(27 days)
Not Found.
No
The description mentions "processes the video signals" but does not provide any details suggesting the use of AI or ML algorithms for this processing. The performance studies are limited to bench testing of physical characteristics.
Yes
The device is indicated for use in "diagnostic and therapeutic applications" during endoscopic procedures.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "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 system provides "direct visualization" and "receives, processes, and output images," which are key features of a diagnostic device.
No
The device description clearly outlines two hardware components: the SpyScope DS/DS II Access and Delivery Catheter (a sterile, single-use choledochoscope) and the SpyGlass DS Digital Controller (a non-sterile endoscopic video imaging system). While the Controller includes software for processing video signals, the system is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The SpyGlass DS and DS II Direct Visualization System is a medical device used for direct visualization and guiding instruments within the body during endoscopic procedures. It captures video images of the pancreatico-biliary system.
- No Sample Analysis: The device does not analyze samples taken from the body. It provides real-time visual information of internal structures.
Therefore, while it is a diagnostic tool used in a medical setting, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
FBN, KQM, NTN
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.
Mentions image processing
Yes, "receive, process, and output images" and "processes the video signals".
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Video
Anatomical Site
pancreatico-biliary system including the hepatic ducts
Indicated Patient Age Range
Not Found.
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found.
Description of the test set, sample size, data source, and annotation protocol
Not Found.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was successfully completed to establish substantial equivalence between the modified SpyGlass DS and DS II Direct Visualization System and the predicate device. This testing included the following:
- Shaft Diameter
- Surface and edges
- Articulation angle
- Articulation reliability
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found.
§ 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.
0
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January 22, 2019
Boston Scientific Corporation Carter Navarro Sr. Manager, Regulatory Affairs 100 Boston Scientific Wav Marlborough, MA 01752
Re: K183636
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, KQM, NTN Dated: December 21, 2018 Received: December 26, 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.
1
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,
Daniel G. Walter Jr -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
2
Indications for Use
510(k) Number (if known)
K183636
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 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 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.
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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3
Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752-1234 (508) 683-4000
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: December 21, 2018
2. Proposed Device
| Trade Name: | SpyGlass DS and DS II Direct Visualization System |
|---|---|
| Clearance Number: | K183636 |
| 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 and DS II Direct Visualization System |
| Manufacturer: | Boston Scientific Corporation |
| Clearance Number: | K181439 |
| 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
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").
4
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.
5. Indications for Use
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 Deliverv 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.
5
6. Technological Characteristics
The modified SpyGlass DS and DS II Direct Visualization System shares the same intended use, indications for use, fundamental scientific technology, and technological characteristics as the predicate SpyGlass DS and DS II Direct Visualization System (K181439). The modified device incorporates a minor design change to the bond of the working channel sleeve to the multi-lumen extrusion in the insertion of the SpyScope DS Access and Delivery Catheter and SpyScope DS II Access and Delivery Catheter.
7. Performance Data
Bench testing was successfully completed to establish substantial equivalence between the modified SpyGlass DS and DS II Direct Visualization System and the predicate device. This testing included the following:
- Shaft Diameter
- Surface and edges
- Articulation angle ●
- Articulation reliability ●
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.
8. Conclusion
Boston Scientific has demonstrated that the modified SpyGlass DS and DS II Direct Visualization System is substantially equivalent to the currently marketed SpyGlass DS and DS II Direct Visualization System (K181439).