(88 days)
Not Found
No
The summary does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML-driven devices. The PlanPoint™ Software is described as creating a 3D plan and navigation pathways from CT scans, which is a common function of medical imaging software and does not inherently imply AI/ML.
Yes.
The device's intended use explicitly states it is for "diagnostic and therapeutic procedures" and the Flexision™ Biopsy Needle is used to "biopsy tissue from a target area in the lung," which is a therapeutic action.
No
The "Intended Use / Indications for Use" section explicitly states, "It does not make a diagnosis". While the system assists in procedures for diagnostic purposes (e.g., biopsy), the device itself is not described as making a diagnosis.
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, vision probe, biopsy needles), and Accessories. While it includes software (PlanPoint™ Software and System Software), it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device function: The Ion™ Endoluminal System is a robotic-assisted bronchoscopy system used for navigating a catheter and tools within the pulmonary tract for diagnostic and therapeutic procedures, including biopsy. It assists in the collection of a sample (biopsy), but it does not analyze the sample or provide diagnostic information based on the sample itself.
- Intended Use: The intended use clearly states it assists in navigation and enables fiducial marker placement. It explicitly states "It does not make a diagnosis".
- Components: The components described are for navigation, visualization, and sample collection (biopsy needle), not for analyzing biological samples.
- Performance Studies: The performance studies focus on reprocessing, biocompatibility, bench testing of the physical components, and usability, not on the analytical performance of a diagnostic test.
While the system is used in diagnostic procedures (like obtaining a biopsy), the system itself is a surgical/interventional device that facilitates the procedure, rather than an IVD that analyzes a sample to provide diagnostic information. The biopsy sample collected by the Flexision™ Biopsy Needle would then be sent to a laboratory for in vitro analysis (histology, pathology, etc.), which would be the IVD part of the overall diagnostic process.
N/A
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.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
patient CT scans
Anatomical Site
pulmonary tract
Indicated Patient Age Range
It does not make a diagnosis and is not for pediatric use.
Intended User / Care Setting
qualified physicians
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)
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.
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 safely and effectively while following the reprocessing instructions manuals, and therefore successfully validates the added instructions.
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.
Not Found
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The text reads "U.S. FOOD & DRUG ADMINISTRATION".
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
1
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
2
Indications for Use
510(k) Number (if known) K192367
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)
| 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 Road
Sunnyvale, CA 94086 |
|---------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact: | Jennifer Siu
Senior Regulatory Affairs Specialist
Tel: (408) 523-5372
Email: 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 II |
| 21 CFR §874.4680 | |
| 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 (K182188), cleared on February 14, 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 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 IF1000
Catheter & Vision Probe
(K182188) | Subject Device:
Model IF1000
Catheter & 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 IF1000
Catheter & Vision Probe
(K182188) | Subject Device:
Model IF1000
Catheter & Vision Probe
(This Submission) | |
| Intended Use | To provide visualization of patient
airways | SAME as predicate | |
| 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 | SAME as predicate | |
| Principles of Operation | 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 | SAME as predicate | |
| Method of Distal Tip
Movement | Electromechanically (servo/stepper
motors and software) controlled
pull wires | SAME as predicate | |
| Tool Channel Diameter | 2 mm | SAME as predicate | |
| Patient Contact
Materials | Stainless Steel
Silicone
Pellethane plastic
PTFE plastic
Glass
Polyamide resin
Pebax 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 process
or
Automated microbicidal process | |
Table 1. Comparison of Predicate and Subject Devices
5
Verification and validation testing results demonstrate that the subject device reprocessed via the automated microbicidal process is substantially equivalent to the predicate device
6
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
7
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.