(391 days)
The RadialSource Catheter Sheath Introducer is indicated for use in arterial or venous procedures requiring percutaneous introduction of intravascular devices.
The RadialSource™ Transradial Access (TRA) Kit consists of a catheter sheath introducer (CSI), a vessel dilator, a mini-guidewire, and an IV catheter (consisting of an IV cannula and a needle). The CSI is intended to facilitate percutaneous introduction of intravascular devices in arterial or venous procedures through, but not limited to, a radial approach. The vessel dilator and mini-guidewire are used in conjunction with the CSI to gain access to the vasculature. The CSI and vessel dilator contain a lubricious coating intended to reduce friction during insertion into the vessel. The CSI contains a hemostasis valve at the proximal end which minimizes blood loss and air intake to the vasculature. A sideport infusion line extends from the CSI proximal hub and terminates at a 3-way stopcock with a standard luer fitting for flushing/infusion. The CSI and dilator contain radiopaque material for visualization under fluoroscopy.
Here's an analysis of the provided text regarding the acceptance criteria and study for the RadialSource™ Transradial Access Kit:
Given the provided text is for a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than a standalone de novo approval with novel performance criteria, the information will be structured based on what's available.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria with specific thresholds for each test. Instead, it states that the device "passed all verification specification criteria" and "performs as intended without raising new questions of safety and efficacy." The table below will list the tests performed, and the "Reported Device Performance" will reflect the general statement of compliance.
| Acceptance Criteria (Test Type) | Reported Device Performance |
|---|---|
| Biocompatibility Testing (per ISO 10993-1) | "Passed all verification specification criteria." (Implies compliance with specific criteria defined for each subclass of biocompatibility test: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Materials Mediated Rabbit Pyrogen, Bacterial Mutagenicity, In Vitro Chromosome Aberration, In Vitro Mouse Lymphoma, Hemolysis, Partial Thromboplastin Time, Platelet and Leukocyte counts, Complement Activation, Thrombosis (In-vivo)). |
| USP Physicochemical Testing | "Passed all verification specification criteria." |
| Sterilization Testing | "Passed all verification specification criteria." |
| Shelf Life Testing | "Passed all verification specification criteria." |
| Performance Bench Testing: | "Passed all verification specification criteria." (Implies compliance with specific criteria defined for each subclass of performance test: Visual, Dimensional, Functional [Valve Hemostasis, Sheath Hemostasis, Sheath/Dilator Compatibility, Insertion/Retraction Force, Sheath/Dilator Retention, Kink, Tensile Strength, Dilator Luer Taper, Guidewire Fracture, Guidewire Flex, Guidewire Strength of Core Wire to Coil], Packaging Seal Strength/Integrity). |
| Functionality (General) | "Performs as intended." |
| Safety and Efficacy (General) | "Does not raise new questions of safety or efficacy compared to the predicate devices." |
2. Sample Sizes Used for the Test Set and Data Provenance
The document explicitly states: "no pre-clinical (animal) or clinical study was necessary." Therefore, there is:
- No specific test set or sample size dedicated to a clinical study.
- The data provenance for the non-clinical tests (biocompatibility, performance bench testing, etc.) would be from internal Greatbatch Medical testing laboratories or contracted labs. Specific country of origin is not mentioned but typically these are conducted in the country of manufacture or a recognized testing facility. The nature of these tests is by definition retrospective relative to the design and manufacturing of the device for the purpose of regulatory submission.
- For the "Thrombosis (In-vivo)" test, 2 dogs were used for a 4-hour contact. This is the only direct mention of an in-vivo sample size.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Since no clinical study was performed, there was no test set requiring expert ground truth establishment in the conventional sense of a clinical trial (e.g., radiologists interpreting images).
- For the non-clinical tests, the "ground truth" is established by the scientific and technical standards recognized in the industry (e.g., ISO standards for biocompatibility) and the expertise of the test engineers and scientists performing and evaluating the results of these bench and in-vitro tests at Greatbatch Medical or contracted labs. No specific number or qualifications of these individuals are stated.
4. Adjudication Method for the Test Set
- None applicable in the context of a clinical test set with human readers, as no such study was conducted.
- For the non-clinical tests, compliance to specifications would be determined by standard laboratory protocols and quality control measures, but not an "adjudication method" in the sense of expert consensus on ambiguous findings.
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 MRMC study was done. This device is a physical medical device (introducer sheath kit), not an AI/software-as-a-medical-device (SaMD) that would assist human readers with interpretations. Therefore, the concept of human readers improving with AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests, the "ground truth" for evaluating performance criteria is based on pre-defined engineering specifications, international standards (e.g., ISO, USP), and established scientific principles for device function, material properties, and biological interaction. For example, for biocompatibility, the ground truth is whether the material elicits a toxic response as per ISO 10993. For dimensional checks, the ground truth is adherence to design drawings.
8. The Sample Size for the Training Set
- Not applicable. As this is a physical medical device and not an AI/ML system, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no training set for this device.
Summary of Study Type:
The submission relies on non-clinical (bench and in-vitro) testing and biocompatibility testing to demonstrate substantial equivalence to legally marketed predicate devices. The core argument for acceptance is that the RadialSource™ Transradial Access Kit performs as intended, has similar technological characteristics, and does not raise new questions of safety or efficacy compared to its predicates, thus negating the need for pre-clinical animal or clinical studies.
§ 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).