The ViziShot 2 FLEX has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose other than its intended use.

Device Description

The subject device, ViziShot 2 FLEX is a single use aspiration needle to be used in conjunction with compatible ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree.

The subject device consists of a handle, sheath, needle, and stylet. The sheath and needle are attached to the handle, and the removable stylet is located within the needle. Note that although, the device has a component called a needle, the device is often referred to as a needle as well. The device is a single-use sterile device.

Prior to a procedure, the flexible catheter portion is inserted into a bronchoscope's working channel (2.2mm) and advanced forward until fully inserted. The handle is then affixed to the channel port of the endoscope via a lever mechanism that locks onto the Adapter Biopsy Valve.

The needle is advanced through the bronchoscope to the sampling site while visualizing both the target and the needle in real time with ultrasound. The handle facilitates advancement of the needle during puncture of the targeted biopsy site. The sample is obtained by penetrating the lesion with the needle while applying suction at the proximal end of the handle. After completing the sampling, the vacuum from the syringe is released to atmosphere, the handle unlocked from the bronchoscope, and the catheter and needle pulled out from the working channel. The removed tissue can then be prepared for cytopathological or microbiological examination and testing.

The ViziShot 2 FLEX is available in one model only (NA-U403SX-4019), with a needle size of 19 gauge (19G). The two required accessories, the Adapter Biopsy Valve and the Merit Syringe with Stopcock, are packaged with the ViziShot 2 FLEX.

AI/ML Overview

The ViziShot 2 FLEX is a single-use aspiration needle used with ultrasound endoscopes for ultrasound-guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of lesions in the tracheobronchial tree. The device is identical to a previously marketed device (K163469) in formulation, processing, sterilization, and geometry, with the proposed addition of "fine needle biopsy (FNB)" to its Indications for Use, which aligns with the primary predicate device (Cook Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle, K160229).

Here's the breakdown of its acceptance criteria and the study conducted to prove it:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Test	Reported Device Performance
Biocompatibility (per ISO 10993-1, -4, -5, -10, -11, USP <151>, USP <85>)	All patient-contacting surfaces were tested and found to be biocompatible, demonstrating compliance with the specified international and national standards. The device is classified as external communicating, blood path (indirect), and limited duration (<24 hours).
Sterilization/Shelf Life (per ANSI/AAMI/ISO 11607-1, 11135-1, ASTM F1980-16)	Sterilization (ethylene oxide) and packaging were validated. Packaging integrity and performance testing, including accelerated aging per ASTM F1980-16, support a labeled three-year shelf life. The device is delivered sterile and intended for single-patient use.
Bench Performance (Design Verification)	The device was evaluated against physical and performance specifications, addressing outputs of the design process. Tests included: - Sheath and Needle Insertion and Withdrawal Force - Stylet Insertion and Withdrawal Force - Bronchoscope Angulation - Activation Force - Plastic Deformation Angle - Penetration Force - Transmission Force - Device Durability/Handle Durability - Bronchoscope Adapter Sliding Force - Handle Durability - Sheath to Handle Joint Strength - Echogenicity A GLP Comparison study was performed against the predicate (Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle). This study aimed to determine if the ViziShot 2 FLEX 19G needle obtained sufficient tissue samples for histologic and core sample analysis and provided similar quality samples as the predicate. Observations included ease of needle passage through tissue and tissue sampling metrics (weight, length, number of segments, and quality for microscopic evaluation). The results supported the substantial equivalence of the proposed device to the predicate in its ability to obtain adequate tissue samples.

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

Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of clinical cases or patient data, as no clinical or animal studies were performed for this submission. The performance testing was primarily bench-based. For the GLP comparison study, the "test article" was the ViziShot 2 FLEX 19G Needle and the "predicate control article" was the Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle. The number of individual devices or samples tested in this comparison is not explicitly stated, but it would involve a sufficient number to generate statistically meaningful results for mechanical and tissue sampling performance.
Data Provenance: The data provenance is primarily from bench testing conducted in a laboratory setting. No country of origin for clinical or patient data is applicable as such studies were not performed. The GLP comparison study implies a controlled laboratory environment.

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

Since no human "ground truth" (e.g., expert consensus on medical images or pathology slides) was established for a clinical test set, this section is not applicable. The performance tests rely on objective measurements and comparisons, and the GLP comparison study would involve personnel qualified in laboratory testing and potentially pathology for tissue evaluation, though their specific number and qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication was conducted.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The submission explicitly states "No clinical study was performed to demonstrate substantial equivalence." Therefore, no effect size of human readers improving with or without AI assistance is available.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is a physical medical instrument (an aspiration needle), not an algorithm or AI software. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The performance evaluated relates to the physical and functional aspects of the needle itself.

