The Ion™ Endoluminal System (Model IF1000) assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use.

The Flexision™ Biopsy Needle is used with the Ion™ Endoluminal System to biopsy tissue from a target area in the lung.

The PlanPoint™ Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion™ Endoluminal System.

Device Description

The Ion™ Endoluminal System, Model IF1000, is a software-controlled, electromechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. It consists of a Planning Laptop with PlanPoint™ Software, a System Cart with System Software, a Controller, Instruments, and Accessories. The IF1000 Instruments include the Ion™ Fully Articulating Catheter, the Ion™ Peripheral Vision Probe, and the Flexision™ Biopsy Needles.

The Planning Laptop is a separate computer from the System Cart and Controller. A 3D airway model is generated from the patient's chest CT scan using the PlanPoint™ Software.

The System Cart contains the Instrument Arm, electronics for the slave portion of the servomechanism, and two monitors. The System Cart allows the user to navigate the Catheter Instrument with the Controller, which represents the master/slave relationship. For optimal viewing, the physician can position the monitors in both vertical and horizontal axes.

The Controller is the user input device on the Ion™ Endoluminal System. It provides the controls to command insertion, retraction, and articulation of the Catheter. The Controller also has buttons to operate the Catheter control states.

The Catheter Instrument has a tool channel compatible with the Peripheral Vision Probe. Flexision™ Biopsy Needles, and third-party tools. The Vision Probe provides direct visualization of the patient's airways during navigation. Accessories such as the Catheter Guide, Vision Probe Adapter, Suction Adapter, and Swivel Connector facilitate use of the IF1000 Instruments.

AI/ML Overview

The provided text describes the 510(k) summary for the Ion™ Endoluminal System and Flexision™ Biopsy Needle. It details performance data but does not include a specific table of acceptance criteria with reported device performance or a standalone study with quantitative metrics for accuracy, sensitivity, or specificity.

However, I can extract information related to the device's validation and the types of studies conducted.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with specific numerical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it states that "validation and verification testing demonstrate that the subject devices are equivalent to the predicate devices in terms of safety and effectiveness." and that "the design output meets the design input requirements" and "the System meets design specifications and user needs."

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

The document mentions "animal and cadaver testing" and a "summative validation study" for human factors.

Animal and Cadaver Testing:
- Sample Size: Not explicitly stated. The text notes "Cadavers" (plural) and "Live animal models" (plural).
- Data Provenance: Prospective (simulated use conditions). No specific country of origin is mentioned, but typically, these studies are conducted within the submitting company's or collaborating research facilities.
Human Factors Evaluation (Summative Validation Study):
- Sample Size: Not explicitly stated. It involved "intended user groups."
- Data Provenance: Prospective (simulated bronchoscopy suite).

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

The document does not specify the number of experts or their qualifications for establishing ground truth in the animal/cadaver testing or human factors evaluation. It implies that these studies were overseen by qualified personnel as part of the overall design verification and validation process. For the human factors study, "intended user groups" were involved, suggesting participation from physicians or clinical staff who would typically perform such procedures.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the performance studies mentioned. The evaluation of "safety or performance" and "accuracy" in animal/cadaver models, and the assessment of "high-risk use scenarios and essential tasks" in the human factors study, likely relied on expert observation and assessment without a multi-reader adjudication process detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study is described in this document. The focus is on demonstrating the device's safety, effectiveness, and substantial equivalence to predicate devices, rather than a direct comparison of human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is an "endoluminal system" that "assists the user in navigating a catheter and endoscopic tools." The description of the System Cart's "master/slave relationship" with the Controller and the "3D guided navigation view" indicates it is a human-in-the-loop system. While "Software Verification and Validation" was performed, a standalone algorithm-only performance study (without human-in-the-loop) for a clinical outcome is not explicitly discussed. The PlanPoint™ Software "creates a 3D plan... and navigation pathways," which is an algorithmic function, and its verification would have been part of the software testing. However, its performance as an aid to the human user is part of the integrated system.

