(141 days)
The Glidesheath Slender is indicated to facilitate placing a catheter through the skin into the radial artery.
The Glidesheath Slender consists of an introducer (sheath and a dilator), which are packaged together with an entry needle, mini guide wire and guide wire inserter. The Glidesheath Slender 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 either the stainless steel (SS) entry needle version or the Surflo (SR) IV catheter (which includes a needle). There are two different types of stainless-steel entry needles that are available in various gauges and lengths. The two needle types are referenced in the documentation as TPC and TRI. These initials are only used in internal Terumo documents.
The mini guide wire is used for placement of the sheath and dilator into the radial artery. The mini guide wire is offered in three versions made out of three materials, either a stainless-steel spring coil model (stainless steel), a nitinol model with palladium tip (nitinol) or a polyurethane plastic model with a nitinol core (plastic).
During either a diagnostic or interventional catheterization procedure, a physician will perform the following procedure. 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 The mini guide wire is then withdrawn from the vessel.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.
The entry needle, the mini guide wire and the guide wire inserter are all accessories to the Glidesheath Slender sheath/dilator. The accessories for a given product code are provided with the Glidesheat Slender sheath/dilator in an individual package and sterilized together.
The acceptance criteria and study proving the device meets them are detailed for the Glidesheath Slender. The device is a catheter introducer for radial artery access.
Here's a breakdown of the information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a comprehensive list of performance tests conducted on various components of the Glidesheath Slender. The "Reported Device Performance" column implicitly states that the "Glidesheath Slender tested met the predetermined acceptance criteria and results support a determination of substantial equivalence." This means that for each test item listed, the device's performance fell within the acceptable parameters defined by the cited standards (ISO, ASTM, in-house) or internal requirements.
| Component | Test Item | Reference | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| Sheath | Fluoroscopy | ISO 11070:2014, Section 4.5 | ||
| ASTM F640-12 | (Implicit: Device must be visible under fluoroscopy as per standards) | Met predetermined acceptance criteria. | ||
| Sheath visual inspection | In-house standard | (Implicit: Visual quality meets internal specifications) | Met predetermined acceptance criteria. | |
| Sheath Effective Length | In-house standard | (Implicit: Length within specified tolerances) | Met predetermined acceptance criteria. | |
| Side Tube Length | In-house standard | (Implicit: Length within specified tolerances) | Met predetermined acceptance criteria. | |
| Sheath Tip ID | In-house standard | (Implicit: Inner diameter at tip within specified tolerances) | Met predetermined acceptance criteria. | |
| Sheath, Hemostatic Valve Leak | ISO 11070:2014, Annex E | (Implicit: Hemostatic valve must prevent leakage as per standard) | Met predetermined acceptance criteria. | |
| Sheath Pressure Test | ISO 11070:2014, Annex D | |||
| ISO 11070:2013, Annex C | (Implicit: Withstands specified pressure without failure as per standards) | Met predetermined acceptance criteria. | ||
| Sheath Penetration | In-house standard | (Implicit: Achieves appropriate penetration characteristics) | Met predetermined acceptance criteria. | |
| Visual inspection after penetration testing | ISO 11070:2014 - Annex A section A3 | (Implicit: No significant damage or alteration after penetration as per standard) | Met predetermined acceptance criteria. | |
| Sheath Tip Rollback Test | ISO 11070:2014 - Annex A section A3 | (Implicit: Tip integrity maintained during rollback as per standard) | Met predetermined acceptance criteria. | |
| Dilator Hub to Sheath Hub Snap Fit Strength | In-house standard | (Implicit: Connection strength meets internal specifications) | Met predetermined acceptance criteria. | |
| Valve Mobility Resistance | In-house standard | (Implicit: Valve operates smoothly within specified resistance) | Met predetermined acceptance criteria. | |
| Sheath Kink resistance | ISO 11070:2014 Annex A section A.1 | (Implicit: Resists kinking under specified conditions as per standard) | Met predetermined acceptance criteria. | |
| Sheath Tubing/Housing Joint Strength | ISO 11070:2014, Section 7.6 | (Implicit: Joint strength meets specified requirements as per standard) | Met predetermined acceptance criteria. | |
| Cap to Housing Joint Strength | In-house standard | (Implicit: Connection strength meets internal specifications) | Met predetermined acceptance criteria. | |
| Sheath Support to Housing Strength | In-house standard | (Implicit: Support strength meets internal specifications) | Met predetermined acceptance criteria. | |
| Sheath Tubing Tensile Strength | ISO 11070:2014, Section 7.6 | (Implicit: Tensile strength meets specified requirements as per standard) | Met predetermined acceptance criteria. | |
| Sheath Lubricity and Durability | In-house standard | (Implicit: Maintains lubricity and durability over intended use) | Met predetermined acceptance criteria. | |
| Particle capture during simulated use | FDA PTCA Guidance | (Implicit: Particle generation during simulated use is within acceptable limits as per FDA guidance) | Met predetermined acceptance criteria. | |
| Coating integrity after simulated use | In-house standard | (Implicit: Hydrophilic coating maintains integrity after simulated use) | Met predetermined acceptance criteria. | |
