EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)
Device Facts
| Record ID | K260401 |
|---|---|
| Device Name | EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F) |
| Applicant | Olympus Medical Systems Corporation |
| Product Code | PSV · Radiology |
| Decision Date | Aug 27, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
Indications for Use
The EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, display monitor, endoscopic therapy accessories such as an aspiration biopsy needle. The EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F is designed for endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound guided needle aspiration within the airways and tracheobronchial tree. It is intended for use in adult patients. Operator qualifications: Appropriately trained healthcare professionals Device use settings: Professional healthcare facility (no domestic or special environments)
Device Story
Bronchofibervideoscope with integrated electronic curved linear array ultrasound transducer; used with diagnostic ultrasound system, video center, light source, and biopsy needles. Device captures real-time endoscopic video and ultrasound images of airways/tracheobronchial tree. Operated by trained healthcare professionals in professional clinical facilities. Provides visual and ultrasound guidance for needle aspiration procedures; assists in tissue sampling/diagnosis. Benefits include real-time visualization of anatomical structures and lesions for precise biopsy targeting.
Clinical Evidence
No clinical data was collected to support performance of the Subject device. Substantial equivalence is supported by non-clinical bench testing, including acoustic output, durability, imaging performance, biocompatibility, electrical safety, and reprocessing validation.
Technological Characteristics
Electronic curved linear array ultrasound transducer (32 elements, 7-10MHz). Materials: Fluorine resin, fluoro rubber, epoxy, silicone rubber, polyphenylsulfone, PTFE, stainless steel, glass. Dimensions: 5.9mm distal end, 5.7mm insertion tube, 600mm working length. Connectivity: Compatible with Olympus EU-ME3 ultrasound system. Sterilization: Ethylene oxide gas, H2O2 (V-PRO maX, V-PRO maX 2, STERRAD NX/100NX/100S).
Indications for Use
Indicated for endoscopic real-time ultrasound imaging and ultrasound-guided needle aspiration within the airways and tracheobronchial tree in adult patients.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UC190F (K183525)
Reference Devices
- EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F (K172726)
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
August 27, 2026
Olympus Medical Systems Corporation
Wendy Perreault
Regulatory Affairs SME Consultant
Olympus Surgical Technologies of the Americas
800 W. Park Dr.
Westborough, Massachusetts 01581
Re: K260401
Trade/Device Name: Evis Eus Ultrasound Bronchofibervideoscope Olympus Bf-Ucp190f (bf-ucp190f)
Regulation Number: 21 CFR 892.1550
Regulation Name: Ultrasonic pulsed doppler imaging system
Regulatory Class: Class II
Product Code: PSV
Dated: July 29, 2026
Received: July 30, 2026
Dear Wendy Perreault:
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}
K260401 - Wendy Perreault
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 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 (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}
K260401 - Wendy Perreault
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. | K260401 | ? |
| --- | --- | --- |
| Please provide the device trade name(s). | | ? |
| EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F) | | |
| Please provide your Indications for Use below. | | ? |
| The EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, display monitor, endoscopic therapy accessories such as an aspiration biopsy needle. The EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F is designed for endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound guided needle aspiration within the airways and tracheobronchial tree. It is intended for use in adult patients. Operator qualifications: Appropriately trained healthcare professionals Device use settings: Professional healthcare facility (no domestic or special environments) | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
{4}
OLYMPUS®
TRADITIONAL 510(k)
ULTRASOUND BRONCHOFIBERVIDEOSCOPEOLYMPUS BF-UCP190F
510(k) Summary
510(k) Summary: K260401
# 1. COMPANY INFORMATION
- Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
2951 Ishikawa-cho, Hachioji-shi
Tokyo 192-8507, Japan
FDA Establishment Registration #: 8010047
- Official Correspondent
Wendy Perreault
c/o Olympus Surgical Technologies of the Americas
800 West Park Drive
Westborough, MA 01581
Cell: 404-542-5854
Email: wendy.perreault@olympus.com
- Manufacturing Site
Olympus Medical Systems Corp. Hinode Plant
34-3 Hirai, Hinode-machi, Nishitama-gun, Tokyo 1900182, Japan
- Date Prepared: 27-July-2026
# 2. PRODUCT INFORMATION
Trade Name: ULTRASOUND BRONCHOFIBERVIDEOSCOPEOLYMPUS BF-UCP190F
Common Name: Ultrasound Bronchoscope
Classification Name/Regulation Description: Ultrasonic pulsed doppler imaging system
Classification Number: 892.1550
Product Code Names: Ultrasound Bronchoscope; Transducer, ultrasonic, diagnostic
Page 1 of 10
{5}
OLYMPUS
TRADITIONAL 510(k)
ULTRASOUND BRONCHOFIBERVIDEOSCOPEOLYMPUS BF-UCP190F
510(k) Summary
Product Codes: PSV, ITX
Regulatory Class: II
Classification Panel: Ear Nose & Throat
### 3. PREDICATE DEVICE
The Subject device is equivalent to the Predicate device listed below in Table 1.
