(125 days)
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.
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.
The provided text pertains to a 510(k) premarket notification for the Boston Scientific EXALT Model B Single-Use Bronchoscope and EXALT Monitor. This document is a regulatory submission for a medical device and describes its equivalence to predicate devices, focusing on design, physical characteristics, and basic performance parameters.
Based on the provided text, the device is a bronchoscope and monitor system, not an AI/ML-enabled diagnostic device. Therefore, the standard acceptance criteria and study design elements typically associated with AI/ML devices (like sensitivity, specificity, AUC, ground truth establishment by experts, MRMC studies, or training/test set sample sizes for AI models) are not present in this document.
The "study" described in the document is a series of non-clinical, bench performance tests to demonstrate substantial equivalence to predicate devices, rather than a clinical trial or AI model validation study.
Here's an analysis based solely on the provided information, framed to address your query about acceptance criteria and study to the best extent possible given the document's nature:
Acceptance Criteria and Device Performance (Based on provided text)
The document outlines performance testing to establish substantial equivalence to predicate devices. The "acceptance criteria" are implied to be that the subject device's performance characteristics are equivalent or superior to the predicate device's, or fall within similar operational parameters.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied: Equivalent or Superior to Predicate) | Reported Device Performance (EXALT Model B) | Predicate Device Performance (Ambu aScope 4) |
|---|---|---|---|
| Field of View | ≥ 85° | 90° | 85° |
| Direction of View | 0° | 0° | 0° |
| Depth of Field | 6-50 mm | 6-50 mm | 6-50 mm |
| Working Length | 60 cm | 60 cm | 60 cm |
| Articulation Angle (Slim, Regular) | 180° up, 180° down | 180° up, 180° down | 180° up, 180° down |
| Articulation Angle (Large) | ≥ 160° down | 180° up, 180° down | 180° up, 160° down |
| Insertion Tube Outer Diameter (Slim) | 3.8 mm | 3.8 mm | 3.8 mm |
| Insertion Tube Outer Diameter (Regular) | 5.0 mm | 5.0 mm | 5.0 mm |
| Insertion Tube Outer Diameter (Large) | 5.8 mm | 5.8 mm | 5.8 mm |
| Insertion Portion Max Diameter (Slim) | 4.3 mm | 4.3 mm | 4.3 mm |
| Insertion Portion Max Diameter (Regular) | 5.5 mm | 5.5 mm | 5.5 mm |
| Insertion Portion Max Diameter (Large) | 6.3 mm | 6.3 mm | 6.3 mm |
| Minimum Working Channel Diameter (Slim) | ≤ 1.2 mm | 1.0 mm | 1.2 mm |
| Minimum Working Channel Diameter (Regular) | ≤ 2.0 mm | 2.0 mm | 2.0 mm |
| Minimum Working Channel Diameter (Large) | ≤ 2.6 mm | 2.6 mm | 2.6 mm |
| Average Working Channel Diameter (Slim) | 1.2 mm | 1.2 mm | 1.2 mm |
| Average Working Channel Diameter (Regular) | 2.2 mm | 2.2 mm | 2.2 mm |
| Average Working Channel Diameter (Large) | 2.8 mm | 2.8 mm | 2.8 mm |
| Minimum ETT Inner Diameter Size (Slim) | 5.0 mm | 5.0 mm | 5.0 mm |
| Minimum ETT Inner Diameter Size (Regular) | 6.0 mm | 6.0 mm | 6.0 mm |
| Minimum ETT Inner Diameter Size (Large) | 7.0 mm | 7.0 mm | 7.0 mm |
| Minimum DLT Inner Diameter Size (Slim) | 35 Fr | 35 Fr | 35 Fr |
| Minimum DLT Inner Diameter Size (Regular) | 41 Fr | 41 Fr | 41 Fr |
| Minimum DLT Inner Diameter Size (Large) | N/A | N/A | N/A |
| Monitor: Max Resolution | ≥ 800 x 480 | 2736 x 1824 | 800 x 480 |
| Monitor: Orientation | Landscape | Landscape | Landscape |
| Monitor: Display Size | ≥ 8.5" | 12.3" | 8.5" |
| Monitor: Brightness Control | Yes | Yes | Yes |
| Monitor: Contrast Control | Implied Yes (predicate has) | No | Yes |
| Monitor: Storage | ≥ 8 GB | 85 GB | 8 GB |
| Monitor: Battery Life | Implied ≥ 1.5 hours | 1.5 hours | 3 hours |
| Monitor: Operating Env. (Temp) | Within 10-40°C range | 10-33°C | 10-40°C |
| Monitor: Operating Env. (Humidity) | Within 30-85% range | 30-85% | 30-85% |
| Monitor: Operating Env. (Pressure) | Within 700-1090 hPa range | 700-1090 hPa | 800-1090 hPa |
| Monitor: Dimensions (W x H x D) | Comparable | 13.6" x 8.4" x 2.3" | 9.49" x 6.89" x 1.32" |
| Monitor: Weight | Comparable | 4.7 lbs. | 3.31 lbs. |
| Suction Rate | Equivalent or Superior | Superior | (Implicit) |
| Resolution (Bronchoscope) | Satisfactory | (Implicit) | (Implicit) |
| Light Output | Satisfactory | (Implicit) | (Implicit) |
| Durability | Satisfactory | (Implicit) | (Implicit) |
| Photobiological Safety | Satisfactory | (Implicit) | (Implicit) |
| Image Intensity Uniformity | Satisfactory | (Implicit) | (Implicit) |
| Geometric Distortion | Satisfactory | (Implicit) | (Implicit) |
| Noise | Satisfactory | (Implicit) | (Implicit) |
| Dynamic Range | Satisfactory | (Implicit) | (Implicit) |
| Color Performance | Satisfactory | (Implicit) | (Implicit) |
| Biocompatibility | ISO 10993-1 compliant | Compliant | (Implicit) |
| Electrical Safety & EMC | AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-18 compliant | Compliant | (Implicit) |
Notes on Acceptance Criteria:
- For characteristics like "Field of View" or "Max Resolution," the acceptance criterion is implied to be "at least as good as the predicate" or "within a clinically acceptable range similar to the predicate."
