(28 days)
The TightRail Guardian motorized dilator sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads.
The TightRail Guardian motorized dilator sheath is a sterile, single use, prescription only device used for cardiac leads. The device is comprised of:
- Drive Assembly
- Dilation Extension Selection (DES) Assembly
- Motor Drive Handle
- Outer Sheath Accessory
- Fish Tape Accessory
The motorized dilator sheath is advanced or retracted along the target lead to be removed. Pulling the trigger on the handle of the TightRail Guardian device results in activation of the motor and subsequent rotation of the inner shaft and cam blade. Triager activation results in bidirectional rotation mechanism. Actuation of the distal dilation mechanism causes dilation of tissue and fibrous attachments surrounding the lead tarqeted for removal, thereby facilitating removal of said lead. The device has two modes of operation, providing dilation with the blades shielded or extended. The diameter sizes range from 9 French (F) to 13 F. The nominal effective length of the TightRail Guardian is 47.5 cm. The outer sheath accessory may be used for additional support by creating a conduit for the device's shaft assembly. The outer sheath may also be used to maintain venous access for quidewire placement, prior to implantation of a new lead. The fish tape accessory may be used to feed a target lead and locking stylet through the inner lumen of the device.
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. As such, it does not contain the detailed information typically found in a clinical study report or a validation study for an AI-powered medical device.
Specifically, this document describes a mechanical device (a motorized dilator sheath) and its validation through engineering and performance testing, not an AI algorithm. Therefore, most of the requested information regarding AI device acceptance criteria, human reader studies, ground truth establishment, and training/test set details is not applicable to this submission.
The document states: "Preclinical and clinical data was not required to demonstrate substantial equivalence. The design characteristics of the subject device are similar to the predicate. The design verification and validation test results demonstrated that the subject device is as safe and clinically effective as the predicate device." This confirms that the approval was based on demonstrating equivalence in mechanical and performance characteristics to a previously cleared device, not on the performance of a novel AI algorithm.
However, I can extract the relevant "acceptance criteria" and "study" information that is present in the document, which pertains to the engineering and performance testing of this mechanical device.
Acceptance Criteria and Study for the TightRail Guardian Motorized Dilator Sheath (Mechanical Device)
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide specific quantitative acceptance criteria or precise reported performance values in a table format. Instead, it lists the types of design verification and validation testing performed to ensure the device met its specifications and performed comparably to its predicate. The implicit acceptance criterion for all these tests is that the device demonstrated performance equivalent to or better than the predicate, and met all engineering specifications for safety and effectiveness.
| Acceptance Criteria Category (Test Type) | Implicit Acceptance Criteria / Reported Performance Summary |
|---|---|
| Design Verification and Validation Testing | "The design verification and validation test results demonstrated that the subject device is as safe and clinically effective as the predicate device." (General summary of all tests) |
| Simulated Use Testing | Device performed as intended during simulated clinical procedures. |
| Simulated Environment Testing | Device maintained performance and integrity under various environmental conditions (e.g., temperature, humidity, storage, transport). |
| Human Factors Evaluation | Usability and safety aspects for human interaction were evaluated and found acceptable. |
| Linear and Radial Dimensional Testing | Dimensions met specified tolerances (e.g., French sizes 9F, 11F, 13F; nominal effective length 47.5 cm). |
| Device Weight Measurement | Device weight met specified limits. |
| Blade Extension Testing | Blades extended and retracted correctly in both shielded and extended modes, consistently meeting design specifications. |
| Atraumatic Surface Testing | Surfaces designed to contact tissue were smooth and non-damaging. |
| Axial Load Testing | Device maintained structural integrity under specified axial forces. |
| Tensile Testing | Device components withstood specified tensile forces without failure. |
| Flexibility Testing | Shaft demonstrated appropriate flexibility for navigation while maintaining necessary columnar stability. |
| Outer Sheath Compression Testing | Outer sheath maintained patency and structural integrity under compression, suitable for its intended use (additional support, maintaining venous access). |
| EMC/EMI and Electrical Medical Safety Testing | Device met relevant electromagnetic compatibility and electrical safety standards. |
| Radiopacity Evaluation | Device was sufficiently visible under fluoroscopy for clinical use. |
| Sterilization | "Product adoption equivalency per AAMI TIR28:2016" - Demonstrated that the sterilization process renders the device sterile as per AAMI TIR28:2016 standards, ensuring patient safety from microbiological contamination. |
| Biocompatibility | All tests (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Material Mediated Pyrogenicity, Acute Systemic Toxicity, Indirect and Direct Hemolysis, Hemocompatibility) demonstrated the device materials are biologically compatible with the human body for their intended use, without causing adverse biological responses. This implicitly means criteria for each test type (e.g., non-cytotoxic, non-sensitizing etc.) were met. |
Since this is not an AI/software device, the following points are not applicable (N/A) based on the provided document:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): N/A (No test set of patient data/images for an AI algorithm). Testing was engineering-based on physical devices.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No ground truth established by experts for images/data for AI).
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
- 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: N/A (No AI, no human reader study).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (No algorithm).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (No ground truth as defined for diagnostic AI). The "ground truth" for this mechanical device is proper functioning according to engineering specifications and safety standards.
- The sample size for the training set: N/A (No training set for an AI algorithm).
- How the ground truth for the training set was established: N/A (No training set for an AI algorithm).
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).