This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

Device Description

This EVIS EXERA III BRONCHOVIDEOSCOPE 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. The BF-XT190 is indicated for use within the airways and tracheobronchial tree. The BF-XT190 is a video scope used for the endoscopic diagnosis and treatment within the respiratory organs and modification of the BF-MP190F which was previously cleared under K172726.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the EVIS EXERA III Bronchovideoscope Olympus BF-XT190. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria through clinical or analytical performance.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, and detailed study information are not present in the provided text, as this type of submission relies on comparisons to an already cleared device and bench testing for new features.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with corresponding performance metrics for clinical or analytical performance. Instead, it lists the types of performance testing conducted to support substantial equivalence.

Acceptance Criteria (Implied by type of testing)	Reported Device Performance (Summary from text)
Reprocessing validation	Performed in accordance with FDA guidance "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling" (March 2015).
Biocompatibility	Performed in accordance with FDA Guidance "Use of International Standard ISO 10993-1" (June 2013). Included Cytotoxicity, Intracutaneous, Guinea Pig Maximization Sensitization, and Acute Systemic Toxicity tests.
Software verification and validation	Performed in accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 2005) and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (October 2014).
Electrical safety and EMC	Complies with ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012, IEC 60601-2-18:2009 for safety, and IEC 60601-1-2:2014 for EMC.
Bench Performance Testing	Carried out to demonstrate safety and effectiveness. Included Thermal Safety, Mechanical Durability, Photobiological Safety, and Optical Performance tests.
Risk Analysis	Carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. Design verification tests and their acceptance criteria were identified and performed as a result of this analysis.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified for any of the performance tests. The nature of these tests (e.g., biocompatibility, electrical safety) typically involves a specific number of units/samples for testing, but these numbers are not detailed in this summary.
Data Provenance: Not explicitly stated. The company, Olympus Medical Systems Corp., is based in Tokyo, Japan, and the contact person is in the USA. However, the location where the tests were physically performed is not provided. The document implies these are internal validation tests, not clinical studies with patient data.
Retrospective or Prospective: Not applicable as no clinical or patient data study is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth concept, typically involving expert consensus on patient cases for diagnostic devices, is not relevant here as no clinical or patient data study was conducted. The performance testing described relates to the device's physical, electrical, and functional characteristics.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No expert adjudication process is described as there is no clinical or image-based test set requiring expert interpretation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This device is a bronchoscope, not an AI-assisted diagnostic tool. The document explicitly states: "No clinical study was performed to demonstrate substantial equivalence."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a bronchoscope, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as it applies to diagnostic or prognostic data is not relevant to the performance tests described. For bench tests, the "ground truth" would be the established engineering specifications, international standards (e.g., ISO, IEC), and regulatory guidelines (e.g., FDA guidance documents) against which the device's performance is measured. For example:

For biocompatibility: Adherence to ISO 10993-1.
For electrical safety: Compliance with ANSI/AAMI ES 60601-1 and IEC 60601-2-18.
For software: Compliance with FDA software guidance.

8. The sample size for the training set

Not applicable. This device is a bronchoscope, not an AI/ML system that requires a training set.

9. How the ground truth for the training set was established

Not applicable. No training set is mentioned as it is not an AI/ML device.

Summary

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September 5, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K183419

Trade/Device Name: EVIS EXERA III Bronchovideoscope Olympus BF-XT190 Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: August 1, 2019 Received: August 2, 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

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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 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 (QS) 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 medical devices and radiation-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) K183419

Device Name EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190

Indications for Use (Describe)

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190

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

5.1 GENERAL INFORMATION

510(k) Submitter: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
Sheri L. Musgnung Contact Person: 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

5.2 DEVICE IDENTIFICATION

Device Name EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
OLYMPUS BF-XT190 ■ Model Name

Common Name Bronchoscope, its accessories and ancillary equipment
Regulation Number 874.4680
Regulation Name Bronchoscope (flexible or rigid) and accessories
Regulatory Class
Product Code EOQ, Bronchoscope (Flexible Or Rigid)
Classification Panel Ear, Nose, and Throat

5.3 PREDICATE DEVICE

■ Predicate device

Device name	510(k) Submitter	510(k) No.
OLYMPUS BF-MP190F	OLYMPUS MEDICAL SYSTEMS CORP.	K172726

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5.4 DEVICE DESCRIPTION

■ General Description of the subject device

■ Principle of Operation

The BF-XT190 consists of three parts: the control section, the insertion section, and the connector section. The basic principal, the user interface and operation for the bronchoscopic procedure of the BF-XT190 is identical to the predicate BF-MP190F.

