(246 days)
Not Found
No
The summary describes a robot-assisted surgical system controlled by an operator, with no mention of AI or ML capabilities for image analysis, decision support, or autonomous functions.
No
The device is described as providing "robot-assisted visualization and surgical site access" and "accessory channels for compatible flexible instruments." While it facilitates surgery, it does not directly perform a therapeutic action itself; it's a tool for the surgeon.
No
This device is described as a robot-assisted system for surgical site access and visualization, providing channels for surgical instruments. Its purpose is to assist in surgical procedures by providing access and visualization, not to diagnose medical conditions.
No
The device description explicitly mentions hardware components like a flexible scope, a digital camera, and accessory channels for instruments. The performance studies also detail testing related to mechanical requirements, electrical safety, and biocompatibility of patient-contacting materials, all indicative of a physical device with hardware. While software is mentioned and verified, it is part of a larger robotic system that includes hardware.
Based on the provided information, the Medrobotics Flex® System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "robot-assisted visualization and surgical site access to the oropharynx, hypopharynx, and larynx" and provides "accessory channels for compatible flexible instruments used in surgery." This describes a surgical tool for direct visualization and manipulation within the body.
- Device Description: The description reinforces this by detailing a "flexible scope" with a camera and accessory channels for instruments.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The Flex System operates inside the body for surgical procedures.
- Performance Studies: The performance studies focus on aspects relevant to surgical devices, such as electrical safety, biocompatibility, sterilization, and usability in a surgical setting. There are no mentions of studies related to analyzing biological samples or diagnostic accuracy based on such analysis.
Therefore, the Medrobotics Flex® System is a surgical robotic system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Medrobotics Flex® System is a device that is intended for robot-assisted visualization and surgical site access to the oropharynx, hypopharynx, and larynx in adults (≥ 22 years of age). The Flex System also provides accessory channels for compatible flexible instruments used in surgery.
Product codes (comma separated list FDA assigned to the subject device)
EOB, EOX, GCI
Device Description
The Flex® Robotic System is an operator-controlled flexible scope that provides the benefits of both a rigid endoscope and a computer assisted controller. The Flex® Robotic System allows for the scope to be introduced via an operator-controlled user interface easily providing visualization and access of structures within the oropharynx and hypopharynx and larynx. Visualization is provided by a HD 2D/3D digital camera attached at the distal end of the scope. The Flex Robotic System's scope also provides two accessory channels for use of varied flexible instruments.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CMOS based video endoscope
Anatomical Site
oropharynx, hypopharynx, and larynx
Indicated Patient Age Range
adults (≥ 22 years of age)
Intended User / Care Setting
Not Found
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 Flex® Robotic System has been subjected to and successfully tested for function, performance, and safety as per FDA-recognized standards IEC 60601-1 and IEC 60601-1-2, and biocompatibility and toxicity of the patient contacting materials per ISO-10993-1. It has been tested and met acceptance criteria per FDA-recognized standards for the establishment of shelf life, shipping, and validated for sterility by ETO and moist heat to a SAL of 10-6. Processes by which the user may clean and sterilize certain reusable components have been validated in accordance with FDA-recognized standards.
Bench Testing performed:
- Reliability Testing
- Vision and Video Subsystem and System Testing
- Subsystem and System Software Verification and Validation Testing
- Reusable Camera Testing
- Ship Testing
- Mechanical Requirements Testing
- Safety Subsystem Testing
- System Electrical and Board Requirements Testing
Software: Medrobotics followed the FDA guidance document, "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices May 11, 2005," to classify the Flex Robotic System software as a "moderate level of concern." The software was verified and validated, and the software verification and validation documents were prepared and presented in accordance with FDA's guidance document.
Ship Testing: Testing was performed per applicable ISTA standards to demonstrate that all modified components of the Flex Robotic System could withstand anticipated shipping conditions.
Usability/Human Factors Testing: Medrobotics performed usability and human factors testing of the Flex Robotic System in accordance with FDA Guidance Document "Applying Human Factors and Usability Engineering to Medical Devices" (February 3, 2016) and Wiklund's Usability Testing of Medical Devices. The testing demonstrated that the Flex® Robotic System design meets the intended user requirements and facilitates safe and effective user interactions.
Electrical Safety: Tested to demonstrate electrical safety and compliance with IEC 60601-1 Ed: 3.1, ANSI/AAMI ES60601-1:2005/(R)2012, IEC 60601-1-6: 2010, IEC 62366: 2007, IEC 60601-1-4: 2000.
