(57 days)
Not Found
No
The document does not mention AI, ML, or related concepts like deep learning, neural networks, or training/test sets for algorithmic models. The software described focuses on creating 3D plans and navigation pathways from CT scans, which is a common function in image-guided navigation systems and does not inherently require AI/ML.
Yes
The description explicitly states that the device is used 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 intervention.
No
The "Intended Use / Indications for Use" section explicitly states: "It does not make 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, probe, needles), and Accessories. While it includes software (PlanPoint™ Software and System Software), it is not solely software.
Based on the provided information, the Ion™ Endoluminal System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The Ion™ Endoluminal System is described as a system that assists in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization. This is an in vivo procedure (performed inside the body).
- The system's purpose is to facilitate diagnostic and therapeutic procedures within the lung, such as biopsy tissue collection from a target area. While the collected tissue might be used for in vitro diagnostic testing later, the Ion™ system itself is not performing that testing.
- The description explicitly states that the system "does not make a diagnosis". This is a key characteristic of many IVD devices, which are designed to provide diagnostic information.
Therefore, the Ion™ Endoluminal System is a medical device used for in vivo procedures, not an IVD 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
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 IF1000 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 Model IF1000 Instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans
Anatomical Site
pulmonary tract, tracheobronchial tree, lung, airways
Indicated Patient Age Range
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 validation, toxicological risk assessment, and usability testing.
Reprocessing Validation: Automated endoscope reprocessor (AER) equipment were validated to support the automated cleaning process of the Catheter and Vision Probe, to demonstrate the efficacy of the AERs in cleaning 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 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: In order to assess the biological risk to patient contact of the Catheter and Vision Probe from chemical residuals left following the automated cleaning process or reduced rinsing of the existing manual cleaning process, total organic carbon (TOC) testing were performed and evaluated. Testing were performed on the Model IF1000 devices subjected to the automated cleaning process and reduced rinsing of the existing manual process and results analyzed in accordance with ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. All testing were deemed to result in acceptable TOC levels, comparable to the predicate devices.
Bench Testing: No bench testing was performed as the automated cleaning process and reduced rinsing steps of the existing manual cleaning process do not introduce harsher reprocessing chemical or additional mechanical wear to the subject devices requiring additional verification and validation.
Usability Testing: A human factors study was performed to validate the additional instructions added to support the reprocessing instructions manuals updates subject of this submission. The study was conducted in accordance with FDA guidance Applying Human Factors and Usability Engineering to Medical Devices, issued February 3, 2016, and IEC 62366-1:2015/ Amd1:2020 Medical devices – Part 1: Application of usability engineering to medical devices. The study demonstrates that 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 updated instructions.
Animal Testing: No animal studies were performed as the automated cleaning process and reduced rinsing steps of the existing manual cleaning process do not introduce harsher reprocessing chemical or additional mechanical wear to the subject device requiring additional testing.
Clinical Testing: No clinical studies were performed as the automated cleaning process and reduced rinsing steps of the existing manual cleaning process do not introduce harsher reprocessing chemical or additional mechanical wear to the subject device requiring additional testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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".
August 26, 2021
Intuitive Surgical, Inc. Jennifer Siu Sr. Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086
Re: K212048
Trade/Device Name: Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: June 28, 2021 Received: June 30, 2021
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
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 (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/cdrl-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,
Shu-Chen Peng, Ph.D. Assistant Director DHT1C: 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
Enclosure
2
Indications for Use
510(k) Number (if known) K212048
Device Name
Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000); Ion™ Endoluminal System (Ion™ Peripheral Vision Probe) (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 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) |
|---|---|
| ------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------ |
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: | June 28, 2021 |
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 (K201146), cleared on June 26, 2020.
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 IF1000 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 Model IF1000 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 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 K201146. There were no design changes made to the subject devices as a result of the alternative automated cleaning process and reduced rinsing steps of the existing manual cleaning process.