7. The Type of Ground Truth Used

Animal and Cadaver Testing: The ground truth for these studies would have been established through direct observation during the simulated procedures, potentially involving anatomical dissection, histological analysis of biopsied tissue (if sample quality was assessed), and clinical assessment by veterinarians or physicians during animal studies for safety and performance.
Human Factors Evaluation: Ground truth here relates to task completion, error rates, and user interface effectiveness, observed and recorded during simulated use scenarios.

8. The Sample Size for the Training Set

The document does not provide details on sample sizes for training sets. It focuses on the validation and verification of the final product. The PlanPoint™ Software uses patient CT scans to create 3D plans, which implies an underlying model that would have been developed using a training set, but this information is not included in this submission summary.

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

Information on how the ground truth for any potential training data used for the PlanPoint™ Software (e.g., for segmentation or pathway generation models) is not provided in this document.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

February 14, 2019

Intuitive Surgical Sarah Rizk Sr. Regulatory Engineer 1266 Kifer Road Sunnyvale, CA 94086

Re: K182188

Trade/Device Name: Ion Endoluminal System; Flexision Biopsy Needle Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: January 14, 2019 Received: January 15, 2019

Dear Sarah Rizk:

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 (reporting of medical devicerelated 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.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/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 yours.

Srinivas Nandkumar -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182188

Device Name Ion™ Endoluminal System (Model IF1000)

Indications for Use (Describe)

The Flexision™ Biopsy Needle is used with the Ion™ Endoluminal System to biopsy tissue from a target area in the lung.

The PlanPoint™ Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion™ Endoluminal System.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) SUMMARY

1. SUBMITTER

510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Sarah RizkSenior Regulatory EngineerPhone Number: 408-.523-6906Fax Number: 408-523-8907Email: sarah.rizk@intusurg.com
Date Prepared:	August 10, 2018

2. DEVICE AND PREDICATE/REFERENCE DEVICES

Trade Name:	Ion™ Endoluminal System
Common Name:	Bronchoscope (flexible or rigid) and accessories
Classification:	Class II
	21 CFR 874.4680
	Bronchoscope (flexible or rigid) and accessories
Product Codes:	EOQ
Advisory Committee:	Ear, Nose, and Throat
Predicate Devices:	Schoelly Video Bronchoscope (K141366)
Trade Name:	Flexision™ Biopsy Needle
Common Name:	Bronchoscope (flexible or rigid) and accessories
Classification:	Class II
	21 CFR 874.4680
	Bronchoscope (flexible or rigid) and accessories
Product Codes:	EOQ
Advisory Committee:	Ear, Nose, and Throat

In compliance with FDA Guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]", Intuitive Surgical also included the following as reference devices:

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510(k) Number:	K173760
Manufacturer:	Auris Surgical Robotics, Inc.
Trade Name:	superDimension™ Navigation System
510(k) Number:	K173244

3. DEVICE DESCRIPTION

The Planning Laptop is a separate computer from the System Cart and Controller. A 3D airway model is generated from the patient's chest CT scan using the PlanPoint™ Software.

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4. INTENDED USE/INDICATIONS FOR USE

Intended Use

To provide access to and visualization of patient airways.

Indications for Use

The Flexision™ Biopsy Needle is used with the Ion™ Endoluminal System to biopsy tissue from a target area in the lung.

The PlanPoint™ Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion™ Endoluminal System.

5. TECHNOLOGICAL CHARACTERISTICS

The subject Ion™ Endoluminal System, Model IF1000, and the predicate Schoelly Video Bronchoscope (K141366) are similar in terms of technological characteristics and have fundamentally the same indications for use. Like the Schoelly Video Bronchoscope, the IF1000 System is designed for use in performing bronchoscopy biopsy procedures. Similar technological characteristics include the ability to provide direct visualization of the anatomy, a working channel for endoscopic instruments, and suctioning with a suction adapter accessory. The IF1000 System utilizes electromechanical controls for manipulating the Catheter tip, while the predicate device utilizes solely mechanical controls for manipulating the end of the bronchoscope. Table 1 provides a device comparison between the subject Ion™ Endoluminal System, Model IF1000, and the predicate Schoelly Video Bronchoscope (K141366).

