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

Device Description

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

AI/ML Overview

Here's an analysis of the provided text regarding the GlideScope® BFlex™ Single-Use Bronchoscope System, focusing on the acceptance criteria and study information:

Acceptance Criteria and Device Performance

The provided document describes a 510(k) premarket notification for the GlideScope® BFlex™ Single-Use Bronchoscope System. For this type of submission, the primary method of demonstrating safety and effectiveness is through substantial equivalence to a legally marketed predicate device. This often means demonstrating that the new device has similar technological characteristics and performs comparably to the predicate device, meeting established design specifications and relevant standards.

The document does not provide a direct table of specific numerical acceptance criteria and reported device performance values in the way one might expect for a standalone diagnostic algorithm with metrics like sensitivity, specificity, or AUC. Instead, the "acceptance criteria" are implied by successful completion of various engineering and performance tests against established standards and design specifications. The "reported device performance" is a general statement that these tests were passed.

Here's an interpretation based on the provided text:

Acceptance Criteria (Implied)	Reported Device Performance
Meets System Requirements	All System Requirements Testing passed
Meets Hardware Verification standards	All Hardware Verification passed
Meets Software Verification standards	All Software Verification passed
Complies with AAMI / ANSI ES60601-1 (medical electrical equipment safety)	Testing resulted in acceptance criteria passed
Complies with IEC 60601-2-18 (endoscopic equipment safety)	Testing resulted in acceptance criteria passed
Complies with ANSI AAMI IEC 60601-1-2 (EMC for medical equipment)	Testing resulted in acceptance criteria passed
Complies with ISO 8600-1 (general endoscope requirements)	Testing resulted in acceptance criteria passed
Complies with ISO 8600-3 (field of view/direction of view)	Testing resulted in acceptance criteria passed
Complies with ISO 8600-4 (max width of insertion portion)	Testing resulted in acceptance criteria passed
Complies with ANSI AAMI ISO 10993-1 (biological evaluation)	Testing resulted in acceptance criteria passed
Maintains performance over time (Aging Performance)	Testing resulted in acceptance criteria passed
Maintains sterile barrier (Sterile Packaging Integrity)	Testing resulted in acceptance criteria passed
Effective cleaning procedures (Cleaning Testing)	Testing resulted in acceptance criteria passed
Meets design specifications and intended use (Design Validation)	Testing resulted in acceptance criteria passed

Study Details

Based on the provided text, here are the answers to your specific questions:

A table of acceptance criteria and the reported device performance:
- As detailed above, the document implies passing various engineering and performance tests against recognized standards and internal design specifications. A direct table of numerical "acceptance criteria" for metrics like sensitivity/specificity for a diagnostic AI is not present because this is a hardware device (bronchoscope) and a 510(k) submission, not an AI/diagnostic software submission. The overall reported performance is that "All testing resulted in acceptance criteria passed."
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 a "test set" in the context of clinical data or AI model evaluation. The performance testing refers to engineering verification and validation testing of the hardware device, not evaluation against a clinical dataset with ground truth. Therefore, information on sample size, data provenance (country, retrospective/prospective) for a clinical test set is not applicable or provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not applicable and not provided. The "ground truth" here is compliance with engineering standards and design specifications, which is typically assessed by engineers and quality assurance personnel, not clinical experts for diagnostic accuracy.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable and not provided. Adjudication methods are relevant for ambiguous clinical cases in a diagnostic study, which is not what this document describes.
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, an MRMC comparative effectiveness study was not done. The document explicitly states: "The GlideScope® BFlex™ Single-Use Bronchoscope System, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This device is a bronchoscope, not an AI-powered diagnostic tool, so a study of human readers with/without AI assistance is outside the scope of this submission.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This question is not applicable. The device is a bronchoscope, a hardware medical device with an imaging component, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is the successful demonstration of compliance with established engineering standards, design specifications, and regulatory requirements (e.g., ISO, IEC, AAMI standards for medical devices, biological evaluation, electrical safety, etc.). It's not clinical ground truth like pathology or expert consensus.
The sample size for the training set:
- This information is not applicable and not provided. This device is a hardware bronchoscope, not an AI algorithm that undergoes "training" on a dataset.
How the ground truth for the training set was established:
- This information is not applicable and not provided for the same reasons as point 8.

Summary

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January 4, 2019

Verathon Medical (Canada) ULC % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313

Re: K183256

Trade/Device Name: GlideScope BFlex™ Single-Use Bronchoscope System Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOO Dated: December 14, 2018 Received: December 21, 2018

Dear Mark Job:

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 (reporting of medical devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely yours.

Srinivas Nandkumar -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183256

Device Name

GlideScope® BFlex™ Single-Use Bronchoscope System

Indications for Use (Describe)

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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SECTION E: 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:

Teresa Davidson Director, Regulatory Affairs Phone: (425) 629-5516 Email: teresa.davidson@verathon.com

Date Summary Prepared:

October 26, 2018

Establishment Registration Number:

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

Device Trade or Proprietary Name:

GlideScope® BFlex™ Single-Use Bronchoscope System

Device Common or Usual Name:

Flexible Bronchoscope

Device Classification:

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

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Review Panel:

Ear, Nose, and Throat

Predicate Device:

The features and functions of the proposed GlideScope® BFlex™ Single-Use Bronchoscope System is substantially equivalent to the previously cleared Ambu® aScope™ 3 5.0/2.2 flexible bronchoscope and monitor system. The 510(k) clearance number and respective clearance date for the predicate device is below:

Predicate Device	510(k) Number	Clearance Date
Ambu® aScope™ 3 5.0/2.2*Ambu® aScope™ 3 Slim 3.8/1.2Ambu® aView™ Monitor	K130845	November 01, 2013

The specific Ambu® aScope™ 3 5.0/2.2 is the predicate device size for the proposed GlideScope® BFlex™ Single-Use Bronchoscope System. This size scope is labeled as Reqular in Ambu labeling.

Device Description:

Intended Use:

Technological Characteristics:

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

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TechnologicalCharacteristic	Predicate Device AmbuaScope 3 System(K130845)	GlideScope® BFlex™Single Use Sytem(This submission)
Flexible Endoscope	Yes	Yes
Outside diameter offlexible shaft and tip	5.0mm	5.5mm
Inside diameter ofworking channel	2.0mm	2.1mm
Suction Button	Yes	Yes
Single UseBronchoscope	Yes	Yes
Sterility	Sterile by Ethylene Oxide (EO)	Same
Control button for tipmaneuverability	Yes	Yes
Power Source	Rechargeable Lithium-ionbattery	Same
Camera	Yes	Yes
LED Light Source	Yes	Yes
Image Display	Displays image on a reusablemonitor	Same
Extended Viewing	Yes	Yes

Performance Testing:

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

System Requirements Testing
. Hardware Verification
Software Verification
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 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
ANSI AAMI IEC 60601-1-2:2007/(R)2012 ●

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Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests (Edition 3)
. ISO 8600-1 Fourth Edition 2015-10-15 Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements
SO 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
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

Results: All testing resulted in acceptance criteria passed.

Summary of Clinical Tests:

The GlideScope® BFlex™ Single-Use Bronchoscope System, 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™ Single-Use Bronchoscope System is substantially equivalent to the previously cleared predicate Ambu® aScope™ 3 5.0/2.2, Ambu® aScope™ 3 Slim 3.8/1.2, and Ambu® aView™ Monitor bronchoscope system 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.