(270 days)
Performer™ Introducers and Guiding Sheaths are indicated for the percutaneous introduction of therapeutic or diagnostic devices to all heart chambers, including the left atrium via transseptal puncture.
The Performer" Introducer and Guiding Sheath is manufactured using radiopaque fluorinated ethylene propylene (RFEP) tubing with a fluorinated ethylene propylene tungsten tubing (FETT) tip. The tip of the sheath is formed into various curves depending on the device configuration. The proximal end consists of a hemostatic valve with a connecting tube and stopcock. The subject device is available with outside diameters ranging from 4 – 14 French and lengths ranging from 45 – 98 centimeters (smaller sizes sized for pediatric use and larger sizes for adults). The dilator is compatible with wire guides 0.025 – 0.038 inches in diameter. The supplied dilator is designed to extend beyond the tip of the sheath when the dilator is fully inserted through the hemostatic valve of the sheath. The Performer™ Introducer and Guiding Sheath is a sterile device intended for single use only.
The provided document is a 510(k) summary for the Performer™ Introducer and Guiding Sheath, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device through engineering and performance testing, rather than clinical studies involving human patients or complex AI algorithms.
Therefore, many of the requested categories related to AI performance, human reader studies, and large-scale clinical ground truth establishment are not applicable to this document. The testing described is primarily mechanical and material property verification.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | In accordance with ISO 10993-1:2009 for cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity, hemocompatibility, complement activation, and partial thromboplastin time. (Predetermined acceptance criteria were met.) | The predetermined acceptance criteria were met. |
| Age Testing | In accordance with BS EN ISO 11070:2014, after accelerated aging. (Predetermined acceptance criteria for the respective testing were met.) | The predetermined acceptance criteria for the respective testing were met. |
| Dimensional Dilator Taper Extension Testing | Dilator taper or proximal edge of dilator taper in accordance with applicable values of BS EN ISO 11070:2014, Annex A. (Predetermined acceptance criterion was met.) | The predetermined acceptance criterion was met. |
| Dimensional Dilator Endhole Diameter Testing | Dilator endhole in accordance with specified tolerance. (Predetermined acceptance criterion was met.) | The predetermined acceptance criterion was met. |
| Dimensional Dilator Hub Visual Testing | Dilator hub in accordance with specified tolerance. (Predetermined acceptance criteria were met.) | The predetermined acceptance criteria were met. |
| Dimensional Stability and Compatibility Testing | Dilator and sheath in accordance with applicable values of BS EN ISO 11070:2014, Annex A or the specified tolerance. (Predetermined acceptance criteria were met.) | The predetermined acceptance criteria were met. |
| Hub Testing | Cannula hub in accordance with applicable values of ISO-594-1 and ISO 594-2. (Predetermined acceptance criteria were met.) | The predetermined acceptance criteria were met. |
| Liquid Leakage Testing | No liquid leakage when tested in accordance with BS EN ISO 11070-1:2014, Annex D and/or E. (Predetermined acceptance criteria were met.) | The predetermined acceptance criteria were met. |
| Rollback and Kink Testing | No rollback and kink of the sheath when tested in accordance with BS EN ISO 11070, Annex A. (Predetermined acceptance criteria were met.) | The predetermined acceptance criteria were met. |
| Tensile Testing of FLLA to Connecting Tube Joint | FLLA to connecting tube joint in accordance with applicable values of BS EN ISO 11070:2014, Annex C. (Predetermined acceptance criterion was met.) | The predetermined acceptance criterion was met. |
| Tensile Testing of Dilator Hub to Shaft Joint | Dilator hub to shaft joint in accordance with applicable values of BS EN ISO 11070:2014, Annex C. (Predetermined acceptance criterion was met.) | The predetermined acceptance criterion was met. |
| Tensile Testing of Check-Flo Body to Shaft Bond | Check-Flo body and shaft bond in accordance with applicable values of BS EN ISO 11070:2014, Annex C. (Predetermined acceptance criterion was met.) | The predetermined acceptance criterion was met. |
| Tensile Testing of Check-Flo Body to Connecting Tube Junction | Check-Flo body and connecting tube junction in accordance with applicable values of BS EN ISO 11070:2014, Annex C. (Predetermined acceptance criterion was met.) | The predetermined acceptance criterion was met. |
| Simulated Clinical Use Testing | All test articles met the predetermined acceptance criteria for all performance parameters. (Predetermined acceptance criteria were met.) | All test articles evaluated met the predetermined acceptance criteria for all of the performance parameters. |
2. Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for individual tests. It generally states that "tests were performed" or "test articles were evaluated."
- Data provenance (country of origin, retrospective/prospective) is not applicable or provided, as these are engineering tests on manufactured components, not clinical data from patients.
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 these engineering tests is established by adhering to recognized international standards (e.g., ISO, BS EN ISO) and manufacturer specifications, not by expert medical review.
4. Adjudication method for the test set:
- Not applicable. This concept applies to clinical studies where multiple reviewers assess data. For engineering tests, the results are objectively measured against established 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 is not an AI-powered device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For these engineering tests, the "ground truth" is defined by the objective pass/fail criteria outlined in internationally recognized standards (e.g., ISO 10993-1:2009, BS EN ISO 11070:2014, ISO 594-1/2) and the manufacturer's internal specifications.
8. The sample size for the training set:
- Not applicable. This is not an AI-powered device that undergoes a training phase. These are physical device tests.
9. How the ground truth for the training set was established:
- Not applicable. As noted above, there is no "training set" or "ground truth" in the AI sense for this type of device submission.
§ 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).