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.

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.

Device Description

This EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190, 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. The bronchovideoscope (BF-XP190, BF-P190) is indicated for use within the airways and tracheobronchial tree.

The bronchovideoscope (BF-XP190, BF-P190) is a video scope used for endoscopic diagnosis and treatment within the respiratory organs and modification of the BF-XT190 which was previously cleared under K183419.

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, BF-XT190.

AI/ML Overview

This appears to be a 510(k) summary for a bronchoscope, not an AI/ML device. Therefore, the typical acceptance criteria and study designs associated with AI/ML performance (e.g., accuracy, sensitivity, specificity, human-in-the-loop studies, multi-reader multi-case studies, ground truth establishment for AI/ML) are not directly applicable.

The document describes the device as a traditional medical device (a bronchoscope) and demonstrates substantial equivalence to a predicate device based on conventional performance testing, rather than AI/ML performance.

Therefore, I cannot provide an answer based on the requested format because the input document does not contain information about an AI/ML device's acceptance criteria or performance studies in the context of diagnostic or classification tasks.

However, I can summarize the types of performance data that were provided for this traditional medical device:

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

The document doesn't provide a direct table of acceptance criteria vs. specific reported numerical performance values for this bronchoscope in a diagnostic sense. Instead, it states that various tests were "conducted to ensure that the subject devices were carried out to demonstrate their safety and effectiveness" and that the "design verification tests and their acceptance criteria were identified and performed as a result of this risk management." The conclusion is that the device "raise no new issue of safety and effectiveness and are substantially equivalent to the predicate device."

The performance data listed are qualitative in nature, focusing on compliance with standards and successful completion of tests:

Acceptance Criteria Category	Reported Device Performance Summary
Reprocessing Validation	Reprocessing instruction and reprocessing method validation testing was conducted and documentation provided as recommended by FDA Guidance "Reprocessing Medical Devices in Health Care Setting."
Biocompatibility Testing	Conducted in accordance with ISO 10993-1, including Cytotoxicity, Intracutaneous Study, Guinea Pig Maximization Sensitization Test, and Systemic Toxicity Study.
Software V&V Testing	Conducted and documentation provided as recommended by FDA Guidance "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."
Electrical Safety & EMC	Conducted in accordance with ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012, IEC 60601-2-18:2009 (electrical safety), and IEC 60601-1-2:2014 (EMC).
Bench Performance Testing	Thermal Safety Test, Mechanical Durability Test, Photobiological Safety Test were conducted.
Risk Management	Performed in accordance with ISO 14971:2007, and human factors validation conducted in accordance with FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices." Design verification tests and their acceptance criteria were identified and performed as a result of this.

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device that uses a test set of data samples in the way an algorithm would. Performance testing involved physical device testing and compliance with standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic AI/ML algorithms is not relevant for this device. Its performance is evaluated through engineering and biological safety tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Not an AI/ML diagnostic or classification device.

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: Not applicable. This is a standalone medical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is being evaluated in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of traditional medical device submission. Ground truth, in the context of this device, refers to meeting established engineering and safety standards, not diagnostic truth.

8. The sample size for the training set: Not applicable. This is not an AI/ML device with a training set.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device with a training set.

Summary

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January 21, 2021

Olympus Medical Systems Corp. % Anne-Marie Keefe Program Manager Olympus Surgical Technologies of America 118 Turnpike Road, Suite 120 Southborough, Massachusetts 01772

Re: K201758

Trade/Device Name: EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190 Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOQ Dated: December 18, 2020 Received: December 21, 2020

Dear Anne-Marie Keefe:

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.

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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 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 Malvina B. Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201758

Device Name

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190

Indications for Use (Describe)

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.

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are all capitalized and evenly spaced. There is a thin yellow line underneath the word. The registered trademark symbol is located to the right of the letter "S".

Date prepared: January 21, 2021 K201758

510(k) Summary

1. GENERAL INFORMATION

■ 510(k) Submitter:	OLYMPUS MEDICAL SYSTEMS CORP.
	2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507 Japan
■ Contact Person:	Anne-Marie Keefe
	Olympus Surgical Technologies of America
	118 Turnpike Road, Suite 120
	Southborough, MA 01772
	Phone: (508) 804-2448
	Fax: 484-896-7128
	Mobile: (508) 244-1921
	Email: Anne-Marie.Keefe@olymus.com
■ Manufacturing site:	Aizu Olympus Co., Ltd.,
	500 Muranishi, Niidera, Monden-machi, Aizuwakamatsu-shi
	Fukushima 965-8520, Japan

2. DEVICE IDENTIFICATION

■ Device Name:	EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUSBF-XP190EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUSBF-P190
■ Common Name:	BRONCHOVIDEOSCOPE
■ Regulation Number:	874.4680
■ Regulation Name:	Bronchoscope (flexible or rigid) and accessories
■ Regulatory Class:	Class II
■ Product Code:	EOQ (Bronchoscope (Flexible or rigid))
■ Classification Panel:	Ear, Nose and Throat

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Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, dark blue letters. The letters are closely spaced together, creating a solid block of text. Below the word "OLYMPUS" is a horizontal stripe of yellow, which serves as a base or underline for the text. There is a registered trademark symbol to the right of the word.

