← Product Code [EOQ](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ) · K182188
# Ion Endoluminal System ; Flexision Biopsy Needle (K182188)
_Intuitive Surgical · EOQ · Feb 14, 2019 · Ear, Nose, Throat · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K182188
## Device Facts
- **Applicant:** Intuitive Surgical
- **Product Code:** [EOQ](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ.md)
- **Decision Date:** Feb 14, 2019
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.4680
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat
- **Attributes:** Therapeutic
## Intended Use
To provide access to and visualization of patient airways.
## Device Story
Ion™ Endoluminal System is a software-controlled, electromechanical robotic system for pulmonary navigation and biopsy. Input: patient chest CT scans processed by PlanPoint™ Software to generate 3D airway models and navigation pathways. Operation: physician uses a master controller to manipulate a fully articulating catheter via a slave servomechanism; system provides real-time endoscopic visualization via a peripheral vision probe. Output: visual guidance on system monitors; biopsy samples collected via Flexision™ Biopsy Needle. Used in clinical settings (bronchoscopy suite) by physicians. System assists in reaching target areas in the lung for diagnostic/therapeutic procedures, including fiducial marker placement. Benefits include enhanced navigation and access to peripheral lung nodules compared to manual bronchoscopy.
## Clinical Evidence
No human clinical trials. Evidence consists of bench testing (dimensional, mechanical, electrical safety, EMC, biocompatibility, software V&V), animal studies (safety, performance, accuracy in live models), and cadaver studies (anatomical access and reach). Human factors summative validation conducted in simulated bronchoscopy suites to evaluate high-risk use scenarios and essential tasks.
## Technological Characteristics
Electromechanical robotic system; master/slave control architecture. Materials: stainless steel, silicone, Pellethane, PTFE, glass, polyamide, Pebax. Imaging: CMOS sensor, LED illumination. Connectivity: Planning laptop (separate) and system cart. Sterilization: EtO for needles; reprocessing for reusable instruments. Software: PlanPoint™ 3D planning and system control software.
## Regulatory 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.
## Predicate Devices
- Schoelly Video Bronchoscope ([K141366](/device/K141366.md))
- Arcpoint Pulmonary Needle ([K163537](/device/K163537.md))
## Reference Devices
- superDimension™ Navigation System ([K173760](/device/K173760.md))
- superDimension™ Navigation System ([K173244](/device/K173244.md))
## Submission Summary (Full Text)
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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.
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# 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 |
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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).
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| | 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 (<24 hrs). The biocompatibility evaluation of patient-contacting components was conducted in accordance with the following guidance and standard:
- FDA Guidance: "Use of International Standard ISO-10993, "Biological . Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process." June 2016
- ISO 10993-1: Biological evaluation of medical devices ●
All direct and indirect patient-contacting components of the Ion™ Endoluminal System underwent cytotoxicity, intracutaneous irritation, sensitization and/or acute systemic toxicity testing in accordance to ISO 10993-5. ISO 10993-10 and ISO 10993-11. Biocompatibility testing was performed by a third party laboratory in compliance with Good Laboratory Practices (GLP).
# Reprocessing/Sterilization/Packaging/Shelf Life Testing
Cleaning, disinfection, sterilization, and packaging/shelf life testing was conducted for the Ion™ Endoluminal System (IF1000) subsystems, Instruments, and Accessories. Testing was performed in accordance with the following standards and guidances:
- . AAMI TIR30: 2011 A Compendium Of Processes, Materials, Test Methods, And Acceptance Criteria For Cleaning Reusable Medical Devices
- . AAMI TIR12:2010: Technical Information Report - Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers
- AAMI/ANSI/ISO 17665-1:2006 /(R)2013: Sterilization of health care products Moist . heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- AAMI/ANSI ST79:2017: Comprehensive guide to steam sterilization and sterility ● assurance in health care facilities
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- ANSI/AAMI/ISO 11135:2014: Sterilization of health care products Ethylene oxide -. Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 10993-7:2008/(R)2012: Biological evaluation of medical devices Part 7 Ethylene . oxide sterilization residuals
- . ANSI/AAMI/ISO 11737-1:2006/(R)2011: Sterilization of health care products -Microbiological methods-Part 1: Determination of the population of microorganisms on product
- ANSI/AAMI/ISO 11737-2:2009/(R)2014: Sterilization of medical devices -Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- . AAMI TIR28:2009 Product Adoption and Process Equivalence for Ethylene Oxide Sterilization
- . FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (March 17, 2015)
- FDA Guidance: Submission and Review of Sterility Information in Pre-Market ● Notification 510(k) Submissions for Device Labeled as Sterile (January 21, 2016)
- AAMI ST72:2011/(R)2016 Bacterial Endotoxins Test Methods, Routine Monitoring, . And Alternatives To Batch Testing
- FDA Guidance: Pyrogen and Endotoxins Testing: Questions and Answer (June 2012) ●
- ASTM D4169:2016: Standard Practice for Performance Testing of Shipping Containers ● and Systems
- ISO 11607-1: 2006/Am1:2014: Packaging for terminally sterilized medical devices, Part 1: Requirements for materials, sterile barrier systems and packaging systems
- . ASTM F88/F88M:2015: Standard Test Method for Seal Strength of Flexible Barrier Materials
- . ASTM D4332:2014: Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
- . ASTM F1980:2016: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Device
- ASTM F1140/F1140M-13: Standard Test Methods for Internal Pressurization Failure . Resistance of Unrestrained Packages
# EMC and Electrical Safety Testing
The Ion™ Endoluminal System was tested for electrical safety and EMC, including coexistence testing, and complies with IEC 60601-1, IEC 60601-2-18, and IEC 60601-1-2.