				Table 1: Ion™ Endoluminal System Comparison to Schoelly Video Bronchoscope System
--	--	--	--	-----------------------------------------------------------------------------------

Attribute	Subject Device	Predicate Device
	Ion™ Endoluminal System	Schoelly Video BronchoscopeSystem (K141366)
Attribute	Subject Device	Predicate Device
	Ion™ Endoluminal System	Schoelly Video BronchoscopeSystem (K141366)
Device Types	System Cart with Instrument ArmControllerPlanning Laptop with PlanPoint™SoftwareIon™ Fully Articulating CatheterIon™ Peripheral Vision ProbeVision Probe AdapterSuction AdapterCatheter GuideSwivel ConnectorReprocessing accessory kits (includesleakage tester)	Video bronchoscopeCamera Control UnitAccessoriesSuction valve/seal accessoryLeakage tester and reprocessingaccessories
Intended Use	To provide visualization of patientairways.	SAME as subject device
Indications for Use	The Ion™ Endoluminal System assiststhe user in navigating a catheter andendoscopic tools in the pulmonary tractusing endoscopic visualization of thetracheobronchial tree for diagnostic andtherapeutic procedures. The Ion™Endoluminal System enables fiducialmarker placement. It does not make adiagnosis and is not for pediatric use.	The Schoelly Video BronchoscopeSystem is intended for use byphysicians for diagnostic andtherapeutic procedures innasopharyngeal endoscopy,bronchoscopy, tracheoscopy, andlaryngoscopy. The Schoelly VideoBronchoscope is intended to providevisualization via a video monitor.
Principles ofOperation	Visualization of endoluminal spaces vialight delivery and videoNavigation through endoluminal spacesvia tip deflection capabilitiesProvides a working channel throughwhich other instruments can be deliveredto target sites within the airways	SAME as subject device
Tip	Steerable distal tip for control andmanipulation within discrete regions ofthe lung.	SAME as subject device
Method of DistalTip Movement	Electromechanically (servo/steppermotors and software) controlled pullwires.	Manually controlled pull wires.
Steering Method	Robotic master/slave control system withservo motor/encoder and cable interface.	Joy stick on handle.
Tool ChannelDiameter	2 mm	2.2 mm
Attribute	Subject Device	Predicate Device
	Ion™ Endoluminal System	Schoelly Video BronchoscopeSystem (K141366)
Articulation Range	180° in all four directions (pitch and yaw)	Up 210°/ down 130°
IlluminationSource	Light-emitting diodes.	SAME as subject device
Field of View	90°	120°
Direction of View	0°	SAME as subject device
Imaging Sensor	CMOS Imaging Sensor	SAME as subject device
Duration ofVisualization	During navigation of CatheterInstrument, up to the biopsy location.	During navigation of bronchoscopeand biopsy.
Guided Navigation	3D guided navigation view on SystemCart.	None
Location Sensing	Located in Catheter Instrument, duringnavigation and biopsy.	None
ProcedurePlanning	PlanPoint™ Software converts DICOMCT scan data into segmented 3D lungmodel.	None
Registration	System directs user to drive CatheterInstrument for registration	None
Patient ContactMaterials	Stainless SteelSiliconePellethane plasticPTFE plasticGlassPolyamide resinPebax elastomer (TPE)Polyamide	PEEKPolyurethanePTFE plasticFused silicaPolyphenylsulfoneFiber glassRubber
Attribute	Subject Device	Predicate Device
	Flexision™ Biopsy Needle	Arcpoint Pulmonary Needle (K163537)
Intended Use	To retrieve tissue from a targetstructure.	SAME as subject device
Principles ofOperation	Captures sample of tissue forsubsequent diagnosis.	SAME as subject device
Indications forUse	The Flexision™ Biopsy Needle is usedwith the Ion™ Endoluminal System tobiopsy tissue from a target area in thelung.	The Arcpoint pulmonary needle isutilized through a flexible endoscope orwith the superDimension NavigationSystem by physicians who are trained forretrieving specimens from patients withendobronchial lesions, peripheral lungnodules or lung masses.
Anatomical Site	Lung	SAME as subject device
Method ofIntroduction	Endobronchial, delivered to the targetthrough the Fully Articulating Catheter.	SAME as subject device, delivered to thetarget through a flexible endoscope orsuperDimension System ExtendedWorking Channel.
Sample Collection	Aspiration with a syringe.	SAME as subject device
Sizes	23G, 21G, and 19G	21G and 18G
RequiredWorking Channel	2 mm	SAME as subject device
Needle Tip	Sharp, beveled	SAME as subject device
Protrusion Length	1- 3 cm	8 mm
Shaft Marks	Yes	SAME as subject device
Stylet	Yes	SAME as subject device
Radiopaque DistalEnd	Yes	SAME as subject device
Life/Sterility	Single use, EtO sterilized	SAME as subject device
Patient ContactMaterials	PolyamidePebaxStainless Steel	Copolyester elastomer polymerStainless Steel

