Who is the manufacturer of Medrobotics Flex System?

Medrobotics Corporation filed the 510(k) submission for Medrobotics Flex System (K150776).

What is the FDA product code for Medrobotics Flex System?

EOB. It is classified under 21 CFR 874.4760 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for Medrobotics Flex System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Medrobotics Flex System?

Vision-Sciences Flexible Endoscope with digital video processor and Disposable EndoSheath® System (K072073, K102733); NeoGuide Navigator Endoscopy System (K052930, K070622).

Who can help prepare an FDA 510(k) submission like Medrobotics Flex System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Medrobotics Flex System

K150776 · Medrobotics Corporation · EOB · Jul 17, 2015 · Ear, Nose, Throat

Device Facts

Record ID	K150776
Device Name	Medrobotics Flex System
Applicant	Medrobotics Corporation
Product Code	EOB · Ear, Nose, Throat
Decision Date	Jul 17, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.4760
Device Class	Class 2
Attributes	Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K150776 · Jul 17, 2015	Medrobotics Flex System	Medrobotics Corporation	European post-market clinical follow-up study	A post-market clinical follow-up study was conducted to evaluate the effectiveness of the Flex System in providing visualization and surgical site access to the oropharynx, hypopharynx, and larynx in 45 subjects.	post-market clinical follow-up; visualization; surgical access; oropharynx; hypopharynx; larynx

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
European post-market clinical follow-up study; Post-market clinical follow-up	Adults undergoing procedures in the oropharynx, hypopharynx, and larynx; Sample Size: 45 subjects	Not applicable for this study	Visualization and access to five anatomical locations (palatine tonsil area, base of tongue, epiglottis, posterior pharyngeal wall, false vocal cords)

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.

Device Story

Operator-controlled flexible endoscope; provides robot-assisted visualization and surgical site access to oropharynx, hypopharynx, and larynx. Input: digital camera at distal end of endoscope. Transformation: electromechanical controls driven from console-based, computer-controlled physician handle; cable-steered segments; semi-rigid 'follow-the-leader' guiding function. Output: real-time video visualization on monitor; accessory channels for flexible instruments. Used in clinical settings by head and neck surgeons. Physician operates joystick controller at console to navigate scope; haptic feedback provided to user. Benefits: improved access and visualization for surgical procedures in upper airway anatomy.

Clinical Evidence

European post-market clinical follow-up study (N=45 subjects, 46 procedures). Primary endpoints: visualization and access to five anatomical locations (palatine tonsil, base of tongue, epiglottis, posterior pharyngeal wall, false vocal cords). Results: >90% effectiveness in visualization and access for most locations; 89% success rate for surgical procedures. No safety issues reported.

Technological Characteristics

Cable-steered CMOS-based video endoscope; electromechanical controls; console-based physician interface. Features multi-segmented structure with semi-rigid 'follow-the-leader' capability. LED light source. Patient-contacting materials biocompatible per ISO 10993. Flex Scope sterilized via EtO (SAL 10^-6); reusable components cleaned/disinfected per AAMI TIR12/TIR30. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2.

Indications for Use

Indicated for robot-assisted visualization and surgical site access to the oropharynx, hypopharynx, and larynx in adults (≥ 22 years of age). Provides accessory channels for compatible flexible surgical instruments.

Regulatory Classification

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.

Predicate Devices

Vision-Sciences Flexible Endoscope with digital video processor and Disposable EndoSheath® System (K072073, K102733)
NeoGuide Navigator Endoscopy System (K052930, K070622)