# Software Verification and Validation
Software for the Ion™ Endoluminal System underwent software verification and validation testing and results demonstrate that the System meets design specifications and user needs. Software documentation has been provided according to FDA's Guidance for
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Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005.
#### Bench Testing
The Ion™ Endoluminal System, Instruments, and Accessories were subjected to full design verification. A summary of the design verification testing for the System Cart and the Controller is listed below:
| Component | Testing |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System Cart | Bench testing was performed in order to confirm that the design outputs for
the System Cart met the design input requirements. Testing was also
performed to confirm that the requirements regarding EMC, electrical
safety, software, and disinfection had been met. |
| Controller | Bench testing was performed in order to confirm that the design outputs for
the Controller met the design input requirements. Testing was also
performed to confirm that the requirements regarding EMC, electrical
safety, software, and disinfection had been met. |
The Planning Station and PlanPoint™ Software were subjected to full design verification. A summary of the design verification testing for the Planning Station is listed below:
| Component | Testing |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Planning Station | Bench testing was performed in order to confirm that the design outputs for
the Planning Station met the design input requirements. Testing was also
performed to confirm that the requirements regarding software had been
met. |
Testing was performed on each instrument type to verify that the design meets physical, mechanical, user interface, and equipment interface requirements. A summary of the design verification testing for the IF1000 Instruments is described below:
| Component | Testing |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fully Articulating
Catheter | Verification testing was performed to evaluate design specifications such
as physical, mechanical, electrical, and equipment interface requirements.
Testing was also performed to confirm that the requirements regarding
biocompatibility, packaging, cleaning, disinfection validation, and use life
had been met. |
| Peripheral Vision Probe | Verification testing was performed to evaluate design specifications such
as physical, mechanical, electrical, and equipment interface requirements.
A Modulation Transfer Function Analysis was performed to characterize
the Vision Probe's optical performance. Testing was also performed to
confirm that the requirements regarding biocompatibility, packaging,
cleaning, disinfection validation, and use life had been met. |
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| Flexision™ Biopsy
Needles | Verification testing was performed to evaluate design specifications such
as physical, mechanical, electrical, and equipment interface requirements.
Testing was also performed to confirm that the requirements regarding
biocompatibility, packaging, and sterilization validation had been met. |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
A summary of the design verification testing for the IF1000 Accessories is described below:
| Component | Testing |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catheter Guide | Verification testing was performed to evaluate design specifications such
as physical, mechanical, electrical, and equipment interface requirements.
Testing was also performed to confirm that the requirements regarding
biocompatibility, packaging, cleaning, sterilization validation, and use life
had been met. |
| Vision Adapter
Suction Adapter
Swivel Connector | Verification testing was performed to evaluate design specifications such
as physical, mechanical, electrical, and equipment interface requirements.
Testing was also performed to confirm that the requirements regarding
biocompatibility, packaging, and sterilization validation. |
#### Animal and Cadaver Testing
Animal and cadaver testing was performed under simulated use conditions to evaluate safety or performance of the Ion™ Endoluminal System according to its intended use. Cadavers were used to demonstrate clinical performance for anatomical access and reach within the human lung anatomy. Live animal models were used to assess safety, performance and accuracy in cases where a living tissue model was appropriate. These models replicate factors experienced during clinical use, including working with respiration, bleeding, and normal tissue handling. Animal and cadaver testing demonstrated the Ion™ Endoluminal System can be used safely and effectively according to its intended use with no new risks identified.
#### Human Factors Evaluation
A human factors (HF) engineering process was followed in accordance with the following:
- . ANSI/AAMI/IEC 62366-1:2015, Medical devices - Application of usability engineering to medical devices
- . FDA Guidance: "Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff," 2016
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A summative validation study was conducted to evaluate high-risk use scenarios and essential tasks that were not assessed in previous usability validations. This study was conducted by intended user groups in a simulated bronchoscopy suite and involved preoperative preparation and simulated procedures, as well as emergency procedures that involved safety-critical tasks. Training materials and user manuals were developed in concert with the product hardware and software. and were assessed in the validation study.
The Ion™ Endoluminal System has been assessed and found to be safe and effective for its intended use, by the intended users, in its intended use environment.
#### 7. CONCLUSION
Based on the intended use, indications for use, technological characteristics and performance testing, the Ion™ Endoluminal System and the Flexision™ Biospy Needle are substantially equivalent (SE) to the predicate devices. This SE determination is based on bench testing including reliability testing, animal/cadaver validation, simulated clinical procedures in live animals, and human factors assessment. The bench/reliability testing verified that the design requirements and specifications have been met. The animal/cadaver validation provided clinical validation that the system can be used to safely and effectively complete the procedures encompassed by the indications for use statement. Finally, the human factors assessment provided further assurance that risks due to user errors have been identified and mitigated.
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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K182188](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K182188)
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