(84 days)
Not Found
No
The description mentions "processing" video signals but does not provide any details suggesting the use of AI/ML algorithms for this processing. There are no mentions of AI, ML, deep learning, training data, or performance metrics typically associated with AI/ML devices.
Yes
The "Intended Use / Indications for Use" section states: "The SpyGlass Discover Digital 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."
Yes.
The "Intended Use / Indications for Use" section explicitly states: "The SpyGlass Discover Digital System is indicated for use in diagnostic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts." It also mentions that the Controller is intended to "receive, process, and output images from the SpyGlass Discover Digital Catheter for diagnostic applications".
No
The device description clearly outlines two hardware components: the SpyGlass Discover Digital Catheter (a sterile, single-use endoscope) and the SpyGlass Discover Digital Controller (a non-sterile endoscopic video imaging system). While the Controller performs image processing, it is a physical hardware device that receives and outputs signals.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The SpyGlass Discover Digital System is used for direct visualization inside the body during endoscopic procedures. It does not analyze samples like blood, urine, or tissue in a laboratory setting.
- The intended use is for diagnostic applications during endoscopic procedures. This means it's used to visualize and assess the pancreaticobiliary system in real-time, not to perform tests on collected samples.
- The device description focuses on imaging and illumination within the body. It describes a catheter with a camera and light source inserted into the body, and a controller that processes and displays these images. This is characteristic of an endoscopic system, not an IVD.
Therefore, the SpyGlass Discover Digital System is an endoscopic imaging system used for direct visualization within the body, not an IVD.
N/A
Intended Use / Indications for Use
The SpyGlass Discover Digital System is indicated for use in diagnostic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. The SpyGlass Discover Digital System comprises two components: the SpyGlass Discover Digital Catheter and the SpyGlass Discover Digital Controller.
The SpyGlass Discover Digital 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 Discover Digital Controller is intended to provide illumination and receive, process, and output images from the SpyGlass Discover Digital Catheter for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic
Controller:
The SpyGlass Discover Digital Controller is intended to provide illumination and receive, process, and output images from the SpyGlass Discover Digital Catheter for diagnostic 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 Discover Digital System comprises two components: (1) a sterile, single-use endoscope, the SpyGlass Discover Digital Catheter (the "Catheter"); and (2) a non-sterile endoscopic video imaging system, the SpyGlass Discover Digital Controller (the "Controller").
The SpyGlass Discover Digital 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. 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 catheter 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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pancreaticobiliary system including the hepatic ducts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Inderdeep Tiwana, Sr. Regulatory Affairs Specialist, Endoscopy Boston Scientific Corporation 100 Boston Scientific Way, Marlborough, MA 01752
May 21, 2020
Re: K200483
Trade/Device Name: SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FBN Dated: February 27, 2020 Received: February 28, 2020
Dear Inderdeep Tiwana:
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. 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
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Neil R.P. Ogden, MS Assistant Director THT4A4 DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K200483
Device Name
SpyGlass Discover Digital Catheter; SpyGlass Discover Digital Controller
Indications for Use (Describe)
The SpyGlass Discover Digital System is indicated for use in diagnostic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. The SpyGlass Discover Digital System comprises two components: the SpyGlass Discover Digital Catheter and the SpyGlass Discover Digital Controller.
The SpyGlass Discover Digital 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 Discover Digital Controller is intended to provide illumination and receive, process, and output images from the SpyGlass Discover Digital Catheter for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic
Controller:
The SpyGlass Discover Digital Controller is intended to provide illumination and receive, process, and output images from the SpyGlass Discover Digital Catheter for diagnostic 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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Image /page/3/Picture/2 description: The image shows the logo for Boston Scientific. The text is in a serif font and is a dark blue color. The word "Boston" is on top of the word "Scientific".
Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752-1234 (508) 683-4000
510(k) Summary for SpyGlass Discover Digital System (SpyGlass Discover Digital Catheter and SpyGlass Discover Digital Controller)
1. Submitter
Boston Scientific Corporation Endoscopy Division 100 Boston Scientific Way Marlborough, MA 01752
Contact:
| Primary Contact: | Inderdeep Tiwana |
|---|---|
| Sr. Regulatory Specialist | |
| Phone: (508) 683-5008 | |
| E-mail: Inderdeep.tiwana@bsci.com |
- Secondary Contact: Ashley Santos Director, Regulatory Affairs-Endoscopy Phone: (508) 683-4359 Email: Ashley.santos(@bsci.com
Date Prepared: February 26, 2020
2. Device
| Trade Name: | SpyGlass Discover Digital 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) |
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3. Predicate Devices
Classification Regulation:
Catheter:
| Trade Name: | SpyGlass DS Direct Visualization System |
|---|---|
| Device Name: | SpyScope DS II Access and Delivery Catheter |
| Manufacturer: | Boston Scientific Corp. |
| Clearance Number: | K183636 |
| Common Name: | Choledochoscope and accessories, flexible/rigid; |
| Product Code: | FBN, NTN |
| Device Class and Panel: | Class II, Gastroenterology/Urology (FBN, NTN) |
| Classification Regulation: | 21 CFR 876.1500 (FBN, NTN) |
| Trade Name: | Flexible Video-Uretero-Choledochoscope System |
| Manufacturer: | Karl Storz |
| Clearance Number: | K142556 |
| Common Name: | Class II, Gastroenterology/Urology (FBN, FGB) |
| Product Code: | FBN, FGB |
| Device Class and Panel: | Class II, Gastroenterology/Urology |
| Classification Regulation: | 21 CFR 876.1500 |
| Trade Name: | URF-P2 Ureterorenofiberscope / Choledoschofirberscope |
| Manufacturer: | Olympus Medical System Corp. |
| Clearance Number: | K912120 |
| Common Name: | Class II, Gastroenterology/Urology (FBN) |
| Product Code: | FBN |
| Device Class and Panel: | Class II, Gastroenterology/Urology |
| Classification Regulation: | 21 CFR 876.1500 |
| Controller: | |
| Trade Name: | SpyGlass DS Direct Visualization System |
| Device Name: | SpyGlass DS Digital Controller |
| Manufacturer: | Boston Scientific Corp. |
| Clearance Number: | K183636 |
| Common Name: | Surgical camera and accessories; LED light source |
| Product Code: | KQM |
| Device Class and Panel: | Class I General and plastic surgery (KQM) |
Class I, General and plastic surgery (KQM) 21 CFR 878.4160 (KQM)
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4. Device Description
The SpyGlass Discover Digital System comprises two components: (1) a sterile, single-use endoscope, the SpyGlass Discover Digital Catheter (the "Catheter"); and (2) a non-sterile endoscopic video imaging system, the SpyGlass Discover Digital Controller (the "Controller").
The SpyGlass Discover Digital 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. 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 catheter 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 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.
5. Indications for Use
The SpyGlass Discover Digital System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. The SpyGlass Discover Digital System comprises two components: the SpyGlass Discover Digital Catheter and the SpyGlass Discover Digital Controller.
The SpyGlass Discover Digital 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 Discover Digital Controller is intended to provide illumination and receive, process, and output images from the SpyGlass Discover Digital Catheter for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.
6
6. Technological Characteristics
The proposed SpyGlass Discover Digital System shares the same intended use and fundamental scientific technology as the predicate SpyGlass DS Direct Visualization System (K183636). The two systems share same indications for use and nearly identical technological characteristics, including CMOS image sensors for visualization, light-emitting diodes (LEDs) for illumination, and video output capabilities. Most of the SpyGlass Discover Digital Catheter components are identical in dimensions and in mechanical performance to its predicate. The primary design changes incorporated in the SpyGlass Discover Digital Catheter are; (1) a shorter working length, (2) modifications to the pulley to compensate for the shorter working length, (3) longer irrigation and aspiration tubing, and (4) removal of the strap and bracket. Besides these changes, the design, components and materials of SpyGlass Discover Digital Catheter are nearly identical to the SpyScope DS II Access and Delivery Catheter (K183636).
7. Substantial Equivalence
The proposed SpyGlass Discover Digital Catheter is substantially equivalent in design, features and functionality to the SpyScope DS II Access and Delivery Catheter. Its function consists of providing direct visualization of the pancreatico-biliary system. It is also used to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. It provides imaging and illumination by means of a CMOS sensor and plastic optical fibers, 4way steerable navigation, irrigation and aspiration.
The primary difference between the SpyGlass Discover Digital Catheter and the SpyScope DS II Access and Delivery Catheter is its catheter working length. Unlike the SpyScope DS II Access and Delivery Catheter, the SpyGlass Discover Digital Catheter is not intended to be used through a duodenoscope. The SpyGlass Discover Digital Catheter is intended to access target anatomy through three possible methods; Laparoscopically, percutaneously and open surgical.
The secondary predicate devices selected for SpyGlass Discover Digital Catheter are (1) Flexible Video-Uretero-Choledochoscope System (Karl Storz) K142556 and (2) URF-P2 Ureterorenofiberscope / Choledoschofirberscope (Olympus) K912120. These two catheters share similar working catheter length as the SpyGlass Discover Digital Catheter. Hence, the accessing method to the target anatomy is similar to the proposed SpyGlass Discover Digital Catheter.