Electromagnetic Compatibility Testing: Tested and determined to be in compliance with EN 60601-1-2:2007/AC:2010 and IEC 60601-1-2, Ed. 3.0.
Biocompatibility: Biocompatibility testing was performed in accordance with ANSI/AAMI/ISO/EN 10993-1:2009 and FDA Guidance Document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'" (June 2016) for patient contacting parts (Flex Drive and Flex Camera).
Sterilization, Packaging, and Shelf Life for Single Use Flex® Drive: Sterilized via ethylene oxide (EtO) to a sterility assurance level (SAL) of 10-6 in accordance with ANSI/AAMI/ISO 11135-1:2007, ANSI/AAMI/ISO TIR 11135-2:2008, AAMI TIR 28:2009, and ANSI/AAMI/ISO/EN 10993-7:2008. Functional testing demonstrated stability over labeled shelf life.
Cleaning and Sterilization of Reusable System Components (Flex® Camera and Flex® Instrument Support): Validated in accordance with AAMI TIR12:2010, AAMI TIR30:2011, EN ISO 17664:2004, ANSI/AAMI ST81:2004/(R)2010, ISO TS 15883-5:2005, ANSI/AAMI ST77:2013, ANSI/AAMI ST79:2010, ANSI/AAMI/ISO 14937:2009, ANSI/AAMI/ISO 17665-1:2006, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, and ISO 17665-2:2009.
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
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, 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 and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.
October 19, 2017
Medrobotics Corporation John D. Bonasera Vice President of Clinical, Regulatory and Quality Affairs 475 Paramount Drive Raynham, MA 02767
Re: K170453
Trade/Device Name: Medrobotics Flex® Robotic System Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOB. EOX. GCI Dated: September 14, 2017 Received: September 15, 2017
Dear John D. Bonasera:
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. 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.
1
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Eric A. Mann -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
2
Indications for Use
510(k) Number (if known) K170453
Device Name Medrobotics Flex Robotic System
Indications for Use (Describe)
The Medrobotics Flex® System is a device that is intended for robot-assisted visualization and surgical site access to the oropharynx, hypopharynx, and larynx in adults (≥ 22 years of age). The Flex System also provides accessory channels for compatible flexible instruments used in surgery.
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) |
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TRADITIONAL 510(K) SUMMARY
Flex® Robotic System
This Summary of the Traditional 510(k) Substantial Equivalence Information is being submitted in accordance with the requirements of 21 CFR 807.92. All data included in this document is accurate and complete to the best of Medrobotics' knowledge.
| Submitter Name | Medrobotics Corporation |
|---|---|
| Submitter Address | 475 Paramount Drive |
| Raynham, MA 02767 | |
| Contact Person | John D. Bonasera |
| Vice President of Clinical, Regulatory, and Quality Affairs | |
| Phone Number | 508-692-6460 |
| Fax Number | 508-823-1703 |
| Date Prepared | October 18, 2017 |
| Device Trade Name | Flex® Robotic System |
| Device Common Name | Nasopharyngoscope (flexible or rigid) |
| Product Code | EOB |
| Classification | The Medrobotics Flex System has been classified as Class II |
| according to 21 C.F.R. §874.4760 | |
| Predicate Devices | The Medrobotics Flex® System, K150776. |
| Device Description | The Flex® Robotic System is an operator-controlled flexible scope |
| that provides the benefits of both a rigid endoscope and a computer | |
| assisted controller. The Flex® Robotic System allows for the | |
| scope to be introduced via an operator-controlled user interface | |
| easily providing visualization and access of structures within the | |
| oropharynx and hypopharynx and larynx. Visualization is provided | |
| by a HD 2D/3D digital camera attached at the distal end of the | |
| scope. The Flex Robotic System's scope also provides two | |
| accessory channels for use of varied flexible instruments. | |
| Intended Use | The Medrobotics Flex® System is a device that is intended for |
| robot-assisted visualization and surgical site access to the | |
| oropharynx, hypopharynx, and larynx in adults (≥ 22 years of age). | |
| The Flex System also provides accessory channels for compatible | |
| flexible instruments used in surgery. | |
| Substantial Equivalence | The Medrobotics Flex® Robotic System is substantially equivalent |
