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)
Device Facts
| Record ID | K250862 |
|---|---|
| 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) |
| Applicant | Olympus Medical Systems Corp. |
| Product Code | EOQ · Ear, Nose, Throat |
| Decision Date | Jun 23, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4680 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended 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.
Device Story
Flexible bronchovideoscope; consists of control, insertion, and connector sections. Inputs: optical images of airways/tracheobronchial tree. Operation: physician-operated; manual angulation control knobs manipulate distal tip via wires; suction and air/water valves manage fluids/debris; instrument channel allows passage of therapeutic tools (biopsy forceps, etc.). Imaging: utilizes CCD sensor; supports multiple imaging modes (WLI, NBI, RDI, TXI, BAI-MAC) via connection to Olympus CV-1500 video system center. Output: real-time endoscopic video displayed on monitor for physician visualization. Clinical utility: enables diagnostic and therapeutic procedures within respiratory organs; facilitates biopsy and other interventions. Benefits: improved visualization and procedural guidance for airway management.
Clinical Evidence
No clinical data provided. Evidence consists of bench performance testing (thermal, photobiological, resolution, latency, ignition factors for laser/HF/APC) and animal testing to assess imaging modes (WLI, NBI, TXI, BAI-MAC) with the CV-1500 processor.
Technological Characteristics
Flexible endoscope; materials include Fluoro Resin (F-COAT-KAI), Fluoro Rubber (GR1005), Polytetrafluoroethylene, Polysulfone, and glass lenses (Sapphire/OHARA S-LAH58). Sensing: CCD image sensor. Connectivity: proprietary one-touch connector to Olympus video system center. Sterilization: reusable. Software: embedded firmware for pixel defect correction and scope ID; no changes from predicate.
Indications for Use
Indicated for use within the airways and tracheobronchial tree for endoscopy and endoscopic surgery in conjunction with Olympus video system centers, light sources, and ancillary equipment.
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-P190, BF-XP190 (K201758)
- EVIS EXERA III BRONCHOVIDEOSCOPE BF-XT190 (K183419)
- BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 (K222861)
- BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 (K222861)
Related Devices
- K200678 — PENTAX Medical Video Bronchoscope EB-J10 Series · Pentax of America, Inc. · Jul 30, 2020
- K183607 — FUJIFILM Bronchoscope · Fujifilm Corporation · Aug 23, 2019
- K171291 — FUJIFILM Bronchoscope Model EB-530P · Fujifilm Medical Systems U.S.A, Inc. · Jan 19, 2018
- K182253 — FUJIFILM Video Bronchoscopes · Fujifilm Corporation · Apr 4, 2019
- K023376 — EB-1830T3, VIDEO BRONCHOSCOPE · Pentax Precision Instrument Corp. · Oct 16, 2002
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
{1}
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-
{2}
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
{3}
| 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. | K250862 | ? |
| 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, 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. | | |
| 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) | ? |
{4}
OLYMPUS
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
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 |
510(k) Summary
Page 1 of 25
{5}
OLYMPUS
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
| 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 |
510(k) Summary
Page 2 of 25
{6}
OLYMPUS
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
| 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.
510(k) Summary
Page 3 of 25
{7}
OLYMPUS
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
# 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 4 of 25
{8}
OLYMPUS
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
# 6. INDICATIONS FOR USE
EVIS EXERA III BRONCHOVIDEOSCOPIES 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 BRONCHOVIDEOSCOPIES 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 BRONCHOVIDEOSCOPIES 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.
