This instrument has been designed to be used with an Olympus endoscope to electrosurgically collect tissue, to electrosurgically cauterize, or to perform electrosurgical hemostasis within the tracheobronchial tree.

The product is only intended for adult populations.

Device Description

Single Use Hot Biopsy Forceps FD-231 has been designed to be used with an Olympus endoscope to electrosurgically collect tissue, to electrosurgically cauterize, or to perform electrosurgical hemostasis within the tracheobronchial tree.

The Single Use Hot Biopsy Forceps FD-231consists of a handle and insertion portion. Fenestrated cups in the distal end of insertion are activated in the open and closed position by maneuvering the slider in the handle.

During operation, insertion will be inserted into endoscopes. Once the tissue is held by the cups. the tissue is subjected to high frequency electric current transmitted from plug which allows for collecting tissue. Once the tissue is touched by closed cups, the tissue is subjected to high frequency electric current transmitted from plug which allows for cauterization and hemostasis.

By means of high frequency electric current passing through the tissues between electrical plate attached on patient`s skin and the cups, heat will be produced from electricity resistance by the tissue and the heat will be utilized for collecting tissue, cauterization and hemostasis.

AI/ML Overview

This document is a 510(k) summary for the Olympus Single Use Hot Biopsy Forceps FD-231. It describes the device, its intended use, and the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to acceptance criteria and device performance:

**The document does not describe: **

A table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical outcomes. This document focuses on the design and safety aspects of a medical device (hot biopsy forceps), not a diagnostic algorithm. Therefore, typical metrics like sensitivity, specificity, or AUC, as would be relevant for an AI/ML-based diagnostic device, are not applicable here.
Sample size used for a "test set" in the context of diagnostic performance. The "tests" here are engineering and safety validations.
Data provenance (e.g., country of origin, retrospective/prospective).
Number of experts used to establish ground truth or their qualifications.
Adjudication method for a test set.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
Effect size of human readers improving with AI vs. without AI assistance.
Standalone (algorithm only) performance.
Type of ground truth (expert consensus, pathology, outcomes data).
Sample size for a training set.
How ground truth for a training set was established.

Instead, this document describes:

The document describes non-clinical testing to demonstrate the safety and effectiveness of the device, focusing on substantial equivalence to a predicate device. The acceptance criteria in this context are established by engineering standards and internal risk analysis, rather than diagnostic performance metrics.

Here's what can be extracted regarding acceptance criteria and performance, as appropriate for this type of medical device:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Validation)

While not presented in a formal table with pass/fail remarks for each test, the document lists the types of non-clinical tests performed and implies that the device met the criteria for each, as it received 510(k) clearance.

Acceptance Criteria Category/Test	Associated Standard(s) / Basis	Reported Device Performance (Implied)
Functional Performance:
Insertion into/Withdrawal from endoscope	Engineering specifications	Demonstrated acceptable insertion/withdrawal.
Advance/Retraction of Hot Biopsy Forceps	Engineering specifications	Demonstrated acceptable advance/retraction.
Grasp of specimens	Engineering specifications	Demonstrated effective tissue grasping capabilities.
Electrical characteristic	IEC 60601-2-2, internal specifications	Met electrical performance requirements for electrosurgical use (e.g., current transmission for tissue collection, cauterization, hemostasis).
Cutting performance	Engineering specifications	Demonstrated effective cutting performance for tissue collection.
Compatibility with endoscope	Internal specifications, intended use context	Demonstrated compatibility with Olympus endoscopes as intended.
Power limit	Internal specifications	Operated safely within established power limits.
Biocompatibility:
Cytotoxicity	ISO 10993-5	Met criteria (demonstrated non-cytotoxic).
Sensitization	ISO 10993-10	Met criteria (demonstrated non-sensitizing). ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Intracutaneous irritation	ISO 10993-10	Met criteria (demonstrated non-irritating). ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Systemic toxicity	ISO 10993-11	Met criteria (demonstrated no systemic toxicity). ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Sterilization & Packaging:
EO residual & ECH residual	ISO 11135, AAMI/ANSI/ISO 10993-7	Measured to meet defined criteria.
Shelf-life validation (3 years)	ASTM F1980-16	Validated for 3 years via accelerated testing.
Packaging integrity (Peel strength, endurance to splitting, integrity)	AAMI/ANSI/ISO 11607-1, AAMI/ANSI/ISO 11607-2	All packaging tests were met, ensuring sterility maintenance.
Electrical Safety & EMC:
Electromagnetic Compatibility (EMC)	IEC 60601-1-2	Tested and found compliant with EMC requirements.
Electrical Safety	AAMI/ANSI ES 60601-1, IEC 60601-2-18, AAMI/ANSI/IEC 60601-2-2	Tested and found compliant with electrical safety requirements for medical electrical equipment and specific standards for high frequency surgical equipment and endoscopic equipment.
Risk Management:	ISO 14971, internal acceptance criteria	Risk analysis was carried out, and design verification tests and acceptance criteria were identified and met to address identified risks.