Table 1: Predicate device of OLYMPUS BF-UCP190F
| Device name | 510(k) Submitter | 510(k) No. |
| --- | --- | --- |
| EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UC190F | OLYMPUS MEDICAL SYSTEMS CORPORATION | K183525 |
The Predicate device has not been subject to a design-related recall.
The device in Table 2 is used as a Reference device and has also not been subject to a design-related recall.
Table 2: Reference device of OLYMPUS BF-UCP190F
| Device name | 510(k) Submitter | 510(k) No. |
| --- | --- | --- |
| EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F | OLYMPUS MEDICAL SYSTEMS CORPORATION | K172726 |
### 4. DEVICE DESCRIPTION
The EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F has been designed to be used with a diagnostic ultrasound system, video system center, light source, documentation equipment, display monitor, and endoscopic therapy accessories such as an aspiration biopsy needle. It is designed for endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound-guided needle aspiration within the airways and tracheobronchial tree.
The BF-UCP190F consists of three (3) parts: the Control section, the Insertion section, and the Endoscope Connector section.
Page 2 of 10
{6}
OLYMPUS®
TRADITIONAL 510(k)
ULTRASOUND BRONCHOFIBERVIDEOSCOPEOLYMPUS BF-UCP190F
510(k) Summary
## 5. INDICATIONS FOR USE
The EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, display monitor, endoscopic therapy accessories such as an aspiration biopsy needle.
The EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F is designed for endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound guided needle aspiration within the airways and tracheobronchial tree. It is intended for use in adult patients.
Operator qualifications:
Appropriately trained healthcare professionals
Device use settings:
Professional healthcare facility (no domestic or special environments)
## 6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
Compared to the Predicate device, the Subject device offers similar functions. A detailed comparison of the technological characteristics of the Subject and Predicate devices is provided in Table 3 below. The differences between the devices are minor and addressed through testing, and do not raise any new issues/different questions of safety or effectiveness.
Table 3: Subject and Predicate Comparison of Technological Characteristics
| | Subject Device BF-UCP190F | Predicate Device BF-UC190F | How difference in technological characteristic does not raise new questions of safety and effectiveness compared to the Predicate (as applicable) |
| --- | --- | --- | --- |
| Transducer Frequency | 7-10MHz | 7-10MHz | N/A; Identical to Predicate device. |
| Mode | Used with EU-ME3: B, FLOW, PW, THE, ELST | Used with EU-ME2: B, FLOW, PWUsed with EU-ME2 PREMIER PLUS: B, FLOW, PW, THE, ELST | N/A; Identical to Predicate device. |
Page 3 of 10
{7}
TRADITIONAL 510(k)
ULTRASOUND BRONCHOFIBERVIDEOSCOPEOLYMPUS BF-UCP190F
510(k) Summary
OLYMPUS®
| | Subject Device BF-UCP190F | Predicate Device BF-UC190F | How difference in technological characteristic does not raise new questions of safety and effectiveness compared to the Predicate (as applicable) |
| --- | --- | --- | --- |
| Compatible Olympus Ultrasound System | EU-ME3 | EU-ME1 EU-ME2 EU-ME2 PREMIER PLUS | Compatibility is similar for Subject and Predicate devices. Compatibility between the Subject device and the compatible Ultrasound System has been verified successfully through Software, Electrical and Nonclinical Performance Testing. The difference in compatible systems does not raise new questions of safety and effectiveness. |
| Acoustic Output | I_{SPTA} :720 mW/cm2 or less MI :1.9 or less | I_{SPTA} :720 mW/cm2 or less MI :1.9 or less | N/A; Identical to Predicate device. |
| Scanning Direction | Parallel to the Axis of the Insertion Tube | Parallel to the Axis of the Insertion Tube | N/A; Identical to Predicate device. |
| Scanning Field of View | Used with EU-ME3 : 65° | Used with EU-ME1 : 60° Used with EU-ME2 and EU-ME2 PREMIER PLUS: 65° | N/A; Identical to Predicate device. |
| Axial resolution | 1mm or less | 1mm or less | N/A; Identical to Predicate device. |
