This instrument has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, display monitor, EndoTherapy accessories such as an aspiration biopsy needle. This instrument is designed for endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound guided needle aspiration within the airways, tracheobronchial tree, and esophagus.

Device Description

The BF-UC190F has been designed to be used with the video system center, light source, documentation equipment, display monitor, and Endo Therapy accessories such as an aspiration biopsy needle. The BF-UC190F is intended for endoscopic real-time ultrasound imaging for performing endoscopic ultrasound guided needle aspiration within the airways, tracheobronchial tree, and esophagus. The BF-UC190F is a flexible video endoscope and a modification of the XBF-UC180F-DT8 which was previously cleared under K070983. The BF-UC190F consists of three parts: the control section, the insertion section, and the connector section.

AI/ML Overview

The Olympus BF-UC190F Endoscopic Ultrasound Bronchofibervideoscope underwent several performance tests to demonstrate its substantial equivalence to the predicate device, the XBF-UC180F-DT8 (BF-UC180F), and confirm its safety and effectiveness.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria alongside performance data in a direct comparative format for each test. Instead, it states that various tests were conducted and the device conforms to or complies with relevant standards and guidance documents, implying that meeting these standards served as the acceptance criteria.

Acceptance Criteria (Implied from Compliance Statements)	Reported Device Performance (Summary)
Ultrasound Output Display: Conformance to IEC 60601-2-37 Edition 2.0 2007 and FDA Guidance Document, "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers."	Output Display for BF-UC190F conducted and conforms to the specified IEC standard and FDA guidance.
Reprocessing Validation Testing: Conformance to Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling."	Reprocessing instruction and method validation testing conducted, and documentation provided as recommended by the guidance.
Biocompatibility Testing: Conformance to FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."	Biocompatibility testing conducted in accordance with the specified FDA guidance and ISO standard.
Software Verification and Validation Testing: Conformance to FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."	Software verification and validation testing conducted, and documentation provided as recommended by the FDA guidance.
Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with ANSI/AAMI ES60601-1:2005/A2:2012/(R)2012, IEC 60601-2-18:2009 (for safety), and IEC 60601-1-2:2007 (for EMC).	Electrical safety and EMC testing conducted; the system complies with the specified ANSI/AAMI and IEC standards.
Performance Testing - Bench (Thermal Safety, Mechanical Durability): Meets design specifications and requirements, including process verification, design verification, and design validation.	Thermal safety and mechanical durability bench tests conducted and performed as intended, meeting design specifications.
Risk Analysis: Conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007 and human factors validation in accordance with FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices."	Risk analysis conducted, design verification tests and acceptance criteria identified and performed based on this assessment.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide specific sample sizes for the test sets (e.g., number of units tested for thermal safety or mechanical durability, number of biological samples for biocompatibility). It generally states that "testing were conducted."

Data provenance is not explicitly mentioned in terms of "country of origin of the data" or "retrospective or prospective." All tests appear to be prospective bench tests performed by the manufacturer to validate the device's design and compliance with regulatory standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The testing described (e.g., electrical safety, EMC, biocompatibility, mechanical durability) are typically engineering and laboratory-based tests that do not involve "experts to establish ground truth" in the clinical sense (like radiologists marking images). Instead, the "ground truth" for these tests is established by the relevant engineering standards and regulatory requirements.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple experts assess the same data to establish a consensus ground truth. Since the performance data presented are primarily from bench and laboratory tests rather than clinical performance evaluations involving human interpretation, an adjudication method is not applicable and therefore not mentioned in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission focuses on demonstrating substantial equivalence to a predicate device through technological comparison and various non-clinical performance tests, not on comparing reader performance with and without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-In-The-Loop)

A standalone (algorithm only) performance study was not conducted or reported. The device, an endoscope, is a physical instrument for real-time imaging and aspiration, designed to be used by a medical professional. There is no mention of an independent algorithm component for which "standalone performance" without human interaction would be relevant.

