BFlex™ 2 Slim 3.8 Single-Use Bronchoscope is 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 BFlex™ 2 Slim 3.8 Single-Use Bronchoscope is a component to the BFlex™ Single-Use Bronchoscope System. The BFlex™ Single-Use Bronchoscope system consists of a single-use flexible bronchoscope, a reusable monitor, and a reusable cable. The BFlex™ 2 Single-Use Bronchoscope System provides real time viewing and recording for a wide range of airway procedures.

AI/ML Overview

The provided document describes a medical device called the BFlex™ 2 Slim 3.8 Single-Use Bronchoscope and its substantial equivalence to predicate devices. The information primarily focuses on performance testing and usability studies rather than a comparative effectiveness study with AI assistance.

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 that "All testing resulted in acceptance criteria passed" for comprehensive verification and validation testing, but it does not provide specific numerical acceptance criteria or detailed performance metrics for each test. Instead, it lists the types of tests performed.

Acceptance Criteria Category (Implied)	Reported Device Performance
Full System Requirements	Passed
Electrical Safety (IEC 60601-1, IEC 60601-2-18)	Passed
Electromagnetic Compatibility (IEC 60601-1-2)	Passed
Optical testing (ISO 8600-1, ISO 8600-3, ISO 8600-4)	Passed
Biocompatibility (ISO 10993-1)	Passed
Sterile Packaging Integrity	Passed
Cleaning	Passed
Design Validation (Usability Testing)	Excellent with 99.97% task success rate; no patterns of crucial use error or unacceptable negative use-safety assessments for pediatric claims

2. Sample size used for the test set and the data provenance

Test Set (Usability Study):
- Sample Size: Thirty (30) representative end users.
- Data Provenance: The document does not explicitly state the country of origin. It indicates the study was conducted as part of validation testing for the BFlex 2 family and employed methods used for a previously cleared device (K211947). The study was "simulated use scenarios," implying a prospective study design conducted in a controlled environment as opposed to real-world patient data.

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

Number of Experts: Thirty (30) users were involved in the usability study. These users served as the test subjects, and their performance/feedback established the "ground truth" for usability.
Qualifications of Experts:
- Fifteen (15) pediatric anesthesiologists.
- Fifteen (15) adult intensivists or pulmonologists.

4. Adjudication method for the test set

The document does not describe an explicit adjudication method for the usability study in the sense of resolving disagreements between multiple experts on a specific interpretation. The "ground truth" for the usability study was derived from observed participant performance and subjective assessments, suggesting direct measurement or user-reported feedback rather than a consensus process among reviewers.

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

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted.
AI Assistance: The device described (BFlex™ 2 Slim 3.8 Single-Use Bronchoscope) is a physical medical instrument (a bronchoscope). There is no mention of AI assistance or an AI component in its functionality or "human readers" in the context of diagnostic interpretation. Therefore, there's no information on effect size related to AI assistance.

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

Standalone Performance: Not applicable. The device is a physical bronchoscope, not an algorithm. Its performance is inherent to the instrument's design and functionality, not an algorithmic output that could be tested in a standalone manner.

7. The type of ground truth used

For Performance Testing (General): The ground truth for functional performance was established by compliance with recognized international and national standards (e.g., IEC, ISO) and internal design specifications. The document states, "All testing resulted in acceptance criteria passed," implying these standards and specifications defined the "truth."
For Usability Testing: The ground truth was based on observed participant performance and subjective assessments during simulated use scenarios. The "task success rate" and absence of "crucial use error or unacceptable negative use-safety assessments" formed the basis of this ground truth for usability.

8. The sample size for the training set

This document does not describe a training set as the device is a hardware product, not a machine learning algorithm.

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

Not applicable, as there is no mention of a training set for a machine learning model.

Summary

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May 3, 2023

Verathon Medical (Canada) ULC Chauneen Wood Director, RA 2227 Douglas Road Burnaby, B.C. V5C 5A9 Canada

Re: K230948

Trade/Device Name: BFlex™ 2 Slim 3.8 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: April 1, 2023 Received: April 4, 2023

Dear Chauneen Wood:

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

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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 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,

Shuchen Peng -S Shu-Chen Peng, Ph.D. 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) K230948

Device Name BFlex™ 2 Slim 3.8 Single-Use Bronchoscope

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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510(K) SUMMARY

This summary of Safety and Effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR 80792.

