(89 days)
No
The summary describes a robotic navigation system for bronchoscopy that uses CT scans for planning and provides real-time visualization and control. While it uses software for planning and control, there is no mention of AI or ML algorithms being used for tasks like image analysis, decision support, or autonomous navigation. The system appears to be based on traditional software control and robotic principles.
No.
The "Intended Use / Indications for Use" states that the device is for "diagnostic and therapeutic procedures," however, it clarifies that it "assists the user in navigating a catheter and endoscopic tools." It also explicitly states, "It does not make a diagnosis." While a component, the Flexision™ Biopsy Needle, is used for biopsy (a diagnostic procedure), the core device itself is a navigation system. Therapeutic procedures involve treatment, and based on the provided text, this device does not perform treatment itself; it facilitates the navigation of tools that may be used for either diagnostic or therapeutic purposes.
No
The 'Intended Use / Indications for Use' section explicitly states: "It does not make a diagnosis".
No
The device description explicitly states it 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, System Software), it is not solely software.
Based on the provided text, the Ion™ Endoluminal System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves tests performed on samples like blood, urine, tissue, etc., outside of the body.
- Intended Use: The intended use of the Ion™ Endoluminal System is to assist in navigating a catheter and endoscopic tools within the pulmonary tract for diagnostic and therapeutic procedures. It explicitly states it "does not make a diagnosis".
- Device Description: The device description details a system for navigating instruments inside the body, including a catheter, biopsy needle, and visualization tools. It uses CT scans for planning, but the core function is physical manipulation and visualization within the patient.
- Lack of Specimen Analysis: There is no mention of the device analyzing biological specimens or performing tests on samples outside the body. The biopsy needle is used to obtain a tissue sample, but the device itself doesn't perform the diagnostic analysis on that sample.
Therefore, the Ion™ Endoluminal System is an in vivo (within the living body) device used for navigation and intervention, not an in vitro diagnostic device.
N/A
Intended Use / 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 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.
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 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 Ion™ Endoluminal System enables automatic device logs retrieval via the network and connects to a hospital networked Picture Archiving and Communication System (PACS).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans
Anatomical Site
Pulmonary tract, tracheobronchial tree, lung, patient airways
Indicated Patient Age Range
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 the subject device is substantially equivalent to the predicate device, and the design output meets the design input requirements. The performance testing included electromagnetic compatibility (EMC), design verification, software verification and validation, including cybersecurity, and design validation, using simulated animal model.
EMC and Electrical Safety Testing:
The predicate device (K182188) was tested for EMC under IEC 60601-1-2:2007, whereas the subject device (Ion Endoluminal System) was tested for compliance with the new 4th edition version of the standard, IEC 60601-1-2: 2014. The 4th edition EMC testing of the subject device also verified hardware modifications made to the subject device. These modifications consist of the addition of a PCA board called the Wally Network Node (WNN) and a Network Security Device to support networking interfaces.
Software Verification and Validation:
Software for the Ion™ Endoluminal System underwent verification and validation testing. results demonstrate the System meets design specifications and user needs.
Bench testing:
The System Cart and Planning Laptop were subjected to bench testing and results confirm the design outputs for the System Cart and the Planning Laptop meet the design input requirements.
Cybersecurity testing:
The Ion™ Endoluminal System was subjected to Cybersecurity verification and validation testing. 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, animal testing was performedunder simulated use conditions to assess the system performance. Test results demonstrated the Ion™ Endoluminal System performs according to its intended use.
Usability Testing:
Changes made 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.
Clinical Testing:
No clinical testing was required to validate the changes made to the Ion™ Endoluminal System.
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.
