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The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.

Both the predicate Glidesheath Slender 6Fr (GSS 6Fr) and the modified Glidesheath Slender 5Fr & 7Fr (GSS 5Fr & 7Fr) consist of an introducer sheath and a dilator which are packaged together with an entry needle, mini guide wire and guide wire inserter. The GSS devices (all sheath sizes) are used to facilitate placing a catheter through the skin into the radial artery. The sheath and dilator contain bismuth, making these devices visible under fluoroscopy. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel.

The entry needle (cannula) is used to gain access to the radial artery for placement of the mini guide wire. The entry needle is offered in two versions, either a stainless steel entry needle or a Surflo IV catheter (K891087).

The mini guide wire is used for placement of the sheath and dilator into the radial artery. The mini guide wire is offered in two versions, either a stainless steel (spring coil) model or a polyurethane (nitinol core) plastic model.

The mini guide wire is inserted through a cannula placed in the patient's blood vessel. A guide wire inserter is provided to assist in insertion of the mini guide wire into the cannula. Following guide wire insertion, the cannula is removed and the sheath and dilator are then inserted over the mini guide wire and into the blood vessel. The mini guide wire is then withdrawn from the vessel. The dilator maintains the integrity of the sheath and dilates the blood vessel during insertion. Once the sheath is situated in the vessel, the dilator is removed and an appropriate catheter can then be inserted through the sheath.

This document describes a 510(k) premarket notification for the Glidesheath Slender (GSS) device, specifically for the 5Fr and 7Fr sizes. The submission claims substantial equivalence to the predicate GSS (6Fr) device (K122980). Therefore, the study is a non-clinical performance study comparing the modified device to the predicate.

Here's an analysis of the provided information concerning acceptance criteria and the study:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document primarily relies on adherence to established international and internal standards as acceptance criteria. The device performance is generally stated as "met the requirements" or "results were within the predetermined acceptance criteria." Quantitative data for specific performance metrics are not provided in this summary.

2. Sample Size Used for the Test Set and the Data Provenance:

• Sample Size: The document does not explicitly state the sample sizes used for each specific non-clinical test.
• Data Provenance: The tests are "non-clinical tests" and were conducted to "ensure safety and effectiveness of the modified GSS (5Fr & 7Fr) device throughout the shelf-life, verify conformity to applicable ISO and internal standards and acceptance criteria, and demonstrate substantial equivalence to the predicate device." The manufacturer is Terumo Medical Corporation, with production facilities in Japan (Ashitaka Factory of Terumo Corporation). This indicates the data is likely from internal testing by the manufacturer, not from a patient population. It is retrospective in the sense that it evaluates the manufactured device, not prospective in a clinical trial sense. The "country of origin of the data" would be Japan, where the manufacturing and potentially some testing occurs, and potentially the US, where Terumo Medical Corporation is located for regulatory affairs.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This is a non-clinical, performance testing study focused on engineering and material properties. There is no human "ground truth" establishment in the traditional sense, as these tests are based on objective physical standards (e.g., ISO, ASTM, USP, internal engineering standards). Therefore, this question is not applicable to the provided study description.

4. Adjudication Method for the Test Set:

Not applicable, as this is objective non-clinical performance testing against defined standards, not subjective assessments requiring adjudication.

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 a non-clinical performance study of a physical medical device (an introducer sheath), not an AI algorithm or an imaging device involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device.

7. The type of ground truth used:

The "ground truth" in this context refers to the defined specifications and requirements set forth by international standards (ISO, ASTM, USP) and the manufacturer's own internal standards. These are objective engineering and material science metrics. It is not an expert consensus, pathology, or outcomes data in the biological sense.

8. The sample size for the training set:

Not applicable. This is not a machine learning or artificial intelligence study, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable. There is no training set in this context.

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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.

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.

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