This instrument has been designed to be used with ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree.

Device Description

The Single Use Aspiration Needle NA-U401SX-4025N (aka ViziShot 2) is used in conjunction with Olympus ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA). The subject devices consist of a handle section and insertion. The handle section is connected to the endoscope's instrument channel port via the single use adapter biopsy valve (MAJ-1414). The insertion section is composed of the sheath, needle and stylet. The needle tube is stored in the sheath and extended from the sheath to puncture the target tissue to collect specimen by moving the needle slider on the handle. A syringe is attached to the aspiration port on the handle section to aspirate the specimen. The needle is dimpled for echo enhancement. The subject devices will be sold with or without the medallion syringe manufactured by Merit Medical, which consists of the VACLOK Syringe and Stopcock.

AI/ML Overview

This submission (K190239) is for a medical device (Single Use Aspiration Needle NA-U401SX-4025N, also known as ViziShot 2), not an AI/ML device. Therefore, the questions related to AI/ML specific criteria like MRMC studies, standalone algorithm performance, number of experts for ground truth, sample sizes for training/test sets, and adjudication methods are not applicable to the provided document.

The document describes the device, its intended use, and substantial equivalence to a predicate device based on non-clinical testing.

Here's a breakdown of the applicable information:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Sterilization/Shelf-life	Device remains sterile and functional for its intended shelf-life.	- Sterilization/shelf-life testing conducted per FDA's "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." - Accelerated aging test conducted per ASTM F1980-16 for sterile barrier systems. - Real-time aging test for three years will be performed to
demonstrate longer stability and support accelerated aging test results.
Biocompatibility	Device materials are biocompatible and do not pose unacceptable biological risks.	- Biocompatibility testing conducted per FDA's "Use of International Standard ISO 10993-1:2009, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'." - Specific tests completed: Cytotoxicity, Intracutaneous Study, Sensitization, Systemic Toxicity, Pyrogen Study.
Performance - Bench	Device functions as intended and meets design specifications for aspiration, piercing, visibility, etc.	- Bench testing conducted to ensure devices perform as intended and meet design specifications. - Specific tests performed: Piercing, Ultrasound visibility, Needle extraction and retraction, Aspiration, Endoscope compatibility, Handle function, Joint Pull Strength, Breakage Strength. - "Bench testing confirms that the NA-U401SX-4025N meets its essential performances, which are technologically equivalent to those of the reference device."
Risk Analysis	Identified risks are mitigated adequately and meet established in-house acceptance criteria based on ISO 14971:2007.	- Risk analysis conducted in accordance with ISO 14971:2007. - Design verification tests and their acceptance criteria were identified and performed based on this assessment.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the document. The document refers to "bench testing," "accelerated aging test," and "biocompatibility testing," which inherently involve testing a certain number of devices or samples.
Data Provenance: The tests were conducted internally by Olympus ("established in-house acceptance criteria"). The country of origin of the data is not explicitly stated, but the submitter is Olympus Medical Systems Corp. in Tokyo, Japan. The tests are non-clinical (bench, lab-based), so retrospective or prospective doesn't directly apply in the same way it would for clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable as this is not an AI/ML device dealing with "ground truth" established by human experts in the context of diagnostic interpretation. The "ground truth" for the performance tests would be the established engineering and biological standards and specifications the device is designed to meet.

4. Adjudication method for the test set

Not applicable. This is not an AI/ML device involving human interpretation and 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 device is not an AI product.

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

Not applicable. This device is not an AI product.

7. The type of ground truth used

The "ground truth" for this device's performance is based on engineering specifications, established medical device performance standards (e.g., sterilization, biocompatibility, mechanical strength), and a risk analysis based on ISO 14971:2007. It does not involve expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the AI/ML sense.

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

Not applicable. This device does not use a "training set."

Summary

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December 10, 2019

Olympus Medical Systems Corp. % Daphney Germain-Kolawole Senior Project Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, Pennsylvania 18034-0610

Re: K190239

Trade/Device Name: Single Use Aspiration Needle Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: KTI Dated: November 25, 2019 Received: November 26, 2019

Dear Daphney Germain-Kolawole:

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,

for James J. Lee Ph.D. Assistant 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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Indications for Use

510(k) Number (if known) K190239

Device Name Single Use Aspiration Needle

Indications for Use (Describe)

This instrument has been designed to be used with ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree.

Type of Use (Select one or both, as applicable)
☒

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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November 25, 2019

510(k) Summary

1 GENERAL INFORMATION

■ 510(k) Submitter: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507

■ Contact Person: Lisa M. Boyle Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-3676 Fax: 484-896-7128 Email: lisa.boyle@olympus.com

2 DEVICE IDENTIFICATION

■ Device Name	Single Use Aspiration Needle
■ Model Name	NA-U401SX-4025N
■ Common Name	Aspiration Needle
■ Regulation Number	21 CFR 874.4680
■ Regulation Name	Bronchoscope (flexible or rigid) and accessories
■ Regulatory Class	II
■ Product Code	KTI
■ Classification Panel	Ear Nose & Throat

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Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are sans-serif and appear to be a custom font. A thin, horizontal, yellow bar is located underneath the word. The logo is simple and modern.

