(30 days)
Not Found
No
The summary describes a standard video bronchoscope system and does not mention any AI or ML capabilities, image processing beyond real-time viewing, or data sets for training or testing.
No.
The device is described as a bronchoscope system intended for viewing and recording within the airways and tracheobronchial tree. Its function is diagnostic and observational, focusing on providing real-time viewing for airway procedures, rather than delivering a therapeutic intervention or treatment.
No
The device is described as a bronchoscope system intended for real-time viewing and recording for a wide range of airway procedures, providing visualization rather than making a diagnosis.
No
The device description explicitly states that 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, the GlideScope® BFlex™ Single-Use Bronchoscope 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 on the patient's body (in vivo), not on samples taken from the body (in vitro).
- Device Description: The description details a system for real-time viewing and recording during airway procedures, which is consistent with an endoscopic device used directly on a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to provide visual access to the airways.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The GlideScope® BFlex™ Bronchoscope's function is purely for visualization during a medical procedure.
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™ 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.
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
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™ 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
Results: All testing resulted in acceptance criteria passed.
The GlideScope® BFlex™ 5.8 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
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 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
2
Indications for Use
510(k) Number (if known)
Device Name
GlideScope® BFlex™ 5.8 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) | |
|---|---|
| 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-Use | |
| Bronchoscope | Flexible Bronchoscope |
Device Classification:
| Classification Name | Class | Product Code | Classification Regulation |
|---|---|---|---|
| Bronchoscope (Flexible or | |||
| Rigid) 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-Use | ||
| Bronchoscope System | K183256 | January 04, 2019 |
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.
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 |
5
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-Use
Bronchoscope | Proposed GlideScope®
BFlex™ 5.8 Single-Use
Bronchoscope |
|------------------------------------------------------------------------|----------------------------------------------------------------|---------------------------------------------------------------|
| Flexible Endoscope | Yes | Yes |
| Outside Diameter of Flexible
Insertion Tube/Shaft and
Distal Tip | 5.0mm | 5.8mm |
| Minimum Internal Diameter
of 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 Tip
maneuverability | Yes | Yes |
| Power Source | Rechargeable Lithium-ion
Battery | Same |
| Camera | Yes | Yes |
| Direction of View, Relative to
Center 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 a
Reusable 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 ●
7
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.