Reference Devices

Hansen Medical Vascular Catheter Control System (K111004)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or fabric. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 16, 2015 Medrobotics Corporation Mr. John D. Bonasera Director of Regulatory Affairs 475 Paramount Drive Raynham, MA 02767 Re: K150776 Trade/Device Name: Medrobotics Flex 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: June 16, 2015 Received: June 18, 2015 Dear Mr. 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 (QS) 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 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 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 Malvina 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) K150776 Device Name Medrobotics Flex® 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) | | |-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW * The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 510(k) Summary Medrobotics Flex System (K150776) | Date prepared: | July 16, 2015 | |----------------|---------------| |----------------|---------------| #### Applicant's Name and Address | Applicant | Medrobotics Corporation | | |------------------|--------------------------------|--| | Address | 475 Paramount Drive | | | | Raynham, MA 02767 | | | Telephone Number | 508-692-6460 x 254 | | | Fax Number | 508-832-1703 | | | Contact Person: | John D. Bonasera | | | Title | Director of Regulatory Affairs | | #### Name of the Device | Trade Name: | Flex® System | |---------------------------|-------------------------------------------------------| | Common Name: | Nasopharyngoscope (flexible or rigid) | | Classification Name | Nasopharyngoscope (flexible or rigid) and accessories | | Device Classification: | II | | Primary Product Code: | EOB | | Subsequent Product Codes: | EOX and GCI | | FDA Regulation | 21 C.F.R. § 874.4760 | #### Predicate Device The legally marketed predicate device to which substantial equivalence is claimed: - The Vision-Sciences Flexible Endoscope with digital video processor and 1. Disposable EndoSheath® System, K072073, K102733 ("Vision-Sciences System"), and - 2. The NeoGuide Navigator Endoscopy System, K052930, K070622 ("NeoGuide System"). #### Reference Device The Flex System was also compared to the Hansen Medical Vascular Catheter Control System, K111004, because both devices employ a physician controller located at the physician console/workstation to drive and articulate the scope/catheter. #### Device Description The Flex System is an operator-controlled flexible endoscope that provides the benefits of both a rigid endoscope and a computer assisted controller. The Flex System allows for the {4}------------------------------------------------ endoscope to be introduced via an operator-controlled user interface, providing visualization and surgical site access to structures within the oropharynx, and larynx. Like some other video endoscopes, visualization is provided by a digital camera incorporated in the distal end of the endoscope. The Flex System's endoscope 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 Medrobotics believes that the subject device is substantially equivalent to the Vision Sciences System and the NeoGuide System. As shown in the comparison table (Table 3) at the end of this section, the Flex System has very similar functionality and the same intended use as the predicate devices. ### Summary of Performance Testing The subject device has been successfully tested for function and performance in bench, usability/human factors, animal, and clinical studies. In addition, the Flex System has been evaluated for electrical safety and electromagnetic compatibility, and biocompatibility and toxicity testing of the patient-contacting materials. The components of the Flex System have been tested and met acceptance criteria per FDA recognized standards for the establishment of labeled shelf life, shipping, sterilization, cleaning, and disinfection, as applicable. ## Bench Testing The following testing was performed to verify that the Flex System, as a whole, and the components met their performance specifications: - Flex System Components, Mechanical Engineering Verification ● - Flex System Components, Mechanical Engineering Verification- Disposable Reliability - Flex System Components, Mechanical Engineering Verification- Base Reliability - Flex System Components, Mechanical Engineering Verification- Base Cleaning Survivability - Flex System Hi-Res Camera Verification - Flex Cart Verification - Flex System Electrical Design Requirements Electrical Design Verification - Flex Console Safety PCA Verification {5}------------------------------------------------ - Electrical Design Verification - Overall Flex System Functionality (Simulated Use Re-Verification) - Surgical Instrument Compatibility Verification ### Transportation Testing Testing was performed to demonstrate that all components of the Flex System could withstand anticipated shipping conditions. ### Usability/Human Factors Testing Medrobotics performed usability and human factors testing of the Flex System. Such testing was performed in accordance with FDA Draft Guidance Document "Applying Human Factors and Usability Engineering to Optimize Medical Device Design" (June 22, 2011). In addition, Wiklund's Usability Testing of Medical Devices was used as a reference. This testing assessed the performance of the Flex System when used by representative end users (i.e., head and neck surgeons and nurses/surgical technicians) in accordance with the IFU after having been trained on how to use the system. The testing demonstrated that the Flex System design meets the intended user requirements and facilitates safe and effective user interactions with little chance of committing dangerous user errors. ### Animal Testing Medrobotics performed two animal studies to evaluate the safety of the Flex System. Both studies evaluated abrasion and blunt force trauma caused by the Flex Scope (the patient contacting portion of the Flex System) compared to intubation control. The studies were conducted in accordance with Good Laboratory Practice (GLP). Both studies concluded that the Flex Scope does not cause an increased level of abrasion and/or blunt force trauma during visualization and access of the oropharynx and hypopharynx/laryngopharynx when compared to intubation control. ## Electrical Safety The Flex System has been tested to demonstrate electrical safety and compliance with: - UL 60601-1 (1) Issued: 2003/04/25 Ed: 1 Rev: 2006/04/26 Medical Electrical Equipment, Part 1:General Req. for Safety - CSA C22.2#601.1 Issued: 1990/01/01 (R2005) Medical Electrical Equipment Part ● 1: General Requirements for Safety General Instruction No. 1: 1990, Supplement 1: 1994, Amendment 2:1998; General Instruction No. 2: 2003 - ANSVAAMI ES60601-1:2005/(R)2012 Issued: 2012/01/17 Medical electrical ● equipment - Part1: General requirements for basic safety and essential performance with C1:2009/(R)2012 and A2:2010/(R)2012 {6}------------------------------------------------ - CAN/CSA-C22.2 No. 60601-1: 08(R2013) Issued: 2011/06/01 Medical Electrical Equipment -Part 1: General Req. for Basic Safety & Essential Perf.; Cor. 2: 2011 - 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 60601-1-6: 2004. First Edition Issued: 2004/06/24 Medical electrical systems – Part 1- 6:General requirements for safety - Collateral standard: Usability - 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 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. - 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 Scope contains the patient contacting portions of the Flex System. In accordance with ANSI/AAMI/ISO 10993-1:2009, and FDA 510(k) Memorandum - #G95-1 Table 1 Initial Evaluation Tests for Consideration, the Flex Scope is classified as "external communicating device", in contact with "tissue/bone/dentin" and "limited exposure" (≤24 hours). Table 1, below, provides a summary of the biocompatibility and toxicity testing performed on the Flex System. | Test | Outcome of Evaluation | |----------------------------------------|-----------------------| | Cytotoxicity Study | Pass | | ISO Systemic Toxicity Study in Mice | Pass | | ISO Systemic Toxicity Study in Mice | Pass | | ISO -Intracutaneous Study | Pass | | ISO -Intracutaneous Study | Pass | | ISO - Maximization Sensitization Study | Pass | | ISO - Maximization Sensitization Study | Pass | | ISO - Oral Mucosal Irritation Test | Pass | ## Table 1. Summary of Biocompatibility and Toxicity Testing ## Sterilization, Packaging and Shelf Life for Single Use Flex Scope {7}------------------------------------------------ The Flex Scope is supplied sterile and is a single use device. The Flex Scope 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/AAMI/ISO/EN 10993-7:2008, Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals The Flex Scope sterile packaging was validated in accordance with the following standards as part of a study demonstrating that the packaging system is stable over its labeled shelf life: - ISO 11607-1:2006 (R) 2010, Packaging for terminally sterilized medical devices -● Part 1: Requirements for materials, sterile barrier systems and packaging systems - ASTM F1886M-09, Standard Test Method for Determining Integrity of Seals for ● Flexible Packaging by Visual Inspection - ASTM F1929-12, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration - ASTM