| to the predicate device the Medrobotics® Flex System. | |
| Summary of Performance | |
| Testing | The Flex® Robotic System has been subjected to and successfully |
| tested for function, performance, and safety as per FDA- | |
| recognized standards IEC 60601-1 and IEC 60601-1-2, and | |
| biocompatibility and toxicity of the patient contacting materials per | |
| ISO-10993-1. It has been tested and met acceptance criteria per | |
| FDA-recognized standards for the establishment of shelf life, | |
| shipping, and validated for sterility by ETO and moist heat to a | |
| SAL of 10-6. Processes by which the user may clean and sterilize | |
| certain reusable components have been validated in accordance | |
| with FDA-recognized standards. Summaries of this testing are | |
| provided below. |
4
Bench Testing
The following verification and/or validation testing was performed to confirm that the Flex Robotic System, as a whole, and its components met their performance specifications:
- Reliability Testing ●
- Vision and Video Subsystem and System Testing ●
- Subsystem and System Software Verification and Validation Testing ●
- Reusable Camera Testing
- Ship Testing
- Mechanical Requirements Testing
- Safety Subsystem Testing ●
- System Electrical and Board Requirements Testing ●
Software
Medrobotics followed the FDA guidance document, "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices May 11, 2005," to classify the Flex Robotic System software as a "moderate level of concern." The software was verified and validated, and the software verification and validation documents were prepared and presented in accordance with FDA's guidance document.
5
Ship Testing
Testing was performed per applicable ISTA standards to demonstrate that all modified components of the Flex Robotic System could withstand anticipated shipping conditions.
Usability/Human Factors Testing
Medrobotics performed usability and human factors testing of the Flex Robotic System. Such testing was performed in accordance with FDA Guidance Document "Applying Human Factors and Usability Engineering to Medical Devices" (February 3, 2016). In addition, Wiklund's Usability Testing of Medical Devices was used as a reference.
This testing assessed the performance of the Flex® Robotic System when used by representative end users (i.e., surgeons and nurses/technicians) in accordance with the instructions for use after having been trained on how to use the system. The testing demonstrated that the Flex® Robotic System design meets the intended user requirements and facilitates safe and effective user interactions.
Electrical Safety
The Flex® Robotic System has been tested to demonstrate electrical safety and compliance with:
- IEC 60601-1 Ed: 3.1, Medical Electrical Equipment, Part 1: General Req. for Safety
- ANSI/AAMI ES60601-1:2005/(R)2012, Issued: 2012/01/17, Medical electrical ● equipment - Part 1: General requirements for basic safety and essential performance with C1:2009/(R)2012 and A2:2010/(R)2012
- IEC 60601-1-6: 2010. Edition 3.0. Version: 2010/01/27. Medical electrical ● equipment - Part 1- 6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 62366: 2007, Edition 1.0, Issued: 2007/10/18, Ed. 1, Medical Devices – Application Of Usability Engineering To Medical Devices
- IEC 60601-1-4: 2000, Edition 1.1, Issued 2000/04/01, Medical electrical systems -● Part 1- 4: General requirements for safety - Collateral standard: Programmable electrical medical systems
Electromagnetic Compatibility Testing
The Flex® Robotic System was tested and determined to be in compliance with:
- EN 60601-1-2:2007/AC:2010, Electromagnetic emissions and immunity requirements for medical electrical equipment - Group 1 Equipment, Class A for non-life supporting equipment
6
- . IEC 60601-1-2, Ed. 3.0, Electromagnetic emissions and immunity requirements for medical electrical equipment - Group 1 Equipment, Class A for non-life supporting equipment
Biocompatibility
The Flex® Drive and Flex Camera contains the patient contacting portions of the Flex® Robotic System. In accordance with ANSI/AAMI/ISO/EN 10993-1:2009, and the modified matrix in FDA Guidance Document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'" (June 2016), the Flex Drive and Flex Camera is classified as "external communicating device," in contact with "tissue/bone/dentin" and "limited exposure" (≤24 hours). Biocompatibility testing was performed in accordance with the standard and guidance or a rationale for not testing was provided for all patient contacting components.
