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 (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.

AI/ML Overview

The provided text is a 510(k) Summary for the Intuitive Surgical Ion™ Endoluminal System (Model IF1000). This submission specifically focuses on adding an alternative automated microbicidal reprocessing method for certain components (Catheter and Vision Probe) compared to the previously cleared manual method.

Therefore, the acceptance criteria and study proving the device meets them are related to demonstrating that this new reprocessing method does not negatively impact the device's safety and effectiveness and that the device, when reprocessed by the automated method, remains substantially equivalent to the device reprocessed by the manual method.

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All testing passed the predetermined acceptance criteria" for each category. Specific numerical acceptance criteria or performance metrics are not provided in this summary. Instead, the performance is reported as meeting the criteria.

Test Category	Acceptance Criteria (General)	Reported Device Performance
Reprocessing Validation	Demonstrate efficacy of automated reprocessing in disinfecting/sterilizing the devices per AAMI TIR12:2010.	All testing passed the predetermined acceptance criteria. Device efficacy for disinfection/sterilization demonstrated.
Biocompatibility	Assess biological responses to patient contact from chemical residuals per ISO 10993-5:2009 (Cytotoxicity).	All testing passed the predetermined acceptance criteria. No adverse biological responses detected.
Bench Testing	Verify and validate existing functional requirements met after automated microbicidal process.	All testing passed the predetermined acceptance criteria. Functional requirements continue to be met.
Usability Testing	Intended users can successfully understand and perform reprocessing procedure safely and effectively following instructions.	The study demonstrates the intended users can successfully understand and perform the intended reprocessing procedure safely and effectively while following the reprocessing instructions manuals.

2. Sample Sizes Used for the Test Set and Data Provenance:

Reprocessing Validation: "3 automated reprocessing equipment were validated." The sample size for devices reprocessed with each equipment is not specified (e.g., number of cycles, number of devices).
Biocompatibility: "Testing was performed on the Model IF1000 devices subjected to each representative automated reprocessing equipment." Specific sample size not detailed.
Bench Testing: The document lists "Design Verification Testing" and "Reliability Testing" for both the Catheter and Vision Probe. Specific sample sizes for each test are not detailed.
Usability Testing: The sample size of users involved in the human factors study is not provided.
Data Provenance: Not explicitly stated, but implicitly, given the nature of a 510(k) submission for a US market, the testing would be conducted within a controlled environment compliant with US regulatory standards. It's a prospective study designed to validate the new reprocessing method for market clearance.

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

Not Applicable in this Context: This submission is focused on the device's ability to withstand a new reprocessing method and maintain its original safety and performance characteristics, rather than making a diagnostic claim or requiring human expert interpretation for "ground truth" in the typical sense of an AI/ML device study.
The "ground truth" here is objective: whether the device is successfully disinfected/sterilized, retains its functionality, and is safe for patient contact. This is established through validated testing protocols, not expert consensus on diagnostic images.

4. Adjudication Method for the Test Set:

Not Applicable (or Implicit/Internal): Since the studies described are primarily engineering and reprocessing validation, they involve objective measurements against predetermined acceptance criteria. There's no mention of an external adjudication panel of experts for subjective interpretation, as might be found in a clinical imaging study involving human readers. Any "adjudication" would be internal to the testing process, ensuring that results consistently meet the established pass/fail criteria.

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

No: An MRMC comparative effectiveness study was not done. This type of study is typically performed to evaluate the impact of an AI algorithm on human reader performance for diagnostic tasks. This 510(k) is for a physical device with a new reprocessing method validation, not for an AI/ML diagnostic aid.

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

Not Applicable/Implicit: This is not an AI/ML device being evaluated for standalone performance. The "Ion Endoluminal System" does have software (PlanPoint™ and System Software), but the focus of this 510(k) is on the reprocessing of physical instruments. The software's performance itself (e.g., navigation accuracy) was likely evaluated in the original K182188 clearance. Bench testing for the physical components did evaluate their functional performance after reprocessing (which could be considered a form of "standalone" evaluation of the physical device's characteristics).

7. The Type of Ground Truth Used:

Objective, Measured Parameters:
- Reprocessing Validation: Microbial load reduction (e.g., sterilization/disinfection effectiveness confirmed by microbiological assays).
- Biocompatibility: Absence of cytotoxicity (confirmed by cellular assays).
- Bench Testing: Device functional specifications (e.g., mechanical integrity, electrical performance, dimensional accuracy) met after reprocessing (confirmed by engineering measurements and tests).
- Usability Testing: Successful completion of tasks by intended users as per instructions (confirmed by observation and task analysis).

8. The Sample Size for the Training Set:

Not Applicable: This submission does not pertain to an AI/ML device that requires a training set of data. The device itself is a bronchoscope system.

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

Not Applicable: As there is no AI/ML training set, there is no ground truth to be established for it in this context.

