(49 days)
Performer introducers and guiding sheaths are intended to introduce therapeutic devices into the vasculature.
The Performer® Introducer is manufactured using radiopaque tubing with a radiopaque band at the tip. The proximal end consists of a stopcock, connecting tube and the Y-Connector, which connects the sheath to the connecting tube and stopcock; the Y-Connector contains a hemostatic valve. The subject device is available with outside diameters ranging from 5.5 - 7 French and a length of 6 centimeters. The dilator is compatible with wire guides 0.035 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 Y-Connector. The Performer® Introducer is a sterile device intended for single use only.
The provided text describes the 510(k) summary for the Cook Incorporated Performer® Introducer (K173068). It focuses on demonstrating substantial equivalence to a predicate device, primarily through performance testing against established standards rather than clinical studies involving human readers or extensive ground truth adjudication.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Predetermined acceptance criteria met (in accordance with ISO 10993-1:2009 for cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity, hemolysis, partial thromboplastin time, and complement activation) | The predetermined acceptance criteria were met. |
| Dimensional Sheath I.D and Length, and Sheath/Dilator/Wire Guide Compatibility Testing | Sheath inner diameter, sheath length, and sheath/dilator/wire guide compatibility met predetermined acceptance criteria. | The results verified, under the proper clinical use of the subject device, the sheath inner diameter, sheath length, and sheath/dilator/wire guide compatibility met the predetermined acceptance criteria. |
| Gravity Flow Testing | Y-Connector Clamp able to prevent flow through the connecting tube. | The results verified, under the proper clinical use of the subject device, the Y-Connector Clamp was able to prevent flow through the connecting tube. Thus, the predetermined acceptance criterion was met. |
| Leakage Testing | No liquid leakage when tested in accordance with BS EN ISO 11070-1:2014, Annex D and/or E. | The results verified, under the proper clinical use of the subject device, there was no liquid leakage when tested in accordance with BS EN ISO 11070-1:2014, Annex D and/or E. The predetermined acceptance criteria were met. |
| Radiopacity Testing | Test articles visible when imaged under fluoroscopy. | The results verified, under the proper clinical use of the subject device, the test articles were visible when imaged under fluoroscopy. The predetermined acceptance criteria were met. |
| Rollback and Kink Testing | No rollback and/or kink of the sheath when tested in accordance with BS EN ISO 11070, Annex A. | Test results verified, under proper clinical use of the subject device, there was no rollback and/or kink of the sheath when tested in accordance with BS EN ISO 11070, Annex A. The predetermined acceptance criteria were met. |
| Tensile Testing (Joint Strengths) | Bond strengths in accordance with BS EN ISO 11070:2014, Annex C (for Sheath Radiopaque Tip to Shaft Joint, Sheath Shaft to Hub Joint, Hub to Connecting Tube Joint, Connecting Tube to Side-arm Y-Connector Joint, and Dilator Hub to Shaft Joint Strength). | The results verified, under the proper clinical use of the subject device, the bond strengths were in accordance with BS EN ISO 11070:2014, Annex C. The predetermined acceptance criteria were met. |
| Aged Testing | Respective performance tests (listed above) meet predetermined acceptance criteria after accelerated aging to 3 years. | Accelerated aging to the equivalence of three years was conducted on the Performer® Introducers. Thereafter, the performance testing listed here was conducted again on aged Performer® Introducers in accordance with BS EN ISO 11070:2014. The predetermined acceptance criteria for the respective aged performance testing were met. |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test. The testing described is primarily laboratory-based physical and material testing, not human clinical trials or analysis of patient data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in the context of this 510(k) summary. The "test set" refers to the manufactured device units subjected to the various physical performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is a physical medical instrument (catheter introducer), and its performance acceptance criteria are based on engineering standards (e.g., ISO, BS EN ISO) and functional requirements, not on interpretations or diagnoses by medical experts. "Ground truth" for these tests is defined by the objective measurements and adherence to the physical and material properties specified in the standards.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods like "2+1" typically refer to reconciling disagreements among multiple human readers in diagnostic studies. Here, the "test set" involves objective physical and material tests with predefined acceptance criteria. The results are either "met" or "not met" based on measurements against those standards.
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
No such study was done. This 510(k) summary is for a physical medical device (catheter introducer), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No such study was done. This device is not an algorithm.
7. The type of ground truth used
The "ground truth" for the Performer® Introducer's performance is based on objective engineering and material test standards (e.g., ISO 10993-1:2009 for biocompatibility, BS EN ISO 11070-1:2014 for leakage and tensile testing, BS EN ISO 11070 for rollback and kink testing) and predetermined functional requirements (e.g., preventing flow, proper dimensions, visibility under fluoroscopy). It is not pathology, expert consensus, or outcomes data in the typical sense of a diagnostic device.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The device itself is manufactured following a design and tested against established performance standards.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set."
§ 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).