GlideScope® BFlex™ Single-Use Bronchoscopes are intended to work with the video monitor, in conjunction with nonpowered endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

Device Description

The GlideScope® BFlex™ 5.8 Single-Use Bronchoscope is one component of the GlideScope® BFlex™ Single-Use Bronchoscope System. The system consists of a single-use flexible bronchoscope, a reusable monitor, and a reusable cable. The GlideScope® BFlex™ Single-Use Bronchoscope System is intended to provide real time viewing and recording for a wide range of airway procedures. Similar to the predicate GlideScope® BFlex™ 5.0 Single-Use Bronchoscope, the GlideScope® BFlex™ 5.8 Single-Use Bronchoscope is distributed sterile and is for single use only. The GlideScope® BFlex™ bronchoscopes operate with a portable reusable GlideScope video monitor (GVM or Core monitor) for purposes of image display.

AI/ML Overview

This document describes the FDA's 510(k) clearance for the Verathon GlideScope® BFlex™ 5.8 Single-Use Bronchoscope. It is a PMA (Premarket Approval) submission, which means it evaluates the substantial equivalence of a new device to a predicate device already on the market. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to demonstrating substantial equivalence through performance testing, rather than a clinical trial for diagnostic accuracy or effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document states: "Performance testing has been completed to demonstrate that the proposed GlideScope® BFlex™ 5.8 Single-Use Bronchoscope meets the safety and performance requirements established in the design specifications." and "Results: All testing resulted in acceptance criteria passed."

However, the specific acceptance criteria and detailed performance results (e.g., numerical values for each test) are not provided in this summary. The table below lists the types of performance tests conducted, implying that the acceptance criteria are related to the successful outcome of these tests as defined in the design specifications.

Performance Test Category	Implicit Acceptance Criteria (Pass/Fail)	Reported Device Performance
Full System Requirements Testing	Device meets all defined system requirements	Passed
Electrical Safety (AAMI/ANSI ES60601-1, IEC 60601-2-18)	Compliance with specified electrical safety standards	Passed
Electromagnetic Compatibility (ANSI AAMI IEC 60601-1-2)	Compliance with specified EMC standards	Passed
Optical Testing (ISO 8600-1, 8600-3, 8600-4)	Compliance with specified optical performance standards (e.g., field of view, depth of field)	Passed
Biocompatibility (ANSI AAMI ISO 10993-1)	Biocompatibility according to specified standards	Passed
Aging Performance Testing	Device maintains performance over its intended lifespan	Passed
Sterile Packaging Integrity Testing	Packaging maintains sterility and integrity	Passed
Cleaning Testing	Not applicable for a single-use device, likely refers to residual testing for manufacturing materials or for the reusable monitor if mentioned. (The document states: "Similar to the predicate GlideScope® BFlex™ 5.0 Single-Use Bronchoscope, the GlideScope® BFlex™ 5.8 Single-Use Bronchoscope is distributed sterile and is for single use only." so "Cleaning Testing" likely refers to the cleaning validation of the reusable components of the system if any, or general manufacturing cleanliness standards.)	Passed
Design Validation	Device meets its intended use and design requirements	Passed

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes for the performance tests. It states that "The GlideScope® BFlex™ 5.8 Single-Use Bronchoscope, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This implies that the testing was primarily lab-based performance testing of the device and its components, rather than human clinical data. Therefore, data provenance in terms of patient data (country, retrospective/prospective) is not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for this type of submission. The "ground truth" for this device, being a bronchoscope, is primarily its physical and functional performance according to engineering and safety standards, not a diagnostic accuracy against a clinical ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 are used in clinical studies where expert consensus is needed for ground truth establishment. This submission focuses on engineering and performance validation.

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

No MRMC study was done. This is a medical device (bronchoscope) clearance based on substantial equivalence, not an AI diagnostic algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not an algorithm, so "standalone" performance in that context is not applicable. The device's "standalone" performance is its ability to physically function according to its specifications, which was tested during performance testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is compliance with established engineering, safety, and performance standards (e.g., ISO, IEC, AAMI standards) and the specifications derived from the predicate device. This is primarily objective, measurable test results, not clinical ground truth derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Summary

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August 21, 2019

Verathon Medical (Canada) ULC Haleh Ghassemi Technical Manager, Regulatory Affairs 2227 Douglas Road Burnaby, V5C 5A9 Ca

Re: K191948

Trade/Device Name: GlideScope BFlex 5.8 Single-Use Bronchoscope Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: July 19, 2019 Received: July 22, 2019

Dear Haleh Ghassemi:

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

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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 (OS) 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 mediation-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 Srinivas Nandkumar, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia 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

GlideScope® BFlex™ 5.8 Single-Use Bronchoscope

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image shows the logo for Verathon. The logo consists of a stylized "V" shape in blue and green, followed by the word "VERATHON" in blue, sans-serif font. The "V" shape is formed by two intersecting lines, with the left line in blue and the right line in green.

510(K) SUMMARY

This summary of Safety and Effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR 807, Subpart E, section 807.92.

Submitter:

Verathon Medical (Canada) ULC 2227 Douglas Road Burnaby, BC V3W 1P2 Canada

Contact Person:

Haleh Ghassemi Technical Manager, Regulatory Affairs Phone: (425) 629-5517 Email: haleh.ghassemi@verathon.com

Date Summary Prepared:

July 19, 2019

Establishment Registration Number:

Verathon Medical (Canada) ULC Registration Number: 9615393 Owner/Operator Number: 9095489

Device Trade or Proprietary Name:

GlideScope® BFlex™ 5.8 Single-Use Bronchoscope

Device Common or Usual Name:

Flexible Bronchoscope

Device Trade or Proprietary Name	Device Common or Usual Name
GlideScope® BFlex™ 5.8 Single-UseBronchoscope	Flexible Bronchoscope

Device Classification:

Classification Name	Class	Product Code	Classification Regulation
Bronchoscope (Flexible orRigid) and Accessories		EOQ	21 CFR 874.4680

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Image /page/4/Picture/0 description: The image shows the Verathon logo. The logo consists of a stylized "V" shape in blue and green, followed by the word "VERATHON" in blue, with a registered trademark symbol next to it. The logo is simple and modern, with a clean design.