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The subject Flexision™ Biopsy Needle and the predicate Arcpoint Pulmonary Needle, Models ILS-1800-PN and ILS-2100-PN, are similar in terms of technological characteristics and have fundamentally same indications for use. Like the Arcpoint Pulmonary Needle, the Flexision™ Biopsy Needle is designed for retrieving tissue from a target site in the lung. Both the subject and predicate devices use similar means to collect tissue biopsy samples, compatible with the same-sized working channels, and have similar tip geometry. The subject Flexision™ Biopsy Needle differs in needle protrusion length and needle gauge sizes offered. Table 2 provides a device comparison between the subject Flexision™ Biopsy Needle and the predicate Arcpoint Pulmonary Needle (K163537).

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	Table 2: Flexision™ Biopsy Needle Comparison to Arcpoint Pulmonary Needle (K163537)

Results of verification and validation testing demonstrate that the subject devices are equivalent to the predicate devices in terms of safety and effectiveness. Furthermore, the testing did not raise any new risks and did not raise any new safety or effectiveness questions for the subject devices.

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6. PERFORMANCE DATA

Performance testing data (bench, animal, and cadaver tests) demonstrate that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input requirements. The testing included dimensional measurements. mechanical verification, functional verification, reliability testing, electrical safety, electromagnetic compatibility (EMC), biocompatibility of patient-contacting materials, software verification and validation, and simulated use in animals and cadavers.

Biocompatibility Testing

The patient-contacting components of the Ion™ Endoluminal System, IF1000, are classified in accordance with ISO 10993-1 as external communicating, blood path indirect, with limited contact duration (<24 hrs). The biocompatibility evaluation of patient-contacting components was conducted in accordance with the following guidance and standard:

FDA Guidance: "Use of International Standard ISO-10993, "Biological . Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process." June 2016
ISO 10993-1: Biological evaluation of medical devices ●

All direct and indirect patient-contacting components of the Ion™ Endoluminal System underwent cytotoxicity, intracutaneous irritation, sensitization and/or acute systemic toxicity testing in accordance to ISO 10993-5. ISO 10993-10 and ISO 10993-11. Biocompatibility testing was performed by a third party laboratory in compliance with Good Laboratory Practices (GLP).