510(k) Summary
Page 5 of 25
{9}
OLYMPUS
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
# 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. |
510(k) Summary
Page 6 of 25
{10}
OLYMPUS
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
| 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 Bronchovideosopes 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 (<24 hrs). | Surface-contacting device in contact with mucosal membranes. The contact duration is limited exposure (<24 hrs). |
| Depth of Field | 2 - 50 mm | 2 - 50 mm |
| Direction of Forward View | 0° (Forward viewing) | 0° (Forward viewing) |
| Field of View(FOV) | 110° | 110° |
| Distortion | | |
| Magnification of Objective Lens at Optimum Working Distance | 0.017 | 0.017 |
| Pixels per square mm | 226,760 | 226,760 |
| Active Area of CCD Chip | (H)477μm×(V)468μm | (H)477μm×(V)468μm |
| Total Number of Pixels | 50,621 | 50,621 |
| Size of Pixel | (H)2.1μm×(V)2.1μm | (H)2.1μm×(V)2.1μm |
510(k) Summary
Page 7 of 25
{11}
OLYMPUS
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
| Item | Subject Device | Predicate Device | |
| --- | --- | --- | --- |
| | | BF-P190 (combination with CV-1500) | BF-P190 (combination with CV-190/CLV-190) |
| | | TBD | K201758 |
| Type of CCD Chip | | Color | Color |
| Narrow Band Image (NBI) observation | | Available | Available |
| Red Dichromatic Imaging (RDI) observation | | Available | Not Available |
| Pre-freeze function | | Available | Available |
| Electronic zoom function | | Not Available | Not Available |
| Electronic shutter function | | Not Available | Not Available |
| Records of endoscope’s information | | Available | Available |
| Outer Diameter of Distal End | | Φ4.2mm | Φ4.2mm |
| Outer Diameter of Insertion Tube | | Φ4.1mm | Φ4.1mm |
| Bending Section Angulation | | UP:210°, DOWN:130° | UP:210°, DOWN:130° |
| Working Length | | 600mm | 600mm |
| Instrument Channel inner diameter [mm] | | φ2.0 | φ2.0 |
| Distal end enlarged | | | |
| Total Length | | 880mm | 880mm |
| Minimum visible distance | | 3mm | 3mm |
| Direction from which EndoTherapy accessories enter and exit the endoscopic image | | | |
| Material | Insertion Tube (Outer layer) | Fluoro Resin (F-COAT-KAI) | Fluoro Resin (F-COAT-KAI) |
| | Bending section rubber | Fluoro Rubber (GR1005) | Fluoro Rubber (GR1005) |
510(k) Summary
Page 8 of 25
{12}
OLYMPUS
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
| Item | Subject Device | Predicate Device | |
| --- | --- | --- | --- |
| | | BF-P190 (combination with CV-1500) | BF-P190 (combination with CV-190/CLV-190) |
| | | TBD | K201758 |
| | Adhesive on the bending rubber | Epoxy Glue (ES-19MC) | Epoxy Glue (ES-19MC) |
| | Distal end adhesive | Epoxy Glue (ES-19MC) | Epoxy Glue (ES-19MC) |
| | Instrument channel | Polytetrafluoro-ethylene | Polytetrafluoro-ethylene |
| | Distal end | Polysulfone (P1700-216) | Polysulfone (P1700-216) |
| | Objective lens | Glass (Sapphire) | Glass (Sapphire) |
| | Light guide lens | Glass (OHARA S-LAH58) | Glass (OHARA S-LAH58) |
| Control section | | | |
| Configuration of Control section and location of scope switch | | | |
| The insertion tube rotation angle by simply turning a ring on the control section of the scope. | | left or right up to 120° | left or right up to 120° |
| Video connection section | | | |
| Scope connector | | Water resistant one-touch connector | Water resistant one-touch connector |
| Configuration of Video connection section and Light guide connector section | | | |
| Software | | | |
| Correction of pixel defect | | Have | Have |
| Scope information | | | |
510(k) Summary
Page 9 of 25
{13}
OLYMPUS
THE OLD STANDARD OF BIOLOGICAL CHEMISTRY
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
| Item | Subject Device | Predicate Device |
| --- | --- | --- |
| | BF-P190 (combination with CV-1500) | BF-P190 (combination with CV-190/CLV-190) |
| | TBD | K201758 |
| Individual scope information (Scope ID) | Have | Have |
| Compatibility of endotherapy accessories | | |
| High frequency treatment accessories | Available | Available |
| Laser treatment accessories | Not Available | Not Available |
| Other | | |
