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 Model IF1000 Instruments include the Ion™ Fully Articulating Catheter, the Ion™ Peripheral Vision Probe, and the Flexision™ Biopsy Needles. Accessories such as the Catheter Guide, Vision Probe Adapter, Suction Adapter, Swivel Connector, and Vision Probe Bag facilitate use of the Model IF1000 Instruments.

AI/ML Overview

The provided document is a 510(k) summary for the Ion™ Endoluminal System (specifically the Ion™ Fully Articulating Catheter and the Ion™ Peripheral Vision Probe). The submission primarily focuses on changes to the reprocessing methods for these devices, introducing an alternative automated cleaning process and reducing rinsing steps for the existing manual cleaning process. It does not describe a study involving an AI algorithm in the traditional sense of diagnostic or predictive performance.

Therefore, the requested information regarding acceptance criteria and study details for AI performance (such as sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set information) is largely not applicable to this document. The "device" in this context refers to the physical medical instruments, and the "performance" being evaluated is related to their reprocessability and safety after cleaning, not an AI's analytical capabilities.

However, I can extract the acceptance criteria and performance data related to the reprocessing validation and biocompatibility aspects, as these are the core performance assessments presented in this 510(k) summary.

Acceptance Criteria and Device Performance (Related to Reprocessing and Biocompatibility)

The device in question is the Ion™ Endoluminal System (Ion™ Fully Articulating Catheter and Ion™ Peripheral Vision Probe). The study described relates to validating new reprocessing methods (automated cleaning and reduced manual rinsing steps) for these devices.

Due to the nature of this 510(k) submission, which focuses on device reprocessing validation, many of the typical AI-related study components (like expert ground truth, MRMC, training sets) are not present.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Reference Standard)	Reported Device Performance
Reprocessing Validation	Cleaning Efficacy:	Passed: All testing passed the predetermined acceptance criteria.
	- In accordance with AAMI TIR12:2010
	- In accordance with AAMI TIR30:2011/(R)2016
Biocompatibility	Acceptable TOC Levels:	Acceptable: Results analyzed in accordance with ISO 10993-1:2018 deemed to result in acceptable TOC levels, comparable to predicate devices.
	- In accordance with ISO 10993-1:2018
Usability Testing	Successful User Performance:	Successful: Intended users can successfully understand and perform intended reprocessing procedure safely and effectively.
	- In accordance with FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices" (Feb 3, 2016)
	- In accordance with IEC 62366-1:2015/Amd1:2020

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

Reprocessing Validation (Cleaning Efficacy): The document does not specify the exact "sample size" in terms of number of devices tested for cleaning efficacy. It states that "AER equipment were validated" and "Testing was performed on the Model IF1000 devices subjected to the automated cleaning process."
Biocompatibility (TOC Testing): Similar to reprocessing, the exact number of devices tested for TOC is not specified, but it was performed "on the Model IF1000 devices."
Usability Testing: The document does not specify the number of users or sessions in the human factors study.
Data Provenance: The studies described are prospective validation studies conducted by the manufacturer for the specific purpose of this submission. The origin of "data" in terms of patient information is not relevant here as these are laboratory and human factors studies, not clinical trials on patient data.

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

This information is not applicable as the "test set" in this context refers to devices undergoing reprocessing and human factors testing, not an AI algorithm being evaluated against expert-annotated medical image data. The "ground truth" for cleaning validation is objective laboratory measurement against standards, and for usability, it's successful task completion by trained users.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 typically apply to resolving discrepancies in expert labeling for AI ground truth, which is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document does not describe the evaluation of an AI algorithm assisting human readers. It focuses on the reprocessing of physical instruments.

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

No, a standalone algorithm performance study was not done. This submission does not pertain to an AI algorithm.

7. The type of ground truth used

Reprocessing Validation: The ground truth for cleaning efficacy was established through objective laboratory measurements of residual soil levels (e.g., proteins, hemoglobin) against pre-defined limits, as guided by AAMI standards (TIR12, TIR30).
Biocompatibility: The ground truth for biocompatibility was established through objective laboratory measurements of Total Organic Carbon (TOC) residuals, evaluated against acceptable limits defined by ISO 10993-1.
Usability Testing: The ground truth was based on participants successfully and safely completing the specified reprocessing tasks as described in the updated instructions.