Reprocessing/Sterilization/Packaging/Shelf Life Testing

Cleaning, disinfection, sterilization, and packaging/shelf life testing was conducted for the Ion™ Endoluminal System (IF1000) subsystems, Instruments, and Accessories. Testing was performed in accordance with the following standards and guidances:

. AAMI TIR30: 2011 A Compendium Of Processes, Materials, Test Methods, And Acceptance Criteria For Cleaning Reusable Medical Devices
. AAMI TIR12:2010: Technical Information Report - Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers
AAMI/ANSI/ISO 17665-1:2006 /(R)2013: Sterilization of health care products Moist . heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
AAMI/ANSI ST79:2017: Comprehensive guide to steam sterilization and sterility ● assurance in health care facilities

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ANSI/AAMI/ISO 11135:2014: Sterilization of health care products Ethylene oxide -. Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 10993-7:2008/(R)2012: Biological evaluation of medical devices Part 7 Ethylene . oxide sterilization residuals
. ANSI/AAMI/ISO 11737-1:2006/(R)2011: Sterilization of health care products -Microbiological methods-Part 1: Determination of the population of microorganisms on product
ANSI/AAMI/ISO 11737-2:2009/(R)2014: Sterilization of medical devices -Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
. AAMI TIR28:2009 Product Adoption and Process Equivalence for Ethylene Oxide Sterilization
. FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (March 17, 2015)
FDA Guidance: Submission and Review of Sterility Information in Pre-Market ● Notification 510(k) Submissions for Device Labeled as Sterile (January 21, 2016)
AAMI ST72:2011/(R)2016 Bacterial Endotoxins Test Methods, Routine Monitoring, . And Alternatives To Batch Testing
FDA Guidance: Pyrogen and Endotoxins Testing: Questions and Answer (June 2012) ●
ASTM D4169:2016: Standard Practice for Performance Testing of Shipping Containers ● and Systems
ISO 11607-1: 2006/Am1:2014: Packaging for terminally sterilized medical devices, Part 1: Requirements for materials, sterile barrier systems and packaging systems
. ASTM F88/F88M:2015: Standard Test Method for Seal Strength of Flexible Barrier Materials
. ASTM D4332:2014: Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
. ASTM F1980:2016: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Device
ASTM F1140/F1140M-13: Standard Test Methods for Internal Pressurization Failure . Resistance of Unrestrained Packages

EMC and Electrical Safety Testing

The Ion™ Endoluminal System was tested for electrical safety and EMC, including coexistence testing, and complies with IEC 60601-1, IEC 60601-2-18, and IEC 60601-1-2.

Software Verification and Validation

Software for the Ion™ Endoluminal System underwent software verification and validation testing and results demonstrate that the System meets design specifications and user needs. Software documentation has been provided according to FDA's Guidance for

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Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005.

Bench Testing

The Ion™ Endoluminal System, Instruments, and Accessories were subjected to full design verification. A summary of the design verification testing for the System Cart and the Controller is listed below:

Component	Testing
System Cart	Bench testing was performed in order to confirm that the design outputs forthe System Cart met the design input requirements. Testing was alsoperformed to confirm that the requirements regarding EMC, electricalsafety, software, and disinfection had been met.
Controller	Bench testing was performed in order to confirm that the design outputs forthe Controller met the design input requirements. Testing was alsoperformed to confirm that the requirements regarding EMC, electricalsafety, software, and disinfection had been met.

The Planning Station and PlanPoint™ Software were subjected to full design verification. A summary of the design verification testing for the Planning Station is listed below:

Component	Testing
Planning Station	Bench testing was performed in order to confirm that the design outputs forthe Planning Station met the design input requirements. Testing was alsoperformed to confirm that the requirements regarding software had beenmet.

