(185 days)
No
The summary describes a robotic navigation system for bronchoscopy that uses CT scans to create a 3D plan and guide a catheter. While it involves sophisticated software for planning and navigation, there is no mention of AI or ML being used for tasks like image analysis, diagnosis, or autonomous decision-making. The system appears to be a master/slave robotic system guided by the physician.
Yes
The device is described as assisting in "diagnostic and therapeutic procedures" and the Flexision™ Biopsy Needle, used with the system, is for "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". The device is for navigating a catheter and tools for diagnostic and therapeutic procedures, and for tissue biopsy, but it does not perform the diagnosis itself.
No
The device description explicitly states that the Ion™ Endoluminal System is a "software-controlled, electromechanical system" and includes 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 Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside the body (in vitro).
- Device Function: The Ion™ Endoluminal System is a robotic-assisted system used for navigating a catheter and tools within the pulmonary tract for diagnostic and therapeutic procedures. It assists in accessing areas of the lung and placing tools like biopsy needles.
- Lack of In Vitro Testing: The description focuses on the system's ability to navigate and assist in procedures inside the body. While it facilitates the collection of tissue samples (biopsies), the device itself does not perform any testing or analysis of these samples in vitro. The biopsy needle is a tool used with the system to collect the sample, but the system's primary function is navigation and access.
- Intended Use: The intended use clearly states it assists in navigation and procedures within the pulmonary tract. It explicitly states it "does not make a diagnosis."
Therefore, the Ion™ Endoluminal System is a medical device used for interventional procedures within the body, not an In Vitro Diagnostic 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 IF1000 Instruments include the Ion™ Fully Articulating Catheter, the Ion™ Peripheral Vision Probe, and the Flexision™ Biopsy Needles.
The Planning Laptop is a separate computer from the System Cart and Controller. A 3D airway model is generated from the patient's chest CT scan using the PlanPoint™ Software.
The System Cart contains the Instrument Arm, electronics for the slave portion of the servomechanism, and two monitors. The System Cart allows the user to navigate the Catheter Instrument with the Controller, which represents the master/slave relationship. For optimal viewing, the physician can position the monitors in both vertical and horizontal axes.
The Controller is the user input device on the Ion™ Endoluminal System. It provides the controls to command insertion, retraction, and articulation of the Catheter. The Controller also has buttons to operate the Catheter control states.
The Catheter Instrument has a tool channel compatible with the Peripheral Vision Probe. Flexision™ Biopsy Needles, and third-party tools. The Vision Probe provides direct visualization of the patient's airways during navigation. Accessories such as the Catheter Guide, Vision Probe Adapter, Suction Adapter, and Swivel Connector facilitate use of the IF1000 Instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
patient's chest CT scan
Anatomical Site
pulmonary tract, tracheobronchial tree, lung
Indicated Patient Age Range
not for pediatric use.
Intended User / Care Setting
qualified physicians, bronchoscopy suite
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
Performance testing data (bench, animal, and cadaver tests) demonstrate that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input requirements. The testing included dimensional measurements. mechanical verification, functional verification, reliability testing, electrical safety, electromagnetic compatibility (EMC), biocompatibility of patient-contacting materials, software verification and validation, and simulated use in animals and cadavers.
Biocompatibility Testing: The patient-contacting components of the Ion™ Endoluminal System, IF1000, are classified in accordance with ISO 10993-1 as external communicating, blood path indirect, with limited contact duration (
§ 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 shows 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 text logo on the right. The text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
February 14, 2019
Intuitive Surgical Sarah Rizk Sr. Regulatory Engineer 1266 Kifer Road Sunnyvale, CA 94086
Re: K182188
Trade/Device Name: Ion Endoluminal System; Flexision Biopsy Needle Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: January 14, 2019 Received: January 15, 2019
Dear Sarah Rizk:
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.
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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 (reporting of medical devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours.
Srinivas Nandkumar -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182188
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.
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: | Sarah Rizk
Senior Regulatory Engineer
Phone Number: 408-.523-6906
Fax Number: 408-523-8907
Email: sarah.rizk@intusurg.com |
| Date Prepared: | August 10, 2018 |
2. DEVICE AND PREDICATE/REFERENCE DEVICES
| 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 Codes: | EOQ |
| Advisory Committee: | Ear, Nose, and Throat |
| Predicate Devices: | Schoelly Video Bronchoscope (K141366) |
| Trade Name: | Flexision™ Biopsy Needle |
| Common Name: | Bronchoscope (flexible or rigid) and accessories |
| Classification: | Class II |
| 21 CFR 874.4680 | |
| Bronchoscope (flexible or rigid) and accessories | |
| Product Codes: | EOQ |
| Advisory Committee: | Ear, Nose, and Throat |
In compliance with FDA Guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]", Intuitive Surgical also included the following as reference devices:
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| 510(k) Number: | K173760 |
|---|---|
| Manufacturer: | Auris Surgical Robotics, Inc. |
| Trade Name: | superDimension™ Navigation System |
| 510(k) Number: | K173244 |
3. 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 IF1000 Instruments include the Ion™ Fully Articulating Catheter, the Ion™ Peripheral Vision Probe, and the Flexision™ Biopsy Needles.
