(246 days)
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.
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.
The provided document does not describe a study proving the device meets specific acceptance criteria in terms of diagnostic performance or clinical outcomes. Instead, it details the verification and validation (V&V) testing performed to demonstrate that the Medrobotics Flex® Robotic System (K170453), a modified version of a previously cleared predicate device, maintains its functional, performance, and safety specifications. The device is a surgical robotic system for visualization and access, not a diagnostic AI.
Therefore, many of the requested categories, such as "reported device performance," "sample size for test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "training set sample size," and "how ground truth for training set was established," are not applicable to the regulatory submission described. The acceptance criteria relate to engineering and safety standards, rather than diagnostic accuracy or clinical effectiveness in the way an AI model for diagnosis would be evaluated.
Here's an overview of the information that is present in relation to acceptance criteria and "studies" (which are primarily engineering and usability tests):
1. Table of Acceptance Criteria and Reported Device Performance
As noted, this device is a surgical robotic system, and its "performance" is assessed against engineering, safety, and functionality standards. There are no performance metrics directly comparable to those for a diagnostic AI (e.g., sensitivity, specificity). The "acceptance criteria" are compliance with established standards, and the "reported device performance" is that it successfully met these standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Reliability | Testing performed and successfully met specifications. Specific metrics not detailed but implied to meet internal design requirements. (p. 4) |
| Vision and Video Subsystem and System | Testing performed and successfully met specifications. Camera performance and reliability testing demonstrated minor differences from predicate do not raise new questions of safety or effectiveness. (p. 4, 8) |
| Software Verification and Validation | Classified as "moderate level of concern" and verified/validated per FDA guidance. (p. 4) |
| Reusable Camera Testing | Testing performed successfully. (p. 4) |
| Ship Testing | Met applicable ISTA standards, demonstrating ability to withstand anticipated shipping conditions. (p. 4, 5) |
| Mechanical Requirements Testing | Testing performed successfully. (p. 4) |
| Safety Subsystem Testing | Testing performed successfully. (p. 4) |
| System Electrical and Board Requirements | Testing performed successfully. (p. 4) |
| Usability/Human Factors | Met intended user requirements and facilitated safe and effective user interactions per FDA guidance and other reference. (p. 5) |
| Electrical Safety | Compliant with IEC 60601-1 Ed: 3.1, ANSI/AAMI ES60601-1, IEC 60601-1-6, IEC 62366, IEC 60601-1-4. (p. 5, 17) |
| Electromagnetic Compatibility (EMC) | Compliant with EN 60601-1-2:2007/AC:2010 and IEC 60601-1-2 Ed 3.0. (p. 5, 6, 17) |
| Biocompatibility | Patient-contacting materials (Flex Drive and Camera) classified as "external communicating device," "tissue/bone/dentin" contact, "limited exposure" (≤24 hrs). Testing performed per ANSI/AAMI/ISO/EN 10993-1, or rationale provided for not testing. (p. 6, 9) |
| Sterilization (Flex® Drive) | EtO cycle validated to a Sterility Assurance Level (SAL) of 10-6 per ANSI/AAMI/ISO 11135-1, AAMI TIR 11135-2, AAMI TIR 28, ANSI/AAMI/ISO/EN 10993-7. (p. 6) |
| Sterilization (Reusable Components - Flex® Camera, Flex® Instrument Support) | Recommended cleaning and sterilization instructions validated per AAMI TIR12, AAMI TIR30, EN ISO 17664, ANSI/AAMI ST81, ISO TS 15883-5, ANSI/AAMI ST77, ANSI/AAMI ST79, ANSI/AAMI/ISO 14937, ANSI/AAMI/ISO 17665-1, ISO 17665-2, FDA guidance. (p. 6, 7, 17) |
| Shelf Life (Flex® Drive) | Functional testing demonstrated stability over labeled shelf life. (p. 6) |
| Comparison to Predicate Device | Concluded to be substantially equivalent to the predicate device (K150776) in terms of safety and effectiveness, despite minor differences in camera, illumination, and housing. (p. 7-9, 17) |
2. Sample Size for Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The "tests" described are engineering, safety, and functionality validations, not evaluations of diagnostic accuracy on a case dataset.
- Data Provenance: Not applicable. The tests are bench tests, usability studies (likely in a simulated environment with human participants, but not using clinical patient data in the typical sense of AI model evaluation), and compliance testing against international standards for medical devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: The usability/human factors testing involved "representative end users (i.e., surgeons and nurses/technicians)" (p. 5). The exact number is not specified in this summary.
- Qualifications of Experts: "Surgeons and nurses/technicians" are mentioned as representative end-users for usability testing. Further specific qualifications (e.g., years of experience, subspecialty) are not provided in this document.
