The ViziShot 2 FLEX 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. Do not use this device for any purpose other than its intended use.

Device Description

The ViziShot 2 FLEX is intended for use with compatible ultrasound endoscopes for Transbronchial Needle Aspiration (TBNA) of submucosal and extramural lesions of the tracheobronchial tree. The device is supplied sterile and intended for single patient use.

The 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.

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 provided text is a 510(k) Summary for the Olympus Surgical Technologies America ViziShot 2 FLEX, a medical device used for fine needle aspiration. It focuses on demonstrating substantial equivalence to a predicate device (ViziShot FLEX) rather than detailing a specific clinical study with acceptance criteria and performance metrics in the way a clinical trial report would.

Therefore, the information requested regarding acceptance criteria and performance data for the device's intended clinical function (e.g., diagnostic accuracy, success rate of aspiration, number of adequate samples) is not present in the provided document. The document primarily describes bench tests and non-clinical testing to ensure the device's physical and material properties are comparable to the predicate device.

However, I can extract information related to the non-clinical testing that verifies the device's physical performance, which serves as a form of acceptance criteria for its design changes.

1. Table of Acceptance Criteria and Reported Device Performance (for Non-Clinical Testing):

The document does not provide a formal table of quantitative acceptance criteria and specific reported performance for each test in the way requested. Instead, it states that "Engineering bench testing confirms that the modified ViziShot 2 FLEX meets its critical product specifications, which are substantially equivalent to those of the predicate ViziShot FLEX."

Below is a representation of the tests conducted, and the implied 'acceptance criteria' is that the ViziShot 2 FLEX performs equivalently or meets the specifications of the predicate device for each category.

Acceptance Criteria Category (Implied)	Reported Device Performance (Summary from Document)
Biocompatibility	Complies with relevant requirements of ISO-10993 for all patient contacting surfaces, including: - ISO 10993-4 (Interactions with blood) - ISO 10993-5 (In vitro cytotoxicity) - ISO 10993-10 (Irritation and sensitization) - ISO 10993-11 (Systemic toxicity)
Sterilization	Delivered in sterile state, intended for single patient use. - Validated using ANSI/AAMI/ISO 11607-1 (Packaging for terminally sterilized medical devices) - Validated using ANSI/AAMI/ISO 11135-1 (Sterilization of health-care products - ethylene oxide)
Packaging Integrity & Shelf Life	Packaging integrity and performance testing on devices that underwent accelerated aging support a labeled one-year shelf life.
Bench Testing (Physical Performance)	"Engineering bench testing confirms that the modified ViziShot 2 FLEX meets its critical product specifications, which are substantially equivalent to those of the predicate ViziShot FLEX." Specific tests conducted for verification include: - 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 (The document implies that the ViziShot 2 FLEX performed acceptably in all these areas, equivalent to the predicate ViziShot FLEX .)

The following information is not available in the provided document:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information would typically come from a clinical study. The provided document details non-clinical bench testing and biocompatibility testing, not clinical performance. Thus, there is no "test set" in the context of patient data, nor country of origin or retrospective/prospective nature.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set with ground truth established by experts is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 a physical medical instrument (a fine needle aspiration device), not an AI diagnostic algorithm or a system involving human readers in the context of interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. For the non-clinical tests, the "ground truth" would be engineering specifications and standards. For biocompatibility, it's compliance with ISO standards.
The sample size for the training set: Not applicable. No clinical training set is mentioned as this device is not an AI/ML product.
How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide regarding device evaluation:

The document describes non-clinical testing to support the substantial equivalence claim for the ViziShot 2 FLEX. These tests focus on:

Biocompatibility: Performed on all patient-contacting surfaces, complying with ISO 10993 standards.
Sterilization: Validated using ANSI/AAMI/ISO standards to ensure the device is sterile and maintains sterility for a one-year shelf life.
Bench Testing: A range of physical performance tests (e.g., force, durability, angulation, echogenicity) were conducted to ensure the ViziShot 2 FLEX meets its critical product specifications and is "substantially equivalent" to its predicate device, the ViziShot FLEX. The implication is that the device design changes (primarily ergonomic and manufacturing efficiency improvements) did not negatively impact its physical performance or safety.

The 510(k) process often relies on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical data, rather than requiring a full-scale clinical trial to prove efficacy from scratch, especially when the changes are minor and do not alter the fundamental technological characteristics or intended use.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 6, 2017

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

Re: K163469

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: March 9, 2017 Received: March 10, 2017

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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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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)

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 16, 2016

Device Description

Classification Name:	Bronchoscope (flexible or rigid) andaccessories
CFR Citation Number:	21 CFR 874.4680
Product Code:	KTI
Classification:	Class II
Review Panel	Ear Nose & Throat
Trade Name:	ViziShot 2 FLEX
Generic/Common Name:	Aspiration Needle

Predicate Devices

Spiration, Inc. ViziShot FLEX	K152922
-------------------------------	---------

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Product Description

Intended Use

The Intended Use is identical to that of the predicate device.

