(23 days)
Not Found
No
The summary describes a standard endoscopic video imaging system and duodenoscope. There is no mention of AI, ML, or any advanced image processing beyond standard video signal processing for display. The performance studies focus on physical and electrical characteristics, not algorithmic performance.
Yes
The device is intended for "endoscopic surgery within the duodenum" and "treatment" within the duodenum, which are therapeutic interventions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the EXALT Controller is "intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation." This directly indicates that the device (specifically, the EXALT Controller as part of the system) is used for diagnostic purposes.
No
The device description clearly outlines both a physical duodenoscope (EXALT Model D Single-Use Duodenoscope) and a physical controller (EXALT Controller), both of which are hardware components. The performance studies also include testing on physical characteristics like dimensions, articulation, and flow rates, further indicating it is not a software-only device.
Based on the provided information, the EXALT Model D Single-Use Duodenoscope and EXALT Controller are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The EXALT system is used for direct visualization and intervention within the human body (the duodenum). It's an endoscopic system, not a system that analyzes samples taken from the body.
- Intended Use: The intended use clearly states "for endoscopy and endoscopic surgery within the duodenum" and "for endoscopic diagnosis, treatment, and video observation." This describes a procedure performed directly on the patient, not the analysis of a specimen.
- Device Description: The description details how the device is used to visualize and perform procedures inside the body, not how it processes or analyzes biological samples.
Therefore, the EXALT Model D Single-Use Duodenoscope and EXALT Controller fall under the category of medical devices used for direct examination and intervention within the body, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
EXALT Model D Single-Use Duodenoscope:
The EXALT Model D Single-Use Duodenoscope is intended for use with a Boston Scientific endoscopic video imaging system, for endoscopy and endoscopic surgery within the duodenum.
EXALT Controller:
The EXALT Controller is intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation.
Product codes (comma separated list FDA assigned to the subject device)
FDT, FET
Device Description
The EXALT Model D Single-Use Duodenoscope is a sterile, single-use, flexible duodenoscope used to examine the duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery. When connected to an EXALT Controller, the EXALT Model D Single-Use Duodenoscope provides imaging and illumination, 4-way steerable navigation, lens wash, insufflation, suction, facilitates image capture initiation, and allows the delivery of various ancillary devices.
The EXALT Controller is an endoscopic video imaging system that receives video signals from the EXALT Model D Single-Use Duodenoscope, processes the video signals, outputs video images to a video monitor, and outputs electrical signals that interface with external image capture systems. The EXALT Controller also controls the light transmitted by the tip of the EXALT Model D Single-Use Duodenoscope to illuminate the area of interest within the anatomy.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic video imaging
Anatomical Site
Duodenum
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)
Non-clinical testing was successfully performed on the proposed EXALT Model D Single-Use Duodenoscope and EXALT Controller.
Performance testing (bench) was successfully completed to establish substantial equivalence between the proposed EXALT Model D Single-Use Duodenoscope and EXALT Controller and the predicate devices. This testing included the following: Working Length, Insertion Portion Diameter, Articulation Angles, Flow Rates, Reliability, Resolution, Direction of View, Field of View, Light Output.
Biocompatibility of the EXALT Model D Single-Use Duodenoscope was evaluated in accordance with ISO 10993-1. Electrical safety and electromagnetic compatibility of the EXALT Model D Single-Use Duodenoscope and EXALT Controller were evaluated in accordance with AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-2, and IEC 60601-2-18.
Clinical testing was performed to confirm procedural performance of the EXALT Model D Single-Use Duodenoscope and EXALT Controller in endoscopic cholangiopancreatography (ERCP) procedures.
The results of non-clinical and clinical testing demonstrate that the EXALT Model D Single-Use Duodenoscope and EXALT Controller are considered safe and effective for their intended uses. Boston Scientific has demonstrated that the proposed devices are substantially equivalent to the currently marketed predicate devices.
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
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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December 13, 2019
Boston Scientific Corporation Carter Navarro Sr. Regulatory Affairs Manager 100 Boston Scientific Way Marlborough, MA 01752
Re: K193202
Trade/Device Name: EXALT Model D Single-Use Duodenoscope EXALT Controller Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDT, FET Dated: November 19, 2019 Received: November 20, 2019
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
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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 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,
Shanil P. Haugen, Ph.D. Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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)
Device Name
EXALT Model D Single Use Duodenoscope; EXALT Controller
Indications for Use (Describe)
EXALT Model D Single Use Duodenoscope:
The EXALT Model D Single-Use Duodenoscope is intended for use with a Boston Scientific endoscopic video imaging system, for endoscopy and endoscopic surgery within the duodenum.
EXALT Controller:
The EXALT Controller is intended for use with a Boston Scientific endoscopic diagnosis, treatment, and video observation.
