These instruments have been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree and collect tissue, specimens, or cells bronchoscopically. This kit and its components are intended for adult patients only.

Indications for use of each component

Single Use Guide Sheath SG-400C

The single use guide sheath has been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree.

Single Use Biopsy Forceps FB-433D

The biopsy forceps has been designed specifically to collect tissue endoscopically for examination with a flexible bronchoscope within the tracheobronchial tree.

Single Use Cytology Brush BC-205D

The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with the bronchoscope within the tracheobronchial tree.

Device Description

The kit has been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree and collect tissue, specimens, or cells bronchoscopically.

The compatible bronchoscope for the subject Single Use Guide Sheath Kit needs to have the working length 600mm or less (exclude the ultrasonic bronchoscope) and a working channel inner diameter that is no less than 2.0mm.

The guide sheath kit consists of the following components: Guide Sheath, Biopsy Forceps, with/without Cytology Brush. EU stoppers and US Stopper are also included in the kit as accessories. Each component and the accessory stoppers are sterile and packaged in individual package. All of them are collected into one carton box as one final kit product.

AI/ML Overview

This document is a 510(k) premarket notification for the Olympus Medical Systems Corp.'s Single Use Guide Sheath Kit K-401/K-402. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K192164).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission claims substantial equivalence to its predicate device (K192164) and does not explicitly list performance acceptance criteria in a table format with corresponding reported performance values for each criterion. Instead, it states that the only technological difference from the predicate is the outer diameter of the Guide Sheath SG-400C, and that this difference was validated.

Key Difference and Stated Performance:

Feature	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Subject Device)
SG-400C Maximum insertion portion diameter	φ1.95mm (Predicate Device)	φ1.91mm (Subject Device)

The document states, "The difference above has been validated and it is demonstrated that this technological feature does not raise no new safety issues and are substantially equivalent to the predicate device."

Performance Data and Demonstrated Safety/Effectiveness (for SG-400C only):
The following performance tests were conducted to demonstrate safety and effectiveness for the SG-400C only (as FB-433D and BC-205D had no specification changes):

Radiographic Testing
Catheter Joint/Tensile Testing
Dimensional Testing
Simulated Use Testing
Trackability Testing (insertion & withdrawal)

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

The document does not specify the sample sizes used for the performance tests (Radiographic, Catheter Joint/Tensile, Dimensional, Simulated Use, Trackability).
The data provenance is not explicitly stated. However, this is a submission by Olympus Medical Systems Corp. in Japan for a device manufactured in Japan, indicating the testing was likely conducted in Japan. The studies are premarket validation studies, typically prospective, but the specific experimental design (e.g., patient cases, benchtop models) and retrospective/prospective nature of data collection are not detailed.

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

Not applicable. This device is a medical instrument (guide sheath, biopsy forceps, cytology brush), not an AI/software device that requires ground truth established by experts for diagnostic or image interpretation tasks. The evaluation is based on engineering performance tests and adherence to standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not an AI/software device requiring expert adjudication for diagnostic tasks. Performance is assessed against engineering specifications and validated through physical and functional testing.

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

Not applicable. This is a medical device, not an AI diagnostic software. Therefore, an MRMC study and analysis of human reader improvement with/without AI assistance are irrelevant to this submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

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

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation refers to engineering specifications, established medical device standards (e.g., ISO, ASTM, USP), and functional requirements for safe and effective operation. For example, dimensional accuracy, tensile strength, and successful trackability in simulated use are evaluated against predefined acceptable ranges or outcomes.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model, 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 for a physical medical device, there is no ground truth establishment for it.

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 USA seal. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K212667

Trade/Device Name: Single Use Guide Sheath Kit-401, K-402 Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ, BTG Dated: August 20, 2021 Received: August 23, 2021

Dear Teffany Hutto:

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.

Brandon Blakely, PhD Acting Assistant Director DHT1C: Division of 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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Indications for Use

510(k) Number (if known)

Device Name Single Use Guide Sheath Kit K-401, K-402

Indications for Use (Describe) Single Use Guide Sheath Kit K-401, K-402

Indications for use of each component

Single Use Guide Sheath SG-400C

Single Use Biopsy Forceps FB-433D

The biopsy forceps has been designed specifically to collect tissue endoscopically for examination with a flexible bronchoscope within the tracheobronchial tree.

Single Use Cytology Brush BC-205D

The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with the bronchoscope within the tracheobronchial tree.

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/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are spaced closely together, and the word is centered in the image. There is a yellow line underneath the word. The registered trademark symbol is located to the right of the letter "S".

Single Use Guide Sheath Kit K-401/K-402

DATE: August 20, 2021

1. General Information

■ 510(k) submitter:	OLYMPUS MEDICAL SYSTEMS CORP.2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507,JapanEstablishment Registration No: 8010047
■ Contact Person:	Teffany HuttoOlympus Corporation of the Americas3500 Corporate Parkway PO Box 610Center Valley, PA 18034-0610, USAPhone: 512-508-6550FAX: 484-896-7128Email: teffany.hutto@olympus.com
■ Manufacturing site:	Aomori Olympus Co., Ltd.2-248-1 Okkonoki, Kuroishi-shi, Aomori, 036-0357JapanEstablishment Registration No.: 9614691

2. Device Identification

■ Device Trade Name:	Single Use Guide Sheath Kit K-401/K-402[Component]- Single Use Guide Sheath SG-400C- Single Use Biopsy Forceps FB-433D- Single Use Cytology Brush BC-205D
	ET Stopper / US Stopper
■ Common Name:	Guide Sheath Kit & Guiding Device
■ Regulation Number:	874.4680
■ Regulation Name:	Bronchoscope (flexible or rigid) and accessories
■ Regulatory Class:	II
■ Classification Panel:	Ear Nose & Throat510(k) SummaryPage 1 of 6

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Product Code: EOQ , BTG

Predicate Device Information 3.