Testing was performed on each instrument type to verify that the design meets physical, mechanical, user interface, and equipment interface requirements. A summary of the design verification testing for the IF1000 Instruments is described below:

Component	Testing
Fully ArticulatingCatheter	Verification testing was performed to evaluate design specifications suchas physical, mechanical, electrical, and equipment interface requirements.Testing was also performed to confirm that the requirements regardingbiocompatibility, packaging, cleaning, disinfection validation, and use lifehad been met.
Peripheral Vision Probe	Verification testing was performed to evaluate design specifications suchas physical, mechanical, electrical, and equipment interface requirements.A Modulation Transfer Function Analysis was performed to characterizethe Vision Probe's optical performance. Testing was also performed toconfirm that the requirements regarding biocompatibility, packaging,cleaning, disinfection validation, and use life had been met.

Component

Testing

Fully ArticulatingCatheter

Verification testing was performed to evaluate design specifications suchas physical, mechanical, electrical, and equipment interface requirements.Testing was also performed to confirm that the requirements regardingbiocompatibility, packaging, cleaning, disinfection validation, and use lifehad been met.

Peripheral Vision Probe

Verification testing was performed to evaluate design specifications suchas physical, mechanical, electrical, and equipment interface requirements.A Modulation Transfer Function Analysis was performed to characterizethe Vision Probe's optical performance. Testing was also performed toconfirm that the requirements regarding biocompatibility, packaging,cleaning, disinfection validation, and use life had been met.

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Flexision™ BiopsyNeedles	Verification testing was performed to evaluate design specifications suchas physical, mechanical, electrical, and equipment interface requirements.Testing was also performed to confirm that the requirements regardingbiocompatibility, packaging, and sterilization validation had been met.
------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

A summary of the design verification testing for the IF1000 Accessories is described below:

Component	Testing
Catheter Guide	Verification testing was performed to evaluate design specifications suchas physical, mechanical, electrical, and equipment interface requirements.Testing was also performed to confirm that the requirements regardingbiocompatibility, packaging, cleaning, sterilization validation, and use lifehad been met.
Vision AdapterSuction AdapterSwivel Connector	Verification testing was performed to evaluate design specifications suchas physical, mechanical, electrical, and equipment interface requirements.Testing was also performed to confirm that the requirements regardingbiocompatibility, packaging, and sterilization validation.

Animal and Cadaver Testing

Animal and cadaver testing was performed under simulated use conditions to evaluate safety or performance of the Ion™ Endoluminal System according to its intended use. Cadavers were used to demonstrate clinical performance for anatomical access and reach within the human lung anatomy. Live animal models were used to assess safety, performance and accuracy in cases where a living tissue model was appropriate. These models replicate factors experienced during clinical use, including working with respiration, bleeding, and normal tissue handling. Animal and cadaver testing demonstrated the Ion™ Endoluminal System can be used safely and effectively according to its intended use with no new risks identified.

Human Factors Evaluation

A human factors (HF) engineering process was followed in accordance with the following:

. ANSI/AAMI/IEC 62366-1:2015, Medical devices - Application of usability engineering to medical devices
. FDA Guidance: "Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff," 2016

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A summative validation study was conducted to evaluate high-risk use scenarios and essential tasks that were not assessed in previous usability validations. This study was conducted by intended user groups in a simulated bronchoscopy suite and involved preoperative preparation and simulated procedures, as well as emergency procedures that involved safety-critical tasks. Training materials and user manuals were developed in concert with the product hardware and software. and were assessed in the validation study.

The Ion™ Endoluminal System has been assessed and found to be safe and effective for its intended use, by the intended users, in its intended use environment.

7. CONCLUSION

Based on the intended use, indications for use, technological characteristics and performance testing, the Ion™ Endoluminal System and the Flexision™ Biospy Needle are substantially equivalent (SE) to the predicate devices. This SE determination is based on bench testing including reliability testing, animal/cadaver validation, simulated clinical procedures in live animals, and human factors assessment. The bench/reliability testing verified that the design requirements and specifications have been met. The animal/cadaver validation provided clinical validation that the system can be used to safely and effectively complete the procedures encompassed by the indications for use statement. Finally, the human factors assessment provided further assurance that risks due to user errors have been identified and mitigated.

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.