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 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, electro-mechanical 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 follower portion of the servomechanism, and two monitors. The System Cart allows the user to navigate the Catheter Instrument with the Controller, which represents the leader-follower 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 IF1000 System and PlanPoint Software are modified to enable Remote Software Updates from the Intuitive server via secure network communication.

AI/ML Overview

The provided text does not contain specific acceptance criteria or details of a study setup (like sample sizes, expert qualifications, or ground truth establishment) to prove that the device meets defined acceptance criteria for its clinical performance.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with specific performance metrics against pre-defined acceptance criteria.

The key points from the provided text are:

Device: Ion Endoluminal System (IF 1000)
Purpose: Assists users in navigating catheters and endoscopic tools in the pulmonary tract for diagnostic and therapeutic procedures, including fiducial marker placement. It does not make a diagnosis.
Key Modification (subject of this 510(k)): Added support for Remote Software Updates.
Claim: The subject device is "substantially equivalent" to its predicate device (K232984).

Here's a breakdown of why the requested information cannot be fully provided from the given text:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing: The document does not list specific clinical performance acceptance criteria (e.g., accuracy, sensitivity, specificity, or navigation success rates) for the device regarding its primary function (navigation in the pulmonary tract).
Instead, it states: "The performance testing data confirmed that the device performs as intended to its specifications and meets its intended use." This is a general statement, not a reporting of specific performance metrics against quantitative acceptance criteria.
The "performance data" section primarily discusses verification and validation (V&V) of the software (including cybersecurity) and animal testing for system design validation. It doesn't present clinical performance outcomes.

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

Missing for clinical performance: The document mentions "simulated animal models" for "in-vivo animal testing" but does not specify the number of animals or cases in this test set.
Data Provenance: The animal testing implies prospective data collection, but no country of origin is mentioned.

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

Missing: Since no specific clinical performance study with human subjects (or a detailed animal study) requiring expert interpretation for ground truth is described with quantitative results, this information is not present. The animal study was performed to "assess the system performance" generally, not against a pre-established expert-adjudicated ground truth for a specific diagnostic or therapeutic outcome.

4. Adjudication Method for the Test Set:

Missing: Not applicable as detailed expert-adjudicated clinical performance testing for the device's primary function is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No: The document does not mention an MRMC study. The device's clearance is based on substantial equivalence, primarily addressing a software update feature (remote software updates), rather than a comparative effectiveness study of its core functionality or human-AI interaction.
The document implies that "Changes to the subject device do not affect previously identified critical tasks," and usability testing refers back to the predicate device's data. This suggests no new human factors or clinical performance studies related to reader improvement were conducted for this specific 510(k).

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

Not explicitly stated for the core navigation functionality: The device is an "Endoluminal System" that "assists the user," implying a human-in-the-loop system. The PlanPoint™ Software creates a 3D plan, which is a software function, but its performance metrics (e.g., accuracy of path planning) are not detailed as standalone acceptance criteria. The software V&V confirms it "meets design specifications and user needs," but doesn't break out standalone quantitative performance.

7. The Type of Ground Truth Used:

Implied for Animal Testing (Design Validation): The animal testing was for "design validation" and to "assess the system performance." It doesn't specify how "ground truth" was established for precise navigation outcomes within the animal models (e.g., post-mortem pathology, direct visualization, etc.). The focus seems to be on whether the system performed "effectively" generally, rather than hitting a specific, pre-quantified ground truth target.

8. The Sample Size for the Training Set:

Missing: The document refers to "software verification and validation testing" including "unit, subsystem integration, and system level testing" and "regression testing." This refers to software development and testing phases, not typically a separate "training set" in the context of deep learning or AI model development that would require a distinct sample size. While the PlanPoint software creates 3D plans from CT scans, there's no mention of a machine learning component that requires a specific training dataset and its associated ground truth.

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

Missing: Not applicable since a "training set" for an AI or machine learning model, with its corresponding ground truth establishment, is not described.