Submitter:

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

Contact Person:

Chauneen Leah Wood M.S., RAC Director, Regulatory Affairs Phone: (425) 419-4114 Email: chauneen.wood@verathon.com

Date Summary Prepared:

March 31, 2023

Establishment Registration Number:

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

Device Trade or Proprietary Name:

BFlex™ 2 Slim 3.8 Single-Use Bronchoscope

Device Common or Usual Name:

Flexible Bronchoscope

Device Trade or Proprietary Name	Device Common or Usual Name
BFlex™ 2 Slim 3.8 Single-Use Bronchoscope	Flexible Bronchoscope

Device Classification:

Device Panel	Ear, Nose, and Throat Devices
(Medical specialty)	Subpart E - Surgical Devices
Classification Regulation	21 CFR 874.4680
Classification Name	Bronchoscope (flexible or rigid) and accessories
Identification	A bronchoscope (flexible or rigid) and accessories is a tubularendoscopic device with any of a group of accessory devices whichattach to the bronchoscope and is intended to examine or treat thelarynx and tracheobronchial tree. It is typically used with a fiberoptic

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Device Panel(Medical specialty)	Ear, Nose, and Throat DevicesSubpart E – Surgical Devices
Classification Regulation	21 CFR 874.4680
	light source and carrier to provide illumination. The device is made ofmaterials such as stainless steel or flexible plastic. This generic type ofdevice includes the rigid ventilating bronchoscope, rigidnonventilating 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 bronchoscopeaspirating tube, but excludes the fiberoptic light source and carrier.
Product Code	EOQ
Classification	Class II

Predicate Device:

BFlex™ 2 Slim 3.8, and Ultraslim 2.8 Single-Use bronchoscopes are the legally market devices to which BFlex™ 2 Slim 3.8 Single-Use Bronchoscope claims substantial equivalence. The proposed BFlex™ 2 Slim 3.8 Single-Use Bronchoscope has the same intended use, and technological characteristics of the predicate. The predicates identified along with their 510(k) clearance numbers and respective clearance dates included in the table below:

Predicate Device	510(k) Number	Clearance Date
BFlex™ 2 Slim 3.8 Single-Use Bronchoscope System	K193488	January 16, 2020
BFlex™ 2 Ultraslim 2.8 Single-Use Bronchoscope System	K211947	November 03, 2021

Device Description:

Indication for Use:

The BFlex™ 2 Slim 3.8 Single-Use Bronchoscope is intended to work with a video monitor, in conjunction with non-powered endoscopic accessories and other ancillary equipment, for endoscopy within the airways and tracheobronchial tree.

Intended Patient Population:

The BFlex™ 2 Single-Use system is for use in a hospital environment. The BFlex™ 2 bronchoscope is a single-use device designed for use in adults, with the BFlex™ 2 Ultraslim 2.8 and BFlex™ Slim 3.8 also designed for pediatric use (Ultraslim 2.8-6 months to 6 years, Slim 3.8-6 years). It has been verified and validated for the following endotracheal tube (ETT) and endoscope accessory (EA) sizes:

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Model	Minimum ETT InternalDiameter	EA Minimum Working ChannelWidth
BFlex™ 2 Ultraslim 3.8	4.0 mm	-
BFlex™ 2 Slim 3.8	5.0 mm	1.2 mm

Note: There is no guarantee that instruments selected solely using these instrument dimensions will be compatible in combination.

Technological Characteristics:

The proposed BFlex™ 3.8 Single-Use Bronchoscope when compared to the predicate bronchoscopes has similar technological characteristics. See the comparison table below for similarities and differences between the proposed and predicate devices:

Comparison Table

Technological Characteristic	BFlex™ 2 Ultraslim2.8 Single-UseBronchoscope(Predicate)	BFlex™ 2Slim3.8 Single-UseBronchoscope(Predicate)	BFlex™ 2Slim3.8 Single-UseBronchoscope(Proposed)
Flexible Endoscope	Yes	Yes	Yes
Size Distinguishing Color(Non-patient contacting)	Teal	Purple	Purple
Outside Diameter of FlexibleInsertion Tube/Shaft and DistalTip	2.8mm	3.8mm	3.8mm
Minimum Internal Diameter ofWorking Channel	Not Applicable	1.2mm	1.2mm
Suction Port	Not Applicable	Yes	Yes
Accessory Port	Not Applicable	Yes	Yes
Single Use Bronchoscope	Yes	Yes	Yes
Sterility	Sterile by EthyleneOxide (EO)	Sterile by EthyleneOxide (EO)	Identical
Control Button for Tipmaneuverability	Yes	Yes	Yes
Power Source	RechargeableLithium-ion	RechargeableLithium-ion	Identical
Camera	Yes	Yes	Yes
Direction of View, Relative toCenter Line of Distal tip	0°	0°	Identical

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Technological Characteristic	BFlex™ 2 Ultraslim2.8 Single-UseBronchoscope(Predicate)	BFlex™ 2Slim3.8 Single-UseBronchoscope(Predicate)	BFlex™ 2Slim3.8 Single-UseBronchoscope(Proposed)
Field of view, horizontal/vertical	85°	Identical	Identical
Field of View, diagonal	120°	Identical	Identical
Depth of Field	5-50mm	Identical	Identical
Image Resolution	640x480	640x480	Identical
LED Light Source	Yes	Yes	Yes
Image Display	Displays image on aReusable VideoMonitor	Displays image ona Reusable VideoMonitor	Identical
Extended Viewing	Yes	Yes	Yes

Performance Testing:

Performance testing has been completed to demonstrate that the proposed BFlex™ 2 Slim 3.8 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
- ES60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment Part 1: O General requirements for basic safety and essential performance
- IEC 60601-2-18: Edition 3.0 2009-08 Particular requirements for the basic safety o and essential performance of endoscopic equipment
Electromagnetic Compatibility according to
- IEC 60601-1-2:2014 Ed.4.0 Medical electrical equipment Part 1-2: General O requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
Optical testing according to ●
- ISO 8600-1:2015 (Ed. 4.0) O Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements
- ISO 8600-3:2019 (Ed. 2.0) O

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verathon

Optics and Optical instruments - Medical endoscopes and endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics

ISO 8600-4:2014 (Ed. 2.0) o Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
Biocompatibility according to ●
- ISO 10993-1:2018 о

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Sterile Packaging Integrity Testing ●
Cleaning Testing ●
Design Validation
- Usability testing for the proposed BFlex 3.8 Single Use Bronchoscope for use with ● pediatric patients was conducted as part of the validation testing for the BFlex 2 family (all sizes). The usability study performed employed the same methods as was used for validation of the GlideScope BFlex 2.8 Single-Use Bronchoscope (K211947). The usability testing represents aa well-established method according to Section C of the "The Special 510(k) Program", Guidance for Industry ad Food and Drug Administration Staff (September 13, 2019).

This study was conducted with two (2) user groups with thirty (30) representative end users. Primary users included one group of fifteen (15) pediatric anesthesiologists and one group of fifteen (15) adult intensivists or pulmonologists. The assessment was accomplished through thirteen (13) simulated use scenarios with pediatric Anesthesiologist and adult Intensivist/Pulmonologists.

Overall performance using the BFlex 2 system was excellent with 99.97% task success rate for pediatric Anesthesiologists and adult Intensivists or Pulmonologists. The pertinent user and system requirements and results (Table L-5) associated with the pediatric claims for the proposed BFlex 2 Slim 3.8 Single-Use Bronchoscope device can be found in Section L, Table L-5 of the Special 510(k) application. Study data demonstrated based on observed participate performance and subjective assessments, that BFlex 2 bronchoscopes can be used by the intended users, in the intended use environment without patterns of crucial use error or unacceptable negative use-safety assessments.

Results: All testing resulted in acceptance criteria passed.

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verathon

Summary of Clinical Tests:

The Clinical testing was not performed as non-clinical studies were sufficient to support substantial equivalence.

Conclusion:

The information in this 510(k) Premarket Notification demonstrates that the proposed BFlex™ 2 Slim 3.8 Single-Use Bronchoscope is substantially equivalent to the previously cleared predicate BFlex™ 2 Slim 3.8 and Ultraslim 2.8 Single-Use Bronchoscopes 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.