The biopsy forceps has been designed specifically to collect tissue endoscopically for examination in conjunction with a flexible Olympus bronchoscope. The subject device is single-use biopsy forceps sterilized by Ethylene Oxide. The subject device is inserted into the channel of a bronchoscope to collect tissue by biting the surface of lesions with the pair of cups affixed to the distal end of the subject device. Users withdraw the subject device from the bronchoscope channel to collect the biopsy sample. The subject device consists of the Handle and the Insertion portion. The Handle consists of the Body and the Slider. The Insertion portion is divided into the Distal end including the Cups as well as other connection parts, and the Sheath portion including the Operation wire, the Coil sheath and other joint pipes. The Handle Slider is designed to connect to the Operation wire in the Insertion and the Cups, actuating the Cups to open/close by advancing and retracting the Slider.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Olympus Single Use Biopsy Forceps FB-456D. This device is a medical accessory and not an AI/ML powered device, therefore the typical AI/ML-related study criteria (data provenance, expert adjudication, MRMC studies, training/test set details, etc.) are not applicable here.

However, I can extract the relevant acceptance criteria and performance data for this device as detailed in the provided text.

Here's a breakdown of the acceptance criteria and the proof that the device meets them, based on the provided document:

Device: Single Use Biopsy Forceps FB-456D

Indications for Use: The biopsy forceps has been designed specifically to collect tissue endoscopically for examination with a flexible Olympus bronchoscope.

1. Table of Acceptance Criteria and Reported Device Performance

The document outlines a series of non-clinical tests performed to demonstrate substantial equivalence to the predicate device. These tests serve as the acceptance criteria for various performance aspects.

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria (Implicit from passing test)	Reported Device Performance
Risk Management	ISO 14971:2007	In accordance with established in-house acceptance criteria based on ISO 14971:2007.	Risk analysis conducted and design verification tests (identified through risk analysis) were performed.
Biocompatibility	ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11	Compliance with FDA Guidance for ISO 10993-1. Specific tests for cytotoxicity, irritation/skin sensitization, and systemic toxicity.	Biocompatibility testing conducted in accordance with FDA guidance and relevant ISO 10993 parts. (Implies satisfactory results)
Sterilization	ISO 11135:2014, ISO 10993-7	Sterilization validation using Half-cycle approach per ISO 11135:2014. Residuals assessed per ISO 10993-7.	Sterilization validation carried out with satisfactory results.
Shelf-Life	ASTM F1980-16	Validation of shelf-life for three years.	Three-year shelf-life validated by accelerated testing per ASTM F1980-16. Long-term aging analyses will support these results.
Packaging	AAMI/ANSI/ISO 11607-1/2	Requirements for terminally sterilized medical device packaging are met.	Packaging requirements validated.
Performance Testing	In-house tests	1. Compatibility with the endoscope: Demonstrated functional compatibility.	Testing performed; device is compatible. (Implies satisfactory results)
		2. Open and close of the cups: Functional operation.	Testing performed; cups open and close as intended. (Implies satisfactory results)
		3. Performance after repeated operation: Maintains function over multiple uses (within single-use context, likely durability).	Testing performed; performance maintained. (Implies satisfactory results)
		4. Maximum insertion portion diameter: Conforms to specified dimensions.	Testing performed; diameter meets specifications. (Implies satisfactory results)
		5. Visual inspection of the insertion portion: No defects.	Testing performed; insertion portion passes visual inspection. (Implies satisfactory results)
		6. Strength of the junction and cups: Withstands expected forces.	Testing performed; junction and cups demonstrate adequate strength. (Implies satisfactory results)
		7. Strength when opening/closing the cups: Operational integrity.	Testing performed; sufficient strength during operation. (Implies satisfactory results)
		8. Package inspection: Maintains sterility barrier and integrity.	Testing performed; package passes inspection. (Implies satisfactory results)

2. Sample Sizes and Data Provenance

Sample Size for Test Set: This information is not explicitly provided in the document. For non-clinical, physical device testing, sample sizes are typically determined by engineering standards and statistical confidence levels, but the exact numbers are not detailed here.
Data Provenance: The testing was conducted by Olympus Medical Systems Corp. and Aomori Olympus Co., Ltd., both located in Japan. The testing is performed prospectively as part of the device development and validation process before market clearance.

