EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)
Device Facts
| Record ID | K252341 |
|---|---|
| Device Name | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) |
| Applicant | Olympus Medical Systems Corp. |
| Product Code | EOQ · Ear, Nose, Throat |
| Decision Date | Apr 23, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4680 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.
Device Story
Flexible bronchovideoscope (models BF-Q190, BF-H190, BF-1TH190) used for visualization, diagnosis, and treatment within airways and tracheobronchial tree. Device consists of control section (angulation knobs), insertion section (image/light guides, instrument channel), and connector section (to video system center). Physician operates device in clinical settings; uses manual angulation to navigate distal tip; utilizes suction and air/water valves for lens cleaning and fluid removal. Therapeutic instruments (e.g., biopsy forceps) pass through instrument channel. Dual focus mechanism (near/normal) uses Voice Coil Motor (VCM) actuator. Output is real-time endoscopic video displayed on monitor for clinical decision-making. This submission updates the operation manual regarding safe use with laser, high-frequency, and Argon Plasma Coagulation (APC) systems.
Clinical Evidence
No clinical or animal testing performed. Evidence consists of bench testing, specifically ignition factor safety studies for laser, high-frequency, and APC systems, and human factors validation testing.
Technological Characteristics
Flexible bronchovideoscope; CCD-based imaging; Voice Coil Motor (VCM) for dual-focus mechanism; NBI (Narrow Band Imaging) capability. Sterilization via Ethylene Oxide or STERRAD NX. Connectivity via proprietary one-touch connector to Olympus video system center. No changes to materials, dimensions, or software from predicate.
Indications for Use
Indicated for use within the airways and tracheobronchial tree for endoscopy and endoscopic surgery in patients requiring diagnostic or therapeutic bronchoscopy.
Regulatory Classification
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.
Predicate Devices
- EVIS EXERA III BRONCHOVIDEOSCOPE BF-Q190, BF-H190, BF-1TH190 (K121959)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
April 23, 2026
Olympus Medical Systems Corp.
Teffany Hutto
Project Manager, Regulatory Affairs
Olympus Corporation of the Americas
800 West Park Drive
Westborough, Massachusetts 01581
Re: K252341
Trade/Device Name: Evis Exera III Bronchovideoscope (Olympus BF-Q190); Evis Exera III Bronchovideoscope (Olympus BF-H190); Evis Exera III Bronchovideoscope (Olympus BF-1TH190)
Regulation Number: 21 CFR 874.4680
Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories
Regulatory Class: Class II
Product Code: EOQ
Dated: March 24, 2026
Received: March 24, 2026
Dear Teffany Hutto:
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 (the 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 available 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
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K252341 - Teffany Hutto
Page 2
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
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K252341 - Teffany Hutto
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(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-devices/device-advice-comprehensive-regulatory-assistance/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,
JOYCE C. LIN -S
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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K252341 | |
| Device Name EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) | |
| Indications for Use (Describe) This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use 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) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
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OLYMPUS
EVIS EXERA III BRONCHOSCOPE
OLYMPUS BF-Q190, BF-H190 and BF-1TH190
Date Prepared: April 23, 2026
# 510(k) Summary
# K252341
## 1. GENERAL INFORMATION
■ 510(k) Submitter: OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507, Japan
■ Contact Person: Teffany Hutto
Olympus Corporation of the Americas
3500 Corporate Parkway PO Box 610
Center Valley, PA 18034-0610, USA
Phone: 512-508-6550
Fax: 484-896-7128
Email: teffany.hutto@olympus.com
■ Manufacturing site: Aizu Olympus Co., Ltd.,
3-1-1 Niiderakita, Aizuwakamatsu-shi, Fukushima 965-8520, Japan