Summary

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November 26, 2019

Intuitive Surgical, Inc. Jennifer Siu Sr. Regulatory Affairs Specialist 1266 Kifer Rd. Sunnyvale, California 94086

Re: K192367

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: August 29, 2019 Received: August 30, 2019

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

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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 (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 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 Mike 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192367

Device Name Ion™ Endoluminal System (Model IF1000)

Indications for Use (Describe)

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)

X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

1. Submitter

510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Jennifer SiuSenior Regulatory Affairs SpecialistTel: (408) 523-5372Email: jennifer.siu@intusurg.com
Date of Submission:	August 29, 2019

2. Device Information

Trade Name:	Ion™ Endoluminal System
Common Name:	Bronchoscope (flexible or rigid) and accessories
Classification:	Class II21 CFR §874.4680Bronchoscope (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 (K182188), cleared on February 14, 2019.

4. Device Description

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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 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 Model IF1000 Instruments cleared under K182188. There were no design changes made to the subject device as a result of the alternative microbicidal method.

Intuitive is providing an alternative microbicidal method for the reprocessing of the Catheter and Vision Probe instruments, to allow users the choice for these instruments to be reprocessed via an automated microbicidal process instead of the current manual microbicidal process. 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 packaging as a result of the alternative automated microbicidal process. Table 1 provides a comparison between the subject device and predicate device.

		Predicate Device:Model IF1000Catheter & Vision Probe(K182188)	Subject Device:Model IF1000Catheter & Vision Probe(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
	Predicate Device:Model IF1000Catheter & Vision Probe(K182188)	Subject Device:Model IF1000Catheter & Vision Probe(This Submission)
Intended Use	To provide visualization of patientairways	SAME as predicate
Indications for Use	The Ion™ Endoluminal System(Model IF1000) assists the user innavigating a catheter andendoscopic tools in the pulmonarytract using endoscopic visualizationof the tracheobronchial tree fordiagnostic and therapeuticprocedures. The Ion™Endoluminal System enablesfiducial marker placement. It doesnot make a diagnosis and is not forpediatric use	SAME as predicate
Principles of Operation	Visualization of endoluminal spacesvia light delivery and videoNavigation through endoluminalspaces via tip deflection capabilitiesProvides a working channel throughwhich other instruments can bedelivered to target sites within theairways	SAME as predicate
Method of Distal TipMovement	Electromechanically (servo/steppermotors and software) controlledpull wires	SAME as predicate
Tool Channel Diameter	2 mm	SAME as predicate
Patient ContactMaterials	Stainless SteelSiliconePellethane plasticPTFE plasticGlassPolyamide resinPebax elastomer (TPE)Polyamide	SAME as predicate
Reusable	Yes	SAME as predicate
Requires Reprocessing	Yes	SAME as predicate
Reprocessing -Microbicidal Method	Manual microbicidal process	Manual microbicidal processorAutomated microbicidal process

Table 1. Comparison of Predicate and Subject Devices

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Verification and validation testing results demonstrate that the subject device reprocessed via the automated microbicidal process is substantially equivalent to the predicate device

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reprocessed via the manual microbicidal process. Furthermore, the testing did not raise any new risks or any new 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 reprocessing, biocompatibility, bench testing, and usability testing.

Reprocessing Validation

3 automated reprocessing equipment were validated to support the automated microbicidal process of the Catheter and Vision Probe, to demonstrate the efficacy of the automated reprocessing equipment in disinfecting/sterilizing the Model IF1000 devices. 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. All testing passed the predetermined acceptance criteria.

Biocompatibility

In order to assess the biological responses to patient contact of the Catheter and Vision Probe from chemical residuals used during the automated microbicidal process, Cytotoxicity testing was performed. Testing was performed on the Model IF1000 devices subjected to each representative automated reprocessing equipment in accordance with ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. All testing passed the predetermined acceptance criteria.

Bench Testing

A series of bench testing was performed to verify and validate that the Model IF1000 devices continue to meet the existing functional requirements following the automated microbicidal process. The series of testing is outlined below. All testing passed the predetermined acceptance criteria.

Performance Bench Test Results
Test	Conclusion
Design Verification Testing for Catheter	Pass
Design Verification Testing for Vision Probe	Pass
Reliability Testing for Catheter	Pass
Reliability Testing for Vision Probe	Pass

Usability Testing

A human factors study was performed to validate the additional instructions added to support the alternative automated microbicidal process. The study was conducted in accordance with FDA guidances Applying Human Factors and Usability Engineering to Medical Devices, issued February 3, 2016, and Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued March 17, 2015. The study demonstrates the intended users can successfully understand and perform the intended reprocessing procedure

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safely and effectively while following the reprocessing instructions manuals, and therefore successfully validates the added instructions.

Animal Testing

No animal studies were performed as appropriate verification and validation for the subject device were achieved in accordance with the acceptance criteria for the predicate device and from the results of the bench and usability testing.

Clinical Testing

No clinical studies were performed as appropriate verification and validation for the subject device were achieved in accordance with the acceptance criteria for the predicate device and from the results of the bench and usability 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 an automated microbicidal process is substantially equivalent to the predicate device reprocessed via a manual microbicidal process. Testing also supports that the subject device reprocessed via an automated microbicidal process does not raise any new risks or any new questions in safety or effectiveness compared to the predicate device.

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.