(258 days)
No
The summary describes an operator-controlled robotic system for visualization and access, with no mention of AI or ML capabilities in the device description, intended use, or performance studies.
No.
The device is used for visualization and surgical site access, providing tools for surgery rather than directly delivering a therapeutic effect.
No
Explanation: The "Intended Use/Indications for Use" section explicitly states that the device is intended for "robot-assisted control...during visualization of and surgical site access to the anus, recturn and distal colon." The "Device Description" further clarifies that it is an "operator-controlled flexible endoscope that provides the benefits of both a rigid endoscope and a computer assisted controller" for "visualization and access of structures." While visualization might be part of a diagnostic process, the primary stated purpose is for surgical site access and control during surgery, not solely for diagnosing conditions.
No
The device description explicitly states it is a "software-controlled device" but also describes significant hardware components like a flexible endoscope, digital camera, accessory channels, base, cart, console, and monitor. The performance studies also include extensive hardware testing (mechanical, electrical, biocompatibility, sterilization, etc.).
Based on the provided information, the Medrobotics Flex Robotic System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for robot-assisted control of a device for visualization and surgical site access within the body (anus, rectum, and distal colon). This is a surgical/interventional procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as an operator-controlled flexible endoscope used for visualization and access during surgery. It provides accessory channels for surgical instruments. This aligns with a surgical device, not a diagnostic device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. The focus is on providing visualization and access for surgical procedures.
- Performance Studies: The performance studies described are related to the device's mechanical reliability, software functionality, usability in a surgical setting, and safety during surgical procedures (animal and cadaver testing). These are typical for surgical devices, not IVDs which would focus on analytical performance (sensitivity, specificity, etc.) on biological samples.
- Predicate Devices: The predicate devices listed (NeoGuide Navigator Endoscopy System, Medrobotics Flex® System, Storz TEO System) are all surgical or endoscopic systems, not IVD devices.
In summary, the Medrobotics Flex Robotic System is a surgical robotic system designed to assist in procedures within the colon, not a device used for in vitro diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, recturn and distal colon. The Flex Robotic System is intended for use in adults (≥22 years of age).
The Flex Colorectal Drive is intended for robot-assisted visualization of and surgical site access to the anus, rectum, and distal colon in adults (≥22 years of age). The Flex Colorectal Drive also provides accessory channels for compatible flexible instruments used in surgery.
Product codes
FDF
Device Description
The Flex® Robotic System and Flex® Colorectal Drive make up the Flex Robotic Colorectal System. The Flex Robotic Colorectal System is an operator-controlled flexible endoscope that provides the benefits of both a rigid endoscope and a computer assisted controller. The Flex Robotic Colorectal System is a software-controlled device. The Flex® Robotic Colorectal System allows for the endoscope to be introduced via an operator-controlled user interface easily providing visualization and access of structures in the anus, rectum, and distal colon. Visualization is provided by a digital camera attached at the distal end of the endoscope. The Flex Robotic Colorectal System's endoscope also provides two accessory channels for use of varied flexible instruments. The Flex Robotic Colorectal System is intended for professional use only in a hospital setting. The Flex Robotic System is provided non-sterile and reusable. The Flex Robotic Colorectal Drive is provided sterile through EtO sterilization and is intended for single patient use. The patient contacting components of the proposed system are all composed of biocompatible materials.
Mentions image processing
Video Image Processing: Video Data Display
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anus, rectum and distal colon
Indicated Patient Age Range
adults (≥22 years of age)
Intended User / Care Setting
professional use only in a hospital setting
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
Bench Testing: The following verification and/or validation testing was performed to confirm that the Flex Colorectal 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 Colorectal 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 Colorectal System could withstand anticipated shipping conditions.
Usability/Human Factors Testing: Medrobotics performed usability and human factors testing of the Flex Colorectal 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 and Flex® Colorectal Drive 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 and Flex® Colorectal Drive design meets the intended user requirements and facilitates safe and effective user interactions with little chance of committing dangerous user errors.
