← Product Code [EOQ](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ) · K242070 # Ion Endoluminal System (IF 1000) (K242070) _Intuitive Surgical, Inc. · EOQ · Sep 24, 2024 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K242070 ## Device Facts - **Applicant:** Intuitive Surgical, Inc. - **Product Code:** [EOQ](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ.md) - **Decision Date:** Sep 24, 2024 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.4680 - **Device Class:** Class 2 - **Review Panel:** Ear, Nose, Throat - **Attributes:** Therapeutic ## Intended Use To provide access to and visualization of patient airways. ## Device Story The Ion Endoluminal System (IF1000) is a software-controlled, electro-mechanical system for pulmonary tract navigation. It consists of a Planning Laptop (PlanPoint Software), System Cart, Controller, and instruments (catheter, vision probe, biopsy needles). The physician uses the Planning Laptop to generate a 3D airway model from patient CT scans. During procedures, the physician uses the Controller to command catheter insertion, retraction, and articulation via a leader-follower servomechanism. The system provides endoscopic visualization to assist in diagnostic and therapeutic procedures, including fiducial marker placement. The system is used in hospitals by qualified physicians. The subject device adds a remote software update capability via secure network communication, allowing updates without on-site field service engineers, restricted to non-clinical use periods. ## Clinical Evidence No human clinical data provided. Evidence consists of bench testing, including software verification and validation (unit, subsystem, and system level), regression testing, and cybersecurity verification per FDA guidance. System design validation was performed using simulated in-vivo animal models to assess performance under simulated use conditions. ## Technological Characteristics Electro-mechanical system; leader-follower servomechanism; includes Planning Laptop, System Cart, Controller, and endoscopic instruments. Connectivity: Networked for remote software updates via secure communication. Software: System software and PlanPoint software. Sterilization: Not specified. Dimensions/Materials: Not specified. ## Regulatory 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. ## Predicate Devices - Ion Endoluminal System, Model IF1000 ([K232984](/device/K232984.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it. 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). {1}------------------------------------------------ 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). {2}------------------------------------------------ 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 {3}------------------------------------------------ # 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." {4}------------------------------------------------ # 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: | Farzin Bolourchian
Regulatory Affairs, Technical Lead
Phone Number: 408-425-5233
Email: 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 II
21 CFR 874.4680 | | Product Codes: | EOQ | | Review Panel: | Ear, Nose, and Throat | No reference devices were used in this submission. {5}------------------------------------------------ ### 4. 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. #### 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. {6}------------------------------------------------ # 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, Model
IF1000 | Subject Device
Ion 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 for use
with the Ion Endoluminal System. | Identical to the predicate device | | 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 | | Description | Predicate Device (K232984)
Ion Endoluminal System, Model
IF1000 | Subject Device
Ion Endoluminal System, Model
IF1000 | | Principles of
operations | Visualization of endoluminal spaces
via light delivery and video
Navigation through endoluminal
spaces via tip deflection capabilities
Provides a working channel through
which other instruments can be
delivered to target sites within the
airways
Leader/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. | Added support to enable Remote
Software Update from the Intuitive
server via secure network
communication. | | 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. | Added support to enable Remote
Software Update from the Intuitive
server via secure network
communication. | {7}------------------------------------------------ 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 {8}------------------------------------------------ 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. {9}------------------------------------------------ # 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. --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K242070](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K242070) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com