(57 days)
The endoscopic guidewire is intended for use in selective cannulation of the biliary ducts including, but not limited to the common bile, pancreatic, cystic, right and left hepatic ducts. The endoscopic guidewire is designed to be used during endoscopic pancreatic -biliary procedures for catheter introduction and exchanges of catheters, cannulas and sphicterotomes.
Utilizing proprietary processes, these guides are constructed from a steerable, metallic core (Witinol) with a polymer jacket (polyurethane) coating. A hydrophilic coating is applied over the radiopaque polymer jacket. Guidewires are available in 260cm length and in diameters 0.018", 0.025" depending on specific design requirements. Guidewires may have a straight or a pre-shaped distal tip and are available in different tip flexibilities, which are dependent on the grind configuration of the core.
The provided text describes a 510(k) submission for the NaviPro™ Guidewire. The acceptance criteria and the study proving the device meets these criteria are related to non-clinical performance testing and biocompatibility, as this is a medical device approval. The document states that the device is "substantially equivalent" to predicate devices, meaning it does not claim superiority, but rather equivalent safety and effectiveness based on similar design and performance.
Here's an breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of acceptance criteria with numerical targets and corresponding performance results. Instead, it broadly states that testing was performed to establish requirements and demonstrate functionality.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Non-clinical Performance | Test pieces inspected for visual/tactile, dimensional, and mechanical attributes. |
| Material/Design Attributes | Functionality and performance characteristics are comparable to similar currently marketed devices. |
| Biocompatibility | Risk analysis concluded no additional testing required, implying it meets established biocompatibility standards. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Test pieces were tested and inspected," but does not quantify how many pieces were in the test set.
- Data Provenance: The studies are described as "non-clinical" and "biocompatibility testing," suggesting laboratory-based testing rather than human subject data. The manufacturer is Lake Region Medical, located in Chaska, MN, USA, implying the testing was conducted or overseen by them. No mention of retrospective or prospective data in a clinical sense, as it refers to device performance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable in the context of this 510(k) submission. The "ground truth" for a medical device like a guidewire is established through engineering and material science testing against predefined specifications and industry standards (e.g., ISO standards like 10993, 11070, 15223, EN 980, ISO 594, which the device is stated to comply with). It doesn't involve expert consensus on medical images or patient outcomes in the way an AI diagnostic device would.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in diagnostic accuracy studies where human interpretation is involved. For non-clinical device performance testing, the "adjudication" is based on meeting engineering specifications and test methodologies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any evaluation of how much human readers improve with AI vs. without AI assistance. This type of study is relevant for AI-powered diagnostic devices, not for basic medical devices like guidewires.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a guidewire, a physical medical instrument, not an algorithm. Therefore, there is no "standalone" algorithm performance to evaluate.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on engineering specifications, industry standards (e.g., ISO), and comparison to functionally equivalent predicate devices. The non-clinical testing "demonstrate[d] the device is as safe, as effective and performs as safely and effectively as the legally marketed device."
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device. There is no "training set" in the machine learning sense. The development process would involve iterative design, prototyping, and testing, but not machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this physical medical device.
§ 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.