3 PREDICATE DEVICE

■ Predicate device

Device name	510(k) Submitter	510(k) No.
ViziShot 2 FLEX (NA-U403SX-4019)	Olympus Surgical TechnologiesAmerica	K163469

■ Reference device

Device name	510(k) Submitter	510(k) No.
Single Use Aspiration NeedleNA-U401SX	OLYMPUS MEDICALSYSTEMS CORP.	K160098
Echotip Ultra Endobronchial HighDefinition Ultrasound Needle, EchotipProcore Endobronchial HighDefinition Ultrasound Biopsy Needle	Cook Ireland Ltd.	K160229

4 DEVICE DESCRIPTION

■ General Description of the subject device

The Single Use Aspiration Needle NA-U401SX-4025N (aka ViziShot 2) is used in conjunction with Olympus ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA).

The subject devices consist of a handle section and insertion. The handle section is connected to the endoscope's instrument channel port via the single use adapter biopsy valve (MAJ-1414). The insertion section is composed of the sheath, needle and stylet. The needle tube is stored in the sheath and extended from the sheath to puncture the target tissue to collect specimen by moving the needle slider on the handle. A syringe is attached to the aspiration port on the handle section to aspirate the specimen. The needle is dimpled for echo enhancement.

The subject devices will be sold with or without the medallion syringe manufactured by Merit Medical, which consists of the VACLOK Syringe and Stopcock.

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■ Principle of Operation

Ultrasound emitted by the ultrasound transducer of the ultrasound endoscope diffusely reflects at dimples on the echo-enhanced region of the needle tube.

The ultrasound transducer detects the part of the ultrasound which diffusely reflects and the echo-enhanced region is indicated on an ultrasound image.

The needle tube and stylet are extracted from the sheath by moving the needle slider to the distal side and is drawn into the sheath by moving the needle slider in the counter direction.

The subject devices are used with specified ultrasound endoscopes for aspirating tissue or cells by piercing the target area in an ultrasound image and attaching the medallion syringe to the aspiration port on the handle section.

5 INDICATIONS FOR USE

This instrument has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree.

6 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE

The Single Use Aspiration Needle NA-U401SX-4025N has the same technological characteristics and design as the predicate device except for the following new features:

Needle width
Needle shape
Needle tip shape
Sheath composition

Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device.

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A side by side comparison of the subject device and the predicate device is provided below.

	Subject Device	Predicate Device (PD)
Item	NA-U401SX-4025N	NA-U403SX-4019 (K163469)
Indications forUse	This instrument has been designedto be used with ultrasoundendoscopes for ultrasound guidedfine needle aspiration (FNA) ofsubmucosal and extramural lesionsof the tracheobronchial tree.	The ViziShot 2 FLEX has beendesigned to be used withultrasound endoscopes forultrasound guided fine needleaspiration (FNA) of submucosaland extramural lesions of thetracheobronchial tree. Do not usethis device for any purpose otherthan its intended use.
RegulationNumber	Similar to PD	874.4680
RegulationName	Identical	Bronchoscope (flexible or rigid)and accessories
RegulatoryClass	Identical	II
Product Code	Identical	KTI
ClassificationPanel	Identical	Ear Nose & Throat
Syringe (foraspiration)	Identical	Equipped
Mode of action	Identical	Single/multiple puncture andaspirate
Energy used	Identical	Manual
Visualization	Identical	Ultrasound guided
ProductSpecificationand Properties	Bench testing confirms that the NA-U401SX-4025N meets its essentialperformances, which are technologically equivalent to those of thereference device.
Reprocessing	Identical	Single Use, ETO Sterile
Needle Width	25G	19G
PatientContactingMaterials	Polytetrafluoroethylene, StainlessSteel, Nickel titanium	Stainless Steel, PTFE, PEBAX,Nitinol

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7 PERFORMANCE DATA

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

1) Sterilization/Shelf-life testing

Sterilization/shelf-life testing for the Single Use Aspiration Needle NA-U401SX-4025N 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 Labeled as Sterile".

Accelerated aging test for the NA-U401SX-4025N was conducted in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices. The real-time aging test for three years will be performed to demonstrate longer stability and support the results of the accelerated aging test.

2) Biocompatibility testing

Biocompatibility testing for the Single Use Aspiration Needle NA-U401SX-4025N was conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1:2009, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The following tests were completed:

Cytotoxicity
. Intracutaneous Study
Sensitization
. Systemic Toxicity
. Pyrogen Study

3) Performance testing - Bench

Bench testing for the Single Use Aspiration Needle NA-U401SX-4025N as listed below was conducted to ensure that the subject devices perform as intended and meet design specifications.

Piercing
Ultrasound visibility
Needle extraction and retraction
Aspiration
Endoscope compatibility ।
Handle function ।
Joint Pull Strength
Breakage Strength

4) Performance testing - Animal

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No animal study was performed to demonstrate substantial equivalence.

5) Performance testing - Clinical

No clinical study was performed to demonstrate substantial equivalence.

6) Risk analysis

A Risk analysis for the Single Use Aspiration Needle NA-U401SX-4025N 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.

The following standards have been applied to the Single Use Aspiration Needle NA-U401SX-4025N.

ISO 10993-1: 2009
AAMI/ANSI/ISO 10993-5: 2009
ISO 10993-10: 2010
ISO 10993-11: 2006
ISO 11135: 2014
ISO 10993-7: 2008+Cor1
ISO 11607-1: 2006+A1
ISO 11607-2: 2006+A1
ASTM F1980-16
ISO 14971: 2007

8 CONCLUSIONS

Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate devices, the NA-U401SX-4025N raise no new issue of safety and effectiveness. Therefore, the NA-U401SX-4025N is substantially equivalent to the predicate devices.

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.