(107 days)
The Glidewire® guide wire is designed to direct a catheter to the desired anatomical location, including but not limited to the carotid arteries, during diagnostic or interventional procedures.
The GlideCath® XP catheter is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system, including but not limited to the carotid arteries.
The Destination® Carotid Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the human vasculature including but not limited to the carotid arteries.
The Carotid Access Kit is designed to be used for the introduction of devices during carotid intravascular procedures. The kit consists of a Glidewire® guide wire, GlideCath® XP catheter, Tuohy-Borst Valve (TBV), Destination® Carotid Guiding Sheath and inner sheath. The inner sheath is composed of PTFE and the distal end is tapered to provide a smooth transition from the GlideCath XP to the Destination Carotid Guiding Sheath. All components are STERILE. They are sterilized using Ethylene Oxide (EtO) gas.
Here's a breakdown of the acceptance criteria and study information for the Carotid Access Kit (K060666) based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance | Comments |
|---|---|---|---|
| Performance Equivalence | Substantial equivalence to predicate device performance | "The performance of the Carotid Access Kit is substantially equivalent to the performance of the predicate devices." | Equivalence was shown through bench testing. The document does not provide specific quantitative performance metrics or acceptance thresholds; it relies on the concept of substantial equivalence to existing devices. |
| Sterilization | Sterility Assurance Level (SAL) | "Sterilization conditions have been validated in accordance with ANSI / AAMI / ISO 11135-1994 to provide a Sterility Assurance Level of 10-6." | This meets the standard SAL for sterile medical devices. |
| Biocompatibility | Compliance with ISO 10993 for blood-contacting materials | "The blood contacting materials were found to be biocompatible." | Tested according to FDA General Program Memorandum #G95-1 (5/1/95) and ISO 10993. Device categorized as "Externally Communicating Device, Circulating Blood, Limited Contact (≤24hrs)". |
| Shelf-life | Maximum shelf-life determination | "The maximum shelflife for the kit is 24 months." | Dependent on the shelf-life remaining on individual kit components. |
| Materials | Similar materials to predicate devices; no new safety issues | "The Carotid Access Kit uses similar materials as the predicate device. Differences in materials between the devices do not raise any new issues of safety and effectiveness." | Qualitative assessment. |
| Design/Technology | Similar design and principle of operation/technology to predicate devices | "The Carotid Access kit submitted in this 510(k) is substantially equivalent in intended use, design, principle of operation / technology, materials and performance to the predicate devices..." | Qualitative assessment. |
| Indications for Use | Consistent intended use with predicate devices | "The Carotid Access kit submitted in this 510(k) is substantially equivalent in intended use..." | The intended uses are clearly stated for each component and align with the functions of the predicate devices. |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states that performance equivalence was shown through bench testing. It does not provide information on specific sample sizes for this bench testing, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective). Bench testing typically involves laboratory-controlled experiments rather than patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable or provided. The "study" described is bench testing for mechanical and material properties, sterilization, and biocompatibility, not a clinical study involving human patients where "ground truth" would be established by experts for diagnostic or interventional outcomes.
4. Adjudication Method for the Test Set
This information is not applicable or provided. Since the performance evaluation was based on bench testing of physical and material properties, there would be no need for an adjudication method in the context of clinical expert review.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a manual medical instrument (guide wire, catheter, sheath), not an AI-powered diagnostic or interventional system. Therefore, assessing human reader improvement with AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This device has no algorithmic component. Its operation is "manual or by a manual process."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document describes bench testing, which implies that "ground truth" was established by defined engineering specifications, material standards, and validated laboratory methodologies (e.g., tensile strength tests, flow rate measurements, sterility testing protocols compliant with ISO standards, biocompatibility testing according to ISO 10993). It is not expert consensus, pathology, or outcomes data in the clinical sense.
8. The Sample Size for the Training Set
This information is not applicable or provided. There is no "training set" as this device is not an AI/machine learning system.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided. As there is no training set, there is no ground truth establishment for one.
§ 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).