| Dilator | Fluoroscopy | ISO 11070:2014, Section 4.5 | ||
| ASTM F640-12 | (Implicit: Device must be visible under fluoroscopy as per standards) | Met predetermined acceptance criteria. | ||
| Dilator visual inspection | In-house standard | (Implicit: Visual quality meets internal specifications) | Met predetermined acceptance criteria. | |
| Dilator Useable Length | In-house standard | (Implicit: Length within specified tolerances) | Met predetermined acceptance criteria. | |
| Dilator Tip ID | In-house standard | (Implicit: Inner diameter at tip within specified tolerances) | Met predetermined acceptance criteria. | |
| Dilator OD at Sheath Tip | In-house standard | (Implicit: Outer diameter at sheath tip within specified tolerances) | Met predetermined acceptance criteria. | |
| Dilator Penetration | In-house standard | (Implicit: Achieves appropriate penetration characteristics) | Met predetermined acceptance criteria. | |
| Visual inspection after penetration testing | ISO 11070:2014 - Annex A section A3 | (Implicit: No significant damage or alteration after penetration as per standard) | Met predetermined acceptance criteria. | |
| Dilator Tip Rollback Test | ISO 11070:2014 - Annex A section A3 | (Implicit: Tip integrity maintained during rollback as per standard) | Met predetermined acceptance criteria. | |
| Dilator to Hub Tensile | ISO 11070:2014, Annex C | |||
| ISO 11070:2013, Annex B | (Implicit: Tensile strength of dilator to hub connection meets specified requirements as per standards) | Met predetermined acceptance criteria. | ||
| Dilator Hub to Sheath Hub Snap Fit Strength | In-house standard | (Implicit: Connection strength meets internal specifications) | Met predetermined acceptance criteria. | |
| Particle capture during simulated use | FDA PTCA Guidance | (Implicit: Particle generation during simulated use is within acceptable limits as per FDA guidance) | Met predetermined acceptance criteria. | |
| Biocompatibility | Cytotoxicity | EN ISO 10993-1, FDA Guidance | (Implicit: No cytotoxic effects detected) | Met predetermined acceptance criteria. |
| Sensitization | EN ISO 10993-1, FDA Guidance | (Implicit: No sensitization detected) | Met predetermined acceptance criteria. | |
| Intracutaneous Reactivity | EN ISO 10993-1, FDA Guidance | (Implicit: No significant intracutaneous reaction) | Met predetermined acceptance criteria. | |
| Systemic Toxicity (Acute) | EN ISO 10993-1, FDA Guidance | (Implicit: No acute systemic toxicity) | Met predetermined acceptance criteria. | |
| Pyrogenicity | EN ISO 10993-1, FDA Guidance | (Implicit: No pyrogenic response) | Met predetermined acceptance criteria. | |
| Hemocompatibility | EN ISO 10993-1, FDA Guidance | (Implicit: Compatible with blood, does not cause adverse hematological effects) | Met predetermined acceptance criteria. | |
| Sterilization | Sterility Assay | ISO 11135:2014 | Sterility Assurance Level (SAL) of 10-6 | Achieved SAL of 10-6. |
| Residual Ethylene Oxide (EO) | EN ISO 10993-7:2008 | Not exceeding an average daily dose of 4 mg after 24 hours of heated aeration | Met predetermined acceptance criteria. | |
| Residual Ethylene Chlorohydrin (ECH) | EN ISO 10993-7:2008 | Not exceeding an average daily dose of 9 mg after 24 hours of heated aeration | Met predetermined acceptance criteria. | |
| Shelf Life | Shelf life validation | (Implied in submission) | (Implicit: Device maintains performance and safety for 30 months) | Demonstrated 30 months shelf life, with performance maintained throughout. |
2. Sample Size for the Test Set and Data Provenance:
The document describes non-clinical performance testing, which typically involves testing of device units according to engineering standards rather than a "test set" of patient data. The specific number of units tested for each performance test item is not provided in this summary. The data provenance is internal to the manufacturer (Terumo Medical Corporation) and follows recognized international and in-house standards. This is not patient data, so "country of origin" and "retrospective/prospective" are not applicable in the usual sense for clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not applicable as the document explicitly states: "This 510(k) does not include data from clinical tests." The performance testing described is engineering and biocompatibility testing, where "ground truth" is established by adherence to specified physical and chemical properties and compliance with recognized standards.
4. Adjudication Method for the Test Set:
This information is not applicable as clinical data or expert review of cases is not part of this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "This 510(k) does not include data from clinical tests." Therefore, there is no information on how much human readers improve with AI vs. without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a physical medical instrument (catheter introducer), not an AI algorithm or software.
7. The Type of Ground Truth Used:
For the performance testing, the "ground truth" is established by:
- International Standards: ISO 11070:2014, ASTM F640-12, ISO 11135:2014, EN ISO 10993-1, EN ISO 10993-7:2008.
- FDA Guidance: FDA PTCA Guidance, FDA Guidance on Use of International Standard ISO 10993-1.
- In-house standards: Internal specifications developed by Terumo Medical Corporation.
These standards and guidances define acceptable physical, mechanical, chemical, and biological properties for device components.
8. The Sample Size for the Training Set:
This is not applicable as the device is a physical medical instrument and does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established:
This is not applicable for the same reason as above.
§ 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).