- For physical dimensions (e.g., Insertion Tube Outer Diameter, Monitor Dimensions, Weight), the acceptance criterion is implied to be "comparable to the predicate" such that it does not raise new questions of safety or effectiveness.
- For "Suction Rate," the document explicitly states "equivalent or superior."
- For "Contrast control" on the monitor, the subject device does not have it, while the predicate does. This is presented as a difference but not as a failure to meet acceptance criteria, likely because it was deemed not to affect substantial equivalence for the intended use.
- For "Battery Life," the subject device's 1.5 hours is less than the predicate's 3 hours. This is also a difference but not framed as a failure.
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not specify a "test set sample size" in the context of an AI/ML model. The evaluation described is "performance testing (bench)" on the physical devices. It would involve a sample of the manufactured bronchoscope and monitor units. The exact number of units tested is not stated.
- Data Provenance: Not applicable in the context of clinical/image data for an AI/ML device. The testing is bench-based, likely performed in the manufacturer's labs.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. This device is a bronchoscope and monitor, not an AI/ML diagnostic tool. There is no human image interpretation "ground truth" involved in the substantial equivalence testing described. The "ground truth" for these tests would be objective measurements of physical and performance parameters (e.g., measuring diameter, resolution charts, light meters, suction flow rates).
4. Adjudication Method
- Not applicable. There's no subjective interpretation or annotation process requiring adjudication for this type of device and testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC study was not conducted. This type of study is relevant for AI/ML-assisted diagnostic tools where human reader performance is being evaluated with and without AI assistance. This document describes a medical device (bronchoscope hardware) and its performance validation through bench testing, not an AI algorithm.
6. Standalone Performance (Algorithm Only)
- Not applicable. There is no AI algorithm being evaluated for standalone performance. The document describes the performance of a physical device system (bronchoscope and monitor).
7. Type of Ground Truth Used
- The "ground truth" for the performance tests described (e.g., field of view, resolution, suction rate) is based on objective physical measurements and engineering specifications obtained through bench testing, often against industry standards (e.g., ISO 8600 series). It is not clinical "expert consensus, pathology, or outcomes data."
8. Sample Size for Training Set
- Not applicable. This document does not describe the development or training of an AI/ML model, so there is no "training set."
9. How Ground Truth for Training Set Was Established
- Not applicable. As there is no AI/ML model, there is no training set and no associated ground truth establishment process in the context of medical image analysis.
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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.
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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
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Indications for Use
510(k) Number (if known)
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)
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Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752-1234 (508) 683-4000
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);EXALT Model B Single-Use Bronchoscope (Regular);EXALT Model B Single-Use Bronchoscope (Large)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) andaccessories |
3. Predicate Devices
| Trade Name: | Ambu aScope 4 Broncho Slim 3.8/1.2Ambu aScope 4 Broncho Regular 5.0/2.2Ambu aScope 4 Broncho Large 5.8/2.8Ambu aView Monitor |
|---|---|
| Manufacturer: | Ambu A/S |
| Clearance Number: | K173727 |
| Common Name: | Bronchoscope (flexible or rigid) |
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| 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
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| Item | Subject DeviceEXALT Model B Single-UseBronchoscope | Predicate DeviceAmbu 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 | Slim180° up,180° down | Regular180° up,180° down | Large180° up,180° down | Slim180° up,180° down | Regular180° up,180° down | Large180° up,160° down |
| Insertion TubeOuter Diameter | Slim3.8 mm | Regular5.0 mm | Large5.8 mm | Slim3.8 mm | Regular5.0 mm | Large5.8 mm |
| Insertion PortionMaximumDiameter | Slim4.3 mm | Regular5.5 mm | Large6.3 mm | Slim4.3 mm | Regular5.5 mm | Large6.3 mm |
| Minimum WorkingChannel Diameter | Slim1.0 mm | Regular2.0 mm | Large2.6 mm | Slim1.2 mm | Regular2.0 mm | Large2.6 mm |
| Average WorkingChannel Diameter | Slim1.2 mm | Regular2.2 mm | Large2.8 mm | Slim1.2 mm | Regular2.2 mm | Large2.8 mm |
| Minimum ETTInner DiameterSize | Slim5.0 mm | Regular6.0 mm | Large7.0 mm | Slim5.0 mm | Regular6.0 mm | Large7.0 mm |
| Minimum DLTInner DiameterSize | Slim35 Fr | Regular41 Fr | LargeN/A | Slim35 Fr | Regular41 Fr | LargeN/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 DeviceEXALT Monitor | Predicate DeviceAmbu 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. |
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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.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.