(100 days)
The SpyGlass DS 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 Direct Visualization System comprises two components: the SpyScope DS Access and Delivery Catheter and the SpyGlass DS Digital Controller.
The SpyScope DS Access and Delivery Catheter is 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 for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.
The SpyGlass DS Direct Visualization System comprises two components: (1) the sterile, single-use SpyScope DS Access and Delivery Catheter ("Catheter") and (2) the SpyGlass DS Digital Controller (the "Controller").
The Catheter is a flexible video cholangiopancreatoscope, introduced into the pancreatico-biliary system via a duodenoscope. The Catheter 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 Catheter to a 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 an imaging sensor 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 system that combines the functionality of a camera and an LED light source. The Controller receives video signals from the Catheter, 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 Catheter. The user interface of the Controller comprises a power button, a receptacle to connect the Catheter 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 document provides a 510(k) summary for the Boston Scientific SpyGlass DS Direct Visualization System. It details the device's indications for use, technological characteristics, and a summary of performance data to establish substantial equivalence to predicate devices. However, it does not explicitly state "acceptance criteria" in a numerical or categorical format, nor does it present the study results in a way that directly maps to pre-defined acceptance criteria for performance metrics.
Instead, the document generally states that "All evaluation acceptance criteria were met" for specific tests. It also notes that performance testing (bench) was "successfully completed to establish substantial equivalence."
Given the information provided, here is an attempt to synthesize the requested information, acknowledging the limitations in explicit quantitative acceptance criteria or detailed study results within this summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Inferred from "All evaluation acceptance criteria were met") | Reported Device Performance |
|---|---|---|
| Physical Dimensions | Within specified design ranges and comparable to predicate devices. | Met specifications, minor differences from predicate SpyScope did not raise new safety/effectiveness questions. |
| Diameter | Meets design specifications. | Successfully completed (implied meeting spec). |
| Working length | Meets design specifications. | Successfully completed (implied meeting spec). |
| Working channel diameter | Meets design specifications. | Successfully completed (implied meeting spec). |
| Optical/Imaging Performance | ||
| Field of view | Meets design specifications. | Successfully completed (implied meeting spec). |
| Direction of view | Meets design specifications. | Successfully completed (implied meeting spec). |
| Resolution | Meets design specifications, comparable to predicate devices utilizing CMOS sensors. | Successfully completed (implied meeting spec). |
| Image noise | Acceptable levels for diagnostic and therapeutic applications. | Successfully completed (implied meeting spec). |
| Video latency | Acceptable for real-time visualization during endoscopic procedures. | Successfully completed (implied meeting spec). |
| System frame rate | Sufficient for smooth, real-time video feedback. | Successfully completed (implied meeting spec). |
| Illumination intensity | Sufficient for clear visualization within the pancreatico-biliary system. | Successfully completed (implied meeting spec). |
| Default automatic light control setpoint | Provides appropriate illumination automatically. | Successfully completed (implied meeting spec). |
| Automatic light control response time | Responsive enough for dynamic clinical environments. | Successfully completed (implied meeting spec). |
| Simultaneous video output | Functions as designed across DVI, VGA, S-Video ports. | Successfully completed (implied meeting spec). |
| Mechanical Performance | ||
| Articulation direction | Meets design specifications. | Successfully completed (implied meeting spec). |
| Articulation angle | Meets design specifications. | Successfully completed (implied meeting spec). |
| Surface and edges | Smooth, atraumatic, and safe for use within the body. | Successfully completed (implied meeting spec). |
| Irrigation and working channel system leakage | No unacceptable leakage. | Successfully completed (implied meeting spec). |
| Articulation reliability | Maintains functionality over its intended lifespan/use. | Successfully completed (implied meeting spec). |
| Attachment to duodenoscope reliability | Secure attachment without dislodgement during use. | Successfully completed (implied meeting spec). |
| Duodenoscope compatibility | Compatible with a range of standard duodenoscopes. | Successfully completed (implied meeting spec). |
| Irrigation pump compatibility | Compatible with standard irrigation pumps. | Successfully completed (implied meeting spec). |
| Accessory compatibility | Accommodates intended accessory devices. | Successfully completed (implied meeting spec). |
| Biocompatibility | All tests for Cytotoxicity, Irritation, Sensitization, USP Physiochemical, and Latex met acceptance criteria per ISO 10993-1:2009. | All evaluation acceptance criteria were met. |
| Electrical Safety & EMC | Compliance with IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012, IEC 60601-1-2:2007, and IEC 60601-2-18:2009. | All evaluation acceptance criteria were met. |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "Non-clinical testing" and "Performance testing (bench)." It does not specify a "test set" in terms of patient data or samples from a clinical trial. The testing appears to be primarily bench testing on the device itself (e.g., measuring physical dimensions, optical performance, mechanical reliability) and biocompatibility testing on material samples. Therefore, there is no patient-specific test set or data provenance (country of origin, retrospective/prospective) described in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The described testing is non-clinical bench testing and biocompatibility. Clinical ground truth as established by experts is not described for these tests.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a human-adjudicated test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
No, an MRMC comparative effectiveness study is not mentioned in this 510(k) summary. The study described is non-clinical bench testing.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
Yes, the studies described are standalone performance tests of the device itself (algorithm/system only, without a human specifically "in-the-loop" for performance evaluation against ground truth derived from expert opinion). The "performance data" focuses on the technical specifications and safety of the device components.
7. The Type of Ground Truth Used
For the engineering and device performance aspects (e.g., diameter, resolution, frame rate, articulation), the "ground truth" would be the device's design specifications and industry standards. For biocompatibility, the "ground truth" is established by validated biological assays and ISO standards. For electrical safety and EMC, it's compliance with IEC standards. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" in the context of the described non-clinical studies.
8. The Sample Size for the Training Set
Not applicable. As a physical medical device, not an AI/ML algorithm, there is no training set in the conventional sense of machine learning. The device's design and manufacturing processes are developed based on engineering principles and previous device experience.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set mentioned in the context of this traditional medical device submission.
§ 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.