8. The Sample Size for the Training Set

This information is not applicable. This document does not describe an AI system, and therefore there is no "training set" in the context of machine learning.

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

This information is not applicable as there is no AI training set discussed in this document.

Summary

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August 26, 2021

Intuitive Surgical, Inc. Jennifer Siu Sr. Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086

Re: K212048

Trade/Device Name: Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: June 28, 2021 Received: June 30, 2021

Dear Jennifer Siu:

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

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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 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/cdrl-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,

Shu-Chen Peng, Ph.D. Assistant Director DHT1C: Division of Dental and ENT 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) K212048

Device Name

Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000); Ion™ Endoluminal System (Ion™ Peripheral Vision Probe) (IF1000)

Indications for Use (Describe)

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 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.

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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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:	Jennifer SiuSenior Regulatory Affairs SpecialistTel: (408) 523-5372Email: jennifer.siu@intusurg.com
Date of Submission:	June 28, 2021

2. Device Information

Trade Name:	Ion™ Endoluminal System
Common Name:	Bronchoscope (flexible or rigid) and accessories
Classification:	Class II21 CFR §874.4680Bronchoscope (flexible or rigid) and accessories
Product Code:	EOQ
Review Panel:	Ear, Nose, and Throat

3. Predicate Device

The predicate device for this submission is the Ion™ Endoluminal System (K201146), cleared on June 26, 2020.

4. Device Description

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5. 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.

6. Comparison to Predicate Device

The Model IF1000 Instruments, specifically the Ion™ Fully Articulating Catheter) and the Ion™ Peripheral Vision Probe (Vision Probe), subject to the scope of change under this submission, remain substantially equivalent to the Model IF1000 Instruments cleared under K201146. There were no design changes made to the subject devices as a result of the alternative automated cleaning process and reduced rinsing steps of the existing manual cleaning process.

Intuitive is providing an alternative cleaning method and reducing rinsing steps for the current manual cleaning method for the reprocessing of the Catheter and Vision Probe instruments, to allow users the choice for these instruments to be reprocessed via an automated cleaning process and simplify the current manual cleaning process. There are no changes to the subject devices compared to the predicate devices with regard to indications for use, technological characteristics, device materials, clinical utility, or packaging as a result of the alternative automated cleaning process or reduced rinsing steps of the existing manual cleaning process. Table 1 provides a comparison between the subject devices and predicate devices.

	Predicate Device:Model IF1000Catheter & Vision Probe(K201146)	Subject Device:Model IF1000Catheter & Vision Probe(This Submission)
FDA ProductCode	EOQ	SAME as predicate
	Predicate Device:Model IF1000Catheter & Vision Probe(K201146)	Subject Device:Model IF1000Catheter & Vision Probe(This Submission)
Classification	Class II - 21 CFR §874.4680	SAME as predicate
ClassificationName	Bronchoscope (flexible or rigid) andaccessories	SAME as predicate
Intended Use	To provide access to and visualization ofpatient airways	SAME as predicate
Indications forUse	The Ion™ Endoluminal System (ModelIF1000) assists the user in navigating acatheter and endoscopic tools in thepulmonary tract using endoscopicvisualization of the tracheobronchial tree fordiagnostic and therapeutic procedures. TheIon™ Endoluminal System enables fiducialmarker placement. It does not make adiagnosis and is not for pediatric use	SAME as predicate
Principles ofOperation	Visualization of endoluminal spaces vialight delivery and videoNavigation through endoluminal spaces viatip deflection capabilitiesProvides a working channel through whichother instruments can be delivered to targetsites within the airways	SAME as predicate
Method ofCatheter DistalTip Movement	Electromechanically (servo/stepper motorsand software) controlled pull wires	SAME as predicate
Catheter ToolChannelDiameter	2 mm	SAME as predicate
Vision ProbeIlluminatingSource	Light emitting diodes	SAME as predicate
Vision ProbeDirection ofView	0°	SAME as predicate
Vision ProbeField of View*	90°	120°
Patient ContactMaterials*	Stainless SteelSiliconePellethane plasticPTFE plasticGlassPolyamide resinPebax elastomer (TPE)PolyamideCyanoacrylate	Similar to predicate
	Predicate Device:Model IF1000Catheter & Vision Probe(K201146)	Subject Device:Model IF1000Catheter & Vision Probe(This Submission)
Reusable	Yes	SAME as predicate
RequiresReprocessing	Yes	SAME as predicate
ReprocessingMethod	Manual cleaning and manual microbicidalprocessorManual cleaning and automatedmicrobicidal process	Manual cleaning and manual microbicidalprocessorManual cleaning and automatedmicrobicidal processorAutomated cleaning and automatedmicrobicidal process