- Ground Truth: For usability, the "ground truth" would be safe and effective interaction and meeting user needs, based on observation and feedback from these representative users.
4. Adjudication Method for the Test Set
- Not applicable in the context of diagnostic performance. For usability testing, adjudication methods would typically involve observers and analysis of user performance against predefined tasks and error rates, but specific details are not provided beyond the general statement that testing "demonstrated that the Flex® Robotic System design meets the intended user requirements and facilitates safe and effective user interactions."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
- No, an MRMC comparative effectiveness study was not done. This device is a surgical robotic system for visualization and access, not an AI for image interpretation or diagnosis. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, standalone performance testing (in the sense of an AI algorithm performing a diagnostic task independently) was not done. The primary function of this device is to assist a human surgeon in performing a procedure.
7. The Type of Ground Truth Used
- For biocompatibility: Compliance with ISO 10993 standards and a rationale for not testing for specific components.
- For sterilization: Validation to a Sterility Assurance Level (SAL) of 10-6 and compliance with relevant ISO/AAMI standards.
- For electrical safety and EMC: Compliance with IEC standards.
- For usability: Safe and effective user interaction as observed and assessed by human factors experts (not detailed).
- For functional and performance testing: Meeting internal design specifications and comparing favorably to the predicate device.
- No clinical ground truth (e.g., pathology, outcomes data) was used in the context of diagnostic accuracy, as this is not a diagnostic device.
8. The Sample Size for the Training Set
- Not applicable. This document describes a robotic surgical system, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for the system refers to its design and engineering iterations, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" for an AI model in this context.
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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.
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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); 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
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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 DriveRaynham, MA 02767 |
| Contact Person | John D. BonaseraVice 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 IIaccording 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 scopethat provides the benefits of both a rigid endoscope and a computerassisted controller. The Flex® Robotic System allows for thescope to be introduced via an operator-controlled user interfaceeasily providing visualization and access of structures within theoropharynx and hypopharynx and larynx. Visualization is providedby a HD 2D/3D digital camera attached at the distal end of thescope. The Flex Robotic System's scope also provides twoaccessory channels for use of varied flexible instruments. |
| Intended Use | The Medrobotics Flex® System is a device that is intended forrobot-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 compatibleflexible instruments used in surgery. | |
| Substantial Equivalence | The Medrobotics Flex® Robotic System is substantially equivalentto the predicate device the Medrobotics® Flex System. |
| Summary of PerformanceTesting | The Flex® Robotic System has been subjected to and successfullytested for function, performance, and safety as per FDA-recognized standards IEC 60601-1 and IEC 60601-1-2, andbiocompatibility and toxicity of the patient contacting materials perISO-10993-1. It has been tested and met acceptance criteria perFDA-recognized standards for the establishment of shelf life,shipping, and validated for sterility by ETO and moist heat to aSAL of 10-6. Processes by which the user may clean and sterilizecertain reusable components have been validated in accordancewith FDA-recognized standards. Summaries of this testing areprovided below. |
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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.
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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
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- . 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
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- 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.
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Technological Characteristics
| Device Name | PROPOSEDFlex Robotic System[K170453] | PREDICATEFlex System [K150776] | Similarities and Differences |
|---|---|---|---|
| Operational Principles | Cable steered CMOS based videoendoscope using electromechanicalcontrols to traverse three-dimensionalspace without external support due to itsarticulated segment technology and theability to alternate from a flexible torigid state. The system is driven from aconsole based computer controlledphysician handle. | Cable steered CMOS based video endoscopeusing electromechanical controls to traversethree-dimensional space without externalsupport due to its articulated segmenttechnology and the ability to alternate from aflexible to rigid state. The system is drivenfrom a console based computer controlledphysician handle. | Same. The Flex Robotic System and thepredicate are both cable steered endoscopeswhich traverse three-dimensional spacewithout external support due to itsarticulated segment technology and theability to alternate from a flexible to rigidstate. Both the Flex Robotic System and thepredicate use electromechanical controls toaid steering. Both are driven from a consolebased computer controlled physician handle. |