| Total weight | 840g | 840g |
Table 2 – BF-XP190
| Item | Subject Device | Predicate Device |
| --- | --- | --- |
| | BF-XP190 (combination with CV-1500) | BF-XP190 (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. |
| Indications for Use | The EVIS EXERA III Bronchovideosopes BF-XP190 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-XP190
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 |
510(k) Summary
Page 10 of 25
{14}
OLYMPUS
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
| Item | Subject Device | | Predicate Device | |
| --- | --- | --- | --- | --- |
| | BF-XP190 (combination with CV-1500) | | BF-XP190 (combination with CV-190/CLV-190) | |
| | TBD | | K201758 | |
| Duration and type of contact | Surface-contacting device in contact with mucosal membranes. The contact duration is limited exposure (<24 hrs). | | Surface-contacting device in contact with mucosal membranes. The contact duration is limited exposure (<24 hrs). | |
| Depth of Field | 2 - 50 mm | | 2 - 50 mm | |
| Direction of Forward View | 0° (Forward viewing) | | 0° (Forward viewing) | |
| Field of View(FOV) | 110° | | 110° | |
| Distortion | | | | |
| Magnification of Objective Lens at Optimum Working Distance | 0.017 | | 0.017 | |
| Pixels per square mm | 226,760 | | 226,760 | |
| Active Area of CCD Chip | (H)477μm×(V)468μm | | (H)477μm×(V)468μm | |
| Total Number of Pixels | 50,621 | | 50,621 | |
| Size of Pixel | (H)2.1μm×(V)2.1μm | | (H)2.1μm×(V)2.1μm | |
| Type of CCD Chip | Color | | Color | |
| Narrow Band Image (NBI) observation | Available | | Available | |
| Red Dichromatic Imaging (RDI) observation | Available | | Not Available | |
| Pre-freeze function | Available | | Available | |
| Electronic zoom function | Not Available | | Not Available | |
| Electronic shutter function | Not Available | | Not Available | |
| Records of endoscope’s information | Available | | Available | |
510(k) Summary
Page 11 of 25
{15}
OLYMPUS
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
| Item | Subject Device | Predicate Device | |
| --- | --- | --- | --- |
| | | BF-XP190 (combination with CV-1500) | BF-XP190 (combination with CV-190/CLV-190) |
| | | TBD | K201758 |
| Outer Diameter of Distal End | | Φ3.1 mm
(Tapered part of distal tip: ø 2.9 mm) | Φ3.1 mm
(Tapered part of distal tip: ø 2.9 mm) |
| Outer Diameter of Insertion Tube | | Φ2.8 mm | Φ2.8 mm |
| Bending Section Angulation | | UP:210°, DOWN:130° | UP:210°, DOWN:130° |
| Working Length | | 600mm | 600mm |
| Instrument Channel inner diameter [mm] | | φ1.2 | φ1.2 |
| Distal end enlarged | | | |
| Total Length | | 880mm | 880mm |
| Minimum visible distance | | 3mm | 3mm |
| Direction from which EndoTherapy accessories enter and exit the endoscopic image | | | |
| Material | Insertion Tube (Outer layer) | Fluoro Resin (F-COAT-KAI) | Fluoro Resin (F-COAT-KAI) |
| | Bending section rubber | Fluoro Rubber (GR1005) | Fluoro Rubber (GR1005) |
| | Adhesive on the bending rubber | Epoxy Glue (ES-19MC) | Epoxy Glue (ES-19MC) |
| | Distal end adhesive | Epoxy Glue (ES-19MC) | Epoxy Glue (ES-19MC) |
| | Instrument channel | Polytetrafluoro-ethylene | Polytetrafluoro-ethylene |
| | Distal end | Steel (SUS303) | Steel (SUS303) |
| | Objective lens | Glass (Sapphire) | Glass (Sapphire) |
| | Light guide lens | Glass (OHARA S-LAH58) | Glass (OHARA S-LAH58) |
510(k) Summary
Page 12 of 25
{16}
OLYMPUS
traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
| Item | Subject Device | Predicate Device | |
| --- | --- | --- | --- |
| | | BF-XP190 (combination with CV-1500) | BF-XP190 (combination with CV-190/CLV-190) |
| | | TBD | K201758 |
| | | | |
| Control section | | | |
| Configuration of Control section and location of scope switch | | | |
| The insertion tube rotation angle by simply turning a ring on the control section of the scope. | left or right up to 120° | left or right up to 120° | |
| Video connection section | | | |
| Scope connector | Water resistant one-touch connector | Water resistant one-touch connector | |
| Configuration of Video connection section and Light guide connector section | | | |
| Software | | | |
| Correction of pixel defect | Have | Have | |