Sterilization, Packaging, and Shelf Life for Single Use Flex® Drive
The Flex® Drive is supplied sterile and is a single use device. The Flex® Drive is sterilized via ethylene oxide (EtO). The EtO cycle has been validated to a sterility assurance level (SAL) of 10-6, in accordance with the following standards:
- ANSI/AAMI/ISO 11135-1:2007, Sterilization of health care products Ethylene ● Oxide – Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
- ANSI/AAMI/ISO TIR 11135-2:2008, Sterilization of health care products -Ethylene Oxide - Part 2: Guidance on the application of ANSI/AAMI/ISO 11135-1
- AAMI TIR 28:2009. Product adoption and process equivalence for ethylene oxide sterilization
- ANSI/A AMI/ISO/EN 10993-7:2008. Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals
Functional testing has been performed to demonstrate the Flex Drive is stable over the labeled shelf life.
Cleaning and Sterilization of Reusable System Components
The Flex Robotic System includes reusable components, the Flex® Camera and Flex® Instrument Support which are provided non-sterile. These components are intended to be cleaned and sterilized before each use. The recommended cleaning and sterilization instructions were validated in accordance with the following standards:
- . AAMI TIR12:2010, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
- AAMI TIR30:2011. A compendium of processes. materials, test methods, and ● acceptance criteria for cleaning reusable medical devices
7
- EN ISO 17664:2004, Sterilization of medical devices Information to be provided ● by the manufacturer for the processing of resterilizable medical devices
- ANSI/AAMI ST81:2004/(R)2010, Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
- ISO TS 15883-5:2005, Washers-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy
- . ANSI/AAMI ST77:2013, Containment devices for reusable medical device sterilization
- ANSI/AAMI ST79:2010, A1:2010, A2:2011, A3:2012, A4: 2013, (R)2014 -● Comprehensive guide to steam sterilization and sterility assurance in health care facilities
- ANSI/AAMI/ISO 14937:2009. Sterilization of health care products – General requirements for characterization of sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices
- ANSI/A AMI/ISO 17665-1:2006, Sterilization of health care products - Moist heat -Requirements for the development, validation and routine control of sterilization process for medical devices
- . Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Document issued on March 17, 2015, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluations
- ISO 17665-2:2009, Sterilization of health care products - Moist heat - Part 2: Guidance of the application of ISO 17665-1
Conclusion
Based on the indications for use, performance testing, pre-clinical study data and technological characteristics, the Medrobotics modified Flex® Robotic System been shown to be as safe and effective for its stated intended use as the predicate device, Medrobotics Flex System, to which substantial equivalence is claimed.
8
Technological Characteristics
| Device Name | PROPOSED
Flex Robotic System
[K170453] | PREDICATE
Flex System [K150776] | Similarities and Differences |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operational Principles | Cable steered CMOS based video
endoscope using electromechanical
controls to traverse three-dimensional
space without external support due to its
articulated segment technology and the
ability to alternate from a flexible to
rigid state. The system is driven from a
console based computer controlled
physician handle. | Cable steered CMOS based video endoscope
using electromechanical controls to traverse
three-dimensional space without external
support due to its articulated segment
technology and the ability to alternate from a
flexible to rigid state. The system is driven
from a console based computer controlled
physician handle. | Same. The Flex Robotic System and the
predicate are both cable steered endoscopes
which traverse three-dimensional space
without external support due to its
articulated segment technology and the
ability to alternate from a flexible to rigid
state. Both the Flex Robotic System and the
predicate use electromechanical controls to
aid steering. Both are driven from a console
based computer controlled physician handle. |
| Anatomical Access | Trans-oral access is gained through use
of a retractor | Trans-oral access is gained through use of a
retractor | Same. The Flex Robotic System and the
predicate Flex System require use of a
retractor to gain entry to the anatomy. |
| Access for Compatible
Instruments | Compatible flexible instruments through
accessory channels on the Flex Drive | Compatible flexible instruments through
accessory channels on the Flex Drive | Same. The proposed and predicate systems
both allow for use of compatible flexible
instruments through the scope instrument
channels. |
| Scope Rigidity | Flexible / Semi-Rigid endoscope | Flexible / Semi-Rigid endoscope | Same. The proposed and predicate devices
are both flexible / semi-rigid endoscopes. |
| Advance/retract | Electromechanically aided with
physician controller on console | Electromechanically aided with physician
controller on console | Same. The Flex Robotic System and the
predicate Flex System are advanced and
retracted with the assistance of
electromechanical controls driven by the
physician controller on the console. |
| Device Name | PROPOSED
Flex Robotic System
[K170453] | PREDICATE
Flex System [K150776] | Similarities and Differences |
| Steering | Electromechanical joystick controls (the
Physician Controller) on a console aid
steering | Electromechanical joystick controls (the
Physician Controller) on a console aid
steering | Same. The Flex Robotic System and
predicate Flex System utilize the identical
physician controller. |
| Direct Visualization | Yes, during entire procedure in 2D. 3D
visualization is an option that can be
enabled by the user. | Yes, during entire procedure in 2D | Similar. The Flex Robotic System and the
predicate allow the physician to maintain
direct visualization of the anatomy of
interest during the entire procedure in 2D.