3. Number of Experts Used to Establish Ground Truth & Qualifications

Not applicable. This device is not an AI/ML diagnostic tool requiring human expert interpretation for ground truth establishment. The "ground truth" here is based on objective, quantitative measurements and adherence to established engineering and biocompatibility standards.

4. Adjudication Method for Test Set

Not applicable. As this is not a diagnostic AI/ML device, there are no human expert readings requiring adjudication. Performance is assessed against pre-defined engineering specifications and standard compliance.

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

Not applicable. This is not an AI/ML-assisted diagnostic device, so no MRMC study looking at human reader performance with or without AI assistance was conducted.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical biopsy forceps, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective measurements, adherence to internationally recognized scientific and engineering standards (e.g., ISO, ASTM), and in-house established acceptance criteria. For example, biocompatibility is assessed against ISO standards, sterility against ISO standards, and mechanical performance against defined engineering thresholds.

8. Sample Size for Training Set

Not applicable. This is a physical medical device, not an AI/ML model that requires a "training set" of data.

9. How Ground Truth for Training Set Was Established

Not applicable. No training set for an AI/ML model.

Summary

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April 24, 2020

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. % Jonathan Gilbert Regulatory Affairs Consultant to OCA Olympus Corporation of the Americas 3500 Corporation Parkway PO Box 610 Center Valley, Pennsylvania 18034-0610

Re: K200397

Trade/Device Name: Single Use Biopsy Forceps FB-456D Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: February 15, 2020 Received: February 18, 2020

Dear Jonathan Gilbert:

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 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

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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 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 Michael J. Ryan 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 Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K200397

Device Name

Single Use Biopsy Forceps FB-456D

Indications for Use (Describe)

The biopsy forceps has been designed specifically to collect tissue endoscopically for examination with a flexible Olympus bronchoscope.

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)

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

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Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly shadowed, giving them a three-dimensional appearance. A thin, light-yellow line is visible beneath the word, adding a subtle highlight.

K200397 510(k) Summary Single Use Biopsy Forceps FB-456D

April 23, 2020

1. General Information

■ 510(k) submitter:	OLYMPUS MEDICAL SYSTEMS CORP.
	2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507,
	Japan
	Establishment Registration No: 8010047
■ Contact Person:	Jon Gilbert fbo Sheri L. Musgnung
	Olympus Corporation of the Americas
	3500 Corporate Parkway PO Box 610
	Center Valley, PA 18034-0610, USA
	Phone: 484-896-5691
	FAX: 484-896-7128
	Email: sheri.musgnung@olympus.com
■ Manufacturing site:	Aomori Olympus Co., Ltd.
	2-248-1 Okkonoki, Kuroishi-shi, Aomori, 036-0357
	Japan
	Establishment Registration No.: 9614691
2. Device Identification
■ Device Trade Name:	Single Use Biopsy Forceps FB-456D
■ Common Name:	Single Use Biopsy Forceps
■ Regulation Number:	874.4680

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Bronchoscope (flexible or rigid) and accessories ■ Regulation Name:
Regulatory Class: II
Ear Nose & Throat ■ Classification Panel:
Product Code: EOQ

3. Predicate Device Information

Predicate device

Device Name: Single Use Biopsy Forceps FB-433D ■ Common Name: Biopsy Forceps ■ Applicant OLYMPUS MEDICAL SYSTEMS CORP. ■ 510(k) No. K172726

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4. Device Description

The biopsy forceps has been designed specifically to collect tissue endoscopically for examination in conjunction with a flexible Olympus bronchoscope.

The subject device is single-use biopsy forceps sterilized by Ethylene Oxide.