Animal and Cadaver Testing: Medrobotics performed three animal studies to evaluate the safety of the Flex® Robotic System and Flex® Colorectal Drive for transanal access to the colorectal anatomy. The studies were conducted in accordance with Good Laboratory Practice (GLP). One study evaluated abrasion caused by the Flex® Colorectal Drive (the patient contacting portion of the Flex® Robotic System). The study concluded that the Flex® Colorectal Drive does not cause an increased level of abrasion during visualization and access of the anus and rectum in a porcine model when compared to a colonoscope control. The other study demonstrated that the Flex® Robotic System and Flex® Colorectal Drive provided acceptable visualization of and access to the colorectal space and served as a stable platform that enabled the surgeon to perform full thickness surgical procedures (excision, suturing, and bleeding control) on live (porcine) rectal tissue. The third study demonstrated that the Flex® Robotic System and Flex® Colorectal Drive provided acceptable visualization of and access to the colorectal space and served as a stable platform that enabled the surgeon to perform submucosal surgical procedures (excision, suturing, and bleeding control) on live (porcine) rectal tissue. Finally, a study of the use of the Flex® Robotic System and Flex® Colorectal Drive was conducted in six human cadaveric specimens. The results of the study demonstrated that the Flex Robotic System and Flex Colorectal Drive enabled trans-anal entry, maintained insufflation of the colon, and provided visualization and access to perform trans-anal tissue resection and resection closure in human anatomy with a high degree of success.
Electrical Safety: The Flex® Robotic System and Flex® Colorectal Drive have 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 and Flex® Colorectal Drive were 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; Common emitter immunity testing, for cell phones, Wi-Fi, Bluetooth, and some RFID frequencies was performed per the latest edition 60601-1-2:2014 (4th Ed.) Table 9, Section 8.10. Some of the frequencies in Table 9 are tested per 60601-1-2:2007, but power levels are higher and dwell times are longer in Table 9 testing. RFID immunity ad hoc testing was performed for two common RFID emitters not included in Table 9 testing, 125kHz (low frequency RFID, or LF RFID) and 13.56MHz (high frequency RFID, or HF RFID). The testing was based on standard 60601-1-2 conducted EMI testing (modulation) conditions at these frequencies, with increased field strength and longer dwell times. Electro-Surgical Unit (ESU) immunity testing was based on IEC 60601-2-27:2011 Particular Requirements for ECG, Section 202.6.2.101.
Biocompatibility: The Flex® Colorectal Drive, including Flex Camera and Flex Rectoscope, contains the patient contacting portions of the Flex® Colorectal 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 Colorectal Drive 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. The results of these tests demonstrate that the patient contacting portions of the device, as intended for use, are biocompatible and nontoxic.
Sterilization, Packaging, and Shelf Life for Single Use Flex® Colorectal Drive: The Flex® Colorectal Drive is supplied sterile and is a single use device. The Flex® Colorectal Drive is sterilized via ethylene oxide (EtO). The EtO cycle has been validated to a sterility assurance level (SAL) of 10th, 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. Functional testing has been performed to demonstrate the Flex Colorectal Drive is stable over the labeled shelf life.
Cleaning and Sterilization of Reusable System Components: The Flex Colorectal System includes reusable components, the Flex® Camera, Flex® Colorectal Instrument Support and Flex® Rectoscope, 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; 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/AAMI/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. The Flex System also consists of reusable capital equipment supplied non-sterile. 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: 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: 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Flex® Robotic System and Flex® Colorectal Drive have 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.