Technological Characteristics

The technological characteristics of the ViziShot 2 FLEX are the same as those of the predicate ViziShot FLEX. That is they have substantially the same design, material, and energy source. They are both designed to obtain a sample from lung tissue or

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lymph node tissue under ultrasound visualization. Both devices have the following technological characteristics:

Needle length adjustable and lockable ●
Sheath length adjustable and lockable
Secure attachment to scope with controlled device orientation ●
Manual needle movement through bronchoscope to target site
Flexible needle
Stylet resistant to kinking
Echogenic needle tip visible with ultrasound ●
Sharp needle tip ●
Aspiration capability ●

Comparison of Technological Characteristics

The ViziShot 2 FLEX has the same basic technological characteristics as the predicate ViziShot FLEX cleared under K152922. The subject and predicate device operate in the same manner to obtain a tissue biopsy using an ultrasound endoscope. The indications for use of the ViziShot 2 FLEX are the same as that of the predicate.

The ViziShot 2 FLEX handle profile design has been changed from the predicate device to improve ergonomics; as well as to utilize Design for Manufacturing principles to make the manufacturing assembly more efficient. The resulting device functionality, look, and interaction with the physician are equivalent to those of the predicate device ViziShot FLEX. A detailed comparison of the ViziShot 2 FLEX and the ViziShot FLEX is provided in the following table.

	Predicate Device (K152922)	Modified Device
Device Name/Characteristics	ViziShot FLEX	ViziShot 2 FLEX
Indications for Use	The ViziShot FLEX has beendesigned to be used withultrasound endoscopes forultrasound guided fine needleaspiration (FNA) ofsubmucosal and extramurallesions of thetracheobronchial tree. Do notuse this device for anypurpose other than itsintended use.	The ViziShot 2 FLEX has beendesigned to be used withultrasound endoscopes forultrasound guided fine needleaspiration (FNA) ofsubmucosal and extramurallesions of the tracheobronchialtree. Do not use this device forany purpose other than itsintended use.
Use Conditions	Surgical suite, endoscopy orbronchoscopy suite, used witha bronchoscope	Identical
	Predicate Device (K152922)	Modified Device
Device Name/Characteristics	ViziShot FLEX	ViziShot 2 FLEX
Mechanics of Action	Manual	Identical
Mode of Action	Single/multiple puncture andaspirate	Identical
General design	Handle, Sheath, Needle,Stylet	SimilarThe handle profile design hasbeen changed to improveergonomics and utilize Designfor Manufacturing principles.Changes include:• Handle shape and addedrubber finger grip• Sheath adjuster rotates• Snap bonds instead ofscrew and glue
Patient ContactingMaterials	Stainless Steel, PTFE,PEBAX, Nitinol	Stainless Steel, PTFE, PEBAX,Nitinol
Biocompatible	Yes	Yes
Product Specificationand Properties	Engineering bench testing confirms that the modified ViziShot 2FLEX meets its critical product specifications, which aresubstantially equivalent to those of the predicate ViziShotFLEX.
Sterilization	EO	EO
Single Use Only	Yes	Identical
Working OD (mm)	2.08	Identical
Catheter Length (cm)	70	Identical
Needle Gauge	19G	Identical
Typical Needle Length(mm)	20	Identical
Max Needle Length(mm)	40	Identical
Stylet OD (in)	0.0205	Equivalent0.0204
Stylet Surface Finish	Polished	Identical
Accessories	Syringe with stopcockAdapter biopsy valveDevices provided with device	Identical
Packaging	Needle assembly in tray with	Needle assembly, syringe,
	Predicate Device (K152922)	Modified Device
Device Name/Characteristics	ViziShot FLEX	ViziShot 2 FLEX
	snap downs. Tray placed inpouch. Pouch placed in shelfbox (dust cover) for sterilization.After sterilization, the sterilepouched syringe and sterilepouched adapter will be addedto the dust cover.	adapter placed in tray withsnap downs and tyvek lid.Tray placed in shelf boxprior to sterilization.

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Summary of Non-Clinical Testing

Biocompatibility:

Biocompatibility testing on all patient contacting surfaces has been performed in compliance to relevant requirements of ISO-10993. 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

Sterilization:

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 one year shelf life.

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Bench testing:

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

Conclusion:

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

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.