(85 days)
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.
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 in 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 Ion Endoluminal System integrates an optional Tomosynthesis feature, optimizes the existing Cone Beam CT workflow, improves the Navigation View, troubleshoots the airway tree, and enhances the control algorithm to provide an additional safety margin.
N/A
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
September 23, 2025
Intuitive Surgical, Inc.
Jyoti Singh
Regulatory Affairs Project Manager
1266 Kifer Road
Sunnyvale, California 94086
Re: K252045
Trade/Device Name: Ion Endoluminal System (IF1000)
Regulation Number: 21 CFR 874.4680
Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories
Regulatory Class: Class II
Product Code: EOQ
Dated: June 30, 2025
Received: June 30, 2025
Dear Jyoti Singh:
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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K252045 - Jyoti Singh
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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 QS 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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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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K252045 - Jyoti Singh
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Sincerely,
Joyce C. Lin -S
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
Page 4
Indications for Use
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K252045 |
|---|---|
| Please provide the device trade name(s). |
Ion Endoluminal System (IF1000)
| Please provide your Indications for Use below. |
|---|
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.
| Please select the types of uses (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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Intuitive Surgical Traditional 510(k) Submission
Ion™ Endoluminal System
K252045
Page | 1
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) 1990 and 21 CFR 807.92.
1. SUBMITTER
510(k) Owner: Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086
Contact: Jyoti Singh
Regulatory Affairs Project Manager
Email: jyoti.singh@intusurg.com
Date Prepared: June 30, 2025
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 Devices Branch(OHT1B)
3. PREDICATE DEVICE INFORMATION
Manufacturer Name: Intuitive Surgical, Inc.
510(k) Number: K242070, last cleared on September 24, 2024
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 Devices Branch(OHT1B)
4. REFERENCE DEVICE INFORMATION
Manufacturer Name: Noah Medical Corp.
510(k) Number: K223144, last cleared on March 1, 2023
Trade Name: Galaxy System
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Intuitive Surgical
Traditional 510(k) Submission
Ion™ Endoluminal System
K252045
Page | 2
Common Name: Bronchoscope (flexible or rigid) and accessories
Classification: Class II 21 CFR 874.4680
Product Codes: EOQ
Review Panel: Ear, Nose, and Throat Devices Branch
5. 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 in 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 Ion Endoluminal System integrates an optional Tomosynthesis feature, optimizes the existing Cone Beam CT workflow, improves the Navigation View, troubleshoots the airway tree, and enhances the control algorithm to provide an additional safety margin.
6. 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
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Intuitive Surgical
Traditional 510(k) Submission
Ion™ Endoluminal System
K252045
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.
7. 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 (K242070). The subject device and the predicate device, Ion Endoluminal System (K242070), are based on 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 (K242070)Ion™ Endoluminal System, Model IF1000 | Subject DeviceIon™ Endoluminal System, Model IF1000 |
|---|---|---|
| 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 (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 | Identical to the predicate device |
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Intuitive Surgical
Traditional 510(k) Submission
Ion™ Endoluminal System
K252045
Page | 4
| Description | Predicate Device (K242070)Ion™ Endoluminal System, Model IF1000 | Subject DeviceIon™ Endoluminal System, Model IF1000 |
|---|---|---|
| for use with the Ion™ Endoluminal System. | ||
| Intended Use | To provide access to and visualization 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 |
| Principles of operations | Visualization of endoluminal spaces via light delivery and videoNavigation through endoluminal spaces via tip deflection capabilitiesProvides a working channel through which other instruments can be delivered to target sites within the airwaysLeader/follower servomechanism incorporates servo motor control and system-level coordinated joint control. | Identical to the predicate device |
Major Subsystems
| System Cart and Controller | The System Cart allows users to navigate the Catheter with user inputs from the Controller. | Identical to the predicate device |
|---|---|---|
| System Software | Enables control of the Catheter instrument, System Cart, and Controller to support the System functions. It also performs a variety of additional functions, such as monitoring sensors throughout the system, generating the user interface display outputs, and providing interfaces for manufacturing. | Modified to support Tomosynthesis integration, optimize CBCT workflow, and Navigation View improvements. |
| Instruments and Accessories | • Ion Fully Articulating Catheter• Ion Peripheral Vision Probe• Flexision Biopsy Needles• Vision Probe Adapter• Suction Adapter• Catheter Guide | Added Tomosynthesis Board accessory to support the Tomosynthesis integration |
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Intuitive Surgical
Traditional 510(k) Submission
Ion™ Endoluminal System
K252045
Page | 5
| Description | Predicate Device (K242070)Ion™ Endoluminal System, Model IF1000 | Subject DeviceIon™ Endoluminal System, Model IF1000 |
|---|---|---|
| • Swivel Connector• Vision Probe Bag• Reprocessing accessory kits• Reprocessing Consumables Kitfor use with the Ion™ Endoluminal System. | ||
| Planning Laptop with PlanPoint Software | 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 | Modified PlanPoint Software to support Airway tree troubleshooting |
The modifications mentioned in the subject and predicate device comparison table above are further discussed in the following section.
The subject device's System Software has been modified for Tomosynthesis integration, Cone Beam CT workflow optimization, Navigation View improvements, and the Planpoint Software was modified for Airway Tree Troubleshooting. A new hardware accessory, the Tomosynthesis Board, supports the Tomosynthesis integration. The IF1000 System and PlanPoint Software updates in this release are not required for the device's intended use and do not impact the device's safety and clinical performance. Additionally, the subject device changes do not raise different questions of safety and effectiveness, as confirmed through testing of the subject device. Thus, the subject and the predicate device are substantially equivalent.
This submission references the Galaxy System (K223144) to demonstrate similar technology (Tomosynthesis capability) reviewed by the FDA. Both the Ion Endoluminal and the Galaxy systems use a board containing fiducial markers during fluoroscopic imaging. The Galaxy system uses a fiducial marker board (Galaxy TiLT Board) to collect video frames (fluoroscopic images) of projections of different angles to generate the 3D reconstruction and subsequently update the target lesion in the reconstructed image to support the optional Tomosynthesis capability.
8. PERFORMANCE DATA
Performance testing data demonstrates that the subject device is substantially equivalent to the predicate device (K242070) and that the design output meets the design input requirements. The performance testing for the Ion Endoluminal System included design
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Traditional 510(k) Submission
Ion™ Endoluminal System
K252045
Page | 6
verification and system-level design validation, using an animal model. The following performance testing information supports the substantial equivalence determination.
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 meet 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.
Performance Testing
The Tomosynthesis board underwent design, reliability, environmental, reprocessing, and packaging/transit verification and design validation testing. The testing results demonstrate that the board meets design specifications and user needs.
Animal Testing
For system design validation, in vivo animal testing was performed under simulated use conditions to assess the system's 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.
Cybersecurity Assessment
Changes to the subject device do not affect the cybersecurity posture of the device. Information to demonstrate that the Ion Endoluminal System meets the cybersecurity requirements for a cyber device per section 524B(b) of the FD&C Act is provided in the submission.
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Traditional 510(k) Submission
Ion™ Endoluminal System
K252045
Page | 7
9. CONCLUSION
The subject device and the predicate device, Ion Endoluminal System (K242070), 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 according 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 (K242070).
§ 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.