(44 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on real-time viewing and recording without suggesting advanced image analysis or decision support.
No.
The device is a bronchoscope system used for viewing and recording within the airways, which is a diagnostic and procedural guidance function, not a therapeutic treatment.
Yes
The device is intended to provide "real time viewing and recording for a wide range of airway procedures." This visual information is used to assess the airways and tracheobronchoal tree, which is a diagnostic function.
No
The device description explicitly states that the system consists of a single-use flexible bronchoscope, a reusable monitor, and a reusable cable, indicating the presence of hardware components. The performance studies also include hardware verification.
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 on the patient's body to visualize internal structures.
- Device Description: The description details a flexible bronchoscope, monitor, and cable used for "real time viewing and recording for a wide range of airway procedures". This aligns with an endoscopic device used for direct visualization.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, tissue samples, etc. IVD devices are designed to analyze these types of samples to provide diagnostic information.
Therefore, the GlideScope® BFlex™ Single-Use Bronchoscope System is a medical device used for endoscopic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EOO, EOQ
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.
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
adult patients
Intended User / Care Setting
Not Found
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™ 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
- 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.
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 logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
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.
1
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
2
Indications for Use
510(k) Number (if known) K183256
Device Name
GlideScope® BFlex™ Single-Use Bronchoscope System
Indications for Use (Describe)
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.
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 on the left, followed by the word "VERATHON" in blue, sans-serif font. The "V" shape is also in blue and appears to be made up of two intersecting lines.
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 or | |||
| Rigid) and Accessories | II | EOQ | 21 CFR 874.4680 |
4
Image /page/4/Picture/0 description: The image shows the logo for Verathon. The logo consists of a stylized "V" shape on the left, followed by the word "VERATHON" in blue, sans-serif font. The "V" shape is also in blue and has a sharp, pointed design.
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 3.8/1.2 | ||
| Ambu® 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:
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.
Intended Use:
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.
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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Image /page/5/Picture/0 description: The image contains the logo for Verathon. The logo consists of a stylized "V" shape on the left, followed by the word "VERATHON" in blue, sans-serif font. The "V" shape is formed by two intersecting lines, with the left line extending downwards to form a vertical line.
| Technological
Characteristic | Predicate Device Ambu
aScope 3 System
(K130845) | GlideScope® BFlex™
Single Use Sytem
(This submission) |
|-----------------------------------------------|-------------------------------------------------------|-------------------------------------------------------------|
| Flexible Endoscope | Yes | Yes |
| Outside diameter of
flexible shaft and tip | 5.0mm | 5.5mm |
| Inside diameter of
working channel | 2.0mm | 2.1mm |
| 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 |
| LED Light Source | Yes | Yes |
| Image Display | Displays image on a reusable
monitor | 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 ●
6
Image /page/6/Picture/0 description: The image shows the logo for Verathon. The logo consists of a stylized green symbol resembling a stylized letter "V" or a plant shoot on the left, followed by the word "VERATHON" in blue, sans-serif font. A small registration mark is present to the upper right of the word "VERATHON".
- 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.