## 2. DEVICE IDENTIFICATION
| Trade/Device Name | EVIS EXERA III Bronchovideoscope BF-Q190 |
| --- | --- |
| Model Name | BF-Q190 |
| Common Name | Bronchovideoscope |
| Regulation Number | 874.4680 |
| Regulation Name | Bronchoscope (flexible or rigid) and accessories |
| Regulatory Class | II |
| Product Code | EOQ (Bronchoscope (Flexible or rigid))
NWB (Endoscope, Accessories, Narrow Band Spectrum) |
| Classification Panel | Ear, Nose and Throat |
510(k) Summary
Page 1 of 12
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OLYMPUS
EVIS EXERA III BRONCHOSCOPE
OLYMPUS BF-Q190, BF-H190 and BF-1TH190
| Trade/Device Name | EVIS EXERA III Bronchovideoscope BF-H190 |
| --- | --- |
| Model Name | BF-H190 |
| Common Name | Bronchovideoscope |
| Regulation Number | 874.4680 |
| Regulation Name | Bronchoscope (flexible or rigid) and accessories |
| Regulatory Class | II |
| Product Code | EOQ (Bronchoscope (Flexible or rigid))
NWB (Endoscope, Accessories, Narrow Band Spectrum) |
| Classification Panel | Ear, Nose and Throat |
| Trade/Device Name | EVIS EXERA III Bronchovideoscope BF-1TH190 |
| --- | --- |
| Model Name | BF-1TH190 |
| Common Name | Bronchovideoscope |
| Regulation Number | 874.4680 |
| Regulation Name | Bronchoscope (flexible or rigid) and accessories |
| Regulatory Class | II |
| Product Code | EOQ (Bronchoscope (Flexible or rigid))
NWB (Endoscope, Accessories, Narrow Band Spectrum) |
| Classification Panel | Ear, Nose and Throat |
# 3. PREDICATE DEVICES
| Device name | 510(k) Submitter | 510(k) No. |
| --- | --- | --- |
| EVIS EXERA III BRONCHOVIDEOSCOPE
BF-Q190, BF-H190, BF-1TH190 | OLYMPUS MEDICAL SYSTEMS CORP. | K121959 |
# 4. DEVICE DESCRIPTION
The EVIS EXERA III BRONCHOVIDEOSCOPES (OLYMPUS BF-Q190, OLYMPUS BF-H190, and BF-1TH190) are used for endoscopic diagnosis and treatment within the respiratory organs. These endoscopes consist of three parts: the control section, the insertion section, and the connector section.
510(k) Summary
Page 2 of 12
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OLYMPUS
EVIS EXERA III BRONCHOSCOPE
OLYMPUS BF-Q190, BF-H190 and BF-1TH190
# 5. PRINCIPLE OF OPERATION
The endoscope consists of three parts: the control section, the insertion section, and the connector section. The basic principle including user interface and operation for the procedure of the endoscope is identical to that of the predicate device.
## 1) Control section
The UP/DOWN angulation control knob and the RIGHT/LEFT angulation control knob on the control section is connected to the tip of the bending section by a series of wires. By operating the UP/DOWN angulation control knob and the RIGHT/LEFT angulation control knob, the bending section at the distal end bends vertically or parallel to guide the distal end for insertion and observation.
The observation mode can be selected by focus switching function, “near focus mode” featuring ground-breaking resolving power for close observation or “normal focus mode” for normal observation. To realize the dual focus mechanism, Voice Coil Motor (VCM) is incorporated as an actuator.
The endoscope contains a cylinder to attach a suction valve for suction and air/water valve. Depressing the suction valve will allow the physician to use the endoscope to suction any fluids which are obscuring a good view of the tissue. Therapeutic instruments can be passed through the instrument channel for performing endoscopic biopsy and other therapies. Depressing the air/water valve will allow the doctor to feed water through the endoscope for lens washing. It also can be operated to feed air for removing any fluids or debris adhering to the objective lens.
## 2) Insertion section
The insertion section has main parts including the image guide, light guides that bring light from the video system center through the endoscope, and instrument channel where therapeutic tools can be pushed in and out (also the suction channel).
## 3) Connector section
The connector section connects the endoscope with the video system center (CV-1500) through the universal cord.
510(k) Summary
Page 3 of 12
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OLYMPUS
EVIS EXERA III BRONCHOSCOPE
OLYMPUS BF-Q190, BF-H190 and BF-1TH190
## 6. INDICATIONS FOR USE
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190, OLYMPUS BF-H190, and OLYMPUS BF-1TH190) is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
This instrument is indicated for use within the airways and tracheobronchial tree.