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

Sample Size: Not explicitly stated as a number of devices/units for each test. However, the performance of these tests (e.g., biocompatibility) typically involves a sufficient number of samples as dictated by the relevant standards.
Data Provenance: The device is manufactured by Aomori Olympus Co., Ltd. in Japan. The tests are non-clinical (laboratory/bench testing) and performed according to international standards (ISO, ASTM, IEC, AAMI/ANSI). The data's "provenance" here refers to the engineering validation processes, likely conducted at the manufacturer's or qualified testing facilities. Retrospective/prospective is not applicable as this is not clinical performance data.

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

Not Applicable. This is not a study assessing diagnostic "ground truth" established by human experts. The "ground truth" for the non-clinical tests are the objective measurements and adherence to specified engineering and safety parameters outlined in the standards.

4. Adjudication Method for the Test Set:

Not Applicable. No human interpretation or adjudication of diagnostic images is involved. The "test set" here refers to the physical devices undergoing engineering and safety validation, with acceptance being based on meeting quantitative criteria from standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This type of study is for evaluating the impact of a diagnostic AI on human reader performance. This device is a surgical instrument, not a diagnostic AI.

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

Not Applicable. There is no algorithm or AI component to this device. Its performance is purely mechanical and electrical, measured through non-clinical bench testing.

7. The Type of Ground Truth Used:

Engineering Specifications and Standard Requirements: The "ground truth" for this device's performance acceptance is its adherence to a robust set of international and industry standards (e.g., ISO, IEC, AAMI/ANSI, ASTM) covering electrical safety, biocompatibility, sterilization, packaging, and functional mechanical properties. These standards define the acceptable range or threshold for specific measurements.

8. The Sample Size for the Training Set:

Not Applicable. This is not an AI/ML device, so there is no "training set."

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

Not Applicable. As there is no training set.

In summary, this document demonstrates regulatory clearance for a medical device (hot biopsy forceps) based on non-clinical engineering and safety testing, showing substantial equivalence to a predicate device. It explicitly states that:

Validation from non-clinical testing demonstrated that the differences (compatible endoscope/accessories, electrical specification, material composition/configuration of handle/insertion) do not raise further problems on safety or effectiveness.
"The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment" (based on ISO 14971).
The conclusion is that the device "does not demonstrate any significant changes in intended use and technical characteristics that could affect the safety or effectiveness of the device."

Summary

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Image /page/0/Picture/0 description: The image contains 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.

November 30, 2018

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

Re: K173495

Trade/Device Name: Single Use Hot Biopsy Forceps FD-231 Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: Class II Product Code: QEC Dated: October 30, 2018 Received: October 31, 2018

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 mav, 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 avare 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

James J. Lee -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173495

Device Name Single Use Hot Biopsy Forceps FD-231

Indications for Use (Describe)

The product is only intended for adult populations.

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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Image /page/3/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, yellow line. Underneath the line, the text "Your Vision, Our Future" is written in a smaller, lighter font.

510(k) SUMMARY Single Use Hot Biopsy Forceps FD-231

November 29, 2018

5.1 General Information

■ Applicant:	OLYMPUS MEDICAL SYSTEMS CORP.2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507,JapanEstablishment Registration No: 8010047
■ Official Correspondent:	Jon Gilbert fbo Sheri MusgnungOlympus Corporation of the Americas3500 Corporate Parkway PO Box 610Center Valley, PA 18034-0610, USAPhone: 484-896-3147FAX: 484-896-7128Email: sheri.musgnung@olympus.com
■ Manufacturer:	Aomori Olympus Co., Ltd.2-248-1 Okkonoki, Kuroishi-shi, Aomori, 036-0357,JapanEstablishment Registration No.: 9614691
5.2 Device Identification
■ Device Trade Name:	Single Use Hot Biopsy Forceps FD-231
■ Model Number:	FD-231C
■ Common Name:	Hot Biopsy Forceps
■ Regulation Number:	876.4300
■ Regulation Name:	Endoscopic electrosurgical unit and accessories.
■ Regulatory Class:	II
■ Classification Panel:	Gastroenterology/Urology

QEC ■ Product Code:
510(k) Summary_K173495 Page 2 of 6

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	Predicate device	Reference device 1	Reference device 2
Device name	Disposable HotBiopsy Forceps	Single Use BiopsyForceps FB-433D	OLYMPUS CD-6C-1COAGULATIONELECTRODE
K number	K160625	K172726	K971328
Classification	II	II	II

5.3 Predicate Device and Reference Devices Information

Device Description 5.4

ર્સ્ટ Indications for Use

The product is only intended for adult populations.

