This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

Device Description

The subject device, Bronchovideoscope Olympus XBF-D160HM, is basically identical to the predicate device, EVIS EXERA Bronchovideoscope Olympus BF type 160, except that the subject device is equipped with an optical system for high magnification observation in addition to an optical system for normal observation.

When compared to the predicate device, this high magnification bronchoscope enables more detailed observation of the target area. For example, a run of the capillary blood vessel in the bronchial mucosa can be observed, which is not observable with the predicate device.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, the Bronchovideoscope Olympus XBF-D160HM. The document asserts substantial equivalence to a predicate device, the EVIS EXERA Bronchovideoscope Olympus BF type 160 (K023984). The core of a 510(k) submission is to demonstrate that a new device is as safe and effective as a legally marketed predicate device, not necessarily to prove absolute safety and effectiveness through extensive clinical trials.

Therefore, the information regarding acceptance criteria and a study proving the device meets them will be limited, as this type of submission relies on a comparison to an already approved device rather than new performance studies with specific statistical endpoints.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present specific quantitative acceptance criteria or detailed performance metrics against those criteria in the way a clinical trial for a novel device would. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device. The performance is assessed by comparing technological characteristics and intended use.

Acceptance Criteria (Implicit)	Reported Device Performance (Implicit Comparison)
Intended Use Equivalence	The subject device (XBF-D160HM) has the identical intended use to the predicate device (BF-160). Both are designed for endoscopy and endoscopic surgery within the airways and tracheobronchial tree with ancillary equipment.
Technological Equivalence (Safety & Effectiveness)	The XBF-D160HM is basically identical to the BF-160, with the key difference being the addition of an optical system for high magnification. The document states, "When compared to the predicate device, the XBF-D160HM does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety and effectiveness." The differences in physical dimensions (distal end and insertion tube outer diameter) are considered not to affect safety and effectiveness negatively, as the inner channel diameter remains the same, implying similar accessory compatibility.
Material Equivalence	All patient contact materials are identical to those used in previously cleared 510(k) devices.

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

No specific test set or associated sample size is mentioned in this 510(k) summary. The submission relies on a comparison of technical specifications and intended use against a previously cleared device. There is no independent "test set" of data from patients to evaluate performance. Therefore, data provenance (country, retrospective/prospective) is not applicable in this context.

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

This is not applicable as there was no "test set" and thus no ground truth established by experts in the context of this 510(k) submission. The FDA reviews the provided technical documentation and comparisons to the predicate device.

4. Adjudication Method for the Test Set

Not applicable, as there was no "test set" requiring adjudication.

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 conventional medical device (bronchoscope), not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or required for this type of submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a hardware medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in a 510(k) for substantial equivalence is the safety and effectiveness of the legally marketed predicate device. The new device's performance is not directly measured against an independent ground truth but rather by its similarity and lack of new safety/effectiveness concerns compared to the predicate. Therefore, no pathology, outcomes data, or expert consensus specific to the subject device was used as a ground truth.

8. The Sample Size for the Training Set

Not applicable. This is a hardware medical device, not an algorithm that requires a training set.

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

Not applicable.

Summary

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Kotog4o

APR 1 9 2004

510(k) SUMMARY

Bronchovideoscope Olympus XBF-D160HM

1. General Information

Date Prepared	February 20, 2004
Applicant	Olympus Corporation(Former name: Olympus Optical Co., Ltd.)34-3 Hirai Hinode-machi,Nishitama-gun, Tokyo, 190-0182, JapanEstablishment Registration No.: 3003637092
Submission Correspondent	Shiho OtsukiOlympus Corporation(Former name: Olympus Optical Co., Ltd.)2951 Ishikawa-cho Hachioji-shi, Tokyo 192-8507, JapanPhone: +81-426-42-2891Fax: +81-426-42-2291Email: sh_otsuki@ot.olympus.co.jpEstablishment Registration No.: 8010047
Official Correspondent	Tina Steffanie-OakAssociate Manager, Regulatory Affairs/Clinical MonitorOlympus America Inc.Two Corporate Center Drive, Melville,NY 11747-3157, USAPhone: 631-844-5477FAX: 631-844-5416Email: Tina Steffanie-Oak@olympus.comEstablishment Registration No.: 2429304

2. Device Identification

Trade Name:	Bronchovideoscope Olympus XBF-D160HM
Common Name:	Bronchoscope
Regulation Name:	Bronchoscope (flexible or rigid) and accessories
Regulation Number:	21 CFR 874.4680
Class:
Product Code:	77 EOQ

3. Predicate Device

Predicate Device Name:	EVIS EXERA Bronchovideoscope Olympus BF type 160
Manufacturer:	Olympus Optical Co., Ltd.
510(k) Number:	K023984

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4. Device Description

5. Intended Use

6. Comparison of Technological Characteristics

The XBF-D160HM is identical to the BF-160 in intended use, and similar in specifications except for the optical system. Comparison between the subject device and predicate device is in Table 4.

Specifications	Subject DeviceXBF-D160HM	Predicate DeviceBF-160 (K023984)
Distal End Outer Diameter	☐5.9mm	☐5.3mm
Insertion Tube OuterDiameter	☐5.7mm	☐5.3mm
Inner Channel Diameter	☐2.0mm	☐2.0mm
Optical system	High magnification observationandNormal observation	Normal observation

Table 4 Comparison between the subject device and predicate device

7. Materials

All the patient contact materials used in the subject device are identical to those used in the devices cleared in the past 510(k) submissions.

8. Conclusion

When compared to the predicate device, the XBF-D160HM does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety and effectiveness. Therefore, clinical data is not necessary for its evaluation of safety and efficacy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three wing-like shapes above a wavy line.

APR 1 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Olympus Corporation c/o Tina Steffanic-Oak Associate Manager, Regulatory Affaire/Clinical Monitor Two Corporate Center Drive Melville, NY 11747

Re: K040940

Trade/Device Name: Bronchovideoscope Olympus XBF-D160HM Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessorics) Regulatory Class: Class II Product Code: EOQ Dated: February 20, 2004 Received: April 12, 2004

Dear Ms. Steffanie-Oak:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Codc 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 mcan 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Tina Steffanie-Oak

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. halpi Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): Device Name: Bronchovideoscope Olympus XBF-D160HM Indications For Use:

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use___ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Karen H. Balin

510(k) Number K040940

Page 1 of __ 1 ____

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.