Ion Endoluminal System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. June 26, 2020 Intuitive Surgical, Inc. Jennifer Siu Sr. Regulatory Affairs Specialist 1266 Kifer Rd. Sunnyvale, California 94086 Re: K201146 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: EOQ Dated: April 28, 2020 Received: April 29, 2020 Dear Jennifer Siu: 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ 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 (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 Michael J. Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing. Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201146 Device Name Ion™ Endoluminal System #### 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) | | |-----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### 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 - 1. Submitter | 510(k) Owner: | Intuitive Surgical, Inc.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 | |---------------------|-----------------------------------------------------------------------------------------------------------------| | Contact: | Jennifer Siu<br>Senior Regulatory Affairs Specialist<br>Tel: (408) 523-5372<br>Email: jennifer.siu@intusurg.com | | Date of Submission: | April 28, 2020 | # 2. Device Information | Trade Name: | Ion™ Endoluminal System | |-----------------|----------------------------------------------------------------------------------| | Common Name: | Bronchoscope (flexible or rigid) and accessories | | Classification: | Class II<br>21 CFR §874.4680<br>Bronchoscope (flexible or rigid) and accessories | | Product Code: | EOQ | | Review Panel: | Ear, Nose, and Throat | ## 3. Predicate Device The predicate device for this submission is the Ion™ Endoluminal System (K192367), cleared on November 26, 2019. # 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 Model IF 1000 Instruments include the Ion™ Fully Articulating Catheter, the Ion™ Peripheral Vision Probe, and the Flexision™ Biopsy Needles. Accessories such as the Catheter Guide, Vision Probe Adapter, Suction Adapter, and Swivel Connector facilitate use of the Model IF1000 Instruments. {4}------------------------------------------------ # 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 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 to Predicate Device The Model IF1000 Instruments, specifically the Ion™ Fully Articulating Catheter) and the Ion™ Peripheral Vision Probe (Vision Probe), subject to the scope of change under this submission, remain substantially equivalent to the same Model IF1000 Instruments cleared under K192367. There were no design changes made to the subject device as a result of the reprocessing instructions updates. Intuitive is updating the reprocessing instructions for manual cleaning and manual disinfection of the Catheter and Vision Probe instruments, to improve reprocessing workflow efficiency and streamline these processes. There are no changes to the subject device compared to the predicate device with regard to indications for use, technological characteristics, device design, device materials, clinical utility, packaging, or reprocessing methods as a result of the reprocessing instructions updates. Table 1 provides a comparison between the subject device and predicate device. | Table 1. Comparison of Predicate and Subject Devices | | | |------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | | Predicate Device:<br>Model IF1000<br>Catheter & Vision Probe<br>(K192367) | Subject Device:<br>Model IF1000<br>Catheter & Vision Probe<br>(This Submission) | | FDA Product Code | EOQ | SAME as predicate | | Classification | Class II - 21 CFR §874.4680 | SAME as predicate | | Classification Name | Bronchoscope (flexible or rigid) and<br>accessories | SAME as predicate | | | Predicate Device:<br>Model IF1000<br>Catheter & Vision Probe<br>(K192367) | Subject Device:<br>Model IF1000<br>Catheter & Vision Probe<br>(This Submission) | | Intended Use | To provide access to and visualization of<br>patient airways | SAME as predicate | | Indications for Use | The Ion™ Endoluminal System (Model<br>IF1000) assists the user in navigating a<br>catheter and endoscopic tools in the<br>pulmonary tract using endoscopic<br>visualization of the tracheobronchial tree<br>for diagnostic and therapeutic procedures.<br>The Ion™ Endoluminal System enables<br>fiducial marker placement. It does not<br>make a diagnosis and is not for pediatric<br>use | SAME as predicate | | Principles of Operation | Visualization of endoluminal spaces via<br>light delivery and video<br>Navigation through endoluminal spaces via<br>tip deflection capabilities<br>Provides a working channel through which<br>other instruments can be delivered to target<br>sites within the airways | SAME as predicate | | Method of Distal Tip<br>Movement | Electromechanically (servo/stepper motors<br>and software) controlled pull wires | SAME as predicate | | Tool Channel Diameter | 2 mm | SAME as predicate | | Patient Contact<br>Materials | Stainless Steel<br>Silicone<br>Pellethane plastic<br>PTFE plastic<br>Glass<br>Polyamide resin<br>Pebax elastomer (TPE)<br>Polyamide | SAME as predicate | | Reusable | Yes | SAME as predicate | | Requires Reprocessing | Yes | SAME as predicate | | Reprocessing Method | Manual cleaning<br>Manual or automated microbicidal process | SAME as predicate | # Table 1 Comparison of Predicate and Subject Devices {5}------------------------------------------------ Cleaning and disinfection validation testing results demonstrate that the subject device reprocessed via the updated reprocessing instructions is substantially equivalent to the predicate device reprocessed via the current reprocessing instructions. Furthermore, the testing did not raise any new risks or any new questions in terms of safety and effectiveness for the subject device. {6}------------------------------------------------ # 7. Performance Data The following performance data has been provided in support of the substantial equivalence determination. Testing included reprocessing validations. ## Reprocessing Validation Cleaning and high-level disinfection (HLD) validations were performed to demonstrate the efficacy of the updated reprocessing instructions in continuing to successfully clean and disinfect the Model IF1000 Instruments. Testing was performed in accordance with AAMI TIR12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers and AAMI TIR30:2011/(R)2016 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices. All testing passed the predetermined acceptance criteria. ## Biocompatibility No biocompatibility testing was performed as the reprocessing instructions updates do not introduce new materials or chemicals to the subject device or reprocessing process requiring additional biocompatibility testing. ## Bench Testing No bench testing was performed as the reprocessing instructions updates do not introduce additional mechanical wear to the subject device requiring additional verification and validation. ## Usability Testing No usability testing was performed as the reprocessing instructions updates do not introduce new or critically different reprocessing steps requiring additional usability testing. ## Animal Testing No animal studies were performed as the reprocessing instructions updates do not introduce additional mechanical wear or new or different reprocessing steps for the subject device requiring additional testing. ## Clinical Testing No clinical studies were performed as the reprocessing instructions updates do not introduce additional mechanical wear or new or different reprocessing steps for the subject device requiring additional testing. ## 8. Conclusion Based upon the intended use, design, operating principles, comparison to the predicate device, and conducted testing, it is concluded that the subject device reprocessed via the updated reprocessing instructions is substantially equivalent to the predicate device reprocessed via the current reprocessing instructions. Testing also supports that the subject {7}------------------------------------------------ device reprocessed via the updated reprocessing instructions does not raise any new risks or any new questions in safety or effectiveness for the subject device.