Intuitive is providing an alternative cleaning method and reducing rinsing steps for the current manual cleaning 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 cleaning process and simplify the current manual cleaning process. There are no changes to the subject devices compared to the predicate devices with regard to indications for use, technological characteristics, device materials, clinical utility, or packaging as a result of the alternative automated cleaning process or reduced rinsing steps of the existing manual cleaning process. Table 1 provides a comparison between the subject devices and predicate devices.
| | Predicate Device:
Model IF1000
Catheter & Vision Probe
(K201146) | Subject Device:
Model IF1000
Catheter & Vision Probe
(This Submission) |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Product
Code | EOQ | SAME as predicate |
| | Predicate Device:
Model IF1000
Catheter & Vision Probe
(K201146) | Subject Device:
Model IF1000
Catheter & Vision Probe
(This Submission) |
| 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) 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
Catheter Distal
Tip Movement | Electromechanically (servo/stepper motors
and software) controlled pull wires | SAME as predicate |
| Catheter Tool
Channel
Diameter | 2 mm | SAME as predicate |
| Vision Probe
Illuminating
Source | Light emitting diodes | SAME as predicate |
| Vision Probe
Direction of
View | 0° | SAME as predicate |
| Vision Probe
Field of View* | 90° | 120° |
| Patient Contact
Materials* | Stainless Steel
Silicone
Pellethane plastic
PTFE plastic
Glass
Polyamide resin
Pebax elastomer (TPE)
Polyamide
Cyanoacrylate | Similar to predicate |
| | Predicate Device:
Model IF1000
Catheter & Vision Probe
(K201146) | Subject Device:
Model IF1000
Catheter & Vision Probe
(This Submission) |
| Reusable | Yes | SAME as predicate |
| Requires
Reprocessing | Yes | SAME as predicate |
| Reprocessing
Method | Manual cleaning and manual microbicidal
process
or
Manual cleaning and automated
microbicidal process | Manual cleaning and manual microbicidal
process
or
Manual cleaning and automated
microbicidal process
or
Automated cleaning and automated
microbicidal process |
Table 1. Comparison of Predicate and Subiect Devices
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6
- Note: The Vision Probe's field of view has increased from 90° to 120° for a better view during instrument navigation with minor material changes that do not introduce any new or increased biological risk since clearance of the predicate device under K201146.
Cleaning validation results demonstrate that the subject devices reprocessed via the automated cleaning process and reduced rinsing steps of the existing manual cleaning process are substantially equivalent to the predicate devices reprocessed via the current manual cleaning process. Furthermore, the testing did not raise any new risks or any new questions in terms of safety and effectiveness for the subject devices.
7. Performance Data
The following performance data has been provided in support of the substantial equivalence determination. Testing included reprocessing validation, toxicological risk assessment, and usability testing.
Reprocessing Validation
Automated endoscope reprocessor (AER) equipment were validated to support the automated cleaning process of the Catheter and Vision Probe, to demonstrate the efficacy of the AERs in cleaning 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 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
In order to assess the biological risk to patient contact of the Catheter and Vision Probe from chemical residuals left following the automated cleaning process or reduced rinsing of the existing manual cleaning process, total organic carbon (TOC) testing were performed and evaluated. Testing were performed on the Model IF1000 devices subjected to the automated cleaning process and reduced rinsing of the existing manual process and results analyzed in
7
accordance with ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. All testing were deemed to result in acceptable TOC levels, comparable to the predicate devices.
Bench Testing
No bench testing was performed as the automated cleaning process and reduced rinsing steps of the existing manual cleaning process do not introduce harsher reprocessing chemical or additional mechanical wear to the subject devices requiring additional verification and validation.
Usability Testing
A human factors study was performed to validate the additional instructions added to support the reprocessing instructions manuals updates subject of this submission. The study was conducted in accordance with FDA guidance Applying Human Factors and Usability Engineering to Medical Devices, issued February 3, 2016, and IEC 62366-1:2015/ Amd1:2020 Medical devices – Part 1: Application of usability engineering to medical devices. The study demonstrates that 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 updated instructions.
Animal Testing
No animal studies were performed as the automated cleaning process and reduced rinsing steps of the existing manual cleaning process do not introduce harsher reprocessing chemical or additional mechanical wear to the subject device requiring additional testing.
Clinical Testing
No clinical studies were performed as the automated cleaning process and reduced rinsing steps of the existing manual cleaning process do not introduce harsher reprocessing chemical or additional mechanical wear to the subject device 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 devices reprocessed via an automated cleaning process and reduced rinsing steps of the existing manual cleaning process are substantially equivalent to the predicate devices reprocessed via the current manual cleaning process. Testing also supports that the subject devices reprocessed via an automated cleaning process and reduced rinsing steps of the existing manual cleaning process do not raise any new risks or any new questions in safety or effectiveness for the subject devices.