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510(k) Data Aggregation
(263 days)
OVALUM LTD.
The CiTop™ Guidewire is intended for use in angiographic procedures to facilitate the intra-luminal placement of the wire beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.
The CiTop™ Guidewire has an outside diameter of 0.014" (0.36 mm) and a length of 280 cm. The CiTop™ 0.014" Guidewire can be torqued to facilitate navigation through the vasculature. A handle control is supplied with the guidewire to facilitate torque and tip shaping for deployment and positioning according to standard practices. The distal tip can be momentarily shaped into an arched formation by the operator to aid in releasing a wedged guidewire and allow its advancement through difficult occlusions. A platinum marker coil at the distal tip aids visualization under fluoroscopy. The CiTop™ Guidewire is supported by a stainless steel helical cut accessory shaft with an outside diameter of 0.023" and length of 126cm. The support accessory may be independently torqued and its distal end shaped. The support accessory operates as an aid in the advancement of the CiTop™ Guidewire and as an adjustment to the flexibility of the distal end of the CiTop™ Guidewire . The CiTop™ 0.014" Guidewire is supplied in a protective dispenser, that is packaged in a single-use sterilizeable pouch. The Pouch is labeled, and placed in an individual protective carton for sterilization. The CiTop™ 0.014" Guidewire is a single use/disposable product with a nitinol shaped tip. The Guidewire is used to gain intravascular access to and facilitate the positioning and exchange of interventional devices in small-diameter, tortuous vasculature.
Here's a breakdown of the acceptance criteria and the study information for the CiTop™ 0.014" Guidewire, based on the provided text:
Preamble: This document describes a traditional medical device (guidewire), not an AI/ML powered device. Therefore, many of the typical acceptance criteria and study aspects related to AI (like standalone performance, MRMC studies, training set data, etc.) are not applicable or explicitly stated in this type of 510(k) summary. The evaluation focuses on physical characteristics, biocompatibility, and substantial equivalence to existing predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a physical medical device and not an AI algorithm, the "acceptance criteria" are not reported as specific performance metrics with numerical thresholds (e.g., sensitivity > X%, specificity > Y%). Instead, they are framed as compliance with recognized standards and established performance expectations for guidewires. The reported device performance confirms these general criteria were met.
| Acceptance Criteria (General) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility in accordance with ISO 10993-1 (external communicating, blood contact, short duration) | Materials test results confirmed biocompatibility. |
| Safety and effectiveness as confirmed by design analysis, in vitro, and in vivo data | Design analysis, in vitro and in vivo data confirm the safety and effectiveness, and substantial equivalence to predicate devices. |
| Compliance with FDA's Coronary and Cerebrovascular Guidewire Guidance Document (January 1995) | Device evaluation included in vitro tensile, torque strength, torqueability, tip flexibility, biocompatibility, and catheter compatibility tests (as specified in the guidance document). All data was within device specification requirements, standard requirements, and predicate performance expectations. |
| Substantial equivalence in design, materials, sterilization, principles of operation, and indications for use to predicate devices | The CiTop™ Guidewire is substantially equivalent to predicate devices (Asahi PTCA & PTA guidewire Confianza Pro K041531, Cordis STEER-IT Guidewire K040592, LuMend Frontrunner CTO Catheter and Accessories K013284) based on indications for use, technological characteristics, and safety and performance testing. The components are similar in basic materials, design, construction, and performance. The distal tip is designed to improve performance in passing total occlusions (tip flexibility, shaping, retention/relaxation). |
| Yielding acceptable safety & performance outcomes | Subject product testing yielded acceptable safety & performance outcomes. Verification performance testing also yielded acceptable results. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of a number of guidewires or test repetitions. The document refers to "in vitro" and "in vivo" data, and "subject product testing" and "verification performance testing," implying various tests were conducted. However, specific sample sizes for these tests are not provided.
- Data Provenance: The study was conducted by OVALUM Ltd. based in Rehovot, Israel. The studies involved "in vitro" and "in vivo" data. Whether the "in vivo" data involved human subjects, and if so, their country of origin or whether it was retrospective/prospective, is not detailed in this summary. Given the context of a 510(k) for a physical device, "in vivo" might refer to animal studies or limited human trials, but this is not clarified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as this is a physical medical device. The "ground truth" for guidewire performance is typically based on objective physical measurements (e.g., tensile strength, torqueability values) and observed functional performance, not human expert consensus on interpretations as would be the case for an imaging AI.
4. Adjudication Method for the Test Set
This information is not applicable for a physical guidewire. Adjudication methods like 2+1 or 3+1 are used for expert consensus in diagnostic tasks, not for evaluating the physical properties and performance of a device like a guidewire.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic imaging AI algorithms and their impact on human reading performance. It is not applicable to a physical medical device like a guidewire.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not Applicable. This concept applies to AI algorithms. The CiTop™ Guidewire is a physical device used by a human operator; it does not have a standalone "algorithm-only" mode.
7. The Type of Ground Truth Used
The "ground truth" for the CiTop™ Guidewire was established through:
- Objective physical measurements: In vitro tests of tensile strength, torque strength, torqueability, tip flexibility, and catheter compatibility.
- Biocompatibility testing: Adherence to ISO 10993-1 standards.
- Performance observations: In vivo data and subject product testing to assess functional characteristics and comparison against predicate device performance expectations.
8. The Sample Size for the Training Set
Not Applicable. As this is a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are refined through engineering principles, material science, and iterative testing, not by training a model on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. There is no "training set" ground truth in the AI sense for this device. The design and development of the guidewire rely on established engineering principles, material science knowledge, and adherence to regulatory guidance documents (like the FDA's Coronary and Cerebrovascular Guidewire Guidance Document).
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