(41 days)
Mandrel Guidewires are intended to facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.
The Mandrel wire family is made of a coated (PTFE or Silicone) or uncoated Nitinol or Stainless Steel core wire that is tapered at the distal tip where a coil is secured to the distal end. The distal coil can be anywhere from 2cm to 30cm depending on specific design and can consist of Stainless Steel, Palladium, Platinum, or the proposed Tungsten materials. The guidewire may contain proximal core markers. The Mandrel guidewire family is bound by the following parameters: Lengths: 20cm to 500cm, Outside Diameter: 0.014" To 0.35", Tips: Straight or shaped with various flexibilities, Coil Length: 2cm to 30cm.
This document describes a 510(k) submission for Mandrel Guidewires with the addition of Tungsten as a material option. The submission focuses on demonstrating substantial equivalence to previously marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it states that "all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met" and that "the conclusions drawn from bench testing and biocompatibility testing demonstrate compliance with the design input summary."
The document lists the following tests performed to ensure compliance with the design input summary:
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Visual | Complies with design input summary |
| Radiopacity | Complies with design input summary |
| Lubricity | Complies with design input summary |
| J-Memory Test | Complies with design input summary |
| Body Stiffness | Complies with design input summary |
| Adhesion / Durability | Complies with design input summary |
| Guidewire Pull test | Complies with design input summary |
| Torque Strength | Complies with design input summary |
| Torque Control | Complies with design input summary |
| Dimensional | Complies with design input summary |
| Linear Stiffness | Complies with design input summary |
| Lateral Stiffness | Complies with design input summary |
| Particulate Test | Complies with design input summary |
| ISO Strength of Union | Complies with design input summary |
| ISO Flex Test | Complies with design input summary |
| ISO Corrosion Resistance Test | Complies with design input summary |
| ISO Fracture Test | Complies with design input summary |
| Hydrodurability | Complies with design input summary |
| Cytotoxicity (Biocompatibility) | Complies with pre-defined acceptance criteria |
| Hemolysis (Biocompatibility) | Complies with pre-defined acceptance criteria |
Note: The specific numerical or descriptive acceptance criteria for each test are not provided in this summary, nor are the detailed results. The device performance is generally stated as "complies with design input summary" or "complies with pre-defined acceptance criteria."
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Test devices were manufactured and inspected according to established requirements." However, it does not provide the specific sample size used for the bench testing or biocompatibility testing. The data provenance is internal to Lake Region Medical through their "formal quality systems." There is no mention of country of origin for data or whether the study was retrospective or prospective in the standard sense (as this is a device modification submission, not a clinical trial). The data is generated from laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this device submission. The tests conducted are primarily physical, mechanical, and biological evaluations of the device itself, rather than diagnostic interpretations requiring expert consensus for ground truth. The "ground truth" for these tests would be the established engineering specifications and ISO standards.
4. Adjudication Method for the Test Set
This information is not applicable for the type of testing described (bench and biocompatibility). Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or subjective assessments.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This submission is for a material modification to a guidewire, and the testing focuses on the device's physical, mechanical, and biological properties, not its interpretive performance in a diagnostic context.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
This question is not applicable. The device is a physical medical guidewire, not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to evaluate.
7. The Type of Ground Truth Used
The ground truth used for this submission is based on established engineering design input summaries, internal specifications, and relevant ISO standards for material properties, mechanical performance, and biocompatibility.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of this device submission. The device is not an AI model requiring a dataset for training.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this 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.