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.

Device Description

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device. It describes performance data but does not present a detailed study with acceptance criteria and reported device performance in the format requested. It generally states that "non-clinical testing was successfully performed" and "All acceptance criteria were met," but it doesn't provide the specific criteria or the numerical results against those criteria.

Therefore, I cannot fulfill your request for "A table of acceptance criteria and the reported device performance" based on the provided text.

However, I can extract information related to the other points based on what is available:

1. A table of acceptance criteria and the reported device performance:

As explained above, this information is not provided in sufficient detail in the document. The document states that performance testing was "successfully completed" and that "All acceptance criteria were met," but it does not specify what those criteria were nor the quantitative results.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: Not specified. The document refers to "non-clinical testing" and "performance testing (bench)" which typically involve a number of devices/components rather than patient data.
Data Provenance: Not specified, but given it's "non-clinical" and "bench" testing, it likely occurred in a lab setting rather than involving human subjects or population data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable: This type of information is relevant for studies involving human interpretation (e.g., diagnostic accuracy studies). The "Performance Data" section describes bench testing (e.g., field of view, resolution, irrigation flow rate), which doesn't typically involve experts establishing "ground truth" in the same way clinical diagnostic studies do.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable: Given the nature of the bench testing described, an adjudication method for a test set is not relevant.

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:

No: The document does not mention any MRMC comparative effectiveness study or any studies involving AI. The device is a "Direct Visualization System" (endoscope and related components), not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable: The device is hardware (endoscope, camera, light source) with associated software for image processing and output. It is not an algorithm designed for standalone diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Objective Measurements: For the "Performance Data" listed (Field of view, Resolution, Irrigation flow rate, etc.), the "ground truth" would be established through objective measurement standards and specifications, not expert consensus or clinical outcomes data. For biocompatibility and electrical safety, the "ground truth" is adherence to recognized consensus standards.

8. The sample size for the training set:

Not Applicable: The document does not describe a machine learning model or an algorithm that would require a "training set." The device is a direct visualization system. While it has software for image processing, the context does not suggest a deep learning model requiring a large training dataset for classification or detection.

9. How the ground truth for the training set was established:

Not Applicable: See point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".

August 23, 2018

Boston Scientific Corporation Carter Navarro Sr. Manager, Regulatory Affairs 100 Boston Scientific Way Marlborough, MA 01752

Re: K181439

Trade/Device Name: SpyGlass DS and DS II Direct Visualization System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBN, NTN, KQM Dated: July 26, 2018 Received: July 27, 2018

Dear Carter Navarro:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Glenn B. Bell -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K181439

Device Name

SpyGlass DS and DS II Direct Visualization System

Indications for Use (Describe)

The SpyGlass DS and DS II Direct Visualization System is indiagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

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 applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752-1234 (508) 683-4000

www.bostonscientific.com

1. Submitter

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752

Contact: Carter Navarro Sr. Manager, Regulatory Affairs Telephone: (508) 683-4793 E-mail: carter.navarro@bsci.com

Date Prepared: August 23, 2018

2. Proposed Device

Trade Name:	SpyGlass DS and DS II Direct Visualization System
Common Name:	Choledochoscope and accessories, flexible/rigid;
	Surgical camera and accessories; LED light source
Product Code:	FBN, KQM, NTN
Device Class and Panel:	Class II, Gastroenterology/Urology (FBN, NTN)
	Class I, General and plastic surgery (KQM)
Classification Regulation:	21 CFR 876.1500 Endoscope and Accessories

3. Predicate Device

Trade Name:	SpyGlass DS Direct Visualization System
Manufacturer:	Boston Scientific Corporation
Clearance Number:	K142922
Common Name:	Choledochoscope and accessories, flexible/rigid;Surgical camera and accessories; LED light source
Product Code:	FBN, KQM, NTN
Device Class and Panel:	Class II, Gastroenterology/Urology (FBN, NTN)Class I, General and plastic surgery (KQM)
Classification Regulation:	21 CFR 876.1500 Endoscope and Accessories

4. Device Description

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5. Indications for Use

6. Technological Characteristics

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The proposed SpyGlass DS and DS II Direct Visualization System shares the same intended use and fundamental scientific technology as the predicate SpyGlass DS Direct Visualization System (K142922). The proposed device and the predicate device share indications for use and nearly identical technological characteristics, including CMOS image sensors for visualization, light-emitting diodes (LEDs) for illumination, and video output capabilities. The device components are identical in dimensions and mechanical performance. The proposed device incorporates (1) a new camera in the Scope: (2) minor design and adhesive changes to the distal cap of the Scope to accommodate the new camera; and (3) updated software for the Controller to accommodate the new camera and to provide High Dynamic Range (HDR) image processing when used with the SpyScope DS II Access and Delivery Catheter.

7. Performance Data

Non-clinical testing was successfully performed on the proposed SpyGlass DS and DS II Direct Visualization System.

Performance testing (bench) was successfully completed to establish substantial equivalence between the proposed SpyGlass DS and DS II Direct Visualization System and the predicate device. This testing included the following:

Field of view ●
Direction of view
Resolution ●
Irrigation flow rate
Surface and edges
Articulation reliability
Image noise
Video latency
System frame rate
. Illumination intensity
Automatic light control response time ●

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Biocompatibility of the SpyScope DS II Access and Delivery Catheter was evaluated in accordance with FDA recognized consensus standards. The following tests were performed: Cytotoxicity, Irritation, and Sensitization. All acceptance criteria were met.

Electrical safety and electromagnetic compatibility of the SpyGlass DS and DS II Direct Visualization System were evaluated in accordance with FDA recognized consensus standards. All acceptance criteria were met.

The results of non-clinical testing demonstrate that the proposed SpyGlass DS and DS II Direct Visualization System is considered safe and effective for its intended use.

8. Conclusion

Boston Scientific has demonstrated that the proposed SpyGlass DS and DS II Direct Visualization System is substantially equivalent to the currently marketed SpyGlass DS Direct Visualization System (K142922).

Regulation Number and Section

§ 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.