The option of selecting 3D demonstrated in
user testing is a minor difference that does
not raise new or different questions of safety
or effectiveness |
| Multi-Segmented
Endoscope Structure | Yes | Yes | Same. The Flex Robotic System and the
predicate are both multi-segmented
structures. |
| Semi-rigid follow the
leader / guiding
function | Yes | Yes | Same |
| Electromechanically
cable driven /
controlled segments | Yes | Yes | Same |
| 3D flexible movements
and tip orientation | Yes | Yes | Same |
| Device Name | PROPOSED
Flex Robotic System
[K170453] | PREDICATE
Flex System [K150776] | Similarities and Differences |
| Haptic feedback to
user | Yes | Yes | Same. The Flex Robotic System and the
Flex System both provide haptic feedback to
the user when the scope reaches the limits of
the pre-defined (by the system
specifications) workspace. |
| Fluid Lumen | Yes | Yes | Same |
| Working Channel(s) | Yes 4.7 mm in diameter | Yes 4.7 mm in diameter | Same |
| View optics / Optical
Sensor | Two Glass Lens
Two Solid State CMOS sensors with
1920x1080 resolution | One Glass Lens
One Solid State CMOS sensor with
1280x720 resolution | Similar. The proposed camera incorporates
two Solid State CMOS sensors with higher
resolution and two glass lens assemblies that
provide a minimum resolvable feature size
to 40um.
The predicate camera incorporates one Solid
State CMOS sensor and one glass lens
assembly that provide a minimum resolvable
feature size to 70um.
The camera performance and reliability
testing that was executed, demonstrates that
this minor difference does not raise new or
different questions of safety or effectiveness |
| Device Name | PROPOSED
Flex Robotic System
[K170453] | PREDICATE
Flex System [K150776] | Similarities and Differences |
| Light Source | 4 LEDs, 2 located above the lens
assemblies and 2 located below the lens
assemblies | 6 LEDs, All LEDs are located above the lens
assembly | Similar. The proposed Flex Robotic System
has updated the quantity and location of the
LEDs in the camera to provide a more
consistent illumination. The LEDs and light
output are identical between the two
systems.
The illumination performance testing that
was executed demonstrates that this minor
difference does not raise new or different
questions of safety or effectiveness |
| Device Name | PROPOSED
Flex Robotic System
[K170453] | PREDICATE
Flex System [K150776] | Similarities and Differences |
| Real Time Video | 2D Video Data Display
User selectable 3D visualization | 2D Video Data Display | Similar.
The proposed system includes an option for
the user to select either a 2D and/or a 3D
visualization mode.
The user testing demonstrates that the option
of selecting 3D is a minor difference that
does not raise new or different questions of
safety or effectiveness |
| Device Name | PROPOSED
Flex Robotic System
[K170453] | PREDICATE
Flex System [K150776] | Similarities and Differences |
| Camera Housing | Stainless Steel construction with
transparent windows. Windows are
placed in front of the LEDs to allow
light to pass through the camera
housing. A window is also placed in
front of the lens assemblies to ensure
that the camera can remain sealed
during the sterilization process. | Ultem construction with a transparent
window. The window is located in front of
the LEDs to allow light to pass through the
camera housing. The lens does not sit behind
a transparent window, instead, it protrudes
through the distal end of the housing. | Similar.
Same:
· Both housings contain electronics and
sensor to enable a distally mounted
camera
· Both housings are sealed to prevent
ingress of fluid
Differences:
· Proposed camera has transparent
windows located in front of the lens
assemblies while the predicate Flex
Camera lens assembly protrudes from the
distal side of the Flex Camera. This
ensures that the camera housing can
remain sealed for sterilization purposes
and this design also isolates the imaging
window from the illumination windows
so no stray light from the illumination
LEDs pass into the video, reducing
contrast of the video.
