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510(k) Data Aggregation
(261 days)
WORKER™ Guidewires are for use in facilitating the placement of catheters within the coronary and peripheral vasculature.
WORKER™ Guidewires have a fixed stainless steel core with polytetrafluoroethylene (PTFE) coated stainless steel spring wire to reduce friction. The WORKER™ Guidewires have a diameter of either 0.035" or 0.038" and range in length from 80 to 260 cm. Guidewires are marketed in Standard, Amplatz and Bentson iterations.
The provided document is a 510(k) summary for the WORKER™ Guidewire, a medical device. It details the device's technical characteristics, indications for use, and a comparison to a predicate device, along with the non-clinical performance tests conducted to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that a "series of testing was conducted in accordance with protocols based on requirements outlined in guidance's and industry standards and the below were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence." However, the document does not explicitly list the quantitative acceptance criteria for each test. It only lists the types of tests performed and states that the device "meet[s] the acceptance criteria."
Therefore, here's a table based on the information provided, with the specific acceptance criteria and reported performance being implied as "Met Acceptance Criteria" because the document states they were met without specifying the numerical thresholds.
| Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Tests | (Implied: Conforming to requirements outlined in FDA guidance Coronary and Cerebrovascular Guidewire (January 1995) and relevant industry standards. Specific quantitative criteria not provided in this document.) | Met Acceptance Criteria |
| Tensile Strength | (Implied: Demonstrated sufficient tensile strength to meet product specifications and ensure safe use, likely based on force applied before breakage or deformation.) | Met Acceptance Criteria |
| Torque Strength | (Implied: Demonstrated sufficient resistance to torsional forces, ensuring the guidewire does not twist or break during manipulation.) | Met Acceptance Criteria |
| Torqueability | (Implied: Demonstrated ability to transmit torque from the operator's hand to the distal tip effectively, allowing for precise steering.) | Met Acceptance Criteria |
| Tip Flexibility | (Implied: Demonstrated appropriate flexibility of the guidewire tip to navigate tortuous anatomy without causing damage or kinking.) | Met Acceptance Criteria |
| Coating Adherence/Integrity | (Implied: Demonstrated the PTFE coating remained intact and adhered to the guidewire, preventing flaking or separation during use, which is critical for reducing friction and preventing particulate shedding.) | Met Acceptance Criteria |
| Catheter Compatibility | (Implied: Demonstrated that the guidewire could be smoothly advanced and retracted through various catheters without excessive friction, kinking, or damage to either device.) | Met Acceptance Criteria |
| Particulate Testing | (Implied: Demonstrated that the guidewire did not shed an unacceptable amount of particulates during use, complying with established safety limits for foreign material in the bloodstream.) | Met Acceptance Criteria |
| Radiopacity | (Implied: Demonstrated sufficient visibility under fluoroscopy to allow for accurate positioning and manipulation within the vasculature.) | Met Acceptance Criteria |
| Biocompatibility Testing (per ISO 10993-1) | (Implied: No evidence of adverse biological reactions when in contact with biological systems, as outlined by ISO 10993-1.) | Met Acceptance Criteria |
| Cytotoxicity | (Implied: No toxic effects on cells.) | Met Acceptance Criteria |
| Sensitization | (Implied: No evidence of inducing allergic or hypersensitivity reactions.) | Met Acceptance Criteria |
| Acute systemic toxicity | (Implied: No evidence of adverse systemic effects following a single or repeated exposure over a short period.) | Met Acceptance Criteria |
| Hemocompatibility | (Implied: No adverse effects on blood components, such as hemolysis, thrombosis, or complement activation.) | Met Acceptance Criteria |
| Irritation/intracutaneous reactivity | (Implied: No evidence of local irritation or inflammatory reactions when in contact with tissues.) | Met Acceptance Criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes non-clinical performance and biocompatibility testing of a physical medical device (guidewire), not a clinical study involving patients or a software algorithm evaluating data. Therefore, the concepts of "test set" in the context of patient data, data provenance, or retrospective/prospective studies are not applicable to this submission.
The tests performed are laboratory-based, evaluating the physical and biological characteristics of the device itself. The document does not specify the number of guidewire samples used for each test.
3. 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)
This question pertains to studies where human experts provide a "ground truth" for evaluating an algorithm or a diagnostic device, typically in image analysis or similar fields. Since this document describes the non-clinical testing of a physical guidewire, this information is not applicable. The "ground truth" here is the physical and chemical properties of the device as measured in a lab, against established engineering and biological safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Similar to point 3, the concept of "adjudication" (typically involving multiple human readers/experts to resolve discrepancies) is not applicable to this non-clinical device testing. The results of the mechanical, chemical, and biological tests are based on objective measurements and established laboratory procedures, not subjective human interpretation requiring adjudication.
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
This type of study (MRMC) and the concept of "improving human readers with AI assistance" are specifically related to the evaluation of AI/CADe/CADx software devices, particularly in diagnostic imaging. Since the WORKER™ Guidewire is a physical medical device used for catheter placement, this information is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is also relevant to the evaluation of AI/software algorithms. The WORKER™ Guidewire is a physical device; therefore, this information is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance and biocompatibility tests conducted for the WORKER™ Guidewire, the "ground truth" implicitly refers to:
- Established engineering specifications and performance thresholds for guidewires.
- Industry standards (e.g., ISO 11135-1 for sterilization, ISO 10993-1 for biocompatibility).
- FDA guidance documents (e.g., Coronary and Cerebrovascular Guidewire, January 1995).
These standards and guidelines define what constitutes acceptable performance and safety for such devices.
8. The sample size for the training set
This question is pertinent to machine learning or AI algorithm development. Since this document describes the non-clinical testing of a physical medical device, there is no concept of a "training set."
9. How the ground truth for the training set was established
As there is no "training set" for a physical medical device undergoing non-clinical testing, this question is not applicable.
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