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 (508) 382-4000 www.bostonscientific.com
510(k) Summary for EXALT Endoscopic Visualization System (EXALT Model D Single-Use Duodenoscope and EXALT Controller)
1. Submitter
Boston Scientific Corporation Endoscopy Division 100 Boston Scientific Way Marlborough, MA 01752
- Contact: Carter Navarro Fellow, Regulatory Affairs Phone: (508) 683-4793 E-mail: carter.navarro@bsci.com
Date Prepared: November 19, 2019
2. Device
| Trade Name: | EXALT Model D Single-Use Duodenoscope |
|---|---|
| Common Name: | Duodenoscope and accessories, flexible/rigid |
| Product Code: | FDT |
| Device Class: | Class II |
| Panel: | Gastroenterology/Urology |
| Classification Regulation: | 21 CFR 876.1500, Endoscope and accessories |
| Trade Name: | EXALT Controller |
| Common Name: | Endoscopic video imaging system/component, |
| gastroenterology-urology | |
| Product Code: | FET |
| Device Class: | Class II |
| Panel: | Gastroenterology/Urology |
| Classification Regulation: | 21 CFR 876.1500, Endoscope and accessories |
Image /page/3/Picture/9 description: The image shows the logo for Boston Scientific. The logo is in blue and features the words "Boston Scientific" stacked on top of each other. The font is a serif font, and the overall design is simple and professional. The logo is likely used to represent the company in various marketing and branding materials.
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3. Predicate Devices
| Trade Name: | EVIS EXERA II Duodenovideoscope TJF Type Q180 |
|---|---|
| Manufacturer: | Olympus Medical Systems Corp. |
| Clearance Number: | K143153 |
| Common Name: | Duodenoscope and accessories, flexible/rigid |
| Product Code: | FDT |
| Device Class and Panel: | Class II, Gastroenterology/Urology |
| Classification Regulation: | 21 CFR 876.1500, Endoscope and accessories |
| Trade Name: | CV-170 Video System Center |
| Manufacturer: | Olympus Medical Systems Corp. |
| Clearance Number: | K122831 |
| Common Name: | Endoscopic video imaging system/component, |
| gastroenterology-urology | |
| Product Code: | FET |
| Device Class and Panel: | Class II, Gastroenterology/Urology |
| Classification Regulation: | 21 CFR 876.1500, Endoscope and accessories |
4. Device Description
The EXALT Model D Single-Use Duodenoscope is a sterile, single-use, flexible duodenoscope used to examine the duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery. When connected to an EXALT Controller, the EXALT Model D Single-Use Duodenoscope provides imaging and illumination, 4-way steerable navigation, lens wash, insufflation, suction, facilitates image capture initiation, and allows the delivery of various ancillary devices.
The EXALT Controller is an endoscopic video imaging system that receives video signals from the EXALT Model D Single-Use Duodenoscope, processes the video signals, outputs video images to a video monitor, and outputs electrical signals that interface with external image capture systems. The EXALT Controller also controls the light transmitted by the tip of the EXALT Model D Single-Use Duodenoscope to illuminate the area of interest within the anatomy.
5. Indications for Use
The EXALT Model D Single-Use Duodenoscope is intended for use with a Boston Scientific endoscopic video imaging system, for endoscopy and endoscopic surgery within the duodenum.
The EXALT Controller is intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation.
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6. Technological Characteristics
A direct comparison of key characteristics demonstrates that the EXALT Model D Single-Use Duodenoscope and EXALT Controller are substantially equivalent to their respective predicate devices in terms of intended use, technological characteristics, and performance characteristics.
The EXALT Model D Single-Use Duodenoscope and the EVIS EXERA II Duodenovideoscope TJF Type Q180V share similar mechanical and optical characteristics, including working length, diameters, articulation angles, flow rates, resolution, direction of view, and field of view. The EXALT Model D Single-Use Duodenoscope is sterile, single-use, and not intended for reprocessing, whereas the EVIS EXERA II Duodenovideoscope TJF Type Q180V is intended to be reprocessed.
The EXALT Controller and the Olympus CV-170 Video System Center share similar video formats and outputs and illumination technology, though the light-emitting diodes in the EXALT Endoscopic Visualization System are located in the EXALT Model D Single-Use Duodenoscope rather than the EXALT Controller; whereas the light sources in Olympus endoscopic systems (including the CV-170 Video System Center) are located in the capital equipment.
7. Performance Data
Non-clinical testing was successfully performed on the proposed EXALT Model D Single-Use Duodenoscope and EXALT Controller
Performance testing (bench) was successfully completed to establish substantial equivalence between the proposed EXALT Model D Single-Use Duodenoscope and EXALT Controller and the predicate devices. This testing included the following:
- Working Length
- Insertion Portion Diameter ●
- Articulation Angles ●
- Flow Rates
- Reliability ●
- Resolution ●
- Direction of View
- Field of View
- Light Output .
6
Biocompatibility of the EXALT Model D Single-Use Duodenoscope was evaluated in accordance with ISO 10993-1. Electrical safety and electromagnetic compatibility of the EXALT Model D Single-Use Duodenoscope and EXALT Controller were evaluated in accordance with AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-2, and IEC 60601-2-18.
Clinical testing was performed to confirm procedural performance of the EXALT Model D Single-Use Duodenoscope and EXALT Controller in endoscopic cholangiopancreatography (ERCP) procedures.
8. Conclusion
The results of non-clinical and clinical testing demonstrate that the EXALT Model D Single-Use Duodenoscope and EXALT Controller are considered safe and effective for their intended uses. Boston Scientific has demonstrated that the proposed devices are substantially equivalent to the currently marketed predicate devices.