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 contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 16, 2020
Intuitive Surgical, Inc. Jyoti Singh Sr. Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086
Re: K202370
Trade/Device Name: Ion Endoluminal System Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOO Dated: August 18, 2020 Received: August 19, 2020
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
1
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 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 (OS) 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 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,
for Malvina B. Eydelman, M.D. Director 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) K202370
Device Name Ion™ Endoluminal System (Model 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 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) | |
|---|---|
| ✓ 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
Fax Number: 408-523-8907
Email: jyoti.singh@intusurg.com |
| Date Prepared: | Aug 18, 2020 |
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: | K182188, last cleared on February 14, 2019 |
| 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 |
4
| Review Panel: | Ear, Nose, and Throat |
|---|---|
| 4. REFERENCE DEVICE INFORMATION |
| Manufacturer Name: | Intuitive Surgical, Inc. |
|---|---|
| 510(k) Number: | K182643, last cleared on February 22, 2019 |
| Trade Name: | IRIS 1.0 System |
| Common Name: | System, surgical, computer-controlled instrument |
| Classification: | Class II |
| 21 CFR §892.2050, Picture archiving and communications | |
| system | |
| Product Codes: | LLZ |
| Review Panel: | Radiology |
5. 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 Ion™ Endoluminal System enables automatic device logs retrieval via the network and connects to a hospital networked Picture Archiving and Communication System (PACS).
5
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 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.
7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
7.1 Comparison of Subject with the Predicate Device
The subject of this submission, Ion™ Endoluminal System, Model IF1000 has been developed by modifying Ion Endoluminal System, Model IF1000 (K182188).
The subject device and the predicate device, Ion™ Endoluminal System (K182188) are based on the same intended use, indications for use, operating principles and similar technological characteristics. A brief summary of the technological characteristics of the subject device compared to the predicate device is provided below:
| Description | Predicate Device | Subject Device |
|---|---|---|
| Ion™ Endoluminal System, | ||
| Model IF1000 | ||
| (K182188) | Ion™ Endoluminal System, | |
| Model IF1000 | ||
| (Not assigned) | ||
| Regulation Number | 21 CFR §874.4680 | SAME as Predicate device |
| Classification | Class II | SAME as Predicate device |
| Product Code | EOQ | SAME as Predicate device |
6
=
| Description | Predicate Device | Subject Device |
|---|---|---|
| Ion™ Endoluminal System, | Ion™ Endoluminal System, | |
| Model IF1000 | Model IF1000 | |
| (K182188) | (Not assigned) | |
| 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 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. | SAME as Predicate device |
| Intended Use | To provide access to and visualization
of patient airways. | SAME as Predicate device |
| Prescription use | Rx only | SAME as Predicate device |
| Use Environment | Hospital | SAME as Predicate device |
7
| Description | Predicate Device | Subject Device |
|---|---|---|
| Ion ™ Endoluminal System, | ||
| Model IF1000 | ||
| (K182188) | Ion ™ Endoluminal System, | |
| Model IF1000 | ||
| (Not assigned) | ||
| 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
Master/slave servomechanism
incorporates servo motor control and
system-level coordinated joint
control. | SAME as Predicate device |
| Major subsystems | System Cart and Controller with
incorporated System Software
• Planning Laptop with PlanPoint™ Software | SAME as Predicate device |
| Log retrieval | Manual retrieval via a USB | SAME as Predicate device with
added support for automatic retrieval
via the network. |
| Procedure planning | PlanPoint™ Software uses DICOM
CT scan for preoperative planning.
