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.

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol of a human figure, represented by three overlapping profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 16, 2015

Boston Scientific Corporation Carter Navarro Manager, Regulatory Affairs 100 Boston Scientific Way Mail Stop M-11 Marlborough, MA 01752

Re: K142922

Trade/Device Name: SpyGlass DS Direct Visualization System Regulation Number: 21 CFR 876.1500 Regulation Name: Gastroenterology/Urology Regulatory Class: Class II Product Code: FBN, NTN, KQM Dated: December 19, 2014 Received: December 22, 2014

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. 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. 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 (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -A

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K142922

Device Name SpyGlass DS Direct Visualization System

Indications for Use (Describe)

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/2 description: The image shows the logo for Boston Scientific. The words "Boston Scientific" are written in a serif font. The color of the text is blue.

Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 (508) 382-4000 www.bostonscientific.com

510(k) Summary for SpyGlass™ DS Direct Visualization System

Submitter Boston Scientific Corporation Endoscopy Division 100 Boston Scientific Way Marlborough, MA 01752

Contact: Carter Navarro Manager, Regulatory Affairs Phone: (508) 683-4793 Fax: (508) 683-5939 E-mail: carter.navarro@bsci.com

Date Prepared: October 7, 2014

2. Device

Trade Name:	SpyGlass DS 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 (FBN, NTN)
	21 CFR 878.4160 (KQM)

3. Predicate Devices

Clearance Number:

Trade Name:	ACMI DUR-Digital Ureteroscope andCholedochoscope System
Manufacturer:	ACMI Corporation
Clearance Number:	K060269
Common Name:	Choledochoscope and accessories, flexible/rigid
Product Code:	FBN
Device Class and Panel:	Class II, Gastroenterology/Urology
Classification Regulation:	21 CFR 876.1500
Trade Name:	SpyScope Access and Delivery Catheter
Manufacturer:	Boston Scientific Corporation

K090170

SpyGlass DS Direct Visualization System Premarket Notification

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Common Name:Product Code:	Mini endoscope, gastroenterology-urologyODF
Device Class and Panel:	Class II, Gastroenterology/Urology
Classification Regulation:	21 CFR 876.1500
Trade Name:	SpyGlass Direct Visualization Probe/Ocular
Manufacturer:	Boston Scientific Corporation
Clearance Number:	K052194
Common Name:	Endoscope and/or accessories
Product Code:	KOG
Device Class and Panel:	Class II, Gastroenterology/Urology
Classification Regulation:	21 CFR 876.1500
Trade Name:	Olympus XCHF-B180Y1 Choledochoscope
Manufacturer:	Olympus Medical Systems Corporation
Clearance Number:	K080586
Common Name:	Choledochoscope and accessories, flexible/rigid
Product Code:	FBN
Device Class and Panel:	Class II, Gastroenterology/Urology
Classification Regulation:	21 CFR 876.1500
Trade Name:	Stryker LED Light Source
Manufacturer:	Stryker Endoscopy
Clearance Number:	K082813
Common Name:	Light source, fiberoptic, routine
Product Code:	FCW
Device Class and Panel:	Class II, Gastroenterology/Urology
Classification Regulation:	21 CFR 876.1500

4. Device Description

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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.

5. Indication for Use

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.

6. Technological Characteristics

The proposed SpyGlass DS Direct Visualization System shares similar design features and functions with the predicate devices.

The proposed device and predicate ACMI DUR-Digital Ureteroscope and Choledochoscope System share similar indications for use, both being intended for use for examination of the bile duct, and facilitating diagnostic and therapeutic procedures in the bile duct. The proposed device and predicate ACMI DUR-Digital Ureteroscope and

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Choledochoscope System share similar technological characteristics, including CMOS image sensors for visualization, light-emitting diodes (LEDs) for illumination (the light source is located in the handheld component of the predicate device), and similar video output capabilities. The differences in respect to the dimensions of the Catheter and location of the LEDs do not alter the suitability of the proposed device for its intended use.

In overall appearance, dimensions, and mechanical performance, the proposed SpyScope DS Access and Delivery Catheter is very similar to the SpyScope Access and Delivery Catheter, while adding the optical functionality of the SpyGlass Probe/Ocular. The minor dimensional differences between the proposed SpyScope DS Access and Deliverv Catheter and the predicate SpyScope Access and Delivery Catheter do not raise new questions of safety or effectiveness for the proposed device's intended use in the pancreatico-biliary system. The applicable dimensions are within the range of the predicate Olympus XCHF-B180Y1 Choledochoscope, which has the same indications for use.

The proposed SpyGlass DS Digital Controller and the predicate Stryker LED Light Source share similar technological characteristics, both utilizing LEDs for illumination, and both offering brightness control.

7. Substantial Equivalence

A direct comparison of key characteristics demonstrates that the SpyGlass DS Direct Visualization System is substantially equivalent to the predicate devices in terms of intended use, technological characteristics, and performance characteristics. The SpyGlass DS Direct Visualization System is as safe and effective as the predicate devices.

8. Performance Data

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

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

Diameter ●
. Working length
Working channel diameter ●
Field of view ●
Direction of view ●
Resolution
Articulation direction ●
Articulation angle ●
. Surface and edges
Irrigation and working channel system leakage
Articulation reliability
Attachment to duodenoscope reliability ●
Duodenoscope compatibility ●

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Irrigation pump compatibility ●
Accessory compatibility .
Image noise ●
Video latency ●
System frame rate ●
Illumination intensity ●
Default automatic light control setpoint ●
Automatic light control response time ●
Simultaneous video output ●

Biocompatibility of the SpyScope DS Access and Delivery Catheter was evaluated in accordance with ISO 10993-1:2009 for the body contact category of "surface - mucosal membrane" with a contact duration of "limited (≤24 hours)," and the following tests were performed: Cytotoxicity, Irritation, Sensitization, USP Physiochemical <661>, and Latex. All evaluation acceptance criteria were met.

Electrical safety and electromagnetic compatibility of the SpyGlass DS Direct Visualization System were evaluated in accordance 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.

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

9. Conclusion

Boston Scientific has demonstrated that the proposed SpyGlass DS Direct Visualization System is substantially equivalent to the currently marketed predicate devices.

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.