(18 days)
The Glidesheath Slender Tibial Pedal Kit is indicated to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee.
Both the predicate Glidesheath Slender Tibial Pedal Kit (7cm needle) and the modified Glidesheath Slender Tibial Pedal Kit (4cm needle) are used to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee. It consists of an introducer (sheath and dilator), which are packaged together with a mini guide wire, an entry needle and a guide inserter.
During a diagnostic or interventional procedure in a cath lab, the stainless steel entry needle (cannula) is used to gain access to the vein or artery for placement of the mini guide wire. The nitinol mini guide wire is inserted through the cannula into the patient's blood vessel. The wire is used for placement of the sheath and dilator into the vein or artery. The Guide Inserter which is attached to the Mini Guide Wire holder is used to assist the placement of the wire into the needle.
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 The mini guide wire is then withdrawn from the vessel.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 sheath incorporates a 1-way valve and a 3-way stopcock connected by a side tube. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel. In addition, the sheath and dilator contain bismuth, making these devices visible under fluoroscopy. The sheath, dilator, entry needle, mini guide wire and guide inserter are provided in a single package and sterilized together.
The Glidesheath Slender Tibial Pedal Kit is a disposable, ethylene oxide gas sterilized device intended for single use only.
The provided document is a 510(k) summary for a medical device called the Glidesheath Slender Tibial Pedal Kit. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a comprehensive study involving human readers or algorithm-only performance.
Therefore, many of the requested details such as acceptance criteria, sample sizes for test and training sets, expert qualifications, and adjudication methods are not applicable nor present in this type of submission.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or specific performance metrics as typically seen in efficacy studies for AI/imaging devices. Instead, the "performance" section refers to a "Verification by Analysis" that confirms the modified device meets "predetermined criteria (Product Specifications)." These product specifications are general design and material characteristics as detailed in the comparison table on page 6, rather than clinical performance metrics.
| Acceptance Criteria (Inferred from "Product Specifications") | Reported Device Performance |
|---|---|
| Maintain existing physical characteristics of components beyond the needle length, e.g., Sheath Size, Sheath Length, Hydrophilic Coating, Dilator applicable to Guide Wire OD, Dilator Length, Guide Wire OD, Guide Wire Length. | "Meets the predetermined criteria (Product Specifications)." |
| Maintain existing material compatibility and integrity. | "All materials for components are identical to the predicate, with the exception of the entry needle length." |
| Maintain existing sterilization efficacy. | "No changes have been made to the sterilization processes, packaging or shelf-life of the device relative to predicate." |
| Biological safety (biocompatibility). | "No additional biocompatibility testing was completed... No changes to materials or components for the Glidesheath Slender Tibial Pedal Kit, other than the transitory/transient patient contacting shorter needle length." |
| Mechanical integrity and functionality. | "The differences between the predicate and proposed devices do not raise any new issues regarding safety and effectiveness. Therefore, no additional physical testing is required to ensure the safety and effectiveness of the proposed Glidesheath Slender Tibial Pedal kit throughout the shelf life." |
| Risk assessment (ISO 14971:2012 compliance). | "A Product Risk Analysis was conducted... it was determined that there were no new or increased risks associated with the change." |
| Entry Needle Length | The new device adds a 40mm entry needle length option to the existing 70mm. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable. The submission is a Special 510(k) for a modification (different needle length) to an already cleared device. It relies on a "Verification by Analysis" and comparison to the predicate device, not a new clinical study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as no test set requiring ground truth established by experts was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no test set requiring expert adjudication was used.
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
This information is not applicable. The device is a catheter introducer kit, not an AI or imaging diagnostic device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable, as the evaluation was based on engineering verification and comparison to a predicate device, not clinical ground truth.
8. The sample size for the training set
This information is not applicable as no training set was used.
9. How the ground truth for the training set was established
This information is not applicable as no training set was used.
§ 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).