The Planning Laptop is a separate computer from the System Cart and Controller. A 3D airway model is generated from the patient's chest CT scan using the PlanPoint™ Software.
The System Cart contains the Instrument Arm, electronics for the slave portion of the servomechanism, and two monitors. The System Cart allows the user to navigate the Catheter Instrument with the Controller, which represents the master/slave relationship. For optimal viewing, the physician can position the monitors in both vertical and horizontal axes.
The Controller is the user input device on the Ion™ Endoluminal System. It provides the controls to command insertion, retraction, and articulation of the Catheter. The Controller also has buttons to operate the Catheter control states.
The Catheter Instrument has a tool channel compatible with the Peripheral Vision Probe. Flexision™ Biopsy Needles, and third-party tools. The Vision Probe provides direct visualization of the patient's airways during navigation. Accessories such as the Catheter Guide, Vision Probe Adapter, Suction Adapter, and Swivel Connector facilitate use of the IF1000 Instruments.
5
4. 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.
5. TECHNOLOGICAL CHARACTERISTICS
The subject Ion™ Endoluminal System, Model IF1000, and the predicate Schoelly Video Bronchoscope (K141366) are similar in terms of technological characteristics and have fundamentally the same indications for use. Like the Schoelly Video Bronchoscope, the IF1000 System is designed for use in performing bronchoscopy biopsy procedures. Similar technological characteristics include the ability to provide direct visualization of the anatomy, a working channel for endoscopic instruments, and suctioning with a suction adapter accessory. The IF1000 System utilizes electromechanical controls for manipulating the Catheter tip, while the predicate device utilizes solely mechanical controls for manipulating the end of the bronchoscope. Table 1 provides a device comparison between the subject Ion™ Endoluminal System, Model IF1000, and the predicate Schoelly Video Bronchoscope (K141366).
| Table 1: Ion™ Endoluminal System Comparison to Schoelly Video Bronchoscope System | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | ----------------------------------------------------------------------------------- |
| Attribute | Subject Device | Predicate Device |
|---|---|---|
| Ion™ Endoluminal System | Schoelly Video Bronchoscope | |
| System (K141366) | ||
| Attribute | Subject Device | Predicate Device |
| Ion™ Endoluminal System | Schoelly Video Bronchoscope | |
| System (K141366) | ||
| Device Types | System Cart with Instrument Arm | |
| Controller | ||
| Planning Laptop with PlanPoint™ | ||
| Software | ||
| Ion™ Fully Articulating Catheter | ||
| Ion™ Peripheral Vision Probe | ||
| Vision Probe Adapter | ||
| Suction Adapter | ||
| Catheter Guide | ||
| Swivel Connector | ||
| Reprocessing accessory kits (includes | ||
| leakage tester) | Video bronchoscope | |
| Camera Control Unit | ||
| Accessories | ||
| Suction valve/seal accessory | ||
| Leakage tester and reprocessing | ||
| accessories | ||
| Intended Use | To provide visualization of patient | |
| airways. | SAME as subject device | |
| Indications for Use | The Ion™ Endoluminal System 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 Schoelly Video Bronchoscope | |
| System is intended for use by | ||
| physicians for diagnostic and | ||
| therapeutic procedures in | ||
| nasopharyngeal endoscopy, | ||
| bronchoscopy, tracheoscopy, and | ||
| laryngoscopy. The Schoelly Video | ||
| Bronchoscope is intended to provide | ||
| visualization via a video monitor. | ||
| 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 subject device | |
| Tip | Steerable distal tip for control and | |
| manipulation within discrete regions of | ||
| the lung. | SAME as subject device | |
| Method of Distal | ||
| Tip Movement | Electromechanically (servo/stepper | |
| motors and software) controlled pull | ||
| wires. | Manually controlled pull wires. | |
| Steering Method | Robotic master/slave control system with | |
| servo motor/encoder and cable interface. | Joy stick on handle. | |
| Tool Channel | ||
| Diameter | 2 mm | 2.2 mm |
| Attribute | Subject Device | Predicate Device |
| Ion™ Endoluminal System | Schoelly Video Bronchoscope | |
| System (K141366) | ||
| Articulation Range | 180° in all four directions (pitch and yaw) | Up 210°/ down 130° |
| Illumination | ||
| Source | Light-emitting diodes. | SAME as subject device |
| Field of View | 90° | 120° |
