< BF-40 Series> These instruments have been designed to be used with an Olympus Light Source, documentation equipment, display monitor, Endo Therapy Accessories and other ancillary equipment for endoscopic diagnostic and treatment within the airways and tracheobronchial tree.

This instrument has been designed to be used with an Olympus Video System Center, Light Source, Documentation Equipment, Display monitor, Endo-Therapy Accessories, Electrosurgical Unit, and other ancillary equipment for endoscopic diagnosis and treatment within the airways and tracheobronchial tree.

These instrument have 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

< BF-40 Series> These instruments have been designed to be used with an Olympus Light Source, documentation equipment, display monitor, Endo-Therapy Accessories and other ancillary equipment for endoscopic diagnostic and treatment within the airways and tracheobronchial tree.

These instrument have 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.

AI/ML Overview

The regulatory filing provided (K023984) is a 510(k) premarket notification for Olympus Bronchoscopes (BF-40, 240, and 160 series). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study proving device performance against those criteria in the way one might expect for a novel AI/software device.

Instead, the submission details a change in material for a component and argues that this change does not affect safety and effectiveness. Therefore, the information requested regarding acceptance criteria and a study proving their fulfillment, especially in the context of an AI device, is largely not present in this document.

However, I can extract the information that is implicitly part of a 510(k) substantial equivalence submission for a physical medical device like a bronchoscope:

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

The document does not provide a table of performance acceptance criteria or specific reported performance metrics for the reasons stated above. The "acceptance criterion" in a 510(k) for device modifications is primarily demonstrating that the modified device is substantially equivalent to the predicate device in terms of safety and effectiveness, and that the change does not introduce new questions of safety or efficacy.

Acceptance Criterion (Implicit for 510(k) Device Modification)	Reported Device Performance (Implicit for this submission)
Clinical safety and effectiveness unchanged by material change	Assessed to be unchanged
Biocompatibility of new material	Expected to be compatible (implied by typical pre-market processes for material changes)
Mechanical integrity and function maintained	Expected to be maintained
Intended Use remains consistent	Consistent with predicate device

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

This information is not directly applicable or provided in the context of this 510(k) submission. A material change typically involves engineering tests, biocompatibility testing (often in vitro or animal studies if new to medical devices), and potentially some form of simulated use or bench testing, rather than a clinical "test set" as one might see for an AI algorithm. No specific sample sizes for such tests are mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This type of information is relevant for studies relying on expert review for ground truth, which is not the case for this physical device modification.

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

Not applicable.

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, as this is not an AI-powered device.

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

Not applicable, as this is not an AI-powered device.

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

Not applicable. For a physical device with a material change, "ground truth" typically relates to objective engineering specifications, material properties, and functionality tests, rather than clinical diagnostic agreement.

8. The sample size for the training set

Not applicable, as this is not an AI-powered device.

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

Not applicable, as this is not an AI-powered device.

Summary of Study (as per 510(k) for this device):

The "study" or evidence provided in this particular 510(k) is the assertion that the difference between the predicate devices and subject devices is only a change in material of the Biopsy Port, and that this change in material would not affect safety and effectiveness of the device. This is the core of the substantial equivalence argument.

While the document K023984 references "clinical data" in other sections, the publicly accessible portions of this specific 510(k) summary do not detail specific clinical studies for these devices beyond stating their intended use and comparing them to a predicate device when a material change is involved. For a material change, the supporting evidence would typically include:

Material characterization: Data showing the physical and chemical properties of the new material.
Biocompatibility testing: According to ISO 10993 or similar standards, to ensure the new material is safe for patient contact.
Bench testing: To demonstrate that mechanical performance (e.g., flexibility, strength, torqueability, fluid paths) of the bronchoscope with the new biopsy port material is equivalent to or better than the predicate.
Sterilization validation: Ensuring the new material can withstand the validated sterilization process without degradation.

The 510(k) process focuses on demonstrating substantial equivalence, often through a combination of engineering analysis, bench testing, and sometimes non-clinical or limited clinical data, rather than a full-scale clinical trial with specific performance acceptance criteria like those expected for novel technologies or AI.

Summary

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K023984

JAN 31 2003

Revised 1/27/03

SMDA 510(k) SUMMARY

Olympus Bronchoscopes BF-40, 240 and 160 series

A. Submitter's Name, Address, Phone and Fax Numbers

Name & Address of manufacturer:

Registration No .: Address, Phone and Fax Numbers: Of R&D Endoscope Division

Olympus Optical Co., Ltd. 34-3 Hirai Hinide-Machi, Nishitama-Gun , Tokyo 190-00182, Japan 3003637092 2951 Ishikawa-Cho, Hachioji-shi, Tokyo 192-8507 Japan 81- 426-42-2891 TEL FAX 81-426-46-5613

B. Name of Contact Person

Name: Address, Phone and Fax Numbers: Laura Storms-Tyler Olympus America Inc. Two Corporate Center Drive Melville, New York 11747-3157 TEL: (631) 844-5688 FAX: (631) 844-5416

C. Trade Name, Common Name, Classification Name and Predicate Devices


Trade Name:	Olympus Bronchoscopes BF-40 series
Common Name:	Bronchoscope
Classification:	21 CFR 874.4680 Bronchoscopes (flexible or rigid) and accessories, Class II
*Predicate Device:	BF-N20(#K910423)

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- Predicate Device:

The difference between the predicate devices and subjects devices is only a change in material of the Biopsy Port. The change in material would not effect safety and effectiveness of the device.

D. Description of the Device(s)

< BF-40 Series>

These instruments have been designed to be used with an Olympus Light Source, documentation equipment, display monitor, Endo-Therapy Accessories and other ancillary equipment for endoscopic diagnostic and treatment within the airways and tracheobronchial tree.

E. Intended Use of the Device(s)

< BF-40 Series>

These instruments have 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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 31 2003

Olympus Optical Co., LTD c/o Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, NY 11747-3157

Re: K023984

Trade/Device Name: Olympus Bronchoscopes BF-40, 240, 160 Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscopes (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOO Dated: November 26, 2002 Received: December 2, 2002

Dear Ms. Storms-Tyler:

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 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 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 halyi korenthal

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 STATEMENT

510(k) Number(if known): Not assigned yet. KO2 3984 Device Name: Olympus Bronchoscopes BF-40, 240, 160 Indications for Use:

< BF-40 Series>

These instruments have been designed to be used with an Olympus Light Source, documentation equipment, display monitor, Endo Therapy Accessories and other ancillary equipment for endoscopic diagnostic and treatment within the airways and tracheobronchial tree.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

✓

Over-The-Counter Use_

(Per 21 CFR 801.109)

Kuen Bahr

Division of Ophthalmic Nose and Throat De

510(k) Number

(Optional Format 1-2-96)

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.