(30 days)
Not Found
No
The summary describes a standard video bronchoscope system with a single-use scope and reusable monitor. There is no mention of AI, ML, image processing beyond real-time viewing, or any data analysis or interpretation capabilities that would suggest the use of AI/ML. The performance studies focus on basic device functionality and safety, not algorithmic performance.
No
The device is a bronchoscope intended for viewing and recording within the airways and tracheobronchial tree, not for treating conditions.
No
The device description states its purpose is "to provide real time viewing and recording for a wide range of airway procedures." This indicates it is for visualization and procedural guidance, not for diagnosing conditions.
No
The device description explicitly states the system consists of a single-use flexible bronchoscope, a reusable monitor, and a reusable cable, indicating significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "endoscopy within the airways and tracheobronchial tree." This describes a procedure performed directly on a patient's body to visualize internal structures.
- Device Description: The description reinforces this by detailing a flexible bronchoscope used for "real time viewing and recording for a wide range of airway procedures."
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health. The provided text does not mention the analysis of any biological samples.
Therefore, the GlideScope® BFlex™ Single-Use Bronchoscope is a medical device used for direct visualization within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EOQ
Device Description
The GlideScope® BFlex™ 3.8 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 and 5.8 Single-Use Bronchoscopes, the GlideScope® BFlex™ 3.8 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airways and tracheobronchial tree
Indicated Patient Age Range
The GlideScope® BFlex™ bronchoscope is a single-use device designed for use in adults.
Intended User / Care Setting
hospital environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing has been completed to demonstrate that the proposed GlideScope® BFlex™ 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
- 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
- Electromagnetic Compatibility according to
- ANSI AAMI IEC 60601-1-2:2014 Edition 4.0 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
- 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
Results: All testing resulted in acceptance criteria passed.
Summary of Clinical Tests:
The GlideScope® BFlex™ 3.8 Single-Use Bronchoscope, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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January 16, 2020
Verathon Medical (Canada) ULC Teresa Davidson Director, Regulatory Affairs 2227 Douglas Road Burnaby, BC V3W 1P2 Canada
Re: K193488
Trade/Device Name: GlideScope BFlex 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: December 16, 2019 Received: December 17, 2019
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
1
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 Michael Ryan 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193488
Device Name
GlideScope® BFlex™ 3.8 Single-Use Bronchoscope
Indications for Use (Describe)
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.
| 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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Image /page/3/Picture/0 description: The image shows the logo for Verathon. The logo consists of a stylized "V" shape in teal, with the word "VERATHON" in teal, sans-serif font to the right of the "V". The "V" shape is formed by two curved lines that converge at the bottom, resembling a stylized plant or sprout.
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:
December 16, 2019
Establishment Registration Number:
Verathon Medical (Canada) ULC Registration Number: 9615393 Owner/Operator Number: 9095489
Device Trade or Proprietary Name:
GlideScope® BFlex™ 3.8 Single-Use Bronchoscope
Device Common or Usual Name:
Flexible Bronchoscope
| Device Trade or Proprietary Name | Device Common or Usual Name |
|---|---|
| GlideScope® BFlex™ 3.8 Single-Use | |
| Bronchoscope | Flexible Bronchoscope |
Device Classification:
| Classification Name | Class | Product Code | Classification Regulation |
|---|---|---|---|
| Bronchoscope (Flexible or | |||
| Rigid) and Accessories | II | 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. The "V" shape is formed by two intersecting lines, with the left line in blue and the right line in green. The word "VERATHON" is in a sans-serif font, with a registered trademark symbol after the word.
