(94 days)
No.
The document explicitly states "Mentions AI, DNN, or ML: Not Found". The device description and performance studies do not indicate the presence of an AI model, focusing instead on imaging capabilities and safety.
Yes.
The device is used for "endoscopic diagnosis and treatment," indicating it has a therapeutic function, especially when used with "Endo Therapy accessories (such as a biopsy forceps)" for "endoscopic surgery."
Yes
The "Device Description" section explicitly states that the bronchoscope is "used for endoscopic diagnosis." Additionally, the "Intended Use / Indications for Use" mentions its use for "endoscopy," which is a diagnostic procedure.
No
The device is a bronchoscope, which is a physical instrument with hardware components (control section, insertion section, connector section, CCD image sensor, etc.) used for direct visualization and intervention. While it uses an Olympus video system center and other ancillary equipment, the bronchoscope itself is a physical medical device, not software-only.
No
The device is a bronchoscope used for direct visualization within the airways and tracheobronchial tree for diagnosis and treatment, which is an in-vivo procedure and does not involve in-vitro examination of specimens from the human body.
N/A
Intended Use / Indications for Use
EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-XP190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy 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.
EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-P190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy 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.
EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-XT190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy 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.
BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 is intended to be used with an Olympus video system center, documentation equipment, monitor, Endo Therapy 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.
BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 is intended to be used with an Olympus video system center, documentation equipment, monitor, Endo Therapy 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.
Product codes
EOQ, NWB
Device Description
The EVIS EXERA III BRONCHOVIDEOSCOPES (OLYMPUS BF-XP190, OLYMPUS BF-P190, and BF-XT190) and BRONCHOVIDEOSCOPE BF-H1100 and BF-1TH1100 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airways and tracheobronchial tree
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare facility/hospital
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 - Bench:
Thermal Safety
Photobiological Safety
Color Performance
Resolution
Noise and Dynamic Range
Image Intensity Uniformity
Video Latency
RDI
TXI
BAI-MAC
Automatic Brightness Adjustment
Pre-Freeze
Ignition Factors Safety Study (Laser)*
Ignition Factors Safety Study (High-Frequency)*
Ignition Factors Safety Study (APC)*
Ignition Factors Safety Study (Scope Comparison)*
Performance testing - Animal:
Animal testing was performed to assess the imaging modes of WLI, NBI, TXI, and BAI-MAC with video processor CV-1500.
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.
Key results: Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate device, EVIS EXERA III BRONCHOVIDEOSCOPES (OLYMPUS BF-XP190, OLYMPUS BF-P190, and BF-XT190) and BRONCHOVIDEOSCOPE BF-H1100 and BF-1TH1100 raise no new issue of safety and effectiveness and are substantially equivalent to the predicate device in terms of safety, effectiveness, and performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
FDA 510(k) Clearance Letter and Documentation
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 23, 2025
Olympus Medical Systems Corp.
℅ Teffany Hutto
Project Manager, Regulatory Affairs
Olympus Corporation of the Americas
800 West Park Drive
Westborough, Massachusetts 01581
Re: K250862
Trade/Device Name: Evis Exera IIi Bronchovideoscope (olympus Bf-xp190); Evis Exera IIi Bronchovideoscope (olympus Bf-p190); Evis Exera IIi Bronchovideoscope (olympus Bf-xt190); Bronchovideoscope (olympus Bf-h1100); Bronchovideoscope (olympus Bf-1th1100)
Regulation Number: 21 CFR 874.4680
Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories
Regulatory Class: Class II
Product Code: EOQ
Dated: May 29, 2025
Received: May 29, 2025
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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Page 2
K250862 - Teffany Hutto Page 2
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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 systems (QS) regulation (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 (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-
Page 3
K250862 - Teffany Hutto Page 3
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,
Shuchen Peng -S
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
Page 4
Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.
Please provide the device trade name(s).
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190);
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190);
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190);
BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100);
BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100)
Please provide your Indications for Use below.
EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-XP190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy 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.
EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-P190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy 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.
EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-XT190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy 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.
BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 is intended to be used with an Olympus video system center, documentation equipment, monitor, Endo Therapy 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.
BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 is intended to be used with an Olympus video system center, documentation equipment, monitor, Endo Therapy 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.
Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
Page 5
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
510(k) Summary
Page 1 of 25
Date Prepared: April 21, 2025
510(k) Summary
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-XP190 |
|---|---|
| Model Name | BF-XP190 |
| 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 |
Page 6
| Trade/Device Name | EVIS EXERA III Bronchovideoscope BF-P190 |
|---|---|
| Model Name | BF-P190 |
| 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-XT190 |
|---|---|
| Model Name | BF-XT190 |
| 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 | Bronchovideoscope BF-H1100 |
|---|---|
| Model Name | BF-H1100 |
| 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 |
Page 7
| Trade/Device Name | Bronchovideoscope BF-1TH1100 |
|---|---|
| Model Name | BF-1TH1100 |
| Common Name | Bronchovideoscope |
| Product Code | EOQ (Bronchoscope (Flexible or rigid)) |
| NWB (Endoscope, Accessories, Narrow Band Spectrum) | |
| Regulation Name | Bronchoscope (flexible or rigid) and accessories |
| Regulatory Class | II |
| Product Code | EOQ (Bronchoscope (Flexible or rigid)) |
| Classification Panel | Ear, Nose and Throat |
3. PREDICATE DEVICES
• Predicate devices (BF-XP190, BF-P190 and BF-XT190)
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| EVIS EXERA III BRONCHOVIDEOSCOPE BF-P190, BF-XP190 | OLYMPUS MEDICAL SYSTEMS CORP. | K201758 |
| EVIS EXERA III BRONCHOVIDEOSCOPE BF-XT190 | OLYMPUS MEDICAL SYSTEMS CORP | K183419 |
• Reference devices (BF-XP190, BF-P190 and BF-XT190)
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 | OLYMPUS MEDICAL SYSTEMS CORP. | K222861 |
| BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 | OLYMPUS MEDICAL SYSTEMS CORP | K222861 |
• Predicate devices (BF-H1100 and BF1TH1100)
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 | OLYMPUS MEDICAL SYSTEMS CORP. | K222861 |
| BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 | OLYMPUS MEDICAL SYSTEMS CORP | K222861 |
4. DEVICE DESCRIPTION
The EVIS EXERA III BRONCHOVIDEOSCOPES (OLYMPUS BF-XP190, OLYMPUS BF-P190, and BF-XT190) and BRONCHOVIDEOSCOPE BF-H1100 and BF-1TH1100 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.
Page 8
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.
Page 9
6. INDICATIONS FOR USE
EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-XP190 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.
EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-P190 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.
EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-XT190 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.
BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 is intended to be used with an Olympus video system center, 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.
BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 is intended to be used with an Olympus video system center, 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 equivalent Predicate Device.
Page 10
7. COMPARISON OF TECHNOLOGY 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 to request clearance for use of the BF-XP190, BF-P190, and BF-XT-190 scopes with the recently cleared EVIS X1 VIDEO SYSTEM CENTER CV-1500 under K222861. The BF-XP190, BF-P190, and BF-XT-190 scopes will be used with imaging modes WLI, NBI, RDI, TXI, and BAI-MAC.
This 510(k) will also request clearance to update the labeling to include new instructions on proper use of these scopes, along with the other subject devices, with laser, high frequency, and APC systems for all Subject Devices (BF-P190, BF-XP190, BF-XT190, BF-H1100, and BF-1TH1100)
A side-by-side comparison of the subject device and the predicate device is provided below.
Table 1 – BF-P190
| Item | Subject Device | Predicate Device |
|---|---|---|
| BF-P190 (combination with CV-1500) | BF-P190 (combination with CV-190/CLV-190) | |
| TBD | K201758 | |
| Regulation Number | 874.4680 | 874.4680 |
| Regulatory Class | Class II | Class II |
| Product Code | EOQ; Bronchoscope (Flexible Or Rigid) | EOQ; Bronchoscope (Flexible Or Rigid) |
| Review Panel | Ear Nose and Throat | Ear Nose and Throat |
| Common name | BRONCHOSCOPE | BRONCHOSCOPE |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. | OLYMPUS MEDICAL SYSTEMS CORP. |
Page 11
| Item | Subject Device | Predicate Device |
|---|---|---|
| BF-P190 (combination with CV-1500) | BF-P190 (combination with CV-190/CLV-190) | |
| TBD | K201758 | |
| Indications for Use | The EVIS EXERA III Bronchovideoscopes BF-P190 are 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. | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190 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. |
| Use Environment | Healthcare facility/hospital | Healthcare facility/hospital |
| Single-Use/Reuse | Reusable | Reusable |
| Duration and type of contact | Surface-contacting device in contact with mucosal membranes. The contact duration is limited exposure ( |