Animal and Cadaver Testing: Medrobotics performed three animal studies to evaluate the safety of the Flex® Robotic System and Flex® Colorectal Drive for transanal access to the colorectal anatomy. The studies were conducted in accordance with Good Laboratory Practice (GLP). One study evaluated abrasion caused by the Flex® Colorectal Drive (the patient contacting portion of the Flex® Robotic System). The study concluded that the Flex® Colorectal Drive does not cause an increased level of abrasion during visualization and access of the anus and rectum in a porcine model when compared to a colonoscope control. The other study demonstrated that the Flex® Robotic System and Flex® Colorectal Drive provided acceptable visualization of and access to the colorectal space and served as a stable platform that enabled the surgeon to perform full thickness surgical procedures (excision, suturing, and bleeding control) on live (porcine) rectal tissue. The third study demonstrated that the Flex® Robotic System and Flex® Colorectal Drive provided acceptable visualization of and access to the colorectal space and served as a stable platform that enabled the surgeon to perform submucosal surgical procedures (excision, suturing, and bleeding control) on live (porcine) rectal tissue. Finally, a study of the use of the Flex® Robotic System and Flex® Colorectal Drive was conducted in six human cadaveric specimens. The results of the study demonstrated that the Flex Robotic System and Flex Colorectal Drive enabled trans-anal entry, maintained insufflation of the colon, and provided visualization and access to perform trans-anal tissue resection and resection closure in human anatomy with a high degree of success.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Optics - Pixels: 1280 x 720
Optics - Field of View: > 80° (actual measurement approx.. 86°)
Optics - Depth of Field: 25 - 60 mm
Optics - F-stop: 5.6
Optics - Signal-to-Noise Ratio: 39 dB
Optics - Sensitivity: 3300 nV/lux-sec
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 4, 2017
Medrobotics Corporation John D. Bonasera Director of Regulatory Affairs 475 Paramount Drive Raynham, MA 02767
Re: K162330
Trade/Device Name: Flex Robotic System and Flex Colorectal Drive Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDF Dated: April 7, 2017 Received: April 7, 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.
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.
1
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 device-related 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,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162330
Device Name Flex Robotic System and Flex Colorectal Drive
Indications for Use (Describe)
The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, recturn and distal colon. The Flex Robotic System is intended for use in adults (≥22 years of age).
The Flex Colorectal Drive is intended for robot-assisted visualization of and surgical site access to the anus, rectum, and distal colon in adults (≥22 years of age). The Flex Colorectal Drive also provides accessory channels for compatible flexible instruments used in surgery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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 and Flex® Colorectal Drive
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.
| 510(k) Number | K162330 |
|---|---|
| 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 | April 6, 2017 |
| Device Trade Name | Flex® Robotic System and Flex® Colorectal Drive |
| Device Common Name | Flexible Colonoscope and Accessories |
| Device Classification Name | Endoscope and accessories |
| Product Code | FDF |
| Classification | Class II |
| Predicate Device | The NeoGuide Navigator Endoscopy System, K070622 |
| Reference Device | The Flex® Robotic System and Flex® Colorectal Drive were also |
| compared to the Medrobotics Flex® System, K150776 and the | |
| Storz TEO System, K945209. The proposed system is a modified | |
| version of the cleared Flex System, K150776. The proposed | |
| system includes the Flex® Rectoscope, which, like the Storz | |
| reference device facilitates access to the colorectal anatomy and | |
| allows sealing of the anatomy for insufflation. | |
| Device Description | The Flex® Robotic System and Flex® Colorectal Drive make up |
| the Flex Robotic Colorectal System. The Flex Robotic Colorectal | |
| System is an operator-controlled flexible endoscope that provides | |
| the benefits of both a rigid endoscope and a computer assisted | |
| controller. The Flex Robotic Colorectal System is a software- | |
| controlled device. The Flex® Robotic Colorectal System allows | |
| for the endoscope to be introduced via an operator-controlled user | |
| interface easily providing visualization and access of structures in | |
| the anus, rectum, and distal colon. Visualization is provided by a | |
