(23 days)
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.
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.
This document does not contain the specific acceptance criteria or details of a study structured to prove a device meets those criteria in the manner one would find for an AI/ML medical device. Instead, it is an FDA 510(k) clearance letter for a hardware (medical device) product, specifically an endoscope and its controller.
Therefore, many of the requested points, such as sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and sample size/ground truth for training sets, are not applicable to the information provided. These elements are typically part of a submission for software as a medical device (SaMD) or AI/ML-driven devices.
However, based on the provided text, I can extract and infer information relevant to the device's performance demonstration for its 510(k) clearance, framed in the context of substantial equivalence to predicate devices:
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices seeking 510(k) clearance, the "acceptance criteria" are generally demonstrating substantial equivalence to a legally marketed predicate device across various characteristics. The "reported device performance" refers to how the new device matches or performs comparably to the predicate device in those characteristics.
| Characteristic | Acceptance Criteria (Substantial Equivalence to Predicate) | Reported Device Performance (EXALT Model D / Controller) |
|---|---|---|
| Intended Use | Must be the same as the predicate devices. | Same intended use: "endoscopy and endoscopic surgery within the duodenum" (Duodenoscope); "endoscopic diagnosis, treatment, and video observation" (Controller). |
| Technological Characteristics | Similar mechanical and optical characteristics (working length, diameters, articulation angles, flow rates, resolution, direction of view, field of view). Similar video formats, outputs, and illumination technology. | "Share similar mechanical and optical characteristics, including working length, diameters, articulation angles, flow rates, resolution, direction of view, and field of view." (Duodenoscope)"Share similar video formats and outputs and illumination technology" (Controller). Key difference: LEDs in duodenoscope, not controller (unlike predicate). |
| Performance Data (Bench) | Must demonstrate comparable performance to predicate in specified areas. | Successful performance testing completed for: Working Length, Insertion Portion Diameter, Articulation Angles, Flow Rates, Reliability, Resolution, Direction of View, Field of View, Light Output. |
| Biocompatibility | Must meet ISO 10993-1 standards. | Evaluated in accordance with ISO 10993-1. |
| Electrical Safety / EMC | Must meet AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-2, and IEC 60601-2-18 standards. | Evaluated in accordance with AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-2, and IEC 60601-2-18. |
| Procedural Performance (Clinical) | Must confirm performance in relevant clinical procedures. | Clinical testing performed to confirm procedural performance in endoscopic cholangiopancreatography (ERCP) procedures. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "clinical testing" for procedural performance but does not specify the sample size (i.e., number of patients or procedures) used for this clinical study.
- Data Provenance: The document does not explicitly state the country of origin or whether the clinical data was retrospective or prospective. It only states "Clinical testing was performed to confirm procedural performance...".
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This point is not applicable. For hardware devices like endoscopes, "ground truth" as conceptualized for AI/ML performance (e.g., expert consensus on image interpretation) is not typically established in the same way. The procedural performance evaluation would likely involve assessments by practicing physicians/endoscopists, but their role is to assess the device's functionality and efficacy during the procedure, not to create an image-based "ground truth" dataset for an algorithm.
4. Adjudication Method for the Test Set
This point is not applicable. As there's no specific "test set" in the AI/ML sense (e.g., images requiring interpretation), there's no mention of an adjudication method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This point is not applicable. MRMC studies are typically for evaluating the impact of AI on human reader performance, which is not relevant for this hardware device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This point is not applicable. The EXALT Model D Duodenoscope and EXALT Controller are hardware devices, not standalone algorithms.
7. The Type of Ground Truth Used
The concept of "ground truth" (expert consensus, pathology, outcomes data) as applied to AI/ML image analysis is not relevant here. For a medical device like an endoscope, the "truth" is its functional performance during procedures, its ability to provide clear imaging, enable tool delivery, and adhere to safety standards (biocompatibility, electrical safety). The clinical testing assessed "procedural performance," which means observing the device's operation in real use cases, rather than establishing a diagnostic ground truth from images.
8. The Sample Size for the Training Set
This point is not applicable. Hardware devices like endoscopes do not have "training sets" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
This point is not applicable, as there is no training set for a machine learning algorithm.
{0}------------------------------------------------
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.
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
{1}------------------------------------------------
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
{2}------------------------------------------------
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)
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."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the text "K193202" followed by "Page 1 of 4". The text is in a simple, sans-serif font and is likely part of a document or report. The page number indicates that this is the first page of a four-page document. The alphanumeric code "K193202" could be a document identifier or reference number.
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.
{4}------------------------------------------------
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.
{5}------------------------------------------------
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.
§ 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.