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.

Device Description

The Ion™ Endoluminal System (hereinafter referred to as the Ion System) 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 Ion System 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, Swivel Connector, and Vision Probe Bag facilitate use of the Ion System Instruments.

AI/ML Overview

The provided FDA 510(k) summary for the Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000) focuses on demonstrating substantial equivalence for an increase in the device's use life from 5 to 8 uses. This is not a typical submission for a novel AI/ML-based medical device where performance data relates to diagnostic accuracy, sensitivity, or specificity of an AI algorithm.

Therefore, the information required for explaining an AI device's acceptance criteria and proven performance (specifically sections regarding AI/ML performance, sample sizes for test/training sets, expert consensus, MRMC studies, etc.) is not present in this document. This submission primarily relies on bench testing, cleaning validation, and biocompatibility studies to justify the increased reprocessing cycles.

However, I can extract the acceptance criteria and the reports of meeting those criteria based on the information provided, framed within the context of a device durability/reuse validation:

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria (Inferred from "Passed Predetermined Acceptance Criteria")	Reported Device Performance
Cleaning Validation	Demonstrates cleaning efficacy for 8 use lives, meeting AAMI TIR12:2020 and AAMI ST98:2022 standards.	Testing passed the predetermined acceptance criteria.
Biocompatibility	No new or increased biological risk for 8 use lives, meeting ISO 10993-1:2018 and ISO 10993-5:2009 standards.	Testing passed the predetermined acceptance criteria and did not signal new or different biological risks.
Bench Testing	Catheter continues to meet existing functional requirements for 8 use lives (including reliability/life testing and design verification of instrument to system software compatibility).	All testing passed the predetermined acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in terms of number of units tested. The documentation refers to "testing" in general.
Data Provenance: Not applicable in the context of clinical data for AI performance. The tests are laboratory/bench-based.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable: This submission does not involve human expert interpretation of data to establish ground truth for a diagnostic AI. The "ground truth" here is the adherence to engineering and safety standards validated through laboratory testing.

4. Adjudication Method for the Test Set

Not Applicable: There is no adjudication process described as this is not a study assessing human perception or diagnostic accuracy. Performance is determined by passing predefined engineering and biological safety standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

No: An MRMC study was not performed as this is not a submission for an AI-assisted diagnostic or therapeutic device that impacts human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No (Not Applicable): This is not a submission for an AI algorithm. The "System Software" mentioned is likely operating software for the robotic system, not a diagnostic AI.

7. The Type of Ground Truth Used

Engineering and Safety Standards: The "ground truth" for this device's performance validation is its adherence to established engineering specifications (functional performance over repeated uses) and recognized safety standards (cleaning efficacy, biocompatibility).

8. The Sample Size for the Training Set

Not Applicable: This document describes validation testing for an increased use life, not the development or training of an AI model.

9. How the Ground Truth for the Training Set Was Established

Not Applicable: No AI training set is discussed or implied.

Summary of why the requested AI-specific information is not present:

The FDA 510(k) submission K240135 for the Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000) is specifically for an increase in the device's reusability/use life (from 5 to 8 uses) of an existing cleared device. It primarily relies on non-clinical performance data (bench testing, cleaning validation, biocompatibility) to demonstrate that increasing the use life does not introduce new safety or effectiveness concerns. This is fundamentally different from a submission for a novel AI/ML-based medical device that would require extensive clinical performance data, ground truth establishment, and often comparative studies with human readers.

Summary

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April 3, 2024

Intuitive Surgical, Inc. Jennifer Siu Regulatory Project Manager 1266 Kifer Road Sunnyvale, California 94086

Re: K240135

Trade/Device Name: Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000) Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: January 17, 2024 Received: January 18, 2024

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 (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).

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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.

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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Joyce C. Lin -S

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

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K240135

Device Name

Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (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 Flexision™ Biopsy Needle is used with the lon™ 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 lon™ Endoluminal System.

Type of Use (Select one or both, as applicable)

scription Use (Part 21 CFR 801 Subpart D)

er-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."

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510(k) Summary

1. Submitter

510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Jennifer SiuRegulatory Project ManagerTel: (408) 523-5372Email: jennifer.siu@intusurg.com
Date of Submission:	January 17, 2024

2. Device Information

Trade Name:	Ion™ Endoluminal System
Common Name:	Bronchoscope (flexible or rigid) and accessories
Classification:	Class II21 CFR §874.4680
Product Code:	EOQ
Review Panel:	Ear, Nose, and Throat

3. Predicate Device

The predicate device for this submission is the Ion™ Endoluminal System (K212048), cleared on August 26, 2021.