| digital camera attached at the distal end of the endoscope. The | |
| Flex Robotic Colorectal System's endoscope also provides two | |
| accessory channels for use of varied flexible instruments. The | |
| Flex Robotic Colorectal System is intended for professional use | |
| only in a hospital setting. The Flex Robotic System is provided | |
| non-sterile and reusable. The Flex Robotic Colorectal Drive is | |
| provided sterile through EtO sterilization and is intended for single | |
| patient use. The patient contacting components of the proposed | |
| system are all composed of biocompatible materials. | |
| Intended Use | The Medrobotics Flex Robotic System is intended to provide |
| robot-assisted control of the Flex Colorectal Drive during | |
| visualization of and surgical site access to the anus, rectum and | |
| distal colon. The Flex Robotic System is intended for use in adults | |
| (≥22 years of age). | |
| The Flex Colorectal Drive is intended for robot-assisted | |
| visualization of and surgical site access to the anus, rectum, and | |
| distal colon in adults (≥22 years of age). The Flex Colorectal | |
| Drive also provides accessory channels for compatible flexible | |
| instruments used in surgery. | |
| Substantial Equivalence | The Flex® Robotic System and Flex® Colorectal Drive are |
| substantially equivalent to the NeoGuide Navigator Endoscopy | |
| System (NeoGuide System). As shown in the comparison table at | |
| the end of this section, the Flex® Robotic System and Flex® | |
| Colorectal Drive have very similar functionality and intended use | |
| as the predicate device. | |
| Summary of Performance | |
| Testing | The Flex® Robotic System and Flex® Colorectal Drive have 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 |
4
5
validated in accordance with FDA-recognized standards. Summaries of this testing are provided below.
Bench Testing
The following verification and/or validation testing was performed to confirm that the Flex Colorectal 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 Colorectal 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 Colorectal System could withstand anticipated shipping conditions.
Usability/Human Factors Testing
Medrobotics performed usability and human factors testing of the Flex Colorectal 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 and Flex® Colorectal Drive 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 and Flex® Colorectal Drive design meets the intended user requirements and facilitates safe and effective user interactions with little chance of committing dangerous user errors.
6
Animal and Cadaver Testing
Medrobotics performed three animal studies to evaluate the safety of the Flex® Robotic System and Flex® Colorectal Drive for transanal access to the colorectal anatomy. The studies were conducted in accordance with Good Laboratory Practice (GLP).
One study evaluated abrasion caused by the Flex® Colorectal Drive (the patient contacting portion of the Flex® Robotic System). The study concluded that the Flex® Colorectal Drive does not cause an increased level of abrasion during visualization and access of the anus and rectum in a porcine model when compared to a colonoscope control.
The other study demonstrated that the Flex® Robotic System and Flex® Colorectal Drive provided acceptable visualization of and access to the colorectal space and served as a stable platform that enabled the surgeon to perform full thickness surgical procedures (excision, suturing, and bleeding control) on live (porcine) rectal tissue.
The third study demonstrated that the Flex® Robotic System and Flex® Colorectal Drive provided acceptable visualization of and access to the colorectal space and served as a stable platform that enabled the surgeon to perform submucosal surgical procedures (excision, suturing, and bleeding control) on live (porcine) rectal tissue.
Finally, a study of the use of the Flex® Robotic System and Flex® Colorectal Drive was conducted in six human cadaveric specimens. The results of the study demonstrated that the Flex Robotic System and Flex Colorectal Drive enabled trans-anal entry, maintained insufflation of the colon, and provided visualization and access to perform trans-anal tissue resection and resection closure in human anatomy with a high degree of success.
Electrical Safety
The Flex® Robotic System and Flex® Colorectal Drive have 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
7
- 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 and Flex® Colorectal Drive were 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
- Common emitter immunity testing, for cell phones, Wi-Fi, Bluetooth, and some RFID frequencies was performed per the latest edition 60601-1-2:2014 (4th Ed.) Table 9, Section 8.10. Some of the frequencies in Table 9 are tested per 60601-1-2:2007, but power levels are higher and dwell times are longer in Table 9 testing.