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5.5 INDICATIONS FOR USE

- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190

5.6 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE

The EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 has the same technological characteristics and design as the predicate device except for the following new features:

Instrument channel is wider
Insertion tube is wider
Optical specification has been altered
Bending section angulation is narrower
Function of narrow band imaging (NBI) observation is available
Patient contact materials have been altered

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

Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device.

A side-by-side comparison of the subject device and the predicate device is provided below.

Item	Subject Device EVISEXERA IIIBRONCHOVIDEOSCOPEOLYMPUS BF-XT190	Predicate Device EVIS EXERA IIIBRONCHOFIBER VIDEOSCOPEOLYMPUS BF-MP190F(K172726)
Indications for use	This instrument is intended to beused with an Olympus video systemcenter, light source, documentation	This instrument is intended to be usedwith an Olympus video system center,light source, documentation
	equipment, monitor, EndoTherapy accessories(such as a biopsy forceps), andother ancillary equipment forendoscopy andendoscopic surgery. This instrumentis indicated for use within theairways and tracheobronchial tree.	equipment, monitor, EndoTherapy accessories(such as a biopsy forceps), and otherancillary equipment for endoscopy andendoscopic surgery. This instrument isindicated for use within the airwaysand tracheobronchial tree.
Depth of Field	2 – 50 mm	2 - 50 mm
Direction of ForwardView	0° (Forward viewing)	0° (Forward viewing)
Field of View	110°	90°
NBI observation	Available	Not Available
Outer Diameter of DistalEnd	$Φ$ 6.1mm	$φ$ 3.0mm
Outer Diameter ofInsertion Tube	$Φ$ 6.3mm	$φ$ 3.7mm
Bending SectionAngulation	UP:180°, DOWN:130°	UP:210°, DOWN:130°
Working Length	600mm	600mm
Instrument Channelinner diameter [mm]	$φ$ 3.2	$φ$ 1.7
Configuration of Controlsection and location ofscope switch	Image: OLYMPUS endoscope control section	Image: OLYMPUS endoscope control section

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5.7 PERFORMANCE DATA

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

1) Reprocessing validation testing

Reprocessing instruction and reprocessing method validation testing for the EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 were performed in accordance with the FDA guidance "Guidance for Industry and Food and Drug Administration Staff, - Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling issued on March 17, 2015".

2) Biocompatibility testing

Biocompatibility testing for the EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 were performed in accordance with the FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, issued on June 16, 2013". The biocompatibility testing includes the following tests:

Cytotoxicity Study Using the Colony Assay ISO-10993-5 ।
। Intracutaneous Study in Rabbits - ISO-10993-10
Guinea Pig Maximization Sensitization Test ISO-10993-10 ।
Acute Systemic toxicity ISO 10993-11

3) Software verification and validation testing

Software verification and validation testing for the EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 were performed in accordance with the FDA guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued on October 2, 2014".

4) Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were performed on the EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190. The system complies with the ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2:2014 standards for EMC.

5) Performance testing - Bench

Bench testing for the EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 was carried out to demonstrate the safety and the effectiveness of the subject device.

Thermal Safety Test

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Mechanical Durability Test
Photobiological Safety Test
Optical Performance Test

6) Performance testing - Animal

No animal study was performed to demonstrate substantial equivalence.

7) Performance testing - Clinical

No clinical study was performed to demonstrate substantial equivalence.

8) Risk analysis

Risk analysis for the EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.

5.8 CONCLUSIONS

Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate device, the EVIS EXERA III BRONCHO VIDEOSCOPE OLYMPUS BF-XT190 raised no new issue of safety and effectiveness and are substantially equivalent to the predicate device in terms of safety, efficacy and performance.

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.