4. Device Description

The Ion™ Endoluminal System (hereinafter referred to as the Ion System) is a software-controlled, electromechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endosco pic 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 Ion System 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, Swivel Connector, and Vision Probe Bag facilitate use of the Ion System Instruments.

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5. Intended Use/Indications for Use

Intended Use

To provide access to and visualization of patient airways.

Indications for 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 Ion System Instrument, specifically the Ion™ Fully Articulating Catheter), subject to the scope of change under this submission, remains substantially equivalent to the Ion System Instrument cleared under K212048. There were no changes in design or reprocessing instructions for the subject device as a result of the increase in use life from 5 use lives to 8 use lives for the Catheter.

Intuitive is increasing the use life of the Catheter to 8 use lives. There are no changes to the subject device compared to the predicate device with regard to indications for use, technological characteristics, device materials, clinical utility, or pack aging as a result of the use life increase. Table 1 provides a comparison between the subject device and predicate device.

	Predicate Device:Ion SystemCatheter(K212048)	Subject Device:Ion SystemCatheter(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 accessories	SAME as predicate
Intended Use	To provide access to and visualization of patient airways	SAME as predicate
Indications for Use	The Ion™ Endoluminal System (Model IF1000) assiststhe user in navigating a catheter and endoscopic tools inthe pulmonary tract using endoscopic visualization of thetracheobronchial tree for diagnostic and therapeutic	SAME as predicate

Table 1. Comparison of Predicate and Subject Devices

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	Predicate Device:	Subject Device:
	Ion SystemCatheter	Ion SystemCatheter
	(K212048)	(This Submission)
	procedures. The Ion™ Endoluminal System enablesfiducial marker placement. It does not make a diagnosisand is not for pediatric use
	Visualization of endoluminal spaces via light deliveryand video
Principles ofOperation	Navigation through endoluminal spaces via tip deflectioncapabilities	SAME as predicate
	Provides a working channel through which otherinstruments can be delivered to target sites within theairways
Method ofCatheter Distal TipMovement	Electromechanically (servo/stepper motors and software)controlled pull wires	SAME as predicate
Catheter TipArticulation Range	180° in all four directions (pitch and yaw)	SAME as predicate
Catheter ToolChannel Diameter	2 mm	SAME as predicate
Catheter PatientContact Materials	Stainless steelSiliconePellethane plasticPTFE plasticCyanoacrylateGold-Tin solder	Stainless steelSiliconePellethane plasticPTFE plasticCyanoacrylate
Reusable	Yes	SAME as predicate
RequiresReprocessing	Yes	SAME as predicate
ReprocessingMethod	Manual cleaning and manual microbicidal processorManual cleaning and automated microbicidal processorAutomated cleaning and automated microbicidal process	SAME as predicate
Use Life	5	8

Cleaning validation results demonstrate that the subject device with 8 use lives is substantially equivalent to the predicate device with 5 use lives. Furthermore, the testing did not raise any new risks or new or different questions in terms of safety and effectiveness for the subject device.

7. Performance Data

The following performance data has been provided in support of the substantial equivalence determination. Testing included cleaning validation, toxicological risk assessment, and bench testing.

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Cleaning Validation

The Catheter and its current reprocessing instructions were validated to support cleaning efficacy for 8 use lives. Testing was performed in accordance with AAMI TIR12:2020 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers and AAMI ST98:2022 Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices. Testing passed the predetermined acceptance criteria.

Biocompatibility

In order to confirm that there was no new or increase biological risk for the subject Catheter with 8 use lives, for the entire use life of the device in accordance with the latest ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, cytotoxicity testing was performed in accordance with ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. Testing passed the predetermined acceptance criteria and did not signal new or different biological risks.

Bench Testing

A series of bench testing was performed to verify and validate that the Catheter continues to meet the existing functional requirements for 8 use lives. Reliability (life) testing and design verification testing for instrument to system software compatibility were performed. All testing passed the predetermined acceptance criteria.

Animal Testing

No animal studies were performed as the subject device with 8 use lives does not introduce new or different risks that requiring additional testing.

Clinical Testing

No clinical studies were performed as the subject device with 8 use lives does not introduce new or different risks that requiring additional testing.

8. Conclusion

Based upon the intended use, design, operating principles, comparison to the predicate devices, and conducted testing, it is concluded that the subject device with 8 use lives is substantially equivalent to the predicate device with 5 use lives. Testing also supports that the subject device with 8 use lives does not raise any new or different questions in safety or effectiveness.

Regulation Number and Section

§ 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.