Review Panel:
Ear. Nose, and Throat
Predicate Device:
The features and functions of the proposed GlideScope® BFlex™ 3.8 Single-Use Bronchoscope is substantially equivalent to the previously cleared GlideScope® BFlex™ 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™ 5.0 Single-Use | ||
| Bronchoscope | K183256 | January 04, 2019 |
| GlideScope® BFlex™ 5.8 Single-Use | ||
| Bronchoscope | K191948 | August 21, 2019 |
Device Description:
The GlideScope® BFlex™ 3.8 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 and 5.8 Single-Use Bronchoscopes, the GlideScope® BFlex™ 3.8 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 conjunction 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. It
has been verified and validated for the following endotracheal tube (ETT) and endoscope accessory (EA) sizes:
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Image /page/5/Picture/0 description: The image shows the logo for Verathon. The logo consists of a stylized green checkmark-like symbol on the left, followed by the word "VERATHON" in blue, sans-serif font. A small registration mark is present to the right of the word.
| Model | Minimum ETT Internal Diameter | EA Minimum Working Channel
Width |
|-----------|-------------------------------|-------------------------------------|
| 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 |
Technological Characteristics:
The proposed subject GlideScope® 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:
| Technological
Characteristic | Predicate
GlideScope®
BFlex™ 5.0
Single-Use
Bronchoscope | Predicate
GlideScope®
BFlex™ 5.8
Single-Use
Bronchoscope | Proposed
GlideScope®
BFlex™ 3.8
Single-Use
Bronchoscope |
|-------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------|
| Flexible Endoscope | Yes | Yes | Yes |
| Size Distinguishing
Color
(Non-patient
contacting) | Blue | Yellow | Purple |
| Working Channel
Material
(Patient contacting) | Thermoplastic
Polyurethane
(Medical grade) | Thermoplastic
Polyurethane
(Medical grade) | Fluoropolymer
(Medical grade) |
| Tip sheath adhesive
and primer material
(Patient contacting) | No | No | Yes |
| Outside Diameter of
Flexible Insertion
Tube/Shaft and
Minimum Internal
Diameter of
Working Channel | 5.0mm
2.1mm | 5.8mm
3.0mm | 3.8mm
1.2mm |
| Suction Button | Yes | Yes | Yes |
| Single Use
Bronchoscope | Yes | Yes | Yes |
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Image /page/6/Picture/0 description: The image shows the Verathon logo. The logo consists of a stylized "V" shape in green and blue, followed by the word "VERATHON" in blue. The "V" shape is formed by two curved lines that meet at a point, with the left side in green and the right side in blue. The word "VERATHON" is in a sans-serif font, with a registered trademark symbol next to the "N".
| Technological
Characteristic | Predicate
GlideScope®
BFlex™ 5.0
Single-Use
Bronchoscope | Predicate
GlideScope®
BFlex™ 5.8
Single-Use
Bronchoscope | Proposed
GlideScope®
BFlex™ 3.8
Single-Use
Bronchoscope |
|-----------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------|
| Sterility | Sterile by
Ethylene Oxide
(EO) | Same | Same |
| Control
Button for Tip | Yes | Yes | Yes |
| Power Source | Rechargeable
Lithium-ion
Battery | Same | Same |
| Camera | Yes | Yes | Yes |
| Direction of View,
Relative to | 0° | Same | Same |
| Field of
view. | 85° | Same | Same |
| Field of View, | 120° | Same | Same |
| Depth of Field | 5-50mm | Same | Same |
| Image Resolution | 640x480 | Same | Same |
| LED Light Source | Yes | Yes | Yes |
| Image Display | Displays image
on a Reusable
Video Monitor | Same | Same |
| Extended Viewing | Yes | Yes | Yes |
Performance Testing:
Performance testing has been completed to demonstrate that the proposed GlideScope® BFlex™ 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 ィ
- Electrical Safety according to ィ
- o 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
- o IEC 60601-2-18: Edition 3.0 2009-08
- o AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment
7
Image /page/7/Picture/0 description: The image shows the Verathon logo. The logo consists of a stylized "V" shape in green and blue, followed by the word "VERATHON" in blue, sans-serif font. A small circle is present to the right of the word "VERATHON".
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
- o 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 ﻬ
- Sterile Packaging Integrity Testing r
- Cleaning Testing ﻬ
- Design Validation
Results: All testing resulted in acceptance criteria passed.
Summary of Clinical Tests:
The GlideScope® BFlex™ 3.8 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™ 3.8 Single-Use Bronchoscope is substantially equivalent to the previously cleared predicate GlideScope® BFlex™ 5.0 and 5.8 Single-Use Bronchoscopes with respect to safety, effectiveness, and performance.