(179 days)
This device is an accessory to be used with endoscopic biliary and pancreatic devices to lock the wire guide(s) in place and to prevent reflux of bodily fluids during ERCP
The SnapLoc Wire Lock device is an accessory that is clipped onto the outside of a Duodenoscope during Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures. Its purpose is to help control the wire guides during a procedure, to enable ERCP devices (catheters, baskets, balloons, stents, etc) to pass through the device and to prevent the backflow of bodily fluids during procedures. The SnapLoc wire lock contains features to aid in wire control. The wire is locked into place by simply sliding the wire into one of the locking notches located on the left and right sides of the wire is unlocked by lifting the wire out of the wire locking notch. For control, the proximal end of the wire can be secured by inserting it into one of the docking channels. A silicone seal located between the molded components helps reduce leakage from the duodenoscope. For ease of connection, the wire lock attaches to the duodenoscope by sliding laterally onto the port until secure. The SnapLoc will be sold in three sizes to be compatible with the most commonly used endoscopes from Olympus. Fuji, and Pentax.
The provided text does not contain detailed acceptance criteria or results from a study that proves the device meets those criteria. However, it does outline the types of performance testing conducted to demonstrate that the SnapLoc Wire Lock meets its design input requirements and is substantially equivalent to its predicate device.
Here's an overview of the information that can be extracted from the text regarding the performance testing:
1. A table of acceptance criteria and the reported device performance
The document lists performance tests conducted, but it does not provide specific numerical acceptance criteria or the reported performance data. It generally states that the tests demonstrated conformance to design input requirements and substantial equivalence.
Here's a table based on the types of tests performed, but without specific numerical acceptance criteria or results:
| Acceptance Criterion (Inferred from Test) | Reported Device Performance |
|---|---|
| Force to Connect to Duodenoscope | Conformed to design input requirements |
| Leakage Rate At Scope Seal | Conformed to design input requirements |
| Force to Advance Device Through Wirelock | Conformed to design input requirements |
| Ability to Lock Wireguide | Conformed to design input requirements |
| Leakage Rate at Accessory Seal | Conformed to design input requirements |
| Force to Remove Catheter During Short Wire Exchange | Conformed to design input requirements |
| Translation Distance of Wire in Locked Position | Conformed to design input requirements |
| Force to Detach from Duodenoscope | Conformed to design input requirements |
| Joint Strength during Short Wire Exchange/Stent Use | Conformed to design input requirements |
| Biocompatibility | Demonstrated no new questions of safety or effectiveness |
| Shelf-life (1 year) after accelerated aging | Demonstrated no significant material change |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "Where applicable, each test was performed on each variant of the SnapLoc device based on endoscope compatibility (Olympus, Fuji, Pentax)." It also mentions "representative devices" for accelerated aging testing.
- Sample Size: Not explicitly stated as a number, but implies at least one device per variant (Olympus, Fuji, Pentax) for each test.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It appears to be prospective testing conducted by the manufacturer as part of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not applicable as the testing described is primarily mechanical and material performance testing, not a clinical study involving human expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the type of performance testing described. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish ground truth from ambiguous data.
5. 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
There is no indication that an MRMC study was conducted. The device is a mechanical accessory, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a mechanical accessory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests listed, the "ground truth" is derived from engineering specifications, material science principles, and functional requirements (e.g., a wire should lock, there should be no leakage, specific force thresholds should be met). It's not based on expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set
This is not applicable as the device is not an AI/machine learning device that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable as the device is not an AI/machine learning 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.