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Image /page/5/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, horizontal, yellow line. Underneath the line is the text "Your Vision, Our Future".

5.6 Comparison of Technological Characteristics

Compared to the predicate device, the proposed subject device: Single Use Hot Biopsy Forceps FD-231, has similar technological characteristics except for the following differences:

1. Compatible endoscope and accessories
1. Electrical specification for electrosurgical biopsy
1. Material composition and configuration of handle and insertion portion

Validation from non-clinical testing demonstrated that these technological features do not raise further problems on safety or effectiveness of the subject device.

5.7 Summary of non-clinical testing

The following tests on key features of performance specification were conducted to demonstrate the safety and effectiveness of the subject device as identical as predicate devices.

1. Insertion into /Withdrawal from endoscope of Hot Biopsy Forceps
1. Advance/ retraction of Hot Biopsy Forceps
1. Grasp of specimens
1. Electrical characteristic
1. Cutting performance test
1. Compatibility with endoscope
1. Visual inspection of package
1. Peel strength of the package
1. Endurance to splitting of the package
1. Integrity of the package
1. Joint strength test
1. Power limit

The EO residual and ECH residual were measured after sterilization of the device to meet the criteria defined in ISO 11135 Second edition 2014 and AAMI/ANSI/ISO 10993-7:2008(R)2012.

The shelf-life for three years had been validated in accelerated testing according to ASTM F1980-16 (2016) and the requirements on packaging for terminally sterilized medical device per AAMI/ANSI/ISO 11607-1:2006/(R) 2010 and AAMI/ANSI/ISO 11607-2:2006/(R)2010 are also met.

Biocompatibility testing was performed in accordance with the FDA Guidance, "Use of International Standard ISO-10993-1, 'Biological evaluation of medical devices - Part 1:

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Evaluation and testing within a risk management process" issued on June 16, 2016. The cytotoxicity, sensitization, intracutaneous irritation and system toxicity tests were performed to demonstrate the biocompatibility of the device.

Tests on Electromagnetic Compatibility and Electrical Safety were performed in accordance to requirements per AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-1-2 Edition 3: 2007-03, and in particular we also conducted tests on high frequency surgical equipment and accessories for endoscopes per IEC 60601-2-18: Edition 3.0 2009-08 and AAMI/ANSI/IEC 60601-2-2:2009.

Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971 Second edition 2007-03-01. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.

The following standards have been applied to the Single Use Hot Biopsy Forceps FD-231:

Standard No.	Standard Title
AAMI/ANSI/ES60601-1:2005/(R)2012 and A1:2012	Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance
IEC 60601-1-2 Edition 3: 2007-03	Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and tests
AAMI/ANSI/IEC60601-2-2:2009	Medical electrical equipment - Part 2-2: Particular requirements forthe basic safety and essential performance of high frequencysurgical equipment and high frequency surgical accessories
IEC 60601-2-18: Edition 3.0 2009-08	Medical electrical equipment - Part 2-18: Particular requirements forthe basic safety and essential performance of endoscopic equipment
ISO 10993-1 Fourth edition2009-10-15	Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process
ISO 10993-5 Third edition2009-06-01	Biological evaluation of medical devices - Part 5: Tests for in vitrocytotoxicity

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Standard No.	Standard Title
ISO 10993-10 Third Edition2010-08-01	Biological evaluation of medical devices - Part 10: Tests forirritation and skin sensitization
ISO 10993-11 Second edition2006-08-15	Biological evaluation of medical devices - Part 11: Tests forsystemic toxicity
ISO 11135 Second edition 2014	Sterilization of health-care products - Ethylene oxide - Requirementsfor the development, validation and routine control of a sterilizationprocess for medical devices
AAMI/ANSI/ISO10993-7:2008(R)2012	Biological evaluation of medical devices - Part 7: Ethylene oxidesterilization residuals
ASTM F1980-16 (2016)	Standard Guide for Accelerated Aging of Sterile Barrier Systems forMedical Devices
AAMI/ANSI/ISO11607-1:2006/(R)2010	Packaging for terminally sterilized medical devices - Part 1:Requirements for materials, sterile barrier systems and packagingsystems
AAMI/ANSI/ISO11607-2:2006/(R)2010	Packaging for terminally sterilized medical devices - Part 2:Validation requirements for forming, sealing and assemblyprocesses
ISO 14971 Second edition2007-03-01	Medical devices - Application of risk management to medicaldevices

5.8 Conclusion

Compared to the predicate device, the Single Use Hot Biopsy Forceps FD-231 does not demonstrate any significant changes in intended use and technical characteristics that could affect the safety or effectiveness of the device.

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).