(260 days)
The Liberator® Beacon® Tip Locking Stylet is intended for use in patients requiring the percutaneous removal of cardiac leads, indwelling catheters and foreign objects, with a central lumen.
The Liberator® Beacon® Tip Locking Stylet is a specialized stylet that can be inserted through a cardiac lead's inner conductor lumen, once the proximal connector has been removed. The stylet can then be locked into position within the lead's distal portion allowing for the delivery of tractional forces helpful during the extraction procedure.
The Liberator Beacon® Tip Locking Stylet has a braided Nickel-Chromium integral extender (handle). The locking mechanism that is located at the distal end of the stylet is comprised of a uniquely shaped stainless steel wire-locking coil segment attached to a central stainless steel stylet wire. This locking stylet is activated through the forward advancement of a stainless steel cannula that surrounds the central stainless steel stylet wire. Upon activation by the cannula. the wire-locking coil segment at the distal end of the stylet is advanced forward and is compressed. This compression causes the stacking of successive helices of the wire-locking coil. This stacking results in the outward radial displacement of a number of the wire-locking coil's helices against and into the lead conductor coil through which it has been inserted. This outward radial displacement creates the locking engagement of the Liberator® Beacon® Tip Locking Stylet to the lead conductor central or inner lumen. The device is available in a single size compatible with the internal diameter dimensions of many leads and catheters with a central lumen. Stylet wires for checking lead patency are available separately; they consist of a molded plastic handle on a 0.038 cm (0.015 inches) stainless steel wire, with a wire length of 65 cm.
The Liberator® Beacon® Tip Locking Stylet (and its associated stylet wires) underwent several tests to ensure reliable design and performance and to demonstrate substantial equivalence to the predicate device.
Table of Acceptance Criteria and Reported Device Performance
Unfortunately, the provided text does not explicitly state the specific numerical acceptance criteria for each test (e.g., "minimum pull strength force of X Newtons"). It only confirms that "The acceptance criterion was met" for each test. Therefore, the table below reflects what is verbally stated as acceptance criteria and how the device performed against them.
| Test Name | Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|---|
| Complete Device Test | Withstood the established minimum pull strength force. | Met |
| Collar Tubing Test | Collar tubing materials and solder joints withstood the established minimum pull strength force. | Met |
| Collar Cable Test | Collar cable materials and solder joints withstood the established minimum pull strength force. | Met |
| Mechanical Pull Test | Device locked into a simulated cardiac lead withstood the established minimum pull strength force. | Met |
| Radiopacity Test | Distal end of the locking stylet is radiopaque. | Met |
| Biocompatibility Testing | Passed tests for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, hemolysis, partial thromboplastin time, complement activation, and material mediated pyrogenicity. | Met (Determined to be biocompatible per ISO 10993-1 and FDA guidance) |
| Stylet Wires - Pull Strength | Stylet wire withstood the established minimum pull strength force. | Met |
| Stylet Wires - Cardiac Lead Insertion / Retraction | Stylet wires can pass in and out of a "wet" lead coil a total of two cycles. | Met |
| Stylet Wires - Biocompatibility Testing | Applicable testing for the main device confirmed biological compatibility. | Met |
The provided document describes physical and biological performance tests, not a clinical study involving human patients or ground truth consensus among experts. Therefore, several requested categories are not applicable to this type of submission.
Here's the breakdown:
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document does not specify the sample sizes used for each test.
- The data provenance is not explicitly mentioned, but these are typically in-house testing results from the device manufacturer (Cook Incorporated, in Bloomington, IN, USA). The studies are prospective in nature, as they are conducted specifically for the submission.
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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)
- Not applicable. This submission involves engineering and biocompatibility testing, not clinical data requiring expert human interpretation or "ground truth" establishment in a medical context.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. See point 3. Testing results are typically evaluated against pre-defined engineering specifications.
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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 hardware device (a stylet) and not an AI/software as a medical device (SaMD). No MRMC study was conducted or is relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device, not an algorithm. The "stand-alone" performance refers to the device's inherent physical and material characteristics as tested.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for these tests are pre-defined engineering specifications and widely accepted international standards (e.g., ISO 10993-1 for biocompatibility) and FDA guidance for medical device testing. For example, a "minimum pull strength force" would be a specific numerical value derived from design requirements and clinical needs for the device's function.
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The sample size for the training set
- Not applicable. No training set is used as this is not a machine learning or AI device.
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How the ground truth for the training set was established
- Not applicable. No training set is used.
§ 870.1380 Catheter stylet.
(a)
Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.(b)
Classification. Class II (performance standards).