| Scope information | | | |
| Individual scope information (Scope ID) | Have | Have | |
| Compatibility of endotherapy accessories | | | |
| High frequency treatment accessories | Not Available | Not Available | |
510(k) Summary
Page 13 of 25
{17}
OLYMPUS
THE OLD STANDARD OF BIOLOGICAL CHEMISTRY
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
| Item | Subject Device | Predicate Device |
| --- | --- | --- |
| | BF-XP190 (combination with CV-1500) | BF-XP190 (combination with CV-190/CLV-190) |
| | TBD | K201758 |
| Laser treatment accessories | Not Available | Not Available |
| Other | | |
| Total weight | 840g | 840g |
Table 3 – BF-XT190
| Item | Subject Device | Predicate Device |
| --- | --- | --- |
| | BF-XT190 (combination with CV-1500) | BF-XT190 (combination with CV-190/CLV-190) |
| | TBD | K183419 |
| 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. |
| Indications for Use | The EVIS EXERA III Bronchovideosopes BF-XT190 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-XT190
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 (<24 hrs). | Surface-contacting device in contact with mucosal membranes. The contact duration is limited exposure (<24 hrs). |
510(k) Summary
Page 14 of 25
{18}
OLYMPUS
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
| Item | Subject Device | Predicate Device |
| --- | --- | --- |
| | BF-XT190 (combination with CV-1500) | BF-XT190 (combination with CV-190/CLV-190) |
| | TBD | K183419 |
| Depth of Field | 2 - 50 mm | 2 - 50 mm |
| Direction of Forward View | 0° (Forward viewing) | 0° (Forward viewing) |
| Field of View(FOV) | 110° | 110° |
| Distortion | | |
| Magnification of Objective Lens at Optimum Working Distance | 0.017 | 0.017 |
| Pixels per square mm | 226,760 | 226,760 |
| Active Area of CCD Chip | (H)477μm×(V)468μm | (H)477μm×(V)468μm |
| Total Number of Pixels | 50,621 | 50,621 |
| Size of Pixel | (H)2.1μm×(V)2.1μm | (H)2.1μm×(V)2.1μm |
| Type of CCD Chip | Color | Color |
| Narrow Band Image (NBI) observation | Available | Available |
| Red Dichromatic Imaging (RDI) observation | Available | Not Available |
| Pre-freeze function | Available | Available |
| Electronic zoom function | Not Available | Not Available |
| Electronic shutter function | Not Available | Not Available |
| Records of endoscope’s information | Available | Available |
| Outer Diameter of Distal End | Φ6.1mm | Φ6.1mm |
510(k) Summary
Page 15 of 25
{19}
OLYMPUS
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
| Item | Subject Device | Predicate Device | |
| --- | --- | --- | --- |
| | | BF-XT190 (combination with CV-1500) | BF-XT190 (combination with CV-190/CLV-190) |
| | | TBD | K183419 |
| Outer Diameter of Insertion Tube | | Φ6.3mm | Φ6.3mm |
| Bending Section Angulation | | UP:180°, DOWN:130° | UP:180°, DOWN:130° |
| Working Length | | 600mm | 600mm |
| Instrument Channel inner diameter [mm] | | φ3.2 | φ3.2 |
| Distal end enlarged | | | |
| Total Length | | 880mm | 880mm |
| Minimum visible distance | | 1.5mm | 1.5mm |
| Direction from which EndoTherapy accessories enter and exit the endoscopic image | | | |
| Material | Insertion Tube (Outer layer) | Fluoro Resin (F-COAT-KAI) | Fluoro Resin (F-COAT-KAI) |
| | Bending section rubber | Fluoro Rubber (GR1005) | Fluoro Rubber (GR1005) |
| | Adhesive on the bending rubber | Epoxy Glue (ES-19MC) | Epoxy Glue (ES-19MC) |
| | Distal end adhesive | Epoxy Glue (ES-19MC) | Epoxy Glue (ES-19MC) |
| | Instrument channel | Polytetrafluoro-ethylene | Polytetrafluoro-ethylene |
| | Distal end | Polysulfone (P1700-216) | Polysulfone (P1700-216) |
| | Objective lens | Glass (Sapphire) | Glass (Sapphire) |
| | Light guide lens | Glass (Sapphire) | Glass (Sapphire) |
510(k) Summary
Page 16 of 25
{20}
OLYMPUS
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
| Item | Subject Device | | Predicate Device | |
| --- | --- | --- | --- | --- |
| | BF-XT190 (combination with CV-1500) | | BF-XT190 (combination with CV-190/CLV-190) | |
| | TBD | | K183419 | |
| Configuration of Control section and location of scope switch | | | | |
| The insertion tube rotation angle by simply turning a ring on the control section of the scope. | left or right up to 120° | | left or right up to 120° | |