7. Type of Ground Truth Used

The "ground truth" for the various performance tests is based on established engineering standards, regulatory guidance criteria, and design specifications. For example:

Ultrasound output: Conformance to IEC 60601-2-37 limits.
Reprocessing: Meeting efficacy requirements as outlined in FDA reprocessing guidance.
Biocompatibility: Absence of adverse biological reactions as per ISO 10993-1.
Software: Verification against software requirements specifications and cybersecurity guidelines.
Electrical Safety/EMC: Conformity to IEC standards.
Bench Performance (Thermal/Mechanical): Meeting predefined design requirements and durability targets.

There is no mention of clinical ground truth types like expert consensus, pathology, or outcomes data, as this is a pre-market submission focused on fundamental device safety and performance rather than clinical effectiveness.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. The BF-UC190F is an endoscopic device, not an AI/Machine Learning algorithm that requires a "training set" of data. The "training" for such a device occurs during its design and development through iterative engineering, testing, and validation against established standards.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" in the context of this device. The "ground truth" for the device's development and validation (not a training set) involved adherence to engineering principles, scientific validation methods, and regulatory requirements (as outlined in point 7), established through industry standards, guidance documents, and internal design specifications.

Summary

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September 6, 2019

Olympus Medical Systems Corp. % Sheri Musgnung Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, Pennsylvania 18034-0610

Re: K183525

Trade/Device Name: EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: PSV, ITX Dated: August 8. 2019 Received: August 9, 2019

Dear Sheri Musgnung:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,

for Srinivas Nandkumar, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183525

Device Name

EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UC190F

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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September 3, 2019

510(k) Summary

1 GENERAL INFORMATION

510(k) Submitter: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-machi, Hachioji-shi, Tokyo, Japan 192-8507
Contact Person: Sheri Musgnung Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-3147 Fax: 484-896-7128 Email: sheri.musgnung@olympus.com

2 DEVICE IDENTIFICATION

■ Device Name	EVIS EUS ULTRASOUNDBRONCHOFIBERVIDEOSCOPE OLYMPUS BFUC190F
■ Common Name	Ultrasound Bronchoscope
■ Regulation Number	892.1550
■ Regulation Name	Ultrasonic pulsed doppler imaging system.
■ Regulatory Class	II
■ Product Code	PSV, ITX
■ Classification Panel	Ear, Nose, and Throat

3 PREDICATE DEVICE

Device name	510(k) Submitter	510(k) No.
XBF-UC180F-DT8(AKA BF-UC180F)	OLYMPUS MEDICAL SYSTEMS CORP.	K070983

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The predicate device. XBF-UC180F-DT8. has been name changed after 510(k) clearance. It is marketed as BF-UC180F.

4 DEVICE DESCRIPTIONN

EVIS EUS BRONCHOVIDEOFIBERSCOPE OLYMPUS BF-UC190F

1) General Description of the subject device

The BF-UC190F is a flexible video endoscope and a modification of the XBF-UC180F-DT8 which was previously cleared under K070983.

2) Principle of Operation

The BF-UC190F consists of three parts: the control section, the insertion section, and the connector section.

The control section

The UP/DOWN angulation control lever 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 lever, the bending section at the distal end bends vertically to guide the distal end for insertion and observation within the airways, tracheobronchial tree, and esophagus.

The endoscope contains a cylinder to attach a suction valve for suction. Depressing the suction valve will allow the doctor 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.

The insertion section

The insertion section has main parts including the image guide the light guide, the instrument channel, the balloon channel and the ultrasound transducer.

The light guides bring light from the light source through the endoscope.

The instrument channel outlet (also the suction opening) can be pushed in and out for withdrawing and inserting the therapeutic tools.

The balloon channel feed water to the balloon.

The ultrasound transducer emits and receives the ultrasound wave.

The connector section

The connector section connects the endoscope with the light source (CLV-190).

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This connector contains the ultrasound cable connector to attach the ultrasound cable for connecting the ultrasound system.

The BF-UC190F is equipped with the CCD unit in the control section, as well as the fiber bundle in the insertion tube. Images are transmitted through the fiber bundle, and the CCD unit in the control section changes them to video signals. This feature is identical to the predicate models (XBF-UC180F-DT8; K070983).