Table 1. Comparison of Predicate and Subiect Devices

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Note: The Vision Probe's field of view has increased from 90° to 120° for a better view during instrument navigation with minor material changes that do not introduce any new or increased biological risk since clearance of the predicate device under K201146.

Cleaning validation results demonstrate that the subject devices reprocessed via the automated cleaning process and reduced rinsing steps of the existing manual cleaning process are substantially equivalent to the predicate devices reprocessed via the current manual cleaning process. Furthermore, the testing did not raise any new risks or any new questions in terms of safety and effectiveness for the subject devices.

7. Performance Data

The following performance data has been provided in support of the substantial equivalence determination. Testing included reprocessing validation, toxicological risk assessment, and usability testing.

Reprocessing Validation

Automated endoscope reprocessor (AER) equipment were validated to support the automated cleaning process of the Catheter and Vision Probe, to demonstrate the efficacy of the AERs in cleaning the Model IF1000 devices. Testing was performed in accordance with AAMI TIR12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers and AAMI TIR30:2011/(R)2016 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices. All testing passed the predetermined acceptance criteria.

Biocompatibility

In order to assess the biological risk to patient contact of the Catheter and Vision Probe from chemical residuals left following the automated cleaning process or reduced rinsing of the existing manual cleaning process, total organic carbon (TOC) testing were performed and evaluated. Testing were performed on the Model IF1000 devices subjected to the automated cleaning process and reduced rinsing of the existing manual process and results analyzed in

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accordance with ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. All testing were deemed to result in acceptable TOC levels, comparable to the predicate devices.

Bench Testing

No bench testing was performed as the automated cleaning process and reduced rinsing steps of the existing manual cleaning process do not introduce harsher reprocessing chemical or additional mechanical wear to the subject devices requiring additional verification and validation.

Usability Testing

A human factors study was performed to validate the additional instructions added to support the reprocessing instructions manuals updates subject of this submission. The study was conducted in accordance with FDA guidance Applying Human Factors and Usability Engineering to Medical Devices, issued February 3, 2016, and IEC 62366-1:2015/ Amd1:2020 Medical devices – Part 1: Application of usability engineering to medical devices. The study demonstrates that the intended users can successfully understand and perform the intended reprocessing procedure safely and effectively while following the reprocessing instructions manuals, and therefore successfully validates the updated instructions.

Animal Testing

No animal studies were performed as the automated cleaning process and reduced rinsing steps of the existing manual cleaning process do not introduce harsher reprocessing chemical or additional mechanical wear to the subject device requiring additional testing.

Clinical Testing

No clinical studies were performed as the automated cleaning process and reduced rinsing steps of the existing manual cleaning process do not introduce harsher reprocessing chemical or additional mechanical wear to the subject device requiring additional testing.

8. Conclusion

Based upon the intended use, design, operating principles, comparison to the predicate devices, and conducted testing, it is concluded that the subject devices reprocessed via an automated cleaning process and reduced rinsing steps of the existing manual cleaning process are substantially equivalent to the predicate devices reprocessed via the current manual cleaning process. Testing also supports that the subject devices reprocessed via an automated cleaning process and reduced rinsing steps of the existing manual cleaning process do not raise any new risks or any new questions in safety or effectiveness for the subject 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.