| Lateral resolution | 2mm or less | 2mm or less | N/A; Identical to Predicate device. |
| Depth of penetration | Used with EU-ME3: 40mm or more | Used with EU-ME1 / EU-ME2 / EU-ME2 PREMIER PLUS: 40mm or more | N/A; Identical to Predicate device. |
| Scanning Method | Electrical curved linear array Scanning | Electrical curved linear array Scanning | N/A; Identical to Predicate device. |
| Ultrasound Imaging Method (Contact method) | Direct contact method | • Direct contact method • Balloon Method | Direct contact method is used by both Subject and Predicate devices; the Subject device does not support the balloon method used by the Predicate device. This difference does not affect its Substantial Equivalence to the Predicate and does not raise new questions of safety and effectiveness. |
| Field of View | 80 ° | 80 ° | N/A; Identical to Predicate device. |
| Depth of Field | 2 – 50 mm | 2 – 50 mm | N/A; Identical to Predicate device. |
Page 4 of 10
{8}
OLYMPUS®
TRADITIONAL 510(k)
ULTRASOUND BRONCHOFIBERVIDEOSCOPEOLYMPUS BF-UCP190F
510(k) Summary
| | Subject Device BF-UCP190F | Predicate Device BF-UC190F | How difference in technological characteristic does not raise new questions of safety and effectiveness compared to the Predicate (as applicable) |
| --- | --- | --- | --- |
| Direction of View | 14° (forward-oblique) | 20° (forward-oblique) | Direction of View is similar for Subject and Predicate devices. During insertion into the body cavity, the viewing direction of the Subject device is closer to 0 degrees compared to Predicate Device. A lower oblique angle at the distal end of an endoscope allows the user to see more area in the forward direction when inserting the endoscope into the trachea and bronchus. This allows the viewing direction and insertion direction to be more aligned for the user, improving the ease of insertion. Bench testing supports performance of the Subject device and its equivalence to the Predicate and the difference does not raise new questions of safety and effectiveness. |
| Optimum Working Distance | 4.18 mm | 5.2 mm | Similar for Subject and Predicate devices. The optimum working distance is the optimally focused distance within the range shown in Depth of Field; a difference in this value does not raise new questions of safety and effectiveness of the Subject device as supported by Performance testing. |
| Size of the image guide fiber | 6.6 μm | 6.6 μm | N/A; Identical to Predicate device. |
| Type of CCD Chip | Color | Color | N/A; Identical to Predicate device. |
| Total Number of Pixels | 168096 | 168096 | N/A; Identical to Predicate device. |
| Pixels per square mm | 226757 | 226757 | N/A; Identical to Predicate device. |
| Size of Pixel | 2.1μm(H) x 2.1μm(V) | 2.1μm(H) x 2.1μm(V) | N/A; Identical to Predicate device. |
| Active Area of CCD Chip | 865.2μm(H) x 856.8μm (V) | 865.2μm (H) x 856.8μm (V) | N/A; Identical to Predicate device. |
Page 5 of 10
{9}
OLYMPUS®
TRADITIONAL 510(k)
ULTRASOUND BRONCHOFIBERVIDEOSCOPEOLYMPUS BF-UCP190F
510(k) Summary
| | Subject Device BF-UCP190F | Predicate Device BF-UC190F | How difference in technological characteristic does not raise new questions of safety and effectiveness compared to the Predicate (as applicable) |
| --- | --- | --- | --- |
| Outer Diameter of Distal End | 5.9 mm | 6.6 mm | Outer diameter of Distal End is smaller in Subject device. Testing (including Reprocessing and Bench Testing [including Durability]) supports substantial equivalence of the Subject and Predicate devices, and the difference does not raise new questions of safety or effectiveness. |
| Outer Diameter of Insertion Tube | 5.7 mm | 6.3 mm | Outer diameter of the Insertion Tube is smaller in Subject device, compared to Predicate. Testing (including Reprocessing and Bench Testing [including Durability]) supports substantial equivalence of the Subject and Predicate, and the difference does not raise new questions of safety and effectiveness. |