Ultrasound Operation

Operating controls with ultrasound systems

The primary interface between the device and the user is the console's keyboard. The software controlling the keyboard has been designed as the user cannot set the machine to over-ride any of the internally set controls (such as maximum acoustic power).

In any mode, the keyboard menu will only accept valid inputs. Keys and/or commands are not available in a particular mode.

A trackball or a trackpad are provided for calipers, other graphic and imaging adjustments/ controls.

US CONNECTOR CAP MAJ-2295

This is US connector cap. This is attached to the ultrasound cable connector on the endoscope to protect the ultrasound cable connector and the endoscope from water penetration during reprocessing.

5 INDICATIONS FOR USE

This instrument is designed for endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound guided needle aspiration within the airways, tracheobronchial tree, and esophagus.

6 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE

The BF-UC190F has the same technological characteristics and design as the predicate device except for the following new features:

Outer diameter of the insertion portion a.
b. Outer Diameter of Distal End
Direction of view. C.
d. Angulations
Electrical connector (transmit CCD image signal) e.

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f. More sterilization methods become applicable for endoscope.
g. Irrigation port angle
h. Outlet shape of the balloon channel
i. The compatible cleaning brush is changed from reusable BW-7B and MH-507 to single-use BW-400B and BW-411B
j. Clarification of cleaning procedure and the brush to be used for Balloon groove
k. The shape of transducer

Validation from non-clinical testing demonstrated as defined in the performance data below show that these technological features do not raise any new issues of safety or effectiveness of the subject device.

All other technological characteristics of both the subject and predicate devices are identical.

Item	Subject Device:BF-UC190F	Predicate Device:XBF-UC180F-DT8, K070983
General information
Indication for Use	This instrument has been designed tobe used with diagnostic ultrasoundsystem, video system center, lightsource, documentation equipment,display monitor, Endo Therapyaccessories such as aspiration biopsyneedle.This instrument is designed forendoscopic real-time ultrasoundimaging, for performing endoscopicultrasound guided needle aspirationwithin the airways, tracheobronchialtree, and esophagus.	This instrument has been designed tobe used with a diagnostic ultrasoundsystem (ALOKA CO., LTD), videosystem center, light source,documentation equipment, videomonitor, endo-therapy accessories andother ancillary equipment.This instrument is designed forendoscopic real-time ultrasonic image,ultrasound guided needle aspirationand other endoscopic procedureswithin the airways, tracheobronchialtree, esophagus and surroundingorgans.
Clinical Application	Used with EU-ME1:- Transesophageal (non-cardiac)- Intraluminal ultrasound for upperairways and tracheobronchial treeUsed with EU-ME2 / EU-ME2PREMIR PLUS:- Transesophageal (non-cardiac)- Intraluminal ultrasound for upperairways and tracheobronchial tree	Used with SSD-Alpha5/10:- Transesophageal (non-cardiac)- Airways and tracheobronchial tree
Regulation name	Ultrasonic endoscope, its accessoriesand ancillary equipment	Ultrasonic Endoscope, its accessoriesand ancillary equipment
Regulation number	892.1550	892.1550
Product code	PSV (ultrasound bronchoscope)ITX (transducer, ultrasonic, diagnostic)	PSV (ultrasound bronchoscope)IYN (system, imaging, pulsed doppler,ultrasonic)ITX (transducer, ultrasonic, diagnostic)
Ultrasound specifications

Table 1.1.5-2 Comparison with Predicate Device

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ULTRASOUND BRONCHOFIBERVIDEOSCOPE BF-UC190F

NominalUltrasonicFrequencies OfThe TransducerAssembly	7-10MHz	7-10MHz
-----------------------------------------------------------------------	---------	---------