Summary of what is present:

Acceptance Criteria Mention (General): The document generally states that "performance testing data demonstrates that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements."
Study Types Mentioned:
- Software Verification and Validation (including unit, subsystem integration, system level, and regression testing).
- Cybersecurity Testing.
- Animal Testing (in-vivo, simulated use conditions) for "system design validation."
- Usability Testing (references prior study for predicate as no new critical tasks identified).
Rationale for Substantial Equivalence: The primary rationale for this 510(k) is that the subject device has the "same intended use, indications for use, operating principles, and similar technological characteristics" as the predicate device, with the key modification being a remote software update feature that "does not raise different questions of safety and effectiveness." The testing performed (software V&V, cybersecurity, and animal testing) was to confirm this, not to prove specific clinical performance metrics against quantitative acceptance criteria for navigation efficacy or diagnostic accuracy.

Summary

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September 24, 2024

Intuitive Surgical, Inc. Farzin Bolourchian Regulatory Affair Technical Lead 1266 Kifer Road Sunnyvale, California 94086

Re: K242070

Trade/Device Name: Ion Endoluminal System (IF 1000) Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: July 15, 2024 Received: July 16, 2024

Dear Farzin Bolourchian:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Image /page/2/Picture/3 description: The image shows the name "Joyce C. Lin -S" in a large, bold font. The text is black and is set against a white background. The name appears to be a signature or a title, possibly indicating the author or creator of a document or work.

for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: 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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K242070

Device Name

lon Endoluminal System (IF 1000)

Indications for Use (Describe)

The lon™ 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 lon™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use.

The PlanPoint™ Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the lon™ 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of Safe Medical Device Act (SMDA) 1990 and 21 CFR 807.92.

1. SUBMITTER

510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Farzin BolourchianRegulatory Affairs, Technical LeadPhone Number: 408-425-5233Email: farzin.bolourchian@intusurg.com
Date Prepared:	July 15, 2024

2. SUBJECT DEVICE INFORMATION

Manufacturer Name:	Intuitive Surgical, Inc.
Trade Name:	Ion Endoluminal System, Model IF1000
Common Name:	Bronchoscope (flexible or rigid) and accessories
Classification:	Class II
	21 CFR 874.4680
Product Codes:	EOQ
Review Panel:	Ear, Nose, and Throat

3. PREDICATE DEVICE INFORMATION

Manufacturer Name:	Intuitive Surgical, Inc.
510(k) Number:	K232984, last cleared on December 18, 2023
Trade Name:	Ion Endoluminal System, Model IF1000
Common Name:	Bronchoscope (flexible or rigid) and accessories
Classification:	Class II21 CFR 874.4680
Product Codes:	EOQ
Review Panel:	Ear, Nose, and Throat

No reference devices were used in this submission.

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4. 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.

The IF1000 System and PlanPoint Software are modified to enable Remote Software Updates from the Intuitive server via secure network communication.

5. INTENDED USE/INDICATIONS FOR USE

Intended Use

To provide access to and visualization of patient airways.

Indications for Use

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

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6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject device (Ion Endoluminal System. Model IF1000) has been developed by modifying the predicate device, the Ion Endoluminal System, Model IF1000 (K232984).

The subject device and the predicate device, Ion Endoluminal System, have the same intended use, indications for use, operating principles, and similar technological characteristics. A summary of the technological characteristics of the subject device compared to the predicate device is provided below:

Description	Predicate Device (K232984)Ion Endoluminal System, ModelIF1000	Subject DeviceIon Endoluminal System, ModelIF1000
Regulation Number	21 CFR §874.4680	Identical to the predicate device
Classification	Class II	Identical to the predicate device
Product Code	EOQ	Identical to the predicate device
Indications for use	The Ion Endoluminal System (ModelIF1000) assists the user in navigatinga catheter and endoscopic tools in thepulmonary tract using endoscopicvisualization of the tracheobronchialtree for diagnostic and therapeuticprocedures. The Ion EndoluminalSystem enables fiducial markerplacement. It does not make adiagnosis and is not for pediatric use.The PlanPoint Software uses patientCT scans to create a 3D plan of thelung and navigation pathways for usewith the Ion Endoluminal System.	Identical to the predicate device
Intended Use	To provide access to andvisualization of patient airways.	Identical to the predicate device
Prescription use	Rx only	Identical to the predicate device
Use Environment	Hospital	Identical to the predicate device
Description	Predicate Device (K232984)Ion Endoluminal System, ModelIF1000	Subject DeviceIon Endoluminal System, ModelIF1000
Principles ofoperations	Visualization of endoluminal spacesvia light delivery and videoNavigation through endoluminalspaces via tip deflection capabilitiesProvides a working channel throughwhich other instruments can bedelivered to target sites within theairwaysLeader/follower servomechanismincorporates servo motor control andsystem-level coordinated jointcontrol.	Identical to the predicate device
Major Subsystems
System Cart andController	The System Cart allows users tonavigate the Catheter with userinputs from the Controller.	Identical to the predicate device
System Software	Enables control of the Catheterinstrument, System Cart, andController to support the Systemfunctions. It also performs a varietyof additional functions, such asmonitoring sensors throughout thesystem, generating the user interfacedisplay outputs, and providinginterfaces for manufacturing.	Added support to enable RemoteSoftware Update from the Intuitiveserver via secure networkcommunication.
Planning Laptopwith PlanPointSoftware	The PlanPoint™ Software usespatient CT scans to create a 3D planof the lung and navigation pathwaysfor use with the Ion™ EndoluminalSystem.	Added support to enable RemoteSoftware Update from the Intuitiveserver via secure networkcommunication.

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The added support for the Remote Software Update feature mentioned on the subject and predicate device comparison table above is further discussed in the following section. The IF1000 System and PlanPoint Software have been modified to perform remote software update over a network connection without requiring an Intuitive field service engineer to visit the site. The software update can only be initiated by the user when the device is not in use in a clinical procedure. This capability is not required for the device's intended use and does not impact the device's safety and clinical performance. Additionally, this feature does not raise different questions of safety and effectiveness, as confirmed through testing

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of the subject device. Thus, the subject and the predicate device are substantially equivalent.

7. PERFORMANCE DATA

Performance testing data demonstrates that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The performance testing for the Ion Endoluminal System included software verification and validation, including cybersecurity and design validation, using simulated animal models.

Software Verification and Validation

The System and PlanPoint software underwent verification and validation testing. The software testing included the unit, subsystem integration, and system level testing. The software testing results demonstrate that the System and PlanPoint software meets design specifications and user needs. Each software was also subjected to regression testing. The regression testing verified that the subject device modifications did not impact the unmodified elements of the System and PlanPoint software. Software documentation has been provided per FDA Guidance "Content of Premarket Submissions for Device Software Functions," issued June 14, 2023.

Cybersecurity Testing

The cybersecurity verification and validation testing were conducted, and cybersecurity was evaluated per the FDA's final guidance, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions", issued on September 27, 2023. The cybersecurity verification and validation test results demonstrate the adequacy of the implemented cybersecurity controls.

Animal Testing

For system design validation, in-vivo animal testing was performed under simulated use conditions to assess the system performance. The test results demonstrate that the System performs effectively according to its intended use and does not raise different questions of safety or effectiveness.

Usability Testing

Changes to the subject device do not affect previously identified critical tasks, and no new critical tasks were identified. Therefore, data collected during the previous summative usability study for the predicate device, the Ion Endoluminal System (K182188), remains valid, and no additional testing was required.

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8. CONCLUSION

The subject device and the predicate device, Ion Endoluminal System (K232984), have the same intended use, indications for use, operating principles, and similar technological characteristics. The subject device modifications have been evaluated and do not raise different questions of safety or effectiveness. The performance testing data confirmed that the device performs as intended to its specifications and meets its intended use.

Based on the intended use, indications for use, operating principles, technological characteristics, and performance testing, the subject device, Ion Endoluminal System, is substantially equivalent (SE) to the predicate device.

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.