| Anatomical Access | Trans-oral access is gained through useof a retractor | Trans-oral access is gained through use of aretractor | Same. The Flex Robotic System and thepredicate Flex System require use of aretractor to gain entry to the anatomy. |
| Access for CompatibleInstruments | Compatible flexible instruments throughaccessory channels on the Flex Drive | Compatible flexible instruments throughaccessory channels on the Flex Drive | Same. The proposed and predicate systemsboth allow for use of compatible flexibleinstruments through the scope instrumentchannels. |
| Scope Rigidity | Flexible / Semi-Rigid endoscope | Flexible / Semi-Rigid endoscope | Same. The proposed and predicate devicesare both flexible / semi-rigid endoscopes. |
| Advance/retract | Electromechanically aided withphysician controller on console | Electromechanically aided with physiciancontroller on console | Same. The Flex Robotic System and thepredicate Flex System are advanced andretracted with the assistance ofelectromechanical controls driven by thephysician controller on the console. |
| Device Name | PROPOSEDFlex Robotic System[K170453] | PREDICATEFlex System [K150776] | Similarities and Differences |
| Steering | Electromechanical joystick controls (thePhysician Controller) on a console aidsteering | Electromechanical joystick controls (thePhysician Controller) on a console aidsteering | Same. The Flex Robotic System andpredicate Flex System utilize the identicalphysician controller. |
| Direct Visualization | Yes, during entire procedure in 2D. 3Dvisualization is an option that can beenabled by the user. | Yes, during entire procedure in 2D | Similar. The Flex Robotic System and thepredicate allow the physician to maintaindirect visualization of the anatomy ofinterest during the entire procedure in 2D.The option of selecting 3D demonstrated inuser testing is a minor difference that doesnot raise new or different questions of safetyor effectiveness |
| Multi-SegmentedEndoscope Structure | Yes | Yes | Same. The Flex Robotic System and thepredicate are both multi-segmentedstructures. |
| Semi-rigid follow theleader / guidingfunction | Yes | Yes | Same |
| Electromechanicallycable driven /controlled segments | Yes | Yes | Same |
| 3D flexible movementsand tip orientation | Yes | Yes | Same |
| Device Name | PROPOSEDFlex Robotic System[K170453] | PREDICATEFlex System [K150776] | Similarities and Differences |
| Haptic feedback touser | Yes | Yes | Same. The Flex Robotic System and theFlex System both provide haptic feedback tothe user when the scope reaches the limits ofthe pre-defined (by the systemspecifications) workspace. |
| Fluid Lumen | Yes | Yes | Same |
| Working Channel(s) | Yes 4.7 mm in diameter | Yes 4.7 mm in diameter | Same |
| View optics / OpticalSensor | Two Glass LensTwo Solid State CMOS sensors with1920x1080 resolution | One Glass LensOne Solid State CMOS sensor with1280x720 resolution | Similar. The proposed camera incorporatestwo Solid State CMOS sensors with higherresolution and two glass lens assemblies thatprovide a minimum resolvable feature sizeto 40um.The predicate camera incorporates one SolidState CMOS sensor and one glass lensassembly that provide a minimum resolvablefeature size to 70um.The camera performance and reliabilitytesting that was executed, demonstrates thatthis minor difference does not raise new ordifferent questions of safety or effectiveness |
| Device Name | PROPOSEDFlex Robotic System[K170453] | PREDICATEFlex System [K150776] | Similarities and Differences |
| Light Source | 4 LEDs, 2 located above the lensassemblies and 2 located below the lensassemblies | 6 LEDs, All LEDs are located above the lensassembly | Similar. The proposed Flex Robotic Systemhas updated the quantity and location of theLEDs in the camera to provide a moreconsistent illumination. The LEDs and lightoutput are identical between the twosystems.The illumination performance testing thatwas executed demonstrates that this minordifference does not raise new or differentquestions of safety or effectiveness |
| Device Name | PROPOSEDFlex Robotic System[K170453] | PREDICATEFlex System [K150776] | Similarities and Differences |
| Real Time Video | 2D Video Data DisplayUser selectable 3D visualization | 2D Video Data Display | Similar.The proposed system includes an option forthe user to select either a 2D and/or a 3Dvisualization mode.The user testing demonstrates that the optionof selecting 3D is a minor difference thatdoes not raise new or different questions ofsafety or effectiveness |
| Device Name | PROPOSEDFlex Robotic System[K170453] | PREDICATEFlex System [K150776] | Similarities and Differences |