CT scan sources include CD, DVD
and USB | SAME as predicate device with
added support for using hospital
networked PACS as a CT scan
source. |
7.2 Comparison of Subject with the Reference Device
The reference device, IRIS 1.0 System (K182643) supports the DICOM CT image access via the hospital networked PACS. Same as the subject device (Ion™ Endoluminal System), the IRIS 1.0 system has the capability to query and retrieve DICOM CT from a hospital networked PACS. The DICOM CT query and retrieve feature of the reference device is analogous to the similar feature in the subject device. A brief summary of the technological characteristics of the subject device compared to the reference device is provided below:
8
| Description | Reference Only Device
IRIS 1.0 System (K182643) | Subject Device
Ion™ Endoluminal System, Model
IF1000 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Intuitive Surgical, Inc. | SAME as reference device |
| Common Name | System, surgical, computer-
controlled instrument | Bronchoscope (flexible or rigid) and
accessories |
| Trade Name | IRIS 1.0 System | Ion™ Endoluminal System |
| Classification | Class II | SAME as reference device |
| Regulation description and
Number | Picture archiving and
communications system (21
CFR §892.2050) | Bronchoscope (flexible or rigid) and
accessories (21 CFR §874.4680) |
| Product Code | LLZ | EOQ |
| Review panel | Radiology | Ear, Nose, and Throat |
| Prescription use | Rx only | SAME as reference device |
| Use Environment | Hospital and office setting | SAME as reference device, but
does not include office setting |
| PACS DICOM CT scan
Access | IRIS 1.0 software (Cloud based
mobile software) uses DICOM
CT scan images for preoperative
planning. DICOM CT images
are accessed from the hospital
networked PACS via
query/retrieve processes. | PlanPoint™ Software (installed on
Planning Laptop) uses DICOM CT
scan images for preoperative
planning. DICOM CT images are
accessed from the hospital
networked PACS via query/retrieve
and listen processes.
Query/retrieve process of
PlanPoint™ Software is SAME as
reference device |
8. PERFORMANCE DATA
Performance testing data demonstrates the subject device is substantially equivalent to the predicate device, and the design output meets the design input requirements. The performance testing included electromagnetic compatibility (EMC), design verification, software verification and validation, including cybersecurity, and design validation, using simulated animal model.
Biocompatibility Testing
The scope of this submission does not include changes to patient-contacting components of the Ion™ Endoluminal System, IF1000 therefore, no biocompatibility testing was needed.
9
EMC and Electrical Safety Testing
The predicate device (K182188) was tested for EMC under IEC 60601-1-2:2007, whereas the subject device (Ion Endoluminal System) was tested for compliance with the new 4th edition version of the standard, IEC 60601-1-2: 2014.
The 4th edition EMC testing of the subject device also verified hardware modifications made to the subject device. These modifications consist of the addition of a PCA board called the Wally Network Node (WNN) and a Network Security Device to support networking interfaces.
The electrical safety testing performed for compliance with IEC 60601-1 and IEC 60601-2-18 on predicate device (K182188) remains valid for the subject device because the scope of changes for this submission do not impact the electrical safety of the Ion Endoluminal System.
Software Verification and Validation
Software for the Ion™ Endoluminal System underwent verification and validation testing. results demonstrate the System meets design specifications and user needs. Software documentation has been provided according to FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005.
Bench testing
The System Cart and Planning Laptop were subjected to bench testing and results confirm the design outputs for the System Cart and the Planning Laptop meet the design input requirements. No hardware changes were made to the Controller. Therefore, no performance bench testing was required for the Controller.
Cybersecurity testing
The Ion™ Endoluminal System was subjected to Cybersecurity verification and validation testing. 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.
10
Animal Testing
For system design validation, animal testing was performedunder simulated use conditions to assess the system performance. Test results demonstrated the Ion™ Endoluminal System performs according to its intended use.
Usability Testing
Changes made 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.
Clinical Testing
No clinical testing was required to validate the changes made to the Ion™ Endoluminal Svstem.
9. CONCLUSION
The subject device and the predicate device, Ion™ Endoluminal System (K182188), have the same intended use, indications for use, operating principles and similar technological characteristics. Same as the subject device (Ion™ Endoluminal System) the reference device (Iris System 1.0, K182643) has the capability to query and retrieve DICOM CT from a hospital networked PACS.
The device modifications made to enable the network communication and direct patient CT scan images download via PACS server on the hospital network 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 Ion™ Endoluminal System is substantially equivalent (SE) to the predicate device.