Review Panel:

Ear. Nose, and Throat

Predicate Device:

The features and functions of the proposed GlideScope® BFlex™ 5.8 Single-Use Bronchoscope is substantially equivalent to the previously cleared GlideScope® BFlex™ 5.0 Single-Use Bronchoscope. The 510(k) clearance number and respective clearance date for the predicate device is included in the table below:

Predicate Device	510(k) Number	Clearance Date
GlideScope® BFlex™ 5.0 Single-UseBronchoscope System	K183256	January 04, 2019

Device Description:

Similar to the predicate GlideScope® BFlex™ 5.0 Single-Use Bronchoscope, the GlideScope® BFlex™ 5.8 Single-Use Bronchoscope is distributed sterile and is for single use only. The GlideScope® BFlex™ bronchoscopes operate with a portable reusable GlideScope video monitor (GVM or Core monitor) for purposes of image display.

Intended Use:

GlideScope® BFlex™ Single-Use bronchoscopes are intended to work with a video monitor, in coniunction with non-powered endoscopic accessories and other ancillary equipment, for endoscopy within the airways and tracheobronchial tree.

Intended Patient Population:

The GlideScope® BFIex™ Single-Use system is for use in a hospital environment. The GlideScope® BFlex™ bronchoscope is a single-use device designed for use in adults. It has been verified and validated for the following endotracheal tube (ETT) and endoscope accessory (EA) sizes:

Model	Minimum ETT Internal Diameter	EA Minimum Working Channel Width
BFlex 5.0	6.0 mm	2.1 mm
BFlex 5.8	7.0 mm	3.0 mm

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Technological Characteristics:

The proposed subject GlideScope® BFlex™ 5.8 Single-Use Bronchoscope when compared to the predicate bronchoscope has similar technological characteristics. See the comparison table below for similarities and differences between the proposed and predicate devices:

Technological Characteristic	Predicate GlideScope®BFlex™ 5.0 Single-UseBronchoscope	Proposed GlideScope®BFlex™ 5.8 Single-UseBronchoscope
Flexible Endoscope	Yes	Yes
Outside Diameter of FlexibleInsertion Tube/Shaft andDistal Tip	5.0mm	5.8mm
Minimum Internal Diameterof Working Channel	2.1mm	3.0mm
Suction Button	Yes	Yes
Single Use Bronchoscope	Yes	Yes
Sterility	Sterile by Ethylene Oxide(EO)	Same
Control Button for Tipmaneuverability	Yes	Yes
Power Source	Rechargeable Lithium-ionBattery	Same
Camera	Yes	Yes
Direction of View, Relative toCenter Line of Distal tip	0°	Same
Field of view,horizontal/vertical	85°	Same
Field of View, diagonal	120°	Same
Depth of Field	5-50mm	Same
Image Resolution	640x480	Same
LED Light Source	Yes	Yes
Image Display	Displays image on aReusable Video Monitor	Same
Extended Viewing	Yes	Yes

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Image /page/6/Picture/0 description: The image shows the logo for Verathon. The logo consists of a stylized "V" shape in green, with the word "VERATHON" in blue, sans-serif font to the right of the "V". The "V" shape is formed by two intersecting lines, with the left line extending slightly higher than the right line. The logo is simple and modern, with a clean and professional look.

Performance Testing:

Performance testing has been completed to demonstrate that the proposed GlideScope® BFlex™ 5.8 Single-Use Bronchoscope meets the safety and performance requirements established in the design specifications. Comprehensive verification and validation testing included the following:

Full System Requirements Testing
Electrical Safety according to ●
- AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
- IEC 60601-2-18: Edition 3.0 2009-08 o Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
Electromagnetic Compatibility according to ●
- ANSI AAMI IEC 60601-1-2:2014 Edition 4.0 o Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 4)
Optical testing according to ●
- ISO 8600-1 Fourth Edition 2015-10-15 Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements
- o ISO 8600-3 First edition 1997-07-01 (Amendment 1 2003-12-01 Optics and Optical instruments - Medical endoscopes and endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics [Including: Amendment 1 (2003)]
- ISO 8600-4 Second Edition 2014-03-15 Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
Biocompatibility according to ●
- ANSI AAMI ISO 10993-1:2009/(R)2013 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Aging Performance Testing ●
Sterile Packaging Integrity Testing
Cleaning Testing ●
Design Validation ●

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Image /page/7/Picture/0 description: The image shows the logo for Verathon. The logo consists of a stylized green plant-like symbol on the left, followed by the word "VERATHON" in blue, with a registered trademark symbol next to it. The logo is simple and modern, with a focus on the company name.

Results: All testing resulted in acceptance criteria passed.

Summary of Clinical Tests:

The GlideScope® BFlex™ 5.8 Single-Use Bronchoscope, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.

Conclusion:

The information in this 510(k) Premarket Notification demonstrates that the proposed GlideScope® BFlex™ 5.8 Single-Use Bronchoscope is substantially equivalent to the previously cleared predicate GlideScope® BFlex™ 5.0 Single-Use Bronchoscope with respect to safety, effectiveness, and performance.

Regulation Number and Section

§ 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.