(133 days)
GlideScope® BFlex™ Single-Use Bronchoscopes are intended to work with a video monitor, in conjunction with non-powered endoscopic accessories and other equipment for endoscopy within the airways and tracheobronchial tree.
The GlideScope® BFlex™ 2.8 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™ 3.8, 5.0, and 5.8 Single-Use Bronchoscopes, the GlideScope® BFlex™ 2.8 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 monitors) for purposes of image display.
The provided text describes the 510(k) submission for the GlideScope® BFlex™ 2.8 Single-Use Bronchoscope. It primarily focuses on demonstrating substantial equivalence to predicate devices through design specifications and performance testing, rather than a clinical study involving AI assistance or complex human-in-the-loop evaluations.
Therefore, many of the requested criteria (e.g., sample size for test set with data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone algorithm performance, training set details) are not applicable or not explicitly stated in this document as the device is a bronchoscope, not an AI or imaging diagnostic tool that would typically undergo such rigorous clinical validation studies with ground truth established by experts.
Here's a breakdown based on the provided information:
1. A table of acceptance criteria and the reported device performance:
The document states: "All testing resulted in acceptance criteria passed." However, it does not provide a specific table detailing the acceptance criteria and the quantitative reported performance for each criterion. It lists the types of performance tests conducted.
| Acceptance Criterion Type | Result |
|---|---|
| Full System Requirements Testing | Passed |
| Electrical Safety (AAMI / ANSI ES60601-1, 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 (ANSI AAMI ISO 10993-1) | Passed |
| Aging Performance Testing | Passed |
| Sterile Packaging Integrity Testing | Passed |
| Cleaning Testing | Passed |
| Design Validation (Usability Study per IEC 60601-1-6, IEC 62366-1, AAMI HE75, FDA Guidance) | Found safe and effective |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test. For the Usability study, it mentions "All participants" were able to operate the device safely, but no specific number of participants is given.
- Data Provenance: Not specified regarding country of origin. The testing appeared to be internal performance testing of the device itself, rather than data collected from patients.
- Retrospective or Prospective: Not applicable as these are performance/engineering tests, not a clinical study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the ground truth was established by engineering specifications and recognized electrical, optical, and safety standards, rather than expert consensus on diagnostic imaging. The usability study involved users (likely healthcare professionals), but their role was to test the device's usability, not to establish diagnostic ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable as it's not a diagnostic study requiring adjudication of image interpretation or clinical outcomes.
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:
This is not applicable. This submission is for a medical device (flexible bronchoscope), not an AI-powered diagnostic system. No MRMC study was mentioned or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a bronchoscope, not an algorithm.
7. The type of ground truth used:
The ground truth or "acceptance criteria" for this device are established by engineering design specifications and compliance with international and national standards for medical electrical equipment, optical performance, biocompatibility, and usability (e.g., AAMI/ANSI, IEC, ISO standards).
8. The sample size for the training set:
This is not applicable. This is a hardware medical device; there is no "training set" in the context of an AI algorithm.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for an AI algorithm.
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November 3, 2021
Verathon Medical (Canada) ULC Teresa Davidson Director, Regulatory Affairs 2227 Douglas Road Burnaby, British Columbia V5C 5A9 Canada
Re: K211947
Trade/Device Name: GlideScope BFlex 2.8 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: September 30, 2021 Received: October 4, 2021
Dear Teresa Davidson:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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,
for 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)
K211947
Device Name GlideScope® BFlex™ 2.8 Single-Use Bronchoscope
Indications for Use (Describe)
GlideScope® BFlex™ Single-Use Bronchoscopes are intended to work with a video monitor, in conjunction with nonpowered endoscopic accessories and other equipment for endoscopy within the airways and tracheobronchial tree.
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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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 21, 2021
Establishment Registration Number:
Verathon Medical (Canada) ULC Registration Number: 9615393 Owner/Operator Number: 9095489
Device Trade or Proprietary Name:
GlideScope® BFIex™ 2.8 Single-Use Bronchoscope
Device Common or Usual Name:
Flexible Bronchoscope and accessories
| Device Trade or Proprietary Name | Device Common or Usual Name |
|---|---|
| GlideScope® BFlex™ 2.8 Single-UseBronchoscope | Flexible Bronchoscope and accessories |
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™ 2.8 Single-Use Bronchoscope is substantially equivalent to the previously cleared GlideScope® BFlex™ 3.8. 5.0. and 5.8 Single-Use Bronchoscopes. The 510(k) clearance numbers and respective clearance dates for the predicate devices are included in the table below:
| Predicate Device | 510(k) Number | Clearance Date |
|---|---|---|
| GlideScope® BFlex™ 3.8 Single-UseBronchoscope System | K193488 | January 16, 2020 |
| GlideScope® BFlex™ 5.0 Single-UseBronchoscope System | K183256 | January 04, 2019 |
| GlideScope® BFlex™ 5.8 Single-UseBronchoscope System | K191948 | August 21, 2019 |
Device Description:
The GlideScope® BFlex™ 2.8 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™ 3.8, 5.0, and 5.8 Single-Use Bronchoscopes, the GlideScope® BFlex™ 2.8 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 monitors) for purposes of image display.
Indications for 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® BFlex™ Single-Use system is for use in a hospital environment. The GlideScope BFlex bronchoscope is a single-use device designed for use in adults, with the BFlex 2.8 also designed for pediatric use (6 months to 6 years). It has been verified
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and validated for the following endotracheal tube (ETT) and endoscope accessory (EA) sizes:
| Model | Minimum ETT Internal Diameter | EA Minimum Working Channel Width |
|---|---|---|
| BFlex 2.8 | 4.0 mm | Not applicable |
| BFlex 3.8 | 5.0 mm | 1.2 mm |
| BFlex 5.0 | 6.0 mm | 2.1 mm |
| BFlex 5.8 | 7.0 mm | 3.0 mm |
Contraindications:
The GlideScope® BFlex™ 2.8 Single-Use Bronchoscope does not have a working channel and therefore cannot be used for therapeutic purposes.