| Direction of View | 0° | SAME as subject device |
| Imaging Sensor | CMOS Imaging Sensor | SAME as subject device |
| Duration of | ||
| Visualization | During navigation of Catheter | |
| Instrument, up to the biopsy location. | During navigation of bronchoscope | |
| and biopsy. | ||
| Guided Navigation | 3D guided navigation view on System | |
| Cart. | None | |
| Location Sensing | Located in Catheter Instrument, during | |
| navigation and biopsy. | None | |
| Procedure | ||
| Planning | PlanPoint™ Software converts DICOM | |
| CT scan data into segmented 3D lung | ||
| model. | None | |
| Registration | System directs user to drive Catheter | |
| Instrument for registration | None | |
| Patient Contact | ||
| Materials | Stainless Steel | |
| Silicone | ||
| Pellethane plastic | ||
| PTFE plastic | ||
| Glass | ||
| Polyamide resin | ||
| Pebax elastomer (TPE) | ||
| Polyamide | PEEK | |
| Polyurethane | ||
| PTFE plastic | ||
| Fused silica | ||
| Polyphenylsulfone | ||
| Fiber glass | ||
| Rubber | ||
| Attribute | Subject Device | Predicate Device |
| Flexision™ Biopsy Needle | Arcpoint Pulmonary Needle (K163537) | |
| Intended Use | To retrieve tissue from a target | |
| structure. | SAME as subject device | |
| Principles of | ||
| Operation | Captures sample of tissue for | |
| subsequent diagnosis. | SAME as subject device | |
| 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 Arcpoint pulmonary needle is | |
| utilized through a flexible endoscope or | ||
| with the superDimension Navigation | ||
| System by physicians who are trained for | ||
| retrieving specimens from patients with | ||
| endobronchial lesions, peripheral lung | ||
| nodules or lung masses. | ||
| Anatomical Site | Lung | SAME as subject device |
| Method of | ||
| Introduction | Endobronchial, delivered to the target | |
| through the Fully Articulating Catheter. | SAME as subject device, delivered to the | |
| target through a flexible endoscope or | ||
| superDimension System Extended | ||
| Working Channel. | ||
| Sample Collection | Aspiration with a syringe. | SAME as subject device |
| Sizes | 23G, 21G, and 19G | 21G and 18G |
| Required | ||
| Working Channel | 2 mm | SAME as subject device |
| Needle Tip | Sharp, beveled | SAME as subject device |
| Protrusion Length | 1- 3 cm | 8 mm |
| Shaft Marks | Yes | SAME as subject device |
| Stylet | Yes | SAME as subject device |
| Radiopaque Distal | ||
| End | Yes | SAME as subject device |
| Life/Sterility | Single use, EtO sterilized | SAME as subject device |
| Patient Contact | ||
| Materials | Polyamide | |
| Pebax | ||
| Stainless Steel | Copolyester elastomer polymer | |
| Stainless Steel |
6
7
The subject Flexision™ Biopsy Needle and the predicate Arcpoint Pulmonary Needle, Models ILS-1800-PN and ILS-2100-PN, are similar in terms of technological characteristics and have fundamentally same indications for use. Like the Arcpoint Pulmonary Needle, the Flexision™ Biopsy Needle is designed for retrieving tissue from a target site in the lung. Both the subject and predicate devices use similar means to collect tissue biopsy samples, compatible with the same-sized working channels, and have similar tip geometry. The subject Flexision™ Biopsy Needle differs in needle protrusion length and needle gauge sizes offered. Table 2 provides a device comparison between the subject Flexision™ Biopsy Needle and the predicate Arcpoint Pulmonary Needle (K163537).
8
| Table 2: Flexision™ Biopsy Needle Comparison to Arcpoint Pulmonary Needle (K163537) | ||
|---|---|---|
Results of verification and validation testing demonstrate that the subject devices are equivalent to the predicate devices in terms of safety and effectiveness. Furthermore, the testing did not raise any new risks and did not raise any new safety or effectiveness questions for the subject devices.
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6. PERFORMANCE DATA
Performance testing data (bench, animal, and cadaver tests) demonstrate that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input requirements. The testing included dimensional measurements. mechanical verification, functional verification, reliability testing, electrical safety, electromagnetic compatibility (EMC), biocompatibility of patient-contacting materials, software verification and validation, and simulated use in animals and cadavers.
Biocompatibility Testing
The patient-contacting components of the Ion™ Endoluminal System, IF1000, are classified in accordance with ISO 10993-1 as external communicating, blood path indirect, with limited contact duration (