Ion Endoluminal System (IF1000)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". June 16, 2022 Intuitive Surgical, Inc. Jyoti Singh Sr. Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086 ### Re: K220299 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: May 16, 2022 Received: May 17, 2022 #### 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 (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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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 medical devices and radiation-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). Sincerely, 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220299 Device Name Ion™ Endoluminal System (Model IF1000) #### Indications for Use (Describe) The Ion™ Endoluminal System (Model IF 1000) 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. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X 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." {3}------------------------------------------------ ### 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 Road | | | | Sunnyvale, CA 94086 | | | Contact: | Jyoti Singh | | | | Senior Regulatory Specialist | | | | Phone Number: 408-523-5315 | | | | Email: jyoti.singh(@intusurg.com | | | Date Prepared: | February18, 2022 | | ### 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 | | | | Bronchoscope (flexible or rigid) and accessories | | | Product Codes: | EOQ | | | Review Panel: | Ear, Nose, and Throat | | #### 3. PREDICATE DEVICE INFORMATION | Manufacturer Name: | Intuitive Surgical, Inc. | |--------------------|---------------------------------------------------------------------------------| | 510(k) Number: | K202370, last cleared on November 16, 2020 | | Trade Name: | Ion™ Endoluminal System, Model IF1000 | | Common Name: | Bronchoscope (flexible or rigid) and accessories | | Classification: | Class II<br>21 CFR 874.4680<br>Bronchoscope (flexible or rigid) and accessories | | Product Codes: | EOQ | | Review Panel: | Ear, Nose, and Throat | No reference devices were used in this submission. {4}------------------------------------------------ #### 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 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 IF1000 System software is modified to optionally receive an intra-procedural cone beam CT image to enhance the virtual target location based on user input. #### 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. {5}------------------------------------------------ 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 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 (K202370). The subject device and the predicate device, Ion™ Endoluminal System (K202370) 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 (K202370)<br>Ion™ Endoluminal System, Model<br>IF1000 | Subject Device<br>Ion™ Endoluminal System, Model<br>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<br>(Model IF1000) assists the user in<br>navigating a catheter and endoscopic<br>tools in the pulmonary tract using<br>endoscopic visualization of the<br>tracheobronchial tree for diagnostic<br>and therapeutic procedures. The<br>Ion™ Endoluminal System enables<br>fiducial marker placement. It does not<br>make a diagnosis and is not for<br>pediatric use.<br>The Flexision™ Biopsy Needle is<br>used with the Ion™ Endoluminal<br>System to biopsy tissue from a target<br>area in the lung.<br>The PlanPoint™ Software uses<br>patient CT scans to create a 3D plan | Identical to the predicate device | | Description | Predicate Device (K202370)<br>Ion™ Endoluminal System, Model IF1000 | Subject Device<br>Ion™ Endoluminal System, Model IF1000 | | | 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 as 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 video<br>Navigation through endoluminal spaces via tip deflection capabilities<br>Provides a working channel through which other instruments can be delivered to target sites within the airways<br>Master/slave servomechanism incorporates servo motor control and system-level coordinated joint control. | Identical to the predicate device | | Major subsystems | System Cart and Controller with incorporated System Software Planning Laptop with PlanPoint™ Software | 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 variety of additional functions, such as monitoring sensors throughout the system, generating the user interface display outputs, and providing | added interoperability with the integrated CBCT system to support the integrated CBCT feature | {6}------------------------------------------------ {7}------------------------------------------------ ## 7. PERFORMANCE DATA Performance testing data demonstrates the subject device is substantially equivalent to the predicate device (K202370), and the design output meets the design input requirements. The performance testing included software verification and validation, including cybersecurity, and design validation, using simulated animal model. ### Software Verification and Validation Software documentation has been provided according to FDA's Guidance for Industry and FDA "The Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005.). The System software underwent verification and validation testing. The software testing included unit, subsystem, system level and interoperability testing. The interoperability approach is in alignment with FDA guidance, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices (September 6, 2017). The software testing results demonstrate the System meets design specifications and user needs. The System software was also subjected to regression testing using same test methods and acceptance criteria presented in the predicate device premarket notification K202370. The regression testing verified that the subject device modifications did not impact the unmodified elements of the IF1000 System software. ### Cybersecurity Testing The cybersecurity verification and validation testing was conducted, and cybersecurity was evaluated per FDA's Draft Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (October 18, 2018). Specifically, addressing the following areas: Identify and Protect, Detect, Response and Recover. 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 and accuracy. The test results demonstrate that the System performs effectively according to its intended use and does not raise different questions of safety or effectiveness. ### 8. CONCLUSION The subject device and the predicate device. Ion™ Endoluminal System (K202370) have the same intended use, indications for use, operating principles, and similar technological characteristics. The subject device modifications have been evaluated and {8}------------------------------------------------ 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 (K202370).