Technological Characteristics:
The proposed subject GlideScope® BFlex™ 2.8 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:
| TechnologicalCharacteristic | PredicateGlideScope®BFlex™ 5.0Single-UseBronchoscope | PredicateGlideScope®BFlex™ 5.8Single-UseBronchoscope | PredicateGlideScope®BFlex™ 3.8Single-UseBronchoscope | ProposedGlideScope®BFlex™ 2.8Single-UseBronchoscope |
|---|---|---|---|---|
| Flexible Endoscope | Yes | Yes | Yes | Yes |
| Size DistinguishingColor(Non-patient contacting) | Blue | Yellow | Purple | Teal |
| Working ChannelMaterial(Patient contacting) | ThermoplasticPolyurethane(Medical grade) | ThermoplasticPolyurethane(Medical grade) | Fluoropolymer(Medical grade) | Not applicable |
| Tip sheath adhesiveand primer material(Patient contacting) | Cyanoacrylateadhesive andpolyolefinprimer | Same | Same | Same |
| Tip Sheath Material(Patient contacting) | Medicalthermoplasticelastomers | Same | Same | Different Grade |
| TechnologicalCharacteristic | PredicateGlideScope®BFlex™ 5.0Single-UseBronchoscope | PredicateGlideScope®BFlex™ 5.8Single-UseBronchoscope | PredicateGlideScope®BFlex™ 3.8Single-UseBronchoscope | ProposedGlideScope®BFlex™ 2.8Single-UseBronchoscope |
| Braided Shaft Material(Patient contacting) | Medicalthermoplasticelastomers | Same | Same | Different Grade |
| Outside Diameter ofFlexible InsertionTube/Shaft and DistalTip | 5.0mm | 5.8mm | 3.8mm | 2.8mm |
| Minimum InternalDiameter of WorkingChannel | 2.1mm | 3.0mm | 1.2mm | Not Applicable |
| Suction Port | Yes | Yes | Yes | Not Applicable |
| Accessory Port | Yes | Yes | Yes | Not Applicable |
| Single UseBronchoscope | Yes | Yes | Yes | Yes |
| Sterility | Sterile byEthylene Oxide(EO) | Same | Same | Same |
| Control Button for Tipmaneuverability | Yes | Yes | Yes | Yes |
| Power Source | RechargeableLithium-ionBattery | Same | Same | Same |
| Camera | Yes | Yes | Yes | Yes |
| Direction of View,Relative to Center Lineof Distal tip | 0° | Same | Same | Same |
| Field of view,horizontal/vertical | 85° | Same | Same | Same |
| Field of View, diagonal | 120° | Same | Same | Same |
| Depth of Field | 5-50mm | Same | Same | Same |
| Image Resolution | 640x480 | Same | Same | Same |
| LED Light Source | Yes | Yes | Yes | Yes |
| Image Display | Displays imageon a ReusableVideo Monitor | Same | Same | Same |
| Extended Viewing | Yes | Yes | 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 green "V" shape on the left, followed by the word "VERATHON" in blue, with a trademark symbol after the word. The logo is simple and modern, with a clean font and a bright color scheme.
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Performance Testing:
Performance testing has been completed to demonstrate that the proposed GlideScope® BFlex™ 2.8 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 ●
- IEC 60601-1-2:2014 Ed.4.0/EN 60601-1-2:2015 о Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- Optical testing according to .
- o ISO 8600-1:2015 (Ed. 4.0) Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements
- ISO 8600-3:2019 (Ed. 2.0) o 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
- o ISO 8600-1:2015 (Ed. 4.0) Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements
- Biocompatibility according to ●
- o ANSI AAMI ISO 10993-1:2018 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 .
- o Usability study
- The usability study was conducted per:
- o Usability study
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Image /page/8/Picture/0 description: The image shows the Verathon logo. The logo features a stylized "V" shape in blue and green, with the word "VERATHON" in blue, sans-serif font to the right of the "V" shape. The "V" shape is composed of two intersecting lines, with the left line in green and the right line in blue.
- IEC 60601-1-6. General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 62366-1, 2015, Medical devices Application of usability engineering to medical devices, which calls for usability and validation testing during medical device development, and
- AAMI HE75: 2009, Human factors engineering Design of medical devices
- Guidance for Industry and Food and Drug Administration Staff, - Applying Human Factors and Usability Engineering to Medical Devices (February 03, 2016)
The study was focused on user requirements and risk control measures related to the introduction of the smaller size GlideScope® BFlex™ 2.8 Single-Use Bronchoscope. Both pediatric (ages 6 months to 6 years old) and adult patient populations were considered. A comprehension test in addition to the simulated use scenarios was completed. All participants, overall, were able to operate the GlideScope® BFlex™ 2.8 Single-Use Bronchoscope safely and effectively. The result of this usability testing demonstrated that the GlideScope® BFlex™ 2.8 Single-Use Bronchoscope and associated labeling are safe and effective for the intended use, its intended users, and use environments.
All testing resulted in acceptance criteria passed. Results:
Summary of Clinical Tests:
The GlideScope® BFlex™ 2.8 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™ 2.8 Single-Use Bronchoscope is substantially equivalent to the previously cleared predicate GlideScope® BFIex™ 3.8, 5.0, and 5.8 Single-Use Bronchoscopes with respect to safety, effectiveness, and performance.
§ 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.