(105 days)
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 The mini guide wire is then withdrawn from the vessel.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.
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| Sheath: | |
| Surface (ISO 11070: Sec. 4.3) | Met requirements of applicable standards |
| Corrosion Resistance (ISO 11070: Sec. 4.4) | Met requirements of applicable standards |
| Radiodetectability (ISO 11070: Sec.4.5) | Met requirements of applicable standards |
| Size Designation (ISO 11070: Sec. 7.2) | Met requirements of applicable standards |
| Freedom from Leakage from Sheath Introducer (ISO 11070: Sec. 7.3) | Met requirements of applicable standards |
| Freedom from Leakage through Haemostasis Valve (ISO 11070: Sec. 7.4) | Met requirements of applicable standards |
| Force at Break (sheath) (ISO 11070: Sec. 7.6) | Met requirements of applicable standards |
| Force at Break (sheath to hub) (ISO 11070: Sec. 7.6) | Met requirements of applicable standards |
| Sheath to Dilator Fit (ISO 11070: Annex A.1) | Met requirements of applicable standards |
| Rollback Test (ISO 11070: Annex A.1) | Met requirements of applicable standards |
| Puncture model test (ISO 11070: Annex A.1) | Met requirements of applicable standards |
| Flexibility (Kink Angle) (ISO 11070: Annex A.1) | Met requirements of applicable standards |
| Flexibility (Radius of Curvature) (ISO 11070: Annex A.1) | Met requirements of applicable standards |
| Catheter Insertion and Removal Resistance (Internal Standard) | Met predetermined acceptance criteria |
| Penetration Resistance (Internal Standard) | Met predetermined acceptance criteria |
| External Surface Sliding Performance (Internal Standard) | Met predetermined acceptance criteria |
| Hydrophilic coating Separation Resistance (Internal Standard) | Met predetermined acceptance criteria |
| Hydrophilic coating Particulate Evaluation (FDA Guidance/USP 788) | Met predetermined acceptance criteria |
| Dilator: | |
| Surface (ISO 11070: Sec. 4.3) | Met requirements of applicable standards |
| Size Designation (ISO 11070: Sec. 9.2) | Met requirements of applicable standards |
| Conical Fitting (ISO 11070: Sec 9.3.2/ISO594-1) | Met requirements of applicable standards |
| Strength of Union between Hub and Dilator (ISO 11070: Sec 9.3.3) | Met requirements of applicable standards |
| Biocompatibility: | |
| Cytotoxicity (ISO 10993-5: 2009) | Met requirements of applicable standards |
| Sensitization (ISO 10993-10: 2010) | Met requirements of applicable standards |
| Irritation/Intracutaneous Reactivity (ISO 10993-10: 2010) | Met requirements of applicable standards |
| Acute Systemic Toxicity (ISO 10993-11: 2006) | Met requirements of applicable standards |
| Pyrogenicity (ISO 10993-11: 2006) | Met requirements of applicable standards |
| Hemolysis (ASTM F 756: 2008) | Met requirements of applicable standards |
| Complement Activity (ISO 10993-4: 2002/A1:2006) | Met requirements of applicable standards |
| Thrombosis (ISO 10993-4: 2002/A1:2006) | Met requirements of applicable standards |
| Physiochemical (USP ) | Physiochemical properties do not change throughout shelf life |
| FT-IR (USP ) | Physiochemical properties do not change throughout shelf life |
| Sterilization: | |
| Sterility Assurance Level (ANSI/AAMI/ISO 11135-1) | SAL of 10^-6 achieved |
| Residual Ethylene Oxide (ISO 10993-7) | Levels met requirements for limited exposure devices ( Bacterial Endotoxins Test) |
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.
§ 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).