## INDICATIONS FOR USE COMPARISON
The Indications for Use for the Subject Device is exactly the same as the Indications for Use for the Predicate Device.
## 7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject devices have the same technological characteristics and design as the applicable predicate devices. There have been no modifications from the prior clearances of these devices including:
- Design
- Materials
- Sterilization
- Shelf Life
- Reprocessing
- Packaging
- Software
This 510(k) is a notification to communicate an update to the Operation Manual to provide new instructions on the proper use of the subject devices with laser, high frequency, and Argon Plasma Coagulation (APC) systems.
A side-by-side comparison of the subject device and the predicate device is provided below.
510(k) Summary
Page 4 of 12
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OLYMPUS
EVIS EXERA III BRONCHOSCOPE
OLYMPUS BF-Q190, BF-H190 and BF-1TH190
BF-Q190
| Specifications | Subject device BF-Q190 | Predicate device BF-Q190 |
| --- | --- | --- |
| Indications for Use | This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
This instrument is indicated for use within the airways and tracheobronchial tree. | |
| Common name | BRONCHOVIDEOSCOPE | BRONCHOVIDEOSCOPE |
| Regulation name | Bronchoscope (flexible or rigid) and accessories | Bronchoscope (flexible or rigid) and accessories |
| Regulation number | 874.4680 | 874.4680 |
| Product code | EOQ, EOB, NWB | EOQ, EOB, NWB |
| Classification panel | Ear Nose & Throat | Ear Nose & Throat |
| Sterilization | Ethylene oxide sterilization
STERRAD NX | Ethylene oxide sterilization
STERRAD NX |
Specifications
| Image capture system | 1 Field of View | 120° | 120° |
| --- | --- | --- | --- |
| | 2 Depth of Field | 3-100mm | 3-100mm |
| | 3 Standard Focal Length | 0.558mm | 0.558mm |
| | 4 Optimum Working Distance | 5.7mm | 5.7mm |
| | 5 Direction of View | 0°(Forward viewing) | 0°(Forward viewing) |
| | 6 Highest Resolution | 15.85 line air/mm(Typical) | 15.85 line pair/mm(Typical) |
| | 7 Distortion | | |
| | 8 Magnification of Objective Lens (at Optimum) | 0.093 | 0.093 |
| | 9 F# of Objective Lens (at Optimum) | 5.066 | 5.066 |
| | 10 Total Number of Pixels | 168,096 | 168,096 |
510(k) Summary
Page 5 of 12
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OLYMPUS
EVIS EXERA III BRONCHOSCOPE
OLYMPUS BF-Q190, BF-H190 and BF-1TH190
| Specifications | | Subject device BF-Q190 | Predicate device BF-Q190 |
| --- | --- | --- | --- |
| | 11 Pixels per square mm | 226,757 | 226,757 |
| | 12 Size of Pixel | 2.1μm(H) x 2.1μm(V) | 2.1μm(H) x 2.1μm(V) |
| | 13 Active Area of CCD Chip | 0.8652mm(H) x 0.8568mm(V) | 0.8652mm(H) x 0.8568mm(V) |
| | 14 Type of CCD Chip | Color | Color |
| | Outer Diameter of Distal End | φ4.8mm | φ4.8mm |
| | Outer Diameter of Insertion Tube | φ6.0mm | φ6.0mm |
| | Angulation UP/DOWN | UP:210°, DOWN:130° | UP:210°, DOWN:130° |
| | Working Length | 600mm | 600mm |
| | Inner Diameter of Instrument Channel | φ2.0mm | φ2.0mm |
| | Number of Light guide fibers | 820 | 820 |
| | NBI observation | Available | Available |
| | Insertion tube rotation | 240 deg. | 240 deg. |
| Scope Connector | | Water Resistant One Touch Connector | Water Resistant One Touch Connector |
510(k) Summary
Page 6 of 12
{10}
OLYMPUS
EVIS EXERA III BRONCHOSCOPE