- . RFID immunity ad hoc testing was performed for two common RFID emitters not included in Table 9 testing, 125kHz (low frequency RFID, or LF RFID) and 13.56MHz (high frequency RFID, or HF RFID). The testing was based on standard 60601-1-2 conducted EMI testing (modulation) conditions at these frequencies, with increased field strength and longer dwell times.
- Electro-Surgical Unit (ESU) immunity testing was based on IEC 60601-2-27:2011 Particular Requirements for ECG, Section 202.6.2.101.
Biocompatibility
The Flex® Colorectal Drive, including Flex Camera and Flex Rectoscope, contains the patient contacting portions of the Flex® Colorectal 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 Colorectal Drive 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. The results of these tests demonstrate that the patient contacting portions of the device, as intended for use, are biocompatible and nontoxic.
8
Sterilization, Packaging, and Shelf Life for Single Use Flex® Colorectal Drive
The Flex® Colorectal Drive is supplied sterile and is a single use device. The Flex® Colorectal Drive is sterilized via ethylene oxide (EtO). The EtO cycle has been validated to a sterility assurance level (SAL) of 10th, 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
Functional testing has been performed to demonstrate the Flex Colorectal Drive is stable over the labeled shelf life.
Cleaning and Sterilization of Reusable System Components
The Flex Colorectal System includes reusable components, the Flex® Camera, Flex® Colorectal Instrument Support and Flex® Rectoscope, 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
- 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
9
- 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/AAMI/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
The Flex System also consists of reusable capital equipment supplied non-sterile. 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
Conclusion
Based on the indications for use, performance testing, pre-clinical study data and technological characteristics, the Medrobotics modified Flex® Robotic System and Flex® Colorectal Drive have been shown to be as safe and effective for its stated intended use as the predicate device to which substantial equivalence is claimed.
10
| Device Name | PROPOSED
Flex Robotic Colorectal
System
[K162330] | PREDICATE NeoGuide
System [K070622] | REFERENCE
Flex System [K150776] | REFERENCE
Karl Storz Proctoscope/
TEO System [K945209] |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
Robotic System is intended
to provide robot-assisted
control of the Flex
Colorectal Drive during
visualization of and surgical
site access to the anus,
rectum and distal colon.
The Flex Robotic System is
intended for use in adults
(≥22 years of age).
The Flex Colorectal Drive
is intended for robot-
assisted visualization of and
surgical site access to the
anus, rectum and distal
colon in adults (≥22 years
of age). The Flex
Colorectal Drive also
provides accessory channels
for compatible flexible
instruments used in surgery. | The NeoGuide 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. | 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 Karl Storz Endoscopy
Proctoscopes,
Sigmoidoscopes,
Accessories, and
Proctosigmoidoscopy
Instruments are manually
operated, reusable devices
which are designed for use
by qualified surgeons
during gastroenterological
endoscopic procedures.