7. The Type of Ground Truth Used

For the substantial equivalence determination, the "ground truth" for the device's performance was established through:

Objective Measurements and Standards: Compliance with international and national standards for biocompatibility, sterilization, and packaging/shelf-life (e.g., ISO 10993 series, ANSI/AAMI/ISO standards, ASTM standards).
Bench Testing Specifications: Evaluation against predefined physical and performance specifications (e.g., insertion/withdrawal forces, durability, echogenicity).
Comparison to Predicate: The ability to obtain sufficient tissue samples for histologic and core sample analysis, and similar quality of samples, compared to a legally marketed predicate device (Cook Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle) in a GLP (Good Laboratory Practice) study.

8. The Sample Size for the Training Set

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

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

Not applicable, as there is no training set for this device.

Summary

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March 18, 2020

Olympus Surgical Technologies America Mary Patella Senior Specialist, Regulatory Affairs 136 Turnpike Road Southborough, Massachusetts 01772-2104

Re: K193517

Trade/Device Name: ViziShot 2 FLEX Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: KTI Dated: December 18, 2019 Received: December 19, 2019

Dear Mary Patella:

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

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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 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,

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

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Indications for Use

510(k) Number (if known)

K193517

Device Name ViziShot 2 FLEX

Indications for Use (Describe)

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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510(k) Summary Gyrus ACMI ViziShot 2 FLEX

General Information

Manufacturer:	Olympus Surgical TechnologiesAmericaGyrus ACMI, Inc.136 Turnpike Rd.Southborough, MA 01772-2104Phone: 508-804-2600Fax: 508-804-2624
Establishment Registration Number:	3003790304
Contact Person:	Mary Anne PatellaSenior Specialist, Regulatory Affairs508-804-2771Maryanne.patella@olympus-osta.com)
Date Prepared:	December 18, 2019
Device Description
Classification Name:CFR Citation Number:Product Code:Classification:Review PanelTrade Name:Generic/Common Name:	Bronchoscope (flexible or rigid) andaccessories21 CFR 874.4680KTIClass IIEar Nose & ThroatGyrus ACMI ViziShot 2 FLEXAspiration Needle
Predicate Device
Cook Ireland, Ltd Echotip ProcoreEndobronchial High DefinitionUltrasound Biopsy Needle	K160229
Reference Device
Gyrus ACMI ViziShot 2 FLEX	K163469

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Product Description

Intended Use

Comparison of Proposed and Predicate DeviceThe proposed addition of "fine needle biopsy (FNB)" to the Indications for Use is the same as the primary predicate Cook Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle cleared via K160229.

The ViziShot 2 FLEX has the same technological characteristics and design as the as the reference predicate ViziShot 2 FLEX cleared under K163469. The subject and predicate device operate in the same manner to obtain a tissue biopsy using an ultrasound endoscope. Please refer to the following Substantial Equivalence Table.

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	Proposed Device	PredicateDevice(K160229)	Reference Device(K163469)
Device Name/Characteristics	Gyrus ACMIViziShot 2FLEX	Cook EchotipProcoreEndobronchialHigh DefinitionUltrasoundBiopsy Needle	Gyrus ACMIViziShotFLEX	Comment
Indications forUse	The ViziShot 2FLEX has beendesigned to beused withultrasoundendoscopes forultrasoundguided fineneedleaspiration(FNA) and fineneedle biopsy(FNB) ofsubmucosal andextramurallesions of thetracheobronchialtree. Do not usethis device forany purposeother than itsintended use.	EchotipProcore®EndobronchialHigh DefinitionUltrasoundBiopsy Needlefor use withOlympus EBUSscopes: Thisdevice is usedwith anultrasoundendoscope forfine needlebiopsy, (FNB),of submucosaland extramurallesions within oradjacent to thetracheobronchialtree orgastrointestinaltract.	The ViziShotFLEX has beendesigned to beused withultrasoundendoscopes forultrasoundguided fineneedleaspiration(FNA) ofsubmucosal andextramurallesions of thetracheobronchialtree. Do not usethis device forany purposeother than itsintended use.	Similar tothe CookPredicate.
Use Conditions	Surgical suite,endoscopy orbronchoscopysuite, used with abronchoscope	Surgical suite,endoscopy orbronchoscopysuite, used witha bronchoscope	Surgical suite,endoscopy orbronchoscopysuite, used with abronchoscope	Identical
Mechanics ofAction	Manual	Manual	Manual	Identical
Mode of Action	Single/multiplepuncture andaspirate	Single/multiplepuncture andaspirate	Single/multiplepuncture andaspirate	Identical
General design	Handle, Sheath,Needle, Stylet	Handle, Sheath,Needle, Stylet	Handle, Sheath,Needle, Stylet	Identical
PatientContactingMaterials	Stainless Steel,PTFE, PEBAX,Nitinol	Unknown	Stainless Steel,PTFE, PEBAX,Nitinol	IdenticaltoreferenceViziShot 2FLEX
Biocompatible	Yes	Yes	Yes	Identical
Single UseOnly	Yes	Yes	Yes	Identical
Working OD(mm)	2.08	Unknown	2.08	IdenticaltoreferenceViziShot 2FLEX
Catheter Length(cm)	70	Unknown	70	IdenticaltoreferenceViziShot 2FLEX
Needle Gauge	19G	22G, 25G	19G	Identicalto