OLYMPUS BF-Q190, BF-H190 and BF-1TH190
BF-H190
| Specifications | | Subject device BF-H190 | Predicate device BF-H190 |
| --- | --- | --- | --- |
| Indications for Use | | This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
This instrument is indicated for use within the airways and tracheobronchial tree. | |
| Common name | | BRONCHOVIDEOSCOPE | BRONCHOVIDEOSCOPE |
| Regulation name | | Bronchoscope (flexible or rigid) and accessories | Bronchoscope (flexible or rigid) and accessories |
| Regulation number | | 874.4680 | 874.4680 |
| Product code | | EOQ, EOB, NWB | EOQ, EOB, NWB |
| Classification panel | | Ear Nose & Throat | Ear Nose & Throat |
| Sterilization | | Ethylene oxide sterilization
STERRAD NX | Ethylene oxide sterilization
STERRAD NX |
| Specifications | | | |
| Image capture system | 1 Field of View | 120° | 120° |
| | 2 Depth of Field | 3-100mm | 3-100mm |
| | 3 Standard Focal Length | 0.946mm | 0.946mm |
| | 4 Optimum Working Distance | 6.5mm | 6.5mm |
| | 5 Direction of View | 0°(Forward viewing) | 0°(Forward viewing) |
| | 6 Highest Resolution | 17.78 line pair/mm(Typical) | 17.78 line pair/mm(Typical) |
| | 7 Distortion | | |
| | 8 Magnification of Objective Lens (at Optimum) | 0.138 | 0.138 |
| | 9 F# of Objective Lens (at Optimum) | 7.88 | 7.88 |
| | 10 Total Number of Pixels | 492,980 | 492,980 |
510(k) Summary
Page 7 of 12
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OLYMPUS
EVIS EXERA III BRONCHOSCOPE
OLYMPUS BF-Q190, BF-H190 and BF-1TH190
| Specifications | | Subject device BF-H190 | Predicate device BF-H190 |
| --- | --- | --- | --- |
| | 11 Pixels per square mm | 226,757 | 226,757 |
| | 12 Size of Pixel | 2.1μm(H) x 2.1μm(V) | 2.1μm(H) x 2.1μm(V) |
| | 13 Active Area of CCD Chip | 1.674mm(H) x 1.336mm(V) | 1.674mm(H) x 1.336mm(V) |
| | 14 Type of CCD Chip | Color | Color |
| | Outer Diameter of Distal End | φ5.5mm | φ5.5mm |
| | Outer Diameter of Insertion Tube | φ6.6mm | φ6.6mm |
| | Angulation UP/DOWN | UP:210°, DOWN:130° | UP:210°, DOWN:130° |
| | Working Length | 600mm | 600mm |
| | Inner Diameter of Instrument Channel | φ2.0mm | φ2.0mm |
| | Number of Light guide fibers | 1200 | 1200 |
| | NBI observation | Available | Available |
| | Insertion tube rotation | 240 deg. | 240 deg. |
| Scope Connector | | Water Resistant One Touch Connector | Water Resistant One Touch Connector |
510(k) Summary
Page 8 of 12
{12}
OLYMPUS
EVIS EXERA III BRONCHOSCOPE
OLYMPUS BF-Q190, BF-H190 and BF-1TH190
BF-1TH190
| Specifications | | Subject device BF-1TH190 | Predicate device BF-1TH190 |
| --- | --- | --- | --- |
| Indications for Use | | This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
This instrument is indicated for use within the airways and tracheobronchial tree. | |
| Common name | | BRONCHOVIDEOSCOPE | BRONCHOVIDEOSCOPE |
| Regulation name | | Bronchoscope (flexible or rigid) and accessories | Bronchoscope (flexible or rigid) and accessories |
| Regulation number | | 874.4680 | 874.4680 |
| Product code | | EOQ, EOB, NWB | EOQ, EOB, NWB |
| Classification panel | | Ear Nose & Throat | Ear Nose & Throat |
| Sterilization | | Ethylene oxide sterilization STERRAD NX | Ethylene oxide sterilization STERRAD NX |
| Specifications | | | |
| Image capture system | 1 Field of View | 120° | 120° |
| | 2 Depth of Field | 3-100mm | 3-100mm |
