(215 days)
The HQS introducer (Model 2064-HQS) is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions
The High Quality Sealing (HQS) Introducer comprises 4 elements, a radio- opaque introducer sheath equipped with a haemostasis valve, a radio- opaque dilator, a centering wire device and an extension line with 3 ways stopcock. The range of HQS introducer (18F, 20F, 22F, 24F, 26F) permits the insertion, preserving sealing, of large caliber tools, from OF, up to the nominal size of-the-introducer-sheath.. The introducer and its adjustable valve are easily handled with one hand. The distal tip is designed to perform an efficient introduction of the HQS introducer with the dilator in the vessel. The centering device permits to introduce a guidewire through the valve and to keep a perfect sealing. The extension line is connected to the lateral port of the introducer for the injection during the procedure.
The provided text is a 510(k) summary for a medical device called the "HQS Introducer (Model 2064-HQS)". It describes the device, its intended use, and the non-clinical tests performed to demonstrate its safety and effectiveness for substantial equivalence. It does not describe an AI medical device.
Therefore, the requested information about acceptance criteria and studies (particularly those related to AI performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies) cannot be extracted from this document as it pertains to a physical medical device.
The study described is a series of in-vitro and biocompatibility tests to ensure the physical device meets established standards for safety and performance, not a study to prove AI performance.
Here's what can be extracted about the general acceptance criteria and studies for this physical medical device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions that the device is in compliance with ISO 11070:1999 for "Sterile, single use intravascular catheter introducers" and ISO 10993-1:2009 for biocompatibility. The specific acceptance criteria for each test (e.g., tensile strength, overpressure resistance, useful dimensions) are not quantitatively reported in this summary, but the general statement is that the results demonstrate that the device is in compliance and meets the requirements.
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Bench/Performance Data (In-vitro) | 1. Tensile strength | In compliance with ISO 11070:1999 and product labeling. |
| 2. Overpressure resistance | In compliance with ISO 11070:1999 and product labeling. | |
| 3. Suction resistance | In compliance with ISO 11070:1999 and product labeling. | |
| 4. Introducer useful dimensions (lengths, Inside and Outside diameters) | In compliance with ISO 11070:1999 and product labeling. | |
| 5. Dilator useful dimensions (lengths, Inside and Outside diameters) | In compliance with ISO 11070:1999 and product labeling. | |
| 6. Sealing of the valve | In compliance with ISO 11070:1999 and product labeling. | |
| 7. Operating mechanism resistance | In compliance with ISO 11070:1999 and product labeling. | |
| 8. Visual control (atraumatic surface) | In compliance with ISO 11070:1999 and product labeling. | |
| 9. Resistance to kinking | In compliance with ISO 11070:1999 and product labeling. | |
| 10. Dilator compatibility (introduction / withdrawal) | In compliance with ISO 11070:1999 and product labeling. | |
| 11. Extension line connection | In compliance with ISO 11070:1999 and product labeling. | |
| 12. Centering device compatibility | In compliance with ISO 11070:1999 and product labeling. | |
| 13. Introducer/dilator distal transition | In compliance with ISO 11070:1999 and product labeling. | |
| 14. Compatibility with vascular tools and guidewire | In compliance with ISO 11070:1999 and product labeling. | |
| 15. Radiodetectability test | In compliance with ISO 11070:1999 and product labeling. | |
| 16. Packaging resistance | In compliance with ISO 11070:1999 and product labeling. | |
| 17. Sterilization tests | In compliance with ISO 11070:1999 and product labeling. | |
| 18. Aging tests | In compliance with ISO 11070:1999 and product labeling. | |
| Biocompatibility Tests | • Cytotoxicity (ISO 10993-5:2009) | Materials meet ISO 10993-1:2009 requirements. |
| • Sensitization (ISO 10993-10:2006) | Materials meet ISO 10993-1:2009 requirements. | |
| • Intracutaneous Toxicity (ISO 10993-10:2006) | Materials meet ISO 10993-1:2009 requirements. | |
| • Systemic Toxicity (ISO 10993-11:2006) | Materials meet ISO 10993-1:2009 requirements. | |
| • Pyrogenicity (ISO 10993-11:2006) | Materials meet ISO 10993-1:2009 requirements. | |
| • Hemolysis (ASTM Guideline F756:2008) | Materials meet ISO 10993-1:2009 requirements. | |
| • Prothrombin Time (ISO 10993-4:2006) | Materials meet ISO 10993-1:2009 requirements. | |
| • Coagulation UPTT (ISO 10993-4:2006) | Materials meet ISO 10993-1:2009 requirements. | |
| • Platelet (ISO 10993-4:2006) | Materials meet ISO 10993-1:2009 requirements. | |
| • Complement Activation (ISO 10993-4:2006) | Materials meet ISO 10993-1:2009 requirements. | |
| • Thrombogenicity (ISO 10993-4:2006) | Materials meet ISO 10993-1:2009 requirements. |
2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical product testing, not a dataset for an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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. This is for a physical device, not an AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical device, not an AI.
7. The type of ground truth used: For the physical device, the "ground truth" is defined by the performance standards outlined in ISO 11070:1999 and ISO 10993-1:2009, which specify acceptable physical and biological characteristics.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI.
9. How the ground truth for the training set was established: Not applicable. This is a physical device, not an AI.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).