| Video connection section | | | | |
| Scope connector | Water resistant one-touch connector | | Water resistant one-touch connector | |
| Configuration of Video connection section and Light guide connector section | | | | |
| Software | | | | |
| Correction of pixel defect | Have | | Have | |
| Scope information | | | | |
| Individual scope information (Scope ID) | Have | | Have | |
| Compatibility of endotherapy accessories | | | | |
| High frequency treatment accessories | Available | | Available | |
| Laser treatment accessories | Available | | Available | |
| Other | | | | |
| Total weight | 840g | | 840g | |
510(k) Summary
Page 17 of 25
{21}
OLYMPUS
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
Table 4 – BF-H1100
| | SUBJECT DEVICE
BF-H1100 Bronchoscope | PREDICATE DEVICE
BF-H1100 Bronchoscope
(K222861) |
| --- | --- | --- |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP | OLYMPUS MEDICAL SYSTEMS CORP |
| Classification & Regulation Number | Class II
21 CFR §874.4680,
21 CFR §874.4760,
21 CFR §876.1500 | Class II
21 CFR §874.4680,
21 CFR §874.4760,
21 CFR §876.1500 |
| Product Code | EOQ: Bronchoscope (Flexible or rigid)
EOB: Nasopharyngoscope (Flexible or rigid)
NWB: endoscope, accessories, narrow band spectrum | EOQ: Bronchoscope (Flexible or rigid)
EOB: Nasopharyngoscope (Flexible or rigid)
NWB: endoscope, accessories, narrow band spectrum |
| Indications for Use | The “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. | The “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. |
| Type | - CCD
- CYM color filter
Sequential read image signal | - CCD
- CYM color filter
Sequential read image signal |
| Number of pixels | 465,588 | 465,588 |
| Pixel size | 1.5 μm (H) × 1.5 μm (V) | 1.5 μm (H) × 1.5 μm (V) |
| Optical System | | |
| Direction of View | 0° | 0° |
| Field of View | 120° | 120° |
| Depth of Field | 3 - 100 mm | 3 - 100 mm |
510(k) Summary
Page 18 of 25
{22}
OLYMPUS
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
| | SUBJECT DEVICE
BF-H1100 Bronchoscope | | PREDICATE DEVICE
BF-H1100 Bronchoscope
(K222861) |
| --- | --- | --- | --- |
| Distortion | | | |
| Insertion Section | | | |
| Distal end outer diameter | ø 4.9 mm | ø 4.9 mm | |
| Distal end enlarged | | | |
| Insertion tube outer diameter | ø 4.9 mm | ø 4.9 mm | |
| Insertion section working length | 600 mm | 600 mm | |
| Instrument Channel | | | |
| Channel inner diameter | ø 2.2 mm | ø 2.0 mm | |
| Minimum visible distance | 3 mm | 3 mm | |
| Direction from which EndoTherapy accessories enter and exit the endoscopic image | | | |
510(k) Summary
Page 19 of 25
{23}
OLYMPUS
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
| | SUBJECT DEVICE
BF-H1100 Bronchoscope | PREDICATE DEVICE
BF-H1100 Bronchoscope
(K222861) |
| --- | --- | --- |
| Configuration | | |
| The insertion tube rotation angle by simply turning a ring on the control section of the scope | left or right up to 120° | left or right up to 120° |
| Connector Section | | |
| Configuration | | |
| Bending Section | | |
| Angulation range | UP 210°
DOWN 130° | UP 210°
DOWN 130° |
| Total Length | | |
| Total length | 880 mm | 880 mm |
| Total Weight | | |
| Total Weight | 940 g | 940 g |
| Function | | |
| Pre-freeze function | Available | Available |
| Electronic zoom function | Available | Available |
| Electronic shutter function | Available | Available |
| Records of endoscope’s information | Available | Available |
| NBI observation | Available | Available |
| RDI observation | Available | Available |
510(k) Summary
Page 20 of 25
{24}
OLYMPUS
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
| | SUBJECT DEVICE
BF-H1100 Bronchoscope | PREDICATE DEVICE
BF-H1100 Bronchoscope
(K222861) |
| --- | --- | --- |
| High frequency treatment | Available | Available |
| Laser treatment | Available | Available |
| Scope ID | Available | Available |
Table 5 – BF-1TH1100
| | Subject Device
BF-1TH1100 Bronchoscope | Predicate Device
BF-1TH110 Bronchoscope
(K222861) |
| --- | --- | --- |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP | OLYMPUS MEDICAL SYSTEMS CORP |
