(34 days)
The TandemRX is indicated for use to cannulate and inject contrast media to obtain a cholangiogram of the biliary duct system. The contrast media is injected through the cannula and fluoroscopy or x-ray is performed to obtain the cholangiogram.
The Microvasive TandemRX is a triple lumen ERCP cannula capable of accepting an .035" guidewire in one open channel while simultaneously injecting contrast media through the other two lumens. The two lumens are joined at the proximal end so that injection of contrast medium can be accomplished through a single injection port. The open channel allows for the quick exchange of a guidewire completely isolated from injection agents. No stylet is necessary for scope passage. The TandemRX may be placed with or without the aid of a guidewire.
This medical device (K970054), an injection cannula called the Microvasive TandemRX, is a Class I device used to cannulate and inject contrast media for cholangiograms. The submission primarily focuses on establishing substantial equivalence to a legally marketed predicate device (Microvasive Tandem XL Cannula) rather than presenting a novel performance study with specific acceptance criteria and a detailed study design.
Here's an analysis based on the provided text, addressing your points where possible, and noting where information is absent due to the nature of this 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| N/A (See note below) | Biocompatibility: Satisfactory results on patient- and fluid-contact materials. |
| Performance: Laboratory testing performed to verify safety and performance (specific criteria not detailed). | |
| Equivalence: Determined to be substantially equivalent to the Microvasive Tandem XL Cannula in indications for use, design, and materials. |
Note: The submission does not explicitly state quantitative acceptance criteria for typical performance metrics like accuracy, sensitivity, or specificity, as it's not a diagnostic AI device. The "acceptance criteria" here are implicitly related to demonstrating safety and substantial equivalence through biocompatibility testing and general performance verification.
2. Sample Size for Test Set and Data Provenance
This information is not applicable / not provided in the document. The submission references "laboratory testing regarding characteristics" and a "biocompatibility assessment." These are likely bench tests and material science evaluations, not studies involving patient data or typical "test sets" for diagnostic performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable / not provided. As there's no mention of a diagnostic performance study, there would be no ground truth established by experts in the context of interpreting images or patient conditions.
4. Adjudication Method for the Test Set
This information is not applicable / not provided. No human adjudication process for a test set is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices to assess how AI affects human reader performance. This device is an invasive medical instrument for delivering contrast, not an image analysis tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study in the context of an algorithm's diagnostic accuracy was not done. The "performance characteristics" describe physical and material properties, not algorithmic output.
7. Type of Ground Truth Used
The concept of "ground truth" as typically defined for diagnostic or AI studies (e.g., pathology, clinical outcomes, expert consensus) is not applicable here. The "ground truth" for this device's safety and performance would be established by:
- Biocompatibility Standards: Pre-defined standards for materials in contact with the body.
- Engineering Specifications: Design tolerances, material properties, and functionality verification during mechanical testing.
- Substantial Equivalence: Comparison to the known performance and safety profile of the predicate device.
8. Sample Size for the Training Set
This information is not applicable / not provided. There is no mention of an algorithm or an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable / not provided. As there is no AI model or training set, this question is irrelevant to the provided submission.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device. The "study" that proves the device meets requirements consists of:
- Laboratory testing regarding characteristics: These tests were performed to "verify its safety and performance." The specific tests, methods, and acceptance criteria are not detailed in this summary but would have been included in the full submission. These tests would likely include aspects like flow rate, material integrity, and mechanical strength relevant to its function.
- Biocompatibility assessment: Performed on all patient- and fluid-contact materials. The results were "satisfactory," indicating the materials meet established safety standards for medical devices interacting with the body.
- Comparison to Predicate Device: A thorough comparison of descriptive and technological characteristics was performed between the TandemRX and the legally marketed Microvasive Tandem XL Cannula. This comparison concluded that the devices are "equivalent" in their indications for use and "very similar in design and materials."
The conclusion states that the "information presented provides assurance that the TandemRX will meet the minimum requirements that are considered acceptable for its intended use." This indicates that the combination of laboratory testing, biocompatibility assessment, and the demonstration of substantial equivalence to a predicate device serves as the basis for regulatory acceptance. Specific quantitative acceptance criteria akin to those for diagnostic accuracy studies are not present because this is a different type of 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.