The camera performance, reliability,
sterilization and biocompatibility testing
demonstrate that this minor difference does
not raise new or different questions of safety
or effectiveness |
| Device Name | PROPOSED
Flex Robotic System
[K170453] | PREDICATE
Flex System [K150776] | Similarities and Differences |
| Vision Electronics | 2 printed circuit board assemblies to
enable the passing of video data | 2 printed circuit board assemblies to enable
the passing of video data | Similar.
Same:
• Both proposed and predicate systems
have 2 printed circuit boards responsible
for processing, transmitting, and
displaying live video
• Both proposed and predicate systems
have been designed and tested to conform
to IEC60601-1 Edition 3.1 (2012)
Differences:
• Proposed system uses a ruggedized
external connector to connect the camera
cable to the Flex Base while the existing
system used an integrated board level
connector
• Proposed system uses cable harnesses
instead of mating connectors in the Flex
Base. This design enables the
transmission of high speed signals while
maintaining signal integrity.
• Proposed system uses a different data
protocol to transmit the video data from
the camera to the first video board. This is
a design requirement of the updated
imaging sensors described above.
The vision performance testing that was
executed demonstrates that these minor
differences do not raise new or different
questions of safety or effectiveness |
| Device Name | PROPOSED
Flex Robotic System
[K170453] | PREDICATE
Flex System [K150776] | Similarities and Differences |
| Graphical User
Interface | Touchscreen based interface located on
the Flex Console Monitor | Touchscreen based interface located on the
Flex Console Monitor | Similar.
Same:
• Both systems provide 2D visualization on
the Flex Console Monitor
• Both systems provide a touchscreen
interface to control system settings and
preferences
• Both systems display information and
error messages in identical ways
• Both systems have the same controls for
driving modes, robot control and robot
feedback
Differences:
• Proposed system has the ability to switch
between 2D and 3D visualization on the
external displays
• Proposed system has the ability to choose
which lens to view when in 2D mode
• Proposed system has the ability to display
a 3D calibration image on an external
display to ensure proper placement of the
external monitor
The user testing that was executed
demonstrates that the option of selecting 3D
and the ability to select the active lens to
visualize when in 2D mode is a minor
difference that does not raise new or
different questions of safety or effectiveness |
| Device Name | PROPOSED
Flex Robotic System
[K170453] | PREDICATE
Flex System [K150776] | Similarities and Differences |
| Biocompatibility | Proposed Flex Camera is made of the
following materials:
• Stainless steel housing
• glass windows on distal tip
• silicon strain relief
• PEBAX cable
Patient contacting materials have been
shown to be biocompatible after testing
to ISO 10993 | Predicate Flex Camera is made of the
following materials:
• Ultem
• glass windows on distal tip
• silicon strain relief
• PEBAX cable
Patient contacting materials have been
shown to be biocompatible after testing to
ISO 10993 | Similar.
Similarities:
• Both systems have identical materials in
the strain reliefs, and cable components
• Both systems have been analyzed for
biocompatibility with respect to 10993-1
for in vitro cytotoxicity, irritation and
skin sensitization, and systemic toxicity
Differences
• The plastic camera housing was replaced
with a stainless-steel housing
• The glass used in the lens window is
different grade of glass, but it is
biocompatible.
The biocompatibility testing demonstrates
that these minor material differences do not
raise new or different questions of safety or
effectiveness |
9
10
11
12
13
14
15
16
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| Device Name | PROPOSED
Flex Robotic System
[K170453] | PREDICATE
Flex System [K150776] | Similarities and Differences |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization | Flex Drive is provided Sterile
Sterilization method for the Flex
Camera is moist heat sterilization | Flex Drive is provided Sterile
Sterilization method for the Flex Camera is
moist Ethylene Oxide | Similar: Both the proposed and predicate
Flex Drives are provided sterile. The camera
in the predicate device is sterilized by ETO.
The camera for the proposed device is
sterilized by moist heat.
The S.A.L of both methods is validated to be
10-6.
The sterilization validation testing that was
completed demonstrates that these minor
material differences do not raise new or
different questions of safety or effectiveness |
| Electrical Safety &
EMC | Passed the applicable electromagnetic
compliance (EMC) and electrical safety
requirements of IEC 60601-1-2 and IEC
60601-1 | Passed the applicable electromagnetic
compliance (EMC) and electrical safety
requirements of IEC 60601-1-2 and IEC
60601-1 | Same |