| Shape of Transducer and its Housing | Housing of Transducer includes instrument channel outlet, objective lens, light guide lens, and rectangular ultrasound transducer. | Housing of Transducer includes instrument channel outlet, objective lens, light guide lens, and rectangular ultrasound transducer, as well as a balloon channel outlet and balloon grooves on the distal end of the transducer. | Shape is similar between Subject and Predicate devices. The Subject device does not support the balloon method used by the Predicate device. This difference does not raise new questions of safety and effectiveness. |
| Angulation UP/DOWN | 170°/70° | 160°/70° | The UP/DOWN Angulation is similar for the Subject and Predicate devices. This difference has been evaluated through Bench Testing (including Durability), and it does not raise new questions of safety and effectiveness. |
| Transducer Types | Electronic Curved Linear Array | Electronic Curved Linear Array | N/A; Identical to Predicate device. |
| Size and Spacing of Elements | Array Pitch = 0.17mm | Array Pitch = 0.17mm | N/A; Identical to Predicate device. |
| Geometrical Configuration | Curved Linear Array | Curved Linear Array | N/A; Identical to Predicate device. |
| Total Number of Elements | 32 Elements | 32 Elements | N/A; Identical to Predicate device. |
Page 6 of 10
{10}
TRADITIONAL 510(k)
ULTRASOUND BRONCHOFIBERVIDEOSCOPEOLYMPUS BF-UCP190F
510(k) Summary
OLYMPUS®
| | Subject Device BF-UCP190F | Predicate Device BF-UC190F | How difference in technological characteristic does not raise new questions of safety and effectiveness compared to the Predicate (as applicable) |
| --- | --- | --- | --- |
| Array Dimensions | Elevation Aperture = 1.3mm Elevation Footprint = 1.7mm Scanplane Aperture = 5.4mm Scanplane Footprint = 5.5mm | Elevation Aperture = 1.3mm Elevation Footprint = 1.7mm Scanplane Aperture = 5.4mm Scanplane Footprint = 5.5mm | N/A; Identical to Predicate device. |
| Insertion section working length | 600 mm | 600 mm | N/A; Identical to Predicate device. |
| Inner Diameter of Instrument Channel | 1.7 mm | 2.2 mm | Inner Diameter is similar for the Subject and Predicate devices. Reprocessing and Bench Testing (including Durability) support performance of the Subject device and the slight difference in inner diameter does not raise new questions of safety and effectiveness. |
| Distal end | Polytetrafluoroethylene | Polytetrafluoroethylene | N/A; Identical to Predicate device. |
| Rubber adhesive | ES-19MC | ES-19MC | N/A; Identical to Predicate device. |
| Scope connector | The electrical connector is integrated into the scope connector. The ultrasound connector is separated. The ultrasound connector is only water-resistant when the compatible water-resistant Ultrasound Connector Cap is connected. | The electrical connector is integrated into the scope connector. The ultrasound connector is separated. The ultrasound connector is only water-resistant when the compatible water-resistant Ultrasound Connector Cap is connected. | N/A; Identical to Predicate device. |
| Method of protection from water penetration during reprocessing | The Ultrasound Connector Cap (MAJ-2295) is attached to the ultrasound cable connector on the endoscope to protect the ultrasound cable connector and the endoscope from water penetration during reprocessing. | The Ultrasound Connector Cap (MAJ-2295) is attached to the ultrasound cable connector on the endoscope to protect the ultrasound cable connector and the endoscope from water penetration during reprocessing. | N/A; Identical to Predicate device. |
Page 7 of 10
{11}
OLYMPUS®
TRADITIONAL 510(k)
ULTRASOUND BRONCHOFIBERVIDEOSCOPEOLYMPUS BF-UCP190F
510(k) Summary
| | Subject Device BF-UCP190F | Predicate Device BF-UC190F | How difference in technological characteristic does not raise new questions of safety and effectiveness compared to the Predicate (as applicable) |
| --- | --- | --- | --- |
| Sterilization methods for reprocessing endoscope | - Ethylene oxide gas - H2O2 (V-PRO maX, V-PRO maX 2, STERRAD NX/100NX/100S) | - Ethylene oxide gas - H2O2 (V-PRO maX) | Similar for Subject and Predicate devices. All Reprocessing methods (including the Sterilizer/Sterilization process) are validated in accordance with FDA Guidance and Recognized Consensus Standards. The differences in H2O2 sterilization systems do not affect substantial equivalence of the Subject and Predicate devices and do not raise new questions of safety and effectiveness. |