The subject device is inserted into the channel of a bronchoscope to collect tissue by biting the surface of lesions with the pair of cups affixed to the distal end of the subject device. Users withdraw the subject device from the bronchoscope channel to collect the biopsy sample.

The subject device consists of the Handle and the Insertion portion. The Handle consists of the Body and the Slider. The Insertion portion is divided into the Distal end including the Cups as well as other connection parts, and the Sheath portion including the Operation wire, the Coil sheath and other joint pipes. The Handle Slider is designed to connect to the Operation wire in the Insertion and the Cups, actuating the Cups to open/close by advancing and retracting the Slider.

5. Indications for Use

The biopsy forceps has been designed specifically to collect tissue endoscopically for examination in conjunction with a flexible Olympus bronchoscope.

6. Comparison of Technological Characteristics

In comparison to the predicate device, the subject device, Single Use Biopsy Forceps FB-456D, has similar technological characteristics except for the following differences.

Cup shape -
Maximum insertion portion diameter -
-Bronchoscope compatibility
Configuration of handle -
Patient-contact material -

The differences above have been validated and demonstrate that these technological features do not raise new issues in terms of the claims of substantial equivalence to the subject device.

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7. Summary of non-clinical testing

The technological differences between the predicate device and the subject device have been verified and validated by means of the following tests and standards to endorse the claims of substantial equivalence to the predicate device.

Risk analysis was conducted 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.

Biocompatibility testing for Single Use Biopsy Forceps FB-456D 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".

Sterilization and shelf-life testing for the Single Use Biopsy Forceps FB-456D was conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Sterile". Sterilization validation was carried out with the method of Half-cycle approach in accordance with ISO 11135:2014. The shelf-life for three years has been validated by accelerated testing according to ASTM F1980-16. Three-year aging analyses will be performed to support the results of the accelerated aging test.

The requirements on packaging for terminally sterilized medical device per AAMI/ ANSI/ISO 11607-1/2 have also been validated. Performance testing as below was carried out to demonstrate the safety and the effectiveness of the subject device.

1. Compatibility with the endoscope
1. Open and close of the cups
1. Performance after repeated operation
1. Maximum insertion portion diameter
1. Visual inspection of the insertion portion
1. Strength of the junction and cups
1. Strength when opening/closing the cups
1. Package inspection

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The following standards have been applied to the subject device.

Standard No.	Standard Title
ISO11135 Second Edition2014	Sterilization of Health-Care Products, Ethylene Oxide -Requirements for the Development, Validation andRoutine Control of a Sterilization Process for MedicalDevices
ISO 10993-7 Secondedition 2008-10-15	Biological evaluation of medical devices - part 7: ethyleneoxide sterilization residuals
ISO 11607-1 First edition2006-04-15	Packaging for terminally sterilized medical devices - part1: requirements for materials, sterile barrier systems andpackaging systems
ISO 11607-2 First edition2006-04-15	Packaging for terminally sterilized medical devices - part2: validation requirements for forming, sealing andassembly processes
ASTM F1980-16	Standard Guide For Accelerated Aging Of Sterile BarrierSystems For Medical Devices
ISO 10993-1 Fourthedition 2009-10-15	Biological evaluation of medical devices - part 1:evaluation and testing within a risk management process
ISO 10993-5 Third edition2009-06-01	Biological evaluation of medical devices - part 5: tests forin vitro cytotoxicity
ISO 10993-10 ThirdEdition 2010-08-01	Biological evaluation of medical devices - part 10: testsfor irritation and skin sensitization
ISO 10993-11 Thirdedition 2017-09	Biological evaluation of medical devices - part 11: testsfor systemic toxicity
ISO 14971 Second edition2007-03-01	Medical devices - application of risk management tomedical devices

8. Conclusion

In comparison to the predicate device, the subject Single Use Biopsy Forceps FB-456D device does not raise different questions of safety and effectiveness and is substantially equivalent to the predicate device.

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.