The instruments are
designed to facilitate the
introduction or removal of
instruments, telescopes, and
light during
gastroenterological
endoscopic surgery. |
| Device Name | PROPOSED
Flex Robotic Colorectal
System
[K162330] | PREDICATE NeoGuide
System [K070622] | REFERENCE
Flex System [K150776] | REFERENCE
Karl Storz Proctoscope/
TEO System [K945209] |
| Operational
Principles | Cable steered CMOS based
video endoscope using
electromechanical controls
driven from a console based
computer controlled
physician handle | 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. | Cable steered CMOS based
video endoscope using
electromechanical controls
driven from a console based
computer controlled
physician handle | |
| Energy Source | AC powered | AC powered | AC powered | |
| Software | Yes. Software-driven
endoscope. | Yes. Software-driven
endoscope. | Yes. Software-driven
endoscope. | |
| Device Name | PROPOSED
Flex Robotic Colorectal
System
[K162330] | PREDICATE NeoGuide
System [K070622] | REFERENCE
Flex System [K150776] | REFERENCE
Karl Storz Proctoscope/
TEO System [K945209] |
| Hardware | Major hardware system
components:
- Flex Drive (endoscope)
- Flex Console (including
video monitor and joystick) - Flex Base
- Flex Cart
- Flex Camera (with light
source) - Flex Rectoscope
- Instrument Support Arm | Major hardware system
components: - NeoGuide Colonoscope
(with integrated camera) - Actuation Control Unit
- External Position Sensor
- Cart
- Colonoscope Support Arm
- Isolation Transformer
- Video Monitor
- Light source/insufflation
Unit | Major hardware system
components: - Flex Scope (endoscope),
including camera and light
source - Flex Console (including
video monitor and joystick) - Flex Base
- Flex Cart
- Instrument Support Arm | Major hardware system
components: - Proctoscope
- Sigmoidoscope
- Accessories
- Proctosigmoidoscopy
Instruments |
| Operating
Environment -
Temperature | 50° - 86° F (10° - 30° C) | 50° - 104° F (10° - 40° C) | 50° - 86° F (10° - 30° C) | |
| Operating
Environment -
Relative Humidity | 15 - 75% relative humidity,
non-condensing | 30 - 85% relative humidity | 15 - 75% relative humidity,
non-condensing | |
| Operating
Environment - Air
pressure | 700 - 1060 hPA | 700 - 1060 hPA | 700 - 1060 hPA | |
| Device Name | PROPOSED
Flex Robotic Colorectal
System
[K162330] | PREDICATE NeoGuide
System [K070622] | REFERENCE
Flex System [K150776] | REFERENCE
Karl Storz Proctoscope/
TEO System [K945209] |
| Lubrication | Yes. Lubricate using sterile
petroleum jelly. | Yes. Lubricate using
medical grade water-soluble
lubricant. | No. | |
| Insufflation | Insufflation is necessary for
procedure. | Insufflation is necessary for
procedure. | Not applicable. Insufflation
not used in ENT
procedures. | Insufflation is necessary for
procedure. |
| Insufflation
maintenance | Rectoscope seals the
flexible scope and anatomy
to maintain insufflation. | Rigid scope exterior is self-
sealing against the anus to
maintain insufflation | Not applicable. Insufflation
not used in ENT
procedures. | Rectoscope seals the
flexible scope and anatomy
to maintain insufflation. |
| Anatomical Access | Scope gains access through
entry of the Flex
Rectoscope | No access tools required | Scope gains access through
use of a retractor | Rigid scope gains entry to
the anatomy through this
rectoscope |
| | Obturator dilates the anus as
the rectoscope is inserted | | | Obturator dilates the anus as
the rectoscope is inserted |
| Device Name | PROPOSED
Flex Robotic Colorectal
System
[K162330] | PREDICATE NeoGuide
System [K070622] | REFERENCE
Flex System [K150776] | REFERENCE
Karl Storz Proctoscope/
TEO System [K945209] |
| Rectoscope Ports for
Compatible
Instruments | Yes. The system has both
left (1) and right (1)
instrument ports which seal
against specialized
compatible rigid
laparoscopic instruments to
facilitate two handed
surgery.
Also contains a third
auxiliary port to accept a
variety of laparoscopic
instruments. | Not applicable - does not
use a rectoscope | Not applicable - does not
use a rectoscope | Yes. The system has both
left (1) and right (1)
instrument ports which seal
against specialized
compatible rigid
laparoscopic instruments to
facilitate two handed
surgery.
Also contains a third
auxiliary port to accept a
variety of laparoscopic
instruments. |
| CO2 Port | Yes. 2 leur lock ports to
provide CO2 gas to the
surgical field for
insufflation. | Yes | Not applicable. Insufflation
not used in ENT
procedures. | Yes. 2 leur lock ports to
provide CO2 gas to the
surgical field for
insufflation. |
| Rectoscope Working
Length | 51.8 mm
109 mm | Not applicable - does not
use a rectoscope | Not applicable - does not
use a rectoscope | Ranging from 75 mm to
200 