(87 days)
No reference devices were used in this submission.
No
The document describes software for 3D planning and navigation based on CT scans, but there is no mention of AI or ML algorithms being used for image analysis, planning, or navigation control. The system appears to be based on traditional software control and electromechanical systems.
Yes.
The device's intended use includes assisting in navigation for "diagnostic and therapeutic procedures" and "enables fiducial marker placement," which implies involvement in therapeutic interventions.
No
The text explicitly states: "It does not make a diagnosis". The device assists in navigation for diagnostic and therapeutic procedures but does not perform the diagnosis itself.
No
The device description explicitly states that the Ion™ Endoluminal System is a "software-controlled, electromechanical system" and lists hardware components such as a System Cart, Controller, Instruments (catheter, probe, needles), and a Planning Laptop. While it includes software components (PlanPoint™ Software and System Software), it is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Ion™ Endoluminal System is a robotic system designed to assist physicians in navigating a catheter and tools within the pulmonary tract for diagnostic and therapeutic procedures. It uses endoscopic visualization and CT scans for planning and navigation.
- Lack of Specimen Analysis: The device itself does not analyze biological specimens. While it can be used to facilitate procedures that might involve obtaining specimens (like biopsies using the Flexision™ Biopsy Needles), the system's primary function is navigation and tool manipulation within the body, not the analysis of samples outside the body.
- Intended Use: The intended use clearly states it "assists the user in navigating a catheter and endoscopic tools... for diagnostic and therapeutic procedures." It also explicitly states, "It does not make a diagnosis."
Therefore, the Ion™ Endoluminal System falls under the category of a surgical or interventional system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EOQ
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 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 Ion Endoluminal System enables optional Network and Virtual Reference features, streamlined mid-procedure restart, and enhances the control algorithm to provide an additional safety margin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
patient CT scans
Anatomical Site
pulmonary tract, tracheobronchial tree, lung, airways
Indicated Patient Age Range
The Ion™ Endoluminal System… is not for pediatric use.
Intended User / Care Setting
qualified physicians; Hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing data demonstrates that the subject device is substantially equivalent to the predicate device (K220299) 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.
Cybersecurity testing: The cybersecurity verification and validation testing were conducted, and cybersecurity was evaluated per the FDA’s final guidance, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," issued October 2, 2014. Specifically, cybersecurity threat modeling addressed 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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is in blue. The logo is simple and clean, and it is easily recognizable.
December 18, 2023
Intuitive Surgical, Inc. Jyoti Singh Regulatory Affairs Project Manager 1266 Kifer Road Sunnyvale, California 94086
Re: K232984
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: September 21, 2023 Received: September 22, 2023
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).
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 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 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.
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).
Sincerely,
Shuchen Peng -S
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
Submission Number (if known)
Device Name
Ion Endoluminal System (IF1000)
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)
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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
Regulatory Affairs Project Manager
Phone Number: 408-523-5315
Email: jyoti.singh@intusurg.com | |
| Date Prepared: | September 21, 2023 | |
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: | K220299, last cleared on June 16, 2022 |
| 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.
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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 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 Ion Endoluminal System enables optional Network and Virtual Reference features, streamlined mid-procedure restart, and enhances the control algorithm to provide an additional safety margin.
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 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 (K220299).
The subject device and the predicate device, Ion™ Endoluminal System (K220299), 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 (K220299)
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 |
| Description | Predicate Device (K220299)
Ion™ Endoluminal System, Model
IF1000 | Subject Device
Ion™ Endoluminal System, Model
IF1000 |
| Use Environment | Hospital | Identical to the predicate device |
| 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 |
| 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 optional Network and Virtual Reference features. |
| 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 optional Network and Virtual Reference features and streamline the mid-procedure restart. |
6
The added support for the optional network and virtual reference features mentioned in the subject and predicate device comparison table above are further discussed in the following section.
The subject device preserves the predicate device's networking capability and the ability to use virtual elements for reference navigation guidance. Using the subject device's virtual
7
reference and network features is at the user's discretion and not required for the device's intended use. The added support for the optional network and virtual reference features in the subject device are not required for the device's intended use and do not impact the device's safety and clinical performance. Additionally, these features do not raise different questions of safety and effectiveness, as confirmed through testing of the subject device. Thus, the subject and the predicate devices are substantially equivalent.
7. PERFORMANCE DATA
Performance testing data demonstrates that the subject device is substantially equivalent to the predicate device (K220299) 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, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," issued October 2, 2014. Specifically, cybersecurity threat modeling addressed 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. 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
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.
8. CONCLUSION
The subject device and the predicate device, Ion™ Endoluminal System (K220299), 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 (K220299).