| | 3 Standard Focal Length | 0.946mm | 0.946mm |
| | 4 Optimum Working Distance | 6.5mm | 6.5mm |
| | 5 Direction of View | 0°(Forward viewing) | 0°(Forward viewing) |
| | 6 Highest Resolution | 17.78 line pair/mm(Typical) | 17.78 line pair/mm(Typical) |
| | 7 Distortion | | |
| | 8 Magnification of Objective Lens (at Optimum) | 0.138 | 0.138 |
| | 9 F# of Objective Lens (at Optimum) | 7.88 | 7.88 |
| | 10 Total Number of Pixels | 492,980 | 492,980 |
510(k) Summary
Page 9 of 12
{13}
OLYMPUS
EVIS EXERA III BRONCHOSCOPE
OLYMPUS BF-Q190, BF-H190 and BF-1TH190
| Specifications | | Subject device BF-1TH190 | Predicate device BF-1TH190 |
| --- | --- | --- | --- |
| | 11 Pixels per square mm | 226,757 | 226,757 |
| | 12 Size of Pixel | 2.1μm(H) x 2.1μm(V) | 2.1μm(H) x 2.1μm(V) |
| | 13 Active Area of CCD Chip | 1.674mm(H) x 1.336mm(V) | 1.674mm(H) x 1.336mm(V) |
| | 14 Type of CCD Chip | Color | Color |
| | Outer Diameter of Distal End | φ6.2mm | φ6.2mm |
| | Outer Diameter of Insertion Tube | φ7.2mm | φ7.2mm |
| | Angulation UP/DOWN | UP:180°, DOWN:130° | UP:180°, DOWN:130° |
| | Working Length | 600mm | 600mm |
| | Inner Diameter of Instrument Channel | φ2.8mm | φ2.8mm |
| | Number of Light guide fibers | 1200 | 1200 |
| | NBI observation | Available | Available |
| | Insertion tube rotation | 240 deg. | 240 deg. |
| Scope Connector | | Water Resistant One Touch Connector | Water Resistant One Touch Connector |
510(k) Summary
Page 10 of 12
{14}
OLYMPUS
EVIS EXERA III BRONCHOSCOPE
OLYMPUS BF-Q190, BF-H190 and BF-1TH190
# 8. PERFORMANCE DATA
The following performance data were provided in support of the labeling change to address the proper use of the subject devices with laser, high frequency, and APC systems.
## 1) Performance testing - Bench
Bench testing as listed below was conducted to ensure that the subject device performs as intended and meet design specifications.
- Ignition Factors Safety Study (Laser)
- Ignition Factors Safety Study (High-Frequency)
- Ignition Factors Safety Study (APC)
- Ignition Factors Safety Study (Scope Comparison)
- Human Factors Validation Testing
## 2) Performance testing – Animal/Clinical
Animal and clinical testing were not performed.
## 3) Risk management
Risk management was performed in accordance with ISO 14971:2019. The design verification tests and their acceptance criteria were performed and identified as a result of this risk management.
## 4) Testing not completed
Since there were no design, material, sterilization, reprocessing, packaging, shelf life, or software changes, the following testing was not performed:
- Biocompatibility Testing
- Sterilization / Reprocessing
- Shelf Life
- Stability Testing
- Package Integrity Test
- Software Testing and Cybersecurity
- Electrical Safety and EMC
- Residual Toxicity of Reprocessing Chemicals
- Clinical
510(k) Summary
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{15}
OLYMPUS
EVIS EXERA III BRONCHOSCOPE
OLYMPUS BF-Q190, BF-H190 and BF-1TH190
# 9. CONCLUSIONS
Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate device, EVIS EXERA III BRONCHOVIDEOSCOPES (OLYMPUS BF-Q190, OLYMPUS BF-H190, and BF-1TH190) raise no new questions of safety and effectiveness and are substantially equivalent to the predicate devices in terms of safety, effectiveness, and performance.
510(k) Summary
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