| Compatible Olympus Reprocessor for cleaning and disinfection | OER-Elite | OER-Elite | N/A; Identical to Predicate device. |
| RFID tag for communication with endoscope Reprocessor | Available | Available | N/A; Identical to Predicate device. |
| Individual scope information (Scope ID) | Available | Available | N/A; Identical to Predicate device. |
| Total number of the Image guide fibers | 5500 | 10000 | Subject device has fewer Image guide fibers than Predicate device. Resolution testing supports the performance of the Subject device, and the difference does not affect its substantial equivalence to the Predicate or raise new questions of safety and effectiveness. |
| Materials | Fluorine Resin, Fluoro rubber, Epoxy, Silicone rubber, Polypheylsulfone, Polytetrafluoroethylene, Stainless Steel, Glass, Anti-reflection coating, Polytetrafluoro-ethylene, Silver brazes | Fluorine Resin, Fluoro rubber, Epoxy, Silicone rubber, Polypheylsulfone, Polytetrafluoroethylene, Stainless Steel, Glass, Anti-reflection coating, Polytetrafluoro-ethylene, Silver brazes | Similar for Subject and Predicate devices. The Subject and Predicate devices both use Fluoro Rubber, but they have different grade names (GR 1005 or GR 1003). Biocompatibility, Bench testing (including durability), and Reprocessing testing support the substantial equivalence of the two devices, and the difference does not raise any new questions of safety or effectiveness. |
Page 8 of 10
{12}
OLYMPUS®
TRADITIONAL 510(k)
ULTRASOUND BRONCHOFIBERVIDEOSCOPEOLYMPUS BF-UCP190F
510(k) Summary
# 7. SUMMARY OF NON-CLINICAL PERFORMANCE DATA
Results of the following testing support the safety and performance of the Subject device and demonstrate its equivalence to the Predicate device; all testing passed/met the acceptance criteria, demonstrated compliance with the cited standards and FDA Guidance shown below, and supported equivalent safety and performance to the Predicate device:
- Performance Testing – Bench Testing (including Acoustic Output in compliance with IEC 60601-2-37, IEC 62359, IEC 62127-1, and FDA Guidance: Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Guidance for Industry and Food and Drug Administration Staff [February 21, 2023]; Clinical Accuracy; Color Performance; Depth of Field; Direction of View / Field of View; Distortion; Durability; Image Intensity Uniformity; Noise and Dynamic Range; Photobiological Safety; Resolution; Strain Ratio; Suction Capability; Thermal Safety; Transducer Element Check; and Human Use Factors following FDA Guidance Documents Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff [issued February 3, 2016] and Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff [issued March 17, 2015]).
- Biocompatibility Testing in accordance with FDA Guidance Use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process” (ISO 10993-1; ISO 10993-5; ISO 10993-10; ISO 10993-11, ISO 10993-12; ISO 10993-17; ISO 10993-18; ISO 10993-23; USP Chapter <151>)
- Reprocessing Validation (AAMI TIR12; ANSI AAMI ST58; ANSI AAMI ST98; ISO 11135; ISO 11138-2; ISO 14937; ISO 10993-7)
- Electrical Safety/EMC Testing (IEC 60601-1; IEC ES60601-1; IEC 60601-1-2; IEC 60601-2-18; IEC 60601-2-37; IEC TR 60601-4-2)
- Software and Cybersecurity Testing (The BF-UCP190F software was developed in compliance with the FDA guidance document titled Content of Premarket Submissions for Device Software Functions – Guidance for Industry and Food and Drug Administration Staff issued on June 14, 2023, and Enhanced Documentation is provided for the Subject device. Cybersecurity for the device was implemented in compliance with the FDA guidance document titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions – Guidance for Industry and Food and Drug Administration Staff, issued on September 27, 2023.)
Page 9 of 10
{13}
OLYMPUS
TRADITIONAL 510(k)
ULTRASOUND BRONCHOFIBERVIDEOSCOPEOLYMPUS BF-UCP190F
510(k) Summary
### 8. SUMMARY OF CLINICAL PERFORMANCE DATA
No clinical data was collected to support performance of the Subject device.
### 9. CONCLUSION
The results of non-clinical performance testing demonstrate that the Subject device is as safe and effective as the Predicate device to support a substantial equivalence determination.
Page 10 of 10