■ Predicate device

Device name	510(k) Submitter	510(k) No.
Single Use Guide Sheath Kit K-401/K-402	OLYMPUS MEDICALSYSTEMS CORP.	K192164

Device Description 4. Single Use Guide Sheath Kit K-401/K-402

Components/Accessories in each kit*
Kit Model	K-401	K-402
Guide Sheath	SG-400C
Biopsy Forceps	FB-433D
Cytology Brush	BC-205D-2010	NA
ET StopperColor: White	Quantity: 4	Quantity: 3
US StopperColor: Dark gray	Quantity: 1	Quantity: 1

Table 1 Configuration of Each Kit Model and ts/Accossorios in ooch Izit*

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tree.

This guide sheath is designed to function as an extended working channel. The function of the subject guide sheath is to facilitate obtaining multiple biopsy specimens by leaving the guide sheath in place after localization of the target tissue.

This instrument consists of an insertion portion and a handle portion. The insertion portion is composed of tube and X-ray tip.

The biopsy forceps has been designed specifically to collect tissue endoscopically for examination in conjunction with a flexible bronchoscope. The subject device is allowed to insert into the channel of a bronchoscope with the subject device guide sheath, and then collect tissue with the pair of forceps which is equipped at the distal end of the subject device. Finally, users withdraw the subject device biopsy forceps from the bronchoscope to collect the samples.

The single use cytology brush BC-205D has been designed to collect specimens or cells endoscopically for cytology examination in conjunction with bronchoscopes. The subject device is allowed to insert into the channel of a bronchoscope with the subject device guide sheath, and then collect specimens or cells with the brush which is affixed in the distal end of the subject device. Finally, users withdraw the subject device cytology brush from the bronchoscope to collect the samples.

< ET/US Stopper>

The ET stopper and US stopper are included in the guide sheath kit as accessory. They are used to fasten the sampling devices (EndoTherapy accessories) or ultrasonic probe to the guide sheath, which serve as a mark to keep the sampling devices or ultrasonic probe in relative position to the guide sheath. The ET stopper are made of silicone rubber outside, molded with stainless steel plate inside.

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5. Indications for Use

Single Use Guide Sheath Kit K-401, K-402

- Indications for use of each component

Single Use Guide Sheath SG-400C

Single Use Biopsy Forceps FB-433D

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

Single Use Cytology Brush BC-205D

The cvtology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with the bronchoscope within the tracheobronchial tree.

6. Comparison of Technological Characteristics

In comparison to the predicate device, the subject device Single Use Guide Sheath Kit K-401/K-402 have the same technological characteristics as the predicate device except the outer diameter of the SG-400C guide sheath.

The specifications other than outer diameter of the guide sheath are identical to those of the predicate device.

Table 2 Comparison of SG-400C Maximum insertion portion diameter

SG-400C(Subject Device)	SG-400C(Predicate Device :K192164)
φ1.91mm	φ1.95mm

The difference above has been validated and it is demonstrated that this technological

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feature does not raise no new safety issues and are substantially equivalent to the predicate device.

The following standards have been applied to the Single Use Guide Sheath Kit.

Table 3 The list of applicable FDA recognized standards
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 Secondedition 2019-02	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 Third edition2019-12	Medical devices - application of risk management tomedical devices
ASTM F756	Standard Practice for Assessment of Hemolytic Propertiesof Materials
ISO 10993-4 Third edition2017-04	Biological evaluation of medical devices - Part 4:Selection of tests for interactions with blood
USP General Chapter<151>	Pyrogen Test
USP 42, NF 37, GeneralChapters <85>	Bacterial Endotoxins Test
USP 42, NF 37, GeneralChapters <161>	Medical Devices-Bacterial Endotoxin and Pyrogen Tests

Table 3 The list of applicable FDA recognized standards

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7. Performance Data

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

No modification was applied to sterilization/shelf-life. Therefore, Sterilization/shelf-life testing was not performed.

No modification was made to the patient contacting materials of the subject device. The modified guide sheath can be covered by the existing biocompatibility testing data provided in the predicate device 510(k).

Performance testing was carried out to demonstrate the safety and the effectiveness of the subject devices. Since the FB-433D and BC-205D have no specification changes, these tests were performed for SG-400C only.

-Radiographic Testing
Catheter Joint/Tensile Testing -
Dimensional Testing -
Simulated Use Testing -
Trackability Testing (insertion & withdrawal) -

Risk analysis for the Single Use Guide Sheath Kit and the Single Use Guiding Device was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2019. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.

Clinical testing was not applicable and not performed.

8. Conclusion

In comparison to the predicate devices, the Single Use Guide Sheath Kit raises no new safety issues 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.