(108 days)
The Radifocus Glidewire Endoscopic Wire is intended to be used for selective cannulation of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.
The Radifocus Glidewire Endoscopic Wire is an endoscopic guide wire that is provided sterile and is intended for single use only. It consists of a Nickel Titanium alloy core wire, and a polyurethane containing tungsten and hydrophilic polymer that are applied to the entire wire. There are two shaft configurations: standard and stiff; the stiff shaft has a slightly thicker core wire than that of the standard shaft. The wire distal segment comes in angled or straight configurations and is packaged in a plastic holder that is contained within an individual package. A guide wire inserter is contained within the individual package to assist with the insertion of the wire into an endoscope or catheter.
This document is a 510(k) premarket notification for a medical device called the Radifocus Glidewire Endoscopic Wire. It is a submission to the FDA demonstrating substantial equivalence to a predicate device, not a study describing acceptance criteria and device performance in the context of an AI-based system. Therefore, most of the requested information regarding AI study specifics like sample sizes for test and training sets, expert consensus, MRMC studies, and standalone performance is not applicable to this document.
However, I can extract and describe the acceptance criteria and the studies that prove the device meets these criteria, as presented in the document, which are related to the physical performance and safety of the guidewire.
Acceptance Criteria and Device Performance for the Radifocus Glidewire Endoscopic Wire
The device is a medical guidewire (non-AI), so the acceptance criteria are based on physical performance, biocompatibility, and sterility, rather than diagnostic accuracy or AI performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria & Test | Standard / Basis | Reported Device Performance |
|---|---|---|
| Performance Testing (ISO 11070: 2014) | ||
| Radiodetectability | ISO 11070, Section 4.5 | All samples tested met the standard applicable to each test. |
| Fracture Test | ISO 11070, Section 8.4 | All samples tested met the standard applicable to each test. |
| Flexing Test | ISO 11070, Section 8.5 | All samples tested met the standard applicable to each test. |
| Peak Tensile Force of Guidewire | ISO 11070, Section 8.6 | All samples tested met the standard applicable to each test. |
| Performance Testing (Terumo's Internal Standards) | ||
| Flexibility Test of Distal Tip | Internal Standards (based on predicate) | Meets acceptance criteria |
| Torque transmission | Internal Standards (based on predicate) | Meets acceptance criteria |
| Sliding Resistance/Coating | Internal Standards (based on predicate) | Meets acceptance criteria |
| Integrity (Product appearance) | Internal Standards (based on predicate) | Meets acceptance criteria |
| Bending Strength | Internal Standards (based on predicate) | Meets acceptance criteria |
| Biocompatibility | ISO 10993-1: 2009 | Concluded to be biocompatible for its intended use, identical to predicate which has a history of safe and effective use. Classified as Externally Communicating Device, Tissue/bone/dentin communicating, Limited Contact ( Bacterial Endotoxins Test; FDA Guidance June 2012 |
| Risk Analysis | ISO 14971: 2007 | No issues of safety and effectiveness determined taking into account modifications. |
Regarding the specific questions you asked for an AI study, the following are not applicable to this 510(k) submission for a non-AI medical device (guidewire):
- Sample sizes used for the test set and the data provenance: Not applicable. Device is a physical guidewire, not an AI system processing data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device refers to the physical and chemical properties meeting specified standards.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
However, to address the core of "the study that proves the device meets the acceptance criteria" based on the document:
The studies that prove the device meets the acceptance criteria are non-clinical bench tests and material assessments. These include:
- Performance Testing per ISO 11070: 2014: This standard covers "Sterile single-use intravascular introducers, dilators and guidewires." Tests performed included Radiodetectability, Fracture Test, Flexing Test, and Peak Tensile Force of Guidewire. These tests were conducted on both non-aged and accelerated aged samples.
- Performance Testing per Terumo's Internal Standards: These tests included Flexibility Test of Distal Tip, Torque transmission, Sliding Resistance/Coating, Integrity (Product appearance), and Bending Strength. These were based on the predicate device's expected performance.
- Biocompatibility Testing: Assessed in accordance with ISO 10993-1, classifying the device and confirming material compatibility through comparison to the predicate device's established safety record and identical material composition.
- Sterilization Validation: Demonstrated compliance with ISO 11135 for Ethylene Oxide sterilization, ensuring a Sterility Assurance Level (SAL) of 10^-6 (although the document stated 10^-9, which is a higher level of assurance) and meeting residual EO/ECH limits per ISO 10993-7 for limited exposure devices.
- Pyrogen Testing Validation: Conducted using Limulus Amebocyte Lysate (LAL) testing (Photometric Quantitative Method) in accordance with USP and FDA guidance.
- Risk Analysis: Performed according to ISO 14971 to identify and mitigate potential risks.
These non-clinical tests collectively demonstrate that the Radifocus Glidewire Endoscopic Wire is safe and effective and substantially equivalent to the predicate device, fulfilling the regulatory requirements for the 510(k) submission. No clinical trials were conducted or required for this submission.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.