F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials - ASTM F190-07, Standard Guide for Accelerated Aging of Sterile Barrier Systems for ● Medical Devices ## Cleaning and Sterilization of Reusable System Components The Flex System consists of reusable capital equipment supplied non-sterile, with the exception of the Flex Scope, as discussed above. The Flex Instrument Support is provided non-sterile. The Flex Instrument Support is intended to be cleaned and sterilized before each use. The Flex Instrument Support cleaning instructions were validated in accordance with the following standards: - ANSI/AAMI ST79:2010, Comprehensive guide to steam sterilization and sterility ● assurance in health care facilities - 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 {8}------------------------------------------------ The Flex Instrument Support sterilization process was validated in accordance with the following standards: - ANSI/AAMI/ISO 17665-1:2006, Sterilization of health care products - Moist heat -Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices - ANSI/AAMI ST79:2010, Comprehensive guide to steam sterilization and sterility assurance in health care facilities - AAMI TIR12:2010, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers The Flex Base, Flex Cart, Stand and Flex Console, with the exception of the monitor, are intended to be cleaned and disinfected before each use. None of these components have direct patient contact during a surgical procedure. The Monitor is intended to be cleaned before each use. These pieces of equipment are intended to be covered prior to each use with sterile drapes. The cleaning instructions for the Flex Base, Flex Cart, Stand, Flex Console, and Monitor 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 The disinfection instructions for the Flex Base, Flex Cart, Stand and Flex Console (excluding the Monitor) 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 ## 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 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. ## Clinical Study A European post-market clinical follow up study with 45 subjects was performed using the Flex System. The study protocol required that clinical study subjects undergo two separate procedures. The first was a five-point visualization and access procedure, in which the {9}------------------------------------------------ investigator visualized and accessed (1) the palatine tonsil area; (2) the base of tongue area; (3) the epiglottis; (4) the posterior pharyngeal wall; and (5) the false vocal cords. The second was a surgical procedure to treat the patient's previously diagnosed condition with surgical site access and visualization being provided by the Flex System. Forty five (45) subjects were treated in a total of 46 surgical procedures. #### Five-Point Visualization & Access Procedure As shown in Table 2, below, the Flex System was effective (>90%) in providing visualization and access in the oropharynx, hypopharynx and larynx during the Five-Point Visualization & Access Procedure. | Anatomical Location | Visualization Achieved (N=45) | Access Gained (N=45) | |---------------------------|----------------------------------|-------------------------| | Palatine tonsil area | 45 (100%) | 44 (98%) | | Base of tongue area | 45 (100%) | 44 (98%) | | Epiglottis | 45 (100%) | 44 (98%) | | Posterior pharyngeal wall | 45 (100%) | 44 (98%) | | False vocal cords1, 2 | 42 (93%) | 41 (91%) | Table 2. Five Points Visualization and Access 1 The study investigators reported total inability to visualize and access the false vocal cords in 3 and 4 out of 45 subjects, respectively. - 2 The study investigators reported difficulty in visualization and/or access in 7 out of 42 visualization-achieved/41 access-gained patients. #### Surgical Procedures A variety of surgical procedures were successfully completed (89%) in the oropharynx, hypopharynx and larynx with surgical site access and visualization provided by the Flex System. A wide variety of anatomical locations in the oropharynx, hypopharynx and larynx were visualized and accessed during the surgical procedures. The safety and effectiveness of the Flex System for providing visualization and access to the true vocal cords was not assessed in the study. #### Conclusion Based on the indications for use, technological characteristics, and performance testing, Medrobotics has demonstrated that the Flex System is as safe and effective as the predicate {10}------------------------------------------------ devices for the stated intended use, and the Flex System is, as a result, substantially equivalent to the predicate devices. {11}------------------------------------------------ # Table 3. Proposed and Predicate Device Comparison | | Flex System [K150776] | Vision-Sciences System [K072073] | Vision-Sciences System [K102733] | NeoGuide System [K052930, K070622] | |----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | For endoscopic access and visualization of patient anatomy through a natural orifice. | For endoscopic access and visualization of patient anatomy through a natural orifice. | For endoscopic access and visualization of patient anatomy through a natural orifice. | For endoscopic access and visualization of patient anatomy through a natural orifice. | | 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. | The flexible ENT videoscope with the EndoSheath System is intended for use in flexible endoscopic examination of the upper airway, vocal cords, and/or nasal passages. The digital video processor is intended for use with the VSI flexible video scope. | The flexible ENT-500 Video ENT Scope with EndoSheath Technology is intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages; and for use in diagnostic arthroscopic and endoscopic procedures to provide illumination and visualization of the interior cavity of the body through either a natural or surgical opening. | The NeoGuide Navigator Endoscopy System is intended to provide visualization and diagnostic/therapeutic access to the adult lower gastrointestinal tract (including, but not limited to, the anus, rectum, sigmoid colon, colon, cecum, and ileocecal valve) for endoscopy and endoscopic surgery. | | | Flex System [K150776] | Vision-Sciences System [K072073] | Vision-Sciences System [K102733] | NeoGuide System [K052930, K070622] | | Operational Principles | Cable-steered CMOS- based video endoscope using electromechanical controls driven from a console-based, computer- controlled physician handle. | A cable-steered flexible video laryngoscope with CCD-based imaging allowing for high resolution picture quality. | A cable-steered flexible video laryngoscope with CCD-based imaging allowing for high resolution picture quality. | Cable-steered endoscope using electromechanical controls on the handle distal tip CCD camera and tool channels for instrument-based therapeutic procedures, valves for air insufflation, water irrigation, and suction. | | Rigidity | Flexible/semi-rigid endoscope. | Continuously flexible endoscope. | Continuously flexible endoscope. | Flexible/semi-rigid endoscope. | | Advance/Retract | Electromechanically aided with physician controller on console. | Manual. | Manual. | Manual. | | Steering | Electromechanical joystick controls (the Physician Controller) on a console aid steering. | Manual control. | Manual control. | Electromechanical joystick controls on the handle of the scope aid steering. | | Direct Visualization | Yes, during the entire procedure. | Yes, during the entire procedure. | Yes, during the entire procedure. | Yes, during the entire procedure. | | | Flex System [K150776] | Vision-Sciences System [K072073] | Vision-Sciences System [K102733] | NeoGuide System [K052930, K070622] | | Multi-Segmented Endoscope Structure | Yes. | One continuously extruded flexible structure. | | Yes. | | Semi-Rigid Follow the Leader/Guiding Function | Yes. | No, manual. | | Yes. | | Electromechanically Cable- Driven/Controlled Segments | Yes. | No, manual. | | Yes. | | 3D Flexible Movements and Tip Orientation | Yes. | Yes. | | Yes. | | Haptic Feedback to User | Yes. | No. | | No. | | Fluid Lumen | Yes. | Yes. | | Yes. | | Working Channel(s) | Yes, 4.7 mm in diameter. | Yes. | | Yes, 3.2 mm in diameter. | | | Flex System [K150776] | Vision-Sciences System [K072073] | | NeoGuide System [K052930, K070622] | | View Optics/Optical Sensor | Lens/solid state camera (CMOS). | Lens/solid state camera (CCD). | | Lens/solid state camera (CCD). | | Light Source | LED. | LED. | | LED. | | Video Image Processing | Video data display, | Video data display, | | Video data display, | | Biocompatibility | Patient contacting materials have been shown to be biocompatible after testing to ISO 10993. | Patient contacting materials have been shown to be biocompatible after testing to ISO 10993. | | Patient contacting materials have been shown to be biocompatible after testing to ISO 10993. | | Sterilization | The Flex Scope is provided sterile. The reusable components of the Flex System are provided clean/non- sterile. | Sheath for scope provided sterile. | | Provided clean/non- sterile. | | Electrical Safety and EMC | Passed the applicable electrical safety requirements of IEC 60601-1-2 and IEC 60601-1. | Passed. | | Passed. | {12}------------------------------------------------ {13}------------------------------------------------ {14}------------------------------------------------

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