(70 days)
The Endoscopic Guidewire is intended for use in selective cannulation of the biliary ducts including, but not limited to the common bile, cystic, right and left hepatic ducts. The Endoscopic Guidewire is designed to be used during endoscopic biliary procedures for catheter introduction and exchanges of catheters, cannulas, and sphincterotomes.
The Taxi® Endoscopic Guidewire is a dual colored, spiral patterned guidewire. The quidewire is composed of a Nitinol core with a dual colored PTFE jacket applied over the core to provide endoscopic visualization of wire movement. A polyurethane/lungsten loaded jacket encapsulates the distal end and ensures radiopacity. The distal tip of the guidewire is coated with hydrophilic coating.
The provided text is a 510(k) Summary for the Taxi® Endoscopic Guidewire (K081708). This document outlines the device's characteristics and its substantial equivalence to a predicate device, rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the way one would for an AI/ML-driven diagnostic device.
Therefore, many of the requested categories for defining acceptance criteria and study details are not applicable to the information provided. The document describes non-clinical tests to demonstrate safety and effectiveness for a medical device (guidewire), not a diagnostic algorithm.
Here's an attempt to extract relevant information where possible, and indicate where the requested information is not present in the provided text:
Acceptance Criteria and Device Performance (Limited Information available for a medical device, not a diagnostic algorithm):
| Acceptance Criteria Category | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Functionality | Test pieces were tested and inspected according to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes. (Implied acceptance: meeting these established requirements). | "The results of these tests demonstrated the functionality and performance characteristics of these Guidewires are comparable to the similar currently marketed devices." |
| Biocompatibility | Acceptable per ISO 10993 series. | "Biocompatibility testing per ISO 10993 series has been performed on the Taxi® Endoscopic Guidewire and has been found to be acceptable." |
| Material Composition | Nitinol core, PTFE proximal jacket, Polyurethane distal jacket, Hydrophilic distal coating, Polymer Adhesive / Accelerator for joining agents. | Device is constructed with Nitinol core, PTFE proximal jacket, Polyurethane distal jacket, Hydrophilic distal coating, Polymer Adhesive / Accelerator. (Matching the described construction). |
| Dimensions | Guidewire lengths: 260cm to 450cm; Guidewire diameters: .035"; Tip flexibility: 5CM Standard. | The device parameters specify: .035" Diameter, 260 - 450cm Length, Straight configuration, Standard flex, PTFE shaft, Hydrophilic coating. (Matching the specified parameters). |
| Sterilization Method | ETO | ETO |
Study Details (Not applicable for most items, as this is for a medical device's 510(k) submission, not an AI/ML diagnostic study):
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in terms of specific number of guidewires tested, but "Test pieces" are mentioned.
- Data Provenance: Not applicable. The testing was conducted by the manufacturer, Lake Region Manufacturing, Inc. (LRM).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context refers to established engineering and material science standards for device performance, not expert labels for diagnostic images.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept pertains to resolving discrepancies in expert labeling for diagnostic studies.
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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 device is a guidewire, not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a guidewire, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this medical device's performance is based on established engineering requirements, material specifications (e.g., Nitinol core, PTFE jacket), and performance standards (e.g., ISO 10993 for biocompatibility). The document states, "Test pieces were tested and inspected according to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes."
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The sample size for the training set: Not applicable. This device does not involve a training set as it is not an AI/ML model.
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How the ground truth for the training set was established: Not applicable. This device does not involve a training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets acceptance criteria was a series of non-clinical tests performed by Lake Region Manufacturing, Inc. (LRM). These tests assessed the device's functionality, performance characteristics, and biocompatibility.
- Non-Clinical Tests: "LRM performed testing to established requirements. Test pieces were tested and inspected according to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes." The conclusion was that "The results of these tests demonstrated the functionality and performance characteristics of these Guidewires are comparable to the similar currently marketed devices."
- Biocompatibility Testing: "Biocompatibility testing per ISO 10993 series has been performed on the Taxi® Endoscopic Guidewire and has been found to be acceptable."
The overall conclusion states that the device is "substantially equivalent" to the predicate device (JAGWIRE™ RECANALIZATION GUIDEWIRE K922302) based on these non-clinical evaluations. This substantial equivalence determination by the FDA indicates that the device is considered safe and effective for its intended use without requiring a full clinical trial for approval.
§ 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.