3. PREDICATE DEVICE

■ Predicate device

Device name	510(k) Submitter	510(k) No.
OLYMPUS BF-XT190	OLYMPUS MEDICAL	K183419
EVIS EXERA III BRONCHOVIDEOSCOPE	SYSTEMS CORP.

4. DEVICE DESCRIPTION

= General Description of the subject device

This EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190,

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. The bronchovideoscope (BF-XP190, BF-P190) is indicated for use within the airways and tracheobronchial tree.

■ Principle of Operation

5. INDICATIONS FOR USE

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190 .

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. 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.

6. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE

The EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190 has the same technological characteristics and design as the predicate device except for the following new features:

1.2 mm Inner Diameter of Instrument Channel
3.1 mm Outer Diameter of Distal End -
2.8 mm Outer Diameter of Insertion Tube ।

The EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190 has the same technological characteristics and design as the predicate device except for the following new features:

2.0 mm Inner Diameter of Instrument Channel
4.2 mm Outer Diameter of Distal End
4.1 mm Outer Diameter of Insertion Tube

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.

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OLYMPUS

Item	Subject DeviceBF-XP190	Subject DeviceBF-P190	Predicate DeviceBF-XT190(K183419)
Indicationsfor use	This instrument isintended to be usedwith an Olympus videosystem center, lightsource, documentationequipment, monitor,EndoTherapyaccessories (such as abiopsy forceps), andother ancillaryequipment forendoscopy andendoscopic surgery.This instrument isindicated for usewithin the airways andtracheobronchial tree.	This instrument isintended to be usedwith an Olympus videosystem center, lightsource, documentationequipment, monitor,EndoTherapyaccessories (such as abiopsy forceps), andother ancillaryequipment forendoscopy andendoscopic surgery.This instrument isindicated for usewithin the airways andtracheobronchial tree.	This instrument isintended to be usedwith an Olympus videosystem center, lightsource, documentationequipment, monitor,EndoTherapyaccessories (such as abiopsy forceps), andother ancillaryequipment forendoscopy andendoscopic surgery.This instrument isindicated for usewithin the airways andtracheobronchial tree.
Depth ofField	2 - 50 mm	2 - 50 mm	2 - 50 mm
Direction ofForwardView	0° (Forward viewing)	0° (Forward viewing)	0° (Forward viewing)
Field of View	110°	110°	110°
NBIobservation	Available	Available	Available
OuterDiameter ofDistal End	$Φ$ 3.1mm	$Φ$ 4.2mm	$Φ$ 6.1mm
OuterDiameter of	$Φ$ 2.8mm	$Φ$ 4.1mm	$Φ$ 6.3mm

InsertionTube
BendingSectionAngulation	UP:210°, DOWN:130°	UP:210°, DOWN:130°	UP:180°, DOWN:130°
WorkingLength	600mm	600mm	600mm
InstrumentChannelinnerdiameter	$Φ$ 1.2mm	$Φ$ 2.0mm	$Φ$ 3.2mm
Configurationof Controlsection andlocation ofscope switch	Image: Olympus control section and scope switch 1	Image: Olympus control section and scope switch 2	Image: Olympus control section and scope switch 3

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Image /page/7/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. A small registered trademark symbol is located in the upper right corner of the word, next to the letter "S".

7 PERFORMANCE DATA

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

1) Reprocessing validation testing

Reprocessing instruction and reprocessing method validation testing was conducted and documentations were provided as recommended by 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 was conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO

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10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process issued on June 16, 2016". The biocompatibility testing included 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) ।
Systemic Toxicity Study in Mice (ISO 10993-11)

3) Software verification and validation testing

Software verification and validation testing was conducted and documentation is 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 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 was conducted in accordance with ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for electrical safety and the IEC 60601-1-2:2014 standards for EMC.

5) Performance testing - Bench

Bench testing as listed below was conducted to ensure that the subject devices were carried out to demonstrate their safety and effectiveness.

Thermal Safety Test
। Mechanical durability test
Photobiological Safety 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.

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8) Risk management

Risk management was performed in accordance with ISO 14971: 2007 (Second edition) and the human factors validation was conducted in accordance with the FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices issued on February 3, 2016". The design verification tests and their acceptance criteria were identified and performed as a result of this risk management.

8. CONCLUSIONS

Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate device, the EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190 and BF-P190 raise no new issue of safety and effectiveness and are substantially equivalent to the predicate device in terms of safety, effectiveness, 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.