EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor

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August 9, 2021 Boston Scientific Corporation Carter Navarro Fellow, Regulatory Affairs 100 Boston Scientific Way Marlborough, Massachusetts 01752 ### Re: K211030 Trade/Device Name: EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: July 8, 2021 Received: July 9, 2021 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. {1}------------------------------------------------ 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 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. for Shu-Chen Peng Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211030 Device Name EXALT Model B Single-Use Bronchoscope; EXALT Monitor Indications for Use (Describe) EXALT Model B Single-Use Bronchoscope: The EXALT Model B Single-Use Bronchoscope is intended for use with the EXALT Monitor for endoscopic procedures within the airways and tracheobronchial tree. EXALT Monitor: The EXALT Monitor is intended for use with a Boston Scientific single-use endoscope for endoscopic diagnosis, treatment, and video observations. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X 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. 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Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752-1234 (508) 683-4000 www.bostonscientific.com ## 510(k) Summary for EXALT Bronchoscopic Visualization System (EXALT Model B Single-Use Bronchoscope and EXALT Monitor) ### 1. Submitter Boston Scientific Corporation Endoscopy Division 100 Boston Scientific Way Marlborough, MA 01752 - Contact: Carter Navarro Fellow, Regulatory Affairs Phone: (508) 382-0356 E-mail: carter.navarro@bsci.com Date Prepared: April 5, 2021 ## 2. Device | Trade Name: | EXALT Model B Single-Use Bronchoscope (Slim);<br>EXALT Model B Single-Use Bronchoscope (Regular);<br>EXALT Model B Single-Use Bronchoscope (Large)<br>EXALT Monitor | |----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Bronchoscope (flexible or rigid) | | Product Code: | EOQ | | Device Class: | Class II | | Device Panel: | Ear Nose & Throat | | Classification Regulation: | 21 CFR 874.4680, Bronchoscope (flexible or rigid) and<br>accessories | # 3. Predicate Devices | Trade Name: | Ambu aScope 4 Broncho Slim 3.8/1.2<br>Ambu aScope 4 Broncho Regular 5.0/2.2<br>Ambu aScope 4 Broncho Large 5.8/2.8<br>Ambu aView Monitor | |-------------------|------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer: | Ambu A/S | | Clearance Number: | K173727 | | Common Name: | Bronchoscope (flexible or rigid) | {4}------------------------------------------------ | Product Code: | EOQ | |----------------------------|-------------------------------------------------------------------| | Device Class: | Class II | | Device Panel: | Ear Nose & Throat | | Classification Regulation: | 21 CFR 874.4680, Bronchoscope (flexible or rigid) and accessories | ### 4. Device Description The EXALT Model B Single-Use Bronchoscope is a sterile, single-use bronchoscope available in three sizes (Slim, Regular, and Large). The proposed device facilitates examination of the airways and trachea, delivery of accessories (Regular and Large sizes only), and delivery of live video when connected to an EXALT Monitor. The EXALT Monitor is an electronic device that: - Receives video signals from a Boston Scientific single-use endoscope, ● - Processes the video signals, ● - Displays image on integrated display ● - Outputs video images to a secondary video monitor when connected to AC mains, ● - Outputs electrical signal(s) that interface with external image capture systems, ● and - Saves and exports procedure images and videos. The EXALT Monitor also controls the light transmitted by the tip of the single-use endoscope to illuminate the area of interest within the anatomy. Buttons on the Monitor touch screen enable the user to control the brightness level of the light. # 5. Indications for Use The EXALT Model B Single-Use Bronchoscope is intended for use with the EXALT Monitor for endoscopic procedures within the airways and tracheobronchial tree. The EXALT Monitor is intended for use with a Boston Scientific single-use endoscope for endoscopic diagnosis, treatment, and video observations. # 6. Technological Characteristics The proposed EXALT Model B Single-Use Bronchoscope and EXALT Monitor share similar design features and functions with their respective predicate devices. The EXALT Model B Single-Use Bronchoscope and Ambu aScope 4 Broncho share similar mechanical and optical characteristics, including working length, diameters, articulation angles, resolution, direction of view, and field of view. Suction rates of the proposed device are equivalent or superior to those of the predicate device. Both devices {5}------------------------------------------------ | Item | Subject Device<br>EXALT Model B Single-Use<br>Bronchoscope | | | Predicate Device<br>Ambu aScope 4 Broncho | | | |------------------------------------------|------------------------------------------------------------|----------------------------------|--------------------------------|-------------------------------------------|----------------------------------|--------------------------------| | Field of View | 90° | | | 85° | | | | Direction of View | 0° | | | 0° | | | | Depth of Field | 6-50 mm | | | 6-50 mm | | | | Working Length | 60 cm | | | 60 cm | | | | Articulation Angle | Slim<br>180° up,<br>180° down | Regular<br>180° up,<br>180° down | Large<br>180° up,<br>180° down | Slim<br>180° up,<br>180° down | Regular<br>180° up,<br>180° down | Large<br>180° up,<br>160° down | | Insertion Tube<br>Outer Diameter | Slim<br>3.8 mm | Regular<br>5.0 mm | Large<br>5.8 mm | Slim<br>3.8 mm | Regular<br>5.0 mm | Large<br>5.8 mm | | Insertion Portion<br>Maximum<br>Diameter | Slim<br>4.3 mm | Regular<br>5.5 mm | Large<br>6.3 mm | Slim<br>4.3 mm | Regular<br>5.5 mm | Large<br>6.3 mm | | Minimum Working<br>Channel Diameter | Slim<br>1.0 mm | Regular<br>2.0 mm | Large<br>2.6 mm | Slim<br>1.2 mm | Regular<br>2.0 mm | Large<br>2.6 mm | | Average Working<br>Channel Diameter | Slim<br>1.2 mm | Regular<br>2.2 mm | Large<br>2.8 mm | Slim<br>1.2 mm | Regular<br>2.2 mm | Large<br>2.8 mm | | Minimum ETT<br>Inner Diameter<br>Size | Slim<br>5.0 mm | Regular<br>6.0 mm | Large<br>7.0 mm | Slim<br>5.0 mm | Regular<br>6.0 mm | Large<br>7.0 mm | | Minimum DLT<br>Inner Diameter<br>Size | Slim<br>35 Fr | Regular<br>41 Fr | Large<br>N/A | Slim<br>35 Fr | Regular<br>41 Fr | Large<br>N/A | are available in three sizes (Slim, Regular, and Large). Both devices are sterile, singleuse, and not intended for reprocessing. The EXALT Monitor and Ambu aView Monitor share similar physical and display specifications and similar controls for the respective visualization devices with which they are used. | Item | Subject Device<br>EXALT Monitor | Predicate Device<br>Ambu aView Monitor | |-------------------------------------|---------------------------------|----------------------------------------| | Maximum resolution | 2736 x 1824 | 800 x 480 | | Orientation | Landscape | Landscape | | Display Size | 12.3" | 8.5" | | Brightness control | Yes | Yes | | Contrast control | No | Yes | | Storage | 85 GB | 8 GB | | Battery Life | 1.5 hours | 3 hours | | Operating Environment (Temperature) | 10 - 33°C | 10 - 40°C | | Operating Environment (Humidity) | 30 - 85% | 30 - 85% | | Operating Environment (Pressure) | 700 - 1090 hPa | 800 - 1090 hPa | | Dimensions (W x H x D) | 13.6" x 8.4" x 2.3" | 9.49" x 6.89" x 1.32" | | Weight | 4.7 lbs. | 3.31 lbs. | {6}------------------------------------------------ ## 7. Substantial Equivalence A direct comparison of key characteristics demonstrates that the EXALT Model B Single-Use Bronchoscope and EXALT Monitor are substantially equivalent to their respective currently marketed predicate devices in terms of intended use, technological characteristics, and performance characteristics. The EXALT Model B Single-Use Bronchoscope and EXALT Monitor are substantially equivalent to the currently marketed predicate devices. # 8. Performance Data Non-clinical testing was successfully performed on the proposed EXALT Model B Single-Use Bronchoscope and EXALT Monitor. Performance testing (bench) was successfully completed to establish substantial equivalence between the proposed EXALT Model B Single-Use Bronchoscope and EXALT Monitor and the predicate devices. This testing included the following: - Insertion Portion Width ● - Working Channel Width - Working Length ● - . Field of View - Direction of View - Articulation Angles ● - Suction Rate ● - Resolution ● - Light Output ● - Durability - Photobiological Safety ● - Image Intensity Uniformity - Geometric Distortion - Noise ● - Dynamic Range ● - . Color Performance Applicable performance requirements were evaluated in accordance with the ISO 8600 series. Biocompatibility of the EXALT Model B Single-Use Bronchoscope was evaluated in accordance with ISO 10993-1. Electrical safety and electromagnetic compatibility of the EXALT Model B Single-Use Bronchoscope and EXALT Monitor were evaluated in accordance with AAMI / ANSI ES60601-1, IEC 60601-1-2, and IEC 60601-2-18. The results of non-clinical testing demonstrate that the EXALT Model B Single-Use Bronchoscope and EXALT Monitor are substantially equivalent to the currently marketed predicate devices. # 9. Conclusion Boston Scientific has demonstrated that the proposed EXALT Model B Single-Use Bronchoscope and EXALT Monitor are substantially equivalent to the currently marketed predicate devices.