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Item	Subject Device:BF-UC190F	Predicate Device:XBF-UC180F-DT8, K070983
Mode	Used with EU-ME1:B, Color doppler	Used with SSD-Alpha5/10:B, M, PWD, Color doppler, AmplitudeDoppler, Combined
	Used with EU-ME2 / EU-ME2PREMIR PLUS:
	B, PWD, Color Doppler, Combined,Harmonic imaging
Applicable Ultrasoundsystem	EU-ME1EU-ME2EU-ME2 Premier Plus	ALOKA SSD-Alpha5 Diagnosticultrasound systemALOKA SSD-Alpha10 Diagnosticultrasound system
Scanning Direction	Parallel to the Axis ofthe Insertion Tube	Parallel to the Axis ofthe Insertion Tube
Scanning Field of View	Used with EU-ME1: 60°Used with EU-ME2 / EU-ME2PREMIR PLUS: 65°	60°
Scanning Method	Electrical curved linear arrayScanning	Electrical curved linear array Scanning
Contact Method	Balloon MethodDirect contact method	Balloon MethodDirect contact method
Endoscope specifications
Field of View	80 °	80 °
Depth of Field	2 - 50mm	2 - 50mm
Direction of View	20° (forward-oblique)	35° (forward-oblique)
Outer Diameter ofDistal End	φ6.6mm	φ6.9mm
Outer Diameter ofInsertion Tube	φ6.3mm	φ6.2mm
AngulationUP/DOWN	160°/70°	120°/90°
Working Length	600mm	600mm
Instrument Channel	φ2.2mm	φ2.2mm
Combination use withElectrosurgicalinstruments	Not applicable	Not applicable
NBI observation	Not available	Not available
Scope connector	Electrical connector is integrated toscope connector. Ultrasound connecteris separated. Only when combined withthe water-resistant cap, ultrasoundconnector is water resistant.	Electrical connector (transmit CCDimage signal) and ultrasound connecter isseparated. When combined with thewater-resistant cap, both connecters arewater resistant.
Protect water penetrationduring reprocessing.	US connector cap (MAJ-2295) isattached to the ultrasound cableconnector on the endoscope to protectthe ultrasound cable connector and theendoscope from water penetrationduring reprocessing.	Water resistant cap (MH-553) is attachedto the ultrasound cable connector and thevideoscope cable connector on theendoscope to protect the both connectorsand the endoscope from waterpenetration during reprocessing.
Sterilization methods forreprocessing	-Ethylene oxide gas-H2O2 (V-PRO maX)	-Ethylene oxide gas
Item	Subject Device:BF-UC190F	Predicate Device:XBF-UC180F-DT8, K070983
Compatible Olympusreprocessor for cleaningand disinfection	Not available	Not available
High frequencyaccessories	Not available	Not available
RFID tag forcommunication withendoscope reprocessor	Available	Available
Individual scopeinformation(Scope ID)	Available	Available
Electric safety	Comply to IEC 60601-1,IEC 60601-2-18	Comply to IEC 60601-1,IEC 60601-2-18
EMC	Comply to IEC 60601-1	Comply to IEC 60601-1

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7 PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

1) Ultrasound output display

The Output Display for the BF-UC190F were conducted in accordance with the FDA Guidance Document, "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." The subject device conform to the IEC 60601-2-37 Edition 2.0 2007.

2) Reprocessing validation testing

Reprocessing instruction and reprocessing method validation testing for the BF-UC190F were conducted and documentation was provided as recommended by Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling."

3) Biocompatibility testing

Biocompatibility testing for the BF-UC190F were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."

4) Software verification and validation testing

Software verification and validation testing for the BF-UC190F were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."

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5) Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the BF-UC190F. The system complies with the ANSI/AAMI ES60601-1:2005/A2:2012/(R)2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2:2007 standards for EMC.

6) Performance testing - Bench

Bench testing for the BF-UC190F as listed below was conducted to ensure that the subject device performs as intended and meet design specifications. Device performance was assessed the design requirements, and included process verification, design verification, and design validation.

Thermal safety test
Mechanical durability test

7) Risk analysis

Risk analysis for the BF-UC190F was conducted in accordance with established inhouse acceptance criteria based on ISO 14971:2007 and the human factors validation was conducted in accordance with the FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices." The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.

8 CONCLUSIONS

Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate devices, the BF-UC190F raise no new issue of safety and effectiveness and are substantially equivalent to the predicate devices in terms of safety, effectiveness and performance.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.