Ion Endoluminal System (IF1000)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION September 5, 2025 Intuitive Surgical Inc. Sandi Mar Senior Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086 Re: K252528 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: August 6, 2025 Received: August 11, 2025 Dear Sandi Mar: 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). U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K252528 - Sandi Mar Page 2 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). {2} K252528 - Sandi Mar Page 3 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 {3} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K252528 | | | Device Name Ion Endoluminal System (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 tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis. The system is indicated for use with adult and pediatric populations. Pediatric use is limited to patients who are 5 ft (152.5 cm) or taller and weigh 102 lbs (46 kg) or greater. 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) | | | 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." | | {4} Intuitive Surgical Special 510(k) Submission Ion™ Endoluminal System K252528 # 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: Sandi Mar Senior Regulatory Affairs Specialist Email: sandi.mar@intusurg.com Date Prepared: August 11, 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. 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 {5} Intuitive Surgical Special 510(k) Submission Ion™ Endoluminal System K252528 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 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. The system is indicated for use with adult and pediatric populations. Pediatric use is limited to patients who are 5 ft (152.5 cm) or taller and weigh 102 lbs (46 kg) or greater. 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. Page | 2 {6} Intuitive Surgical Special 510(k) Submission IonTM Endoluminal System K252528 # 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE 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. This application is for a change to the Indications for Use. The Ion Endoluminal System major subsystems consists of a Planning Laptop with PlanPoint Software, System Cart and Controller with System Software, Instruments, and Accessories. There are no substantial changes to the design or technological characteristics of the Ion Endoluminal System. A summary of the technological characteristics of the subject device compared to the predicate device is provided below: | Description | Predicate Device (K242070) IonTM Endoluminal System, Model IF1000 | Subject Device (K252528) IonTM 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 IonTM 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 IonTM Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use. The PlanPointTM Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the IonTM Endoluminal System. | 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. The system is indicated for use with adult and pediatric populations. Pediatric use is limited to patients who are 5 ft (152.5 cm) or taller and weigh 102 lbs (46 kg) or greater. 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. | | 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 | {7} Intuitive Surgical Special 510(k) Submission IonTM Endoluminal System K252528 | Description | Predicate Device (K242070) IonTM Endoluminal System, Model IF1000 | Subject Device (K252528) IonTM Endoluminal System, Model IF1000 | | --- | --- | --- | | Use Environment | Hospital | Identical to the predicate device | # 7. INDICATIONS FOR USE COMPARISON The Indications for Use statement of the subject device is modified to include the pediatric population. Minimum patient factors that represent the appropriate pediatric population that can safely undergo an Ion procedure were derived from clinical literature. The inclusion of pediatric use to the Indications for Use does not change the objective intent of the device and the substantial equivalence can be demonstrated by confirmation through risk analysis that use in an indicated pediatric population does not present new issues of safety or efficacy. The intended use remains the same. # 8. CONCLUSIONS The basis for this submission is the modification of the Indications for Use of the Ion Endoluminal System, Model IF1000 to include the pediatric population. No new risks or changes to the existing risks or safety profile of the device are prompted by this modification. Additionally, there are no new verification or validation activities required to support this modification. The subject device modification does not raise new questions of safety and effectiveness of the device. Based on the intended use, operating principles, technological characteristics, and performance testing, the subject device, Ion Endoluminal System, is substantially equivalent (SE) to the predicate device (K242070).