| Camera Housing | Stainless Steel construction withtransparent windows. Windows areplaced in front of the LEDs to allowlight to pass through the camerahousing. A window is also placed infront of the lens assemblies to ensurethat the camera can remain sealedduring the sterilization process. | Ultem construction with a transparentwindow. The window is located in front ofthe LEDs to allow light to pass through thecamera housing. The lens does not sit behinda transparent window, instead, it protrudesthrough the distal end of the housing. | Similar.Same:· Both housings contain electronics andsensor to enable a distally mountedcamera· Both housings are sealed to preventingress of fluidDifferences:· Proposed camera has transparentwindows located in front of the lensassemblies while the predicate FlexCamera lens assembly protrudes from thedistal side of the Flex Camera. Thisensures that the camera housing canremain sealed for sterilization purposesand this design also isolates the imagingwindow from the illumination windowsso no stray light from the illuminationLEDs pass into the video, reducingcontrast of the video.The camera performance, reliability,sterilization and biocompatibility testingdemonstrate that this minor difference doesnot raise new or different questions of safetyor effectiveness |
| Device Name | PROPOSEDFlex Robotic System[K170453] | PREDICATEFlex System [K150776] | Similarities and Differences |
| Vision Electronics | 2 printed circuit board assemblies toenable the passing of video data | 2 printed circuit board assemblies to enablethe passing of video data | Similar.Same:• Both proposed and predicate systemshave 2 printed circuit boards responsiblefor processing, transmitting, anddisplaying live video• Both proposed and predicate systemshave been designed and tested to conformto IEC60601-1 Edition 3.1 (2012)Differences:• Proposed system uses a ruggedizedexternal connector to connect the cameracable to the Flex Base while the existingsystem used an integrated board levelconnector• Proposed system uses cable harnessesinstead of mating connectors in the FlexBase. This design enables thetransmission of high speed signals whilemaintaining signal integrity.• Proposed system uses a different dataprotocol to transmit the video data fromthe camera to the first video board. This isa design requirement of the updatedimaging sensors described above.The vision performance testing that wasexecuted demonstrates that these minordifferences do not raise new or differentquestions of safety or effectiveness |
| Device Name | PROPOSEDFlex Robotic System[K170453] | PREDICATEFlex System [K150776] | Similarities and Differences |
| Graphical UserInterface | Touchscreen based interface located onthe Flex Console Monitor | Touchscreen based interface located on theFlex Console Monitor | Similar.Same:• Both systems provide 2D visualization onthe Flex Console Monitor• Both systems provide a touchscreeninterface to control system settings andpreferences• Both systems display information anderror messages in identical ways• Both systems have the same controls fordriving modes, robot control and robotfeedbackDifferences:• Proposed system has the ability to switchbetween 2D and 3D visualization on theexternal displays• Proposed system has the ability to choosewhich lens to view when in 2D mode• Proposed system has the ability to displaya 3D calibration image on an externaldisplay to ensure proper placement of theexternal monitorThe user testing that was executeddemonstrates that the option of selecting 3Dand the ability to select the active lens tovisualize when in 2D mode is a minordifference that does not raise new ordifferent questions of safety or effectiveness |
| Device Name | PROPOSEDFlex Robotic System[K170453] | PREDICATEFlex System [K150776] | Similarities and Differences |
| Biocompatibility | Proposed Flex Camera is made of thefollowing materials:• Stainless steel housing• glass windows on distal tip• silicon strain relief• PEBAX cablePatient contacting materials have beenshown to be biocompatible after testingto ISO 10993 | Predicate Flex Camera is made of thefollowing materials:• Ultem• glass windows on distal tip• silicon strain relief• PEBAX cablePatient contacting materials have beenshown to be biocompatible after testing toISO 10993 | Similar.Similarities:• Both systems have identical materials inthe strain reliefs, and cable components• Both systems have been analyzed forbiocompatibility with respect to 10993-1for in vitro cytotoxicity, irritation andskin sensitization, and systemic toxicityDifferences• The plastic camera housing was replacedwith a stainless-steel housing• The glass used in the lens window isdifferent grade of glass, but it isbiocompatible.The biocompatibility testing demonstratesthat these minor material differences do notraise new or different questions of safety oreffectiveness |
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| Device Name | PROPOSEDFlex Robotic System[K170453] | PREDICATEFlex System [K150776] | Similarities and Differences |
|---|---|---|---|
| Sterilization | Flex Drive is provided SterileSterilization method for the FlexCamera is moist heat sterilization | Flex Drive is provided SterileSterilization method for the Flex Camera ismoist Ethylene Oxide | Similar: Both the proposed and predicateFlex Drives are provided sterile. The camerain the predicate device is sterilized by ETO.The camera for the proposed device issterilized by moist heat.The S.A.L of both methods is validated to be10-6.The sterilization validation testing that wascompleted demonstrates that these minormaterial differences do not raise new ordifferent questions of safety or effectiveness |
| Electrical Safety &EMC | Passed the applicable electromagneticcompliance (EMC) and electrical safetyrequirements of IEC 60601-1-2 and IEC60601-1 | Passed the applicable electromagneticcompliance (EMC) and electrical safetyrequirements of IEC 60601-1-2 and IEC60601-1 | Same |
§ 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.