	Table 5.1 Comparison of Proposed and Predicate Device

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	Proposed Device	PredicateDevice(K160229)	Reference Device(K163469)
Device Name/Characteristics	Gyrus ACMIViziShot 2FLEX	Cook EchotipProcoreEndobronchialHigh DefinitionUltrasoundBiopsy Needle	Gyrus ACMIViziShotFLEX	Comment
				referenceViziShot 2FLEX
Typical NeedleLength (mm)	20	Unknown	20	IdenticaltoreferenceViziShot 2FLEX
Max NeedleLength (mm)	40	Unknown	40	IdenticaltoreferenceViziShot 2FLEX
Stylet OD (in)	0.0204	Unknown	0.0204	IdenticaltoreferenceViziShot 2FLEX
Stylet SurfaceFinish	Polished	Unknown	Polished	IdenticaltoreferenceViziShot 2FLEX
Accessories	Syringe withstopcock andAdapter biopsyvalve areprovided withdevice	Syringe withstopcock andDevice adapter/biopsy valve areprovided withdevice	Syringe withstopcock andAdapter biopsyvalve areprovided withdevice	Identical
Packaging	Needleassembly,syringe, adapterplaced in traywith snapdowns andTyvek lid. Trayplaced in shelfbox prior tosterilization.	Needleassembly,syringe, adapterplaced in traywith snapdowns and lid.	Needleassembly,syringe, adapterplaced in traywith snapdowns andTyvek lid. Trayplaced in shelfbox prior tosterilization.	Identical
Sterilization	EO	EO	EO	Identical
Shelf Life	3 Year at launch	Unknown	1 Year at launch	Referencedevicesubsequentto launchachieved 3Year ShelfLife

Summary of Perfomance Testing

The proposed ViziShot 2 FLEX in its final finished form is identical to the reference ViziShot 2 FLEX (previously marketed device) in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).

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

Biocompatibility testing:

Biocompatibility testing on all patient contacting surfaces has been performed in Accordance with the FDA Guidance Document "Use of International Standard ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". Biocompatibility testing included the following tests:

ISO 10993-4: 2002 Biological evaluation of medical devices Part 4: ● Selection of tests for interactions with blood
. ISO 10993-5: 2009 Biological evaluation of medical devices - Part5: Tests for in vitro cytotoxicity
ISO 10993-10: 2010 Biological evaluation of medical devices. Tests for . irritation and sensitization
ISO 10993-11:2006. Biological evaluation of medical devices. Tests for ● systemic toxicity
United States Pharmacopeia 39, National Formulary 34, 2016 <151> Pyrogen ● Test
United States Pharmacopeia 39, National Formulary 34, 2016 <85> Bacterial ● Endotoxins Test

ViziShot 2 FLEX is external communicating, blood path, indirect, and limited duration (<24 hour).

Sterilization/Shelf Life testing:

The ViziShot 2 FLEX will be delivered in a sterile state and is intended for single patient use only. Sterilization (ethylene oxide) and packaging of the device was validated using the following standards:

ANSI/AAMI/ISO 11607-1:2006 Packaging for terminally sterilized medical ● devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ANSI/AAMI/ISO 11135-1:2014 Sterilization of health-care products ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices

Packaging integrity and performance testing on devices that had undergone accelerated aging support a labeled three year shelf life. Accelerated aging tests for the ViziShot 2 FLEX was conducted in accordance with ASTM F1980-16. Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.

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Performance testing - Bench

During design verification, the output of the design process was evaluated against the physical and performance specifications. The following performance tests were conducted:

· Sheath and Needle Insertion and Withdrawal Force
· Stylet Insertion and Withdrawal Force
Bronchoscope Angulation
· Activation Force
Plastic Deformation Angle
· Penetration Force
· Transmission Force
Device Durability/Handle Durability
Bronchoscope Adapter Sliding Force
· Handle Durability
· Sheath to Handle Joint Strength
· Echogenicity

A GLP Comparison of the ViziShot 2 FLEX to the Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle was performed. The purpose of this study was to evaluate the test article. ViziShot 2 FLEX 19G Needle, and a predicate control article to determine if the needles obtain sufficient tissue samples for histologic and core sample analysis and that the test article needle provided similar quality of samples as the predicate. The performance testing in this study included observations on ease of needle passage through the tissue, and tissue sampling metrics to include weight, length, number of segments and quality of the tissues obtained for microscopic evaluation.

Performance testing - Animal

No animal study was performed to demonstrate substantial equivalence.

Performance testing - Clinical

No clinical study was performed to demonstrate substantial equivalence.

Conclusion:

In summary, the Olympus ViziShot 2 FLEX is substantially equivalent to the predicate devices and presents no new questions of safety or effectiveness.

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.