| Classification & Regulation Number | Class II
21 CFR §874.4680,
21 CFR §874.4760,
21 CFR §876.1500 | Class II
21 CFR §874.4680,
21 CFR §874.4760,
21 CFR §876.1500 |
| Product Code | EOQ: Bronchoscope (Flexible or rigid)
EOB: Nasopharyngoscope (Flexible or rigid)
NWB: endoscope, accessories, narrow band spectrum | EOQ: Bronchoscope (Flexible or rigid)
EOB: Nasopharyngoscope (Flexible or rigid)
NWB: endoscope, accessories, narrow band spectrum |
| Indications for Use | The 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. | The 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. |
| Image Sensor | | |
| Type | - CCD
- CYM color filter
- Sequential read image signal | - CCD
- CYM color filter
- Sequential read image signal |
| Number of Pixels | 465,588 | 465,588 |
| Pixel Size | 1.5 μm (H) × 1.5 μm (V) | 1.5 μm (H) × 1.5 μm (V) |
510(k) Summary
Page 21 of 25
{25}
OLYMPUS
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
| | Subject Device
BF-1TH1100 Bronchoscope | Predicate Device
BF-1TH110 Bronchoscope
(K222861) | | | |
| --- | --- | --- | --- | --- | --- |
| Optical System | | | | | |
| Direction of View | 0° | 0° | | | |
| Field of View | 120° | 120° | | | |
| Depth of Field | 3 - 100 mm | 3 - 100 mm | | | |
| Distortion | | | | | |
| Insertion Section | | | | | |
| Distal end outer diameter | ø 5.8 mm | ø 5.8 mm | | | |
| Distal end enlarged | | | Insertion tube outer diameter | ø 6.1 mm | ø 6.1mm |
| Insertion section working length | 600 mm | 600 mm | | | |
| Instrument Channel | | | | | |
| Channel inner diameter | ø 3.0 mm | ø 3.0 mm | | | |
| Minimum visible distance | 3 mm | 3 mm | | | |
510(k) Summary
Page 22 of 25
{26}
OLYMPUS
A LOT OF THEe PREFERENCES
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
| | Subject Device
BF-1TH1100 Bronchoscope | Predicate Device
BF-1TH110 Bronchoscope
(K222861) |
| --- | --- | --- |
| Direction from which EndoTherapy accessories enter and exit the endoscopic image | | |
| Control Section | | |
| Configuration | | |
| The insertion tube rotation angle by simply turning a ring on the control section of the scope. | left or right up to 120° | left or right up to 120° |
| Connector Section | | |
| Configuration | | |
| Bending Section | | |
| Angulation range | UP 180°
DOWN 130° | UP: 180°
DOWN: 130° |
| Total Length | | |
| Total length | 880 mm | 880 mm |
| Total Weight | | |
| Total weight | 950 g | 950 g |
| Function | | |
| Pre-freeze function | Available | Available |
| Electronic zoom function | Available | Available |
| Electronic shutter function | Available | Available |
510(k) Summary
Page 23 of 25
{27}
OLYMPUS
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
| | Subject Device
BF-1TH1100 Bronchoscope | Predicate Device
BF-1TH110 Bronchoscope
(K222861) |
| --- | --- | --- |
| Records of endoscope’s information | Available | Available |
| NBI observation | Available | Available |
| RDI observation | Available | Available |
| High frequency treatment | Available | Available |
| Laser treatment | Available | Available |
| Scope ID | Available | Available |
## 8. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination for BF-XP190, BF-P190, and BF-XT-190:
### 1) Performance testing - Bench
Bench testing as listed below was conducted to ensure that the subject device performs as intended and meet design specifications.
- 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)*
*Testing is also applicable to BF-H1100 and BF-1TH1100 to address the labeling change
510(k) Summary
Page 24 of 25
{28}
OLYMPUS
Traditional 510(k) Notification
EVIS EXERA III Bronchovideoscope BF-P190, BF-XP190, and BF-XT190
BF-H1100 and BF-1TH1100
2) Performance testing - Animal
Animal testing was performed to assess the imaging modes of WLI, NBI, TXI, and BAI-MAC with video processor CV-1500.
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
- Shelf Life
- Stability Testing
- Package Integrity Test
- Software Testing and Cybersecurity
- Electrical Safety and EMC
- Residual Toxicity of Reprocessing Chemicals
- Human Factors
- Clinical
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-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.
510(k) Summary
Page 25 of 25
