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510(k) Data Aggregation
(30 days)
Synchro2 Support Guidewire
The Synchro? Guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.
Like the primary predicate device, the Synchro2 Support Guidewire is a single-use product with a shapeable tip in straight and pre-shape configurations used to gain intravascular access to and facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for neuro and peripheral diagnostic and interventional procedures. The wire can be torqued to facilitate navigation through the vasculature.
This document describes the testing performed for the Stryker Neurovascular Synchro2 Support Guidewire (K190843) to demonstrate its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tip Stiffness | Not explicitly stated in the provided text, but implied as a quantitative measure. | "Met established acceptance criteria" |
| Fracture | Not explicitly stated in the provided text. | "Met established acceptance criteria" |
| Tip Integrity | Not explicitly stated in the provided text. | "Met established acceptance criteria" |
| Particulate Characterization | Not explicitly stated in the provided text. | "Met established acceptance criteria" |
| Coating Integrity Visual Inspection | Not explicitly stated in the provided text. | "Met established acceptance criteria" |
| Biocompatibility | Meet biological safety requirements per EN ISO 10993-1:2009 for externally communicating medical devices with circulating blood contact for less than 24 hours. | Met biological safety requirements (based on previous clearance of predicate device using same materials and processes). |
| Sterilization | Adopted into a validated sterilization process in accordance with EN ISO 11135: 2014/AC: 2014 principles. | Validated sterilization process in accordance with EN ISO 11135: 2014/AC: 2014 principles. |
| Shelf Life | Not affected by aging; no changes to existing shelf life. | "No changes to existing shelf life." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each of the confirmatory tests (Tip Stiffness, Fracture, Tip Integrity, Particulate characterization, Coating integrity). The tests are described as "confirmatory testing."
The data provenance is not explicitly stated in terms of country of origin, nor is it specified whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a medical device modification, these are likely laboratory-based, in-vitro performance tests conducted by the manufacturer (Stryker Neurovascular) in a controlled environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This type of submission (510(k) for a guidewire) relies on engineering and material performance testing rather than clinical expert evaluation of images or patient data to establish ground truth. Therefore, the concept of "experts" as in radiologists or physicians establishing ground truth for a test set is not applicable here. The ground truth for these tests is based on established engineering and material science principles, industry standards, and the performance of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human readers or subjective interpretation where adjudication would be necessary. The tests are objective, quantifiable measurements of physical properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not explicitly mentioned or presented in the provided document. This type of study is typically associated with AI/CAD devices or diagnostic tools where human interpretation plays a significant role. The submission is for a physical medical device (guidewire) and focuses on engineering equivalence.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Not applicable. There is no algorithm or AI component in this device. The testing focuses on the physical performance of the guidewire itself.
7. The Type of Ground Truth Used
The ground truth used for the performance testing is based on:
- Established engineering specifications and design requirements: Each test would have a defined pass/fail criterion based on the device's intended function and safety.
- Performance of the Primary Predicate Device (K053268): The goal is to demonstrate that the modified device performs "as well as" the predicate device. Performance standards are likely derived from the predicate's known characteristics and regulatory clearance.
- Relevant industry standards: Such as ISO standards mentioned for biocompatibility (EN ISO 10993-1:2009) and sterilization (EN ISO 11135: 2014/AC: 2014).
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/machine learning device. The testing describes verification and validation of a physical medical device.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
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