(27 days)
The SpyGlass DS and DS II Direct Visualization System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.
The SpyGlass DS and DS II Direct Visualization System comprises two components: the SpyScope DS Access and Delivery Catheter or SpyScope DS II Access and Delivery Catheter, and the SpyGlass DS Digital Controller.
The SpyScope DS Access and Delivery Catheter and SpyScope DS II Access and Delivery Catheter are intended to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.
The SpyGlass DS Digital Controller is intended to provide illumination and receive, process, and output images from the SpyScope DS Access and Delivery Catheter or SpyScope DS II Access and Delivery Catheter for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.
The SpyGlass DS and DS II Direct Visualization System comprises two components: (1) a sterile, single-use choledochoscope, either the SpyScope DS Access and Delivery Catheter or the SpyScope DS II Access and Delivery Catheter (the "Scope"); and (2) a non-sterile endoscopic video imaging system, the SpyGlass DS Digital Controller (the "Controller").
The Scope is introduced into the pancreatico-biliary system via a duodenoscope. The Scope comprises a handle, an insertion tube, and a connection cable. The handle includes two articulation control knobs, a lever to lock the control knobs in place, connectors for irrigation and aspiration, a working channel port, and a strap to attach the Scope to the duodenoscope. The insertion tube contains one working channel for accessory devices and aspiration, two channels for irrigation, two optical fibers to transmit illumination from the Controller, and wiring to transmit video signals to the Controller. The bending section at the distal portion of the insertion tube is controlled by the user via the articulation control knobs on the handle. The distal end of the insertion tube contains a camera for capturing video and transmitting it to the Controller, elements for transmitting illumination from the Controller, and the distal openings of the irrigation and working channels. The connection cable connects the Catheter handle to the Controller for transmitting illumination and video signals.
The Controller is an endoscopic video imaging component that combines the functionality of a camera and an LED light source. The Controller receives video signals from the Scope, processes the video signals, and outputs video images to an attached monitor. The Controller also generates and controls the illumination transmitted to the distal end of the Scope. The user interface of the Controller comprises a power button, a receptacle to connect the Scope connection cable, buttons to turn illumination on or off and to control the illumination intensity, and an illumination intensity indicator. The Controller outputs video images to an attached monitor via DVI, VGA, or S-Video ports, and the user may select NTSC or PAL video formats according to the geographic region of use.
The provided text describes a 510(k) premarket notification for the "SpyGlass DS and DS II Direct Visualization System," which is an endoscope for diagnostic and therapeutic applications in the pancreatico-biliary system.
The document does not contain information about a study proving that the device meets specific acceptance criteria based on AI performance or clinical efficacy metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K181439) through bench testing. The "acceptance criteria" discussed are related to the physical and functional aspects of the device, rather than performance metrics for an AI or imaging system in the context of diagnostic accuracy.
Therefore, many of the requested items (e.g., AI performance metrics, sample size for AI test sets, number of experts for ground truth, MRMC studies, standalone AI performance) are not applicable or not found in this document.
Here's a breakdown of what is available and what is not:
Acceptance Criteria and Device Performance (Based on Bench Testing for Substantial Equivalence)
The acceptance criteria are implied by the successful completion of specific bench tests designed to show the modified device performs similarly to the predicate.
| Acceptance Criteria (Bench Test Type) | Reported Device Performance (Outcome) |
|---|---|
| Shaft Diameter | Successfully completed |
| Surface and Edges | Successfully completed |
| Articulation Angle | Successfully completed |
| Articulation Reliability | Successfully completed |
The document states: "Bench testing demonstrated that the modified SpyGlass DS and DS II Direct Visualization System is substantially equivalent to the predicate device and considered safe and effective for its intended use."
Study Details (Not Applicable for AI/Clinical Efficacy from this document)
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Sample size used for the test set and the data provenance: Not applicable in the context of AI/clinical image analysis. The "test set" here refers to physical units of the device subjected to bench testing. The document does not specify the number of units tested. Data provenance for clinical data (country of origin, retrospective/prospective) is not provided as this is not a clinical study involving patient data endpoints for diagnostic performance.
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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 for an AI task is not established here. The "truth" for bench testing is the device meeting engineering specifications and performance against a predicate.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This applies to expert review of clinical images.
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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: No MRMC study was done or reported in this document. This device is an endoscope system, 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 is not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this submission's performance data is based on engineering specifications and direct physical measurements/functional testing that demonstrate equivalence to the predicate device.
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The sample size for the training set: Not applicable. No AI model training set is mentioned.
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How the ground truth for the training set was established: Not applicable. No AI model training set is mentioned.
Summary:
This 510(k) submission primarily relies on bench testing to demonstrate substantial equivalence between a modified device and its predicate. The "performance data" presented confirms that the device's physical and functional characteristics (shaft diameter, surface/edges, articulation angle, articulation reliability) were successfully tested and found to be equivalent to the predicate. The document does not describe any studies related to AI performance, clinical diagnostic accuracy, or human-in-the-loop studies that would involve the collection and analysis of clinical image data with expert ground truth.
§ 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.