Results
Found 1 results
510(k) Data Aggregation
(111 days)
The Instylla Delivery Kit is intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media, saline and other aqueous solutions.
The Instylla Delivery Kit is comprised of two 1mL delivery syringes, a syringe holder, and a plunger clip (link).
This document describes a 510(k) premarket notification for the "Instylla Delivery Kit," a piston syringe for administering medical solutions. The document does not contain any information about acceptance criteria or a study proving the device meets said criteria in the context of performance metrics like sensitivity, specificity, accuracy, or any AI/algorithm performance. The provided text details bench and functional testing for mechanical and material properties, rather than clinical performance or AI evaluation.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance data in the context of an AI device.
However, I can extract information related to the device's non-AI performance testing, as detailed in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance testing that was conducted, but it does not explicitly state specific acceptance criteria values or detailed quantitative reported performance metrics. It generally states that these tests were performed "to verify specifications fundamental to the device" and that the syringes are "compliant against FDA recognized standards ISO 7886-1 and ISO 594-2."
| Performance Test | Acceptance Criteria (Not explicitly stated with values in document, generally "meets specifications" or "compliant") | Reported Device Performance |
|---|---|---|
| Visual Inspection | To verify specifications fundamental to the device | Performed |
| Dimensional Verification | To verify specifications fundamental to the device | Performed |
| Functional Testing: | ||
| - Syringe Holder and Plunger Clip Connection Force | To verify specifications fundamental to the device | Performed |
| - Syringe Holder and Plunger Clip Disconnection Force | To verify specifications fundamental to the device | Performed |
| - Syringe Compatibility | To verify specifications fundamental to the device | Performed |
| - Syringe Glide Force and Break Force | To verify specifications fundamental to the device | Performed |
| - Fluids Compatibility | To verify specifications fundamental to the device | Performed |
| - Delivery Integrity | To verify specifications fundamental to the device | Performed |
| Particulate Matter Testing | To verify specifications fundamental to the device | Performed |
| Syringe Compliance | FDA recognized standards ISO 7886-1 and ISO 594-2 | Compliant |
| Biocompatibility Testing: | In accordance with ISO 10993-1 for indirect blood contact (≤24 hours) | Successfully completed |
| - Cytotoxicity | Meets ISO 10993-1 requirements | Performed |
| - Sensitization | Meets ISO 10993-1 requirements | Performed |
| - Irritation or Intracutaneous toxicity | Meets ISO 10993-1 requirements | Performed |
| - Acute Systemic Toxicity | Meets ISO 10993-1 requirements | Performed |
| - Material-Mediated Pyrogenicity | Meets ISO 10993-1 requirements | Performed |
| - Hemolysis | Meets ISO 10993-1 requirements | Performed |
| Sterility | Sterility Assurance Level (SAL) of 10-6 (validated per ISO 11135) | Achieved |
| Endotoxin Level | <20 endotoxin units (EU)/device (validated LAL test) | Achieved |
| Shelf Life | Maintains performance and sterile barrier for 6-months | Demonstrated |
2. Sample size used for the test set and the data provenance:
Not applicable, as this is bench and functional testing of a physical device, not an AI/algorithm test set. No "data provenance" in the sense of patient data is mentioned for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth for physical device testing typically involves laboratory measurements and adherence to engineering specifications and standards.
4. Adjudication method 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. The document explicitly states: "no clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device" due to its substantial equivalence to predicate devices and the nature of the device (a piston syringe).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/algorithm device.
7. The type of ground truth used:
For the non-AI performance tests, the "ground truth" would be established by:
- Engineering specifications and design requirements: For visual inspection, dimensional verification, and functional testing.
- International Standards: ISO 7886-1, ISO 594-2 for syringe compliance.
- Biocompatibility Standards: ISO 10993-1 for biocompatibility tests.
- Sterilization Standards: ISO 11135 for sterility.
- Established Test Methods: For particulate matter, endotoxin, and shelf life.
8. The sample size for the training set:
Not applicable, as this is not an AI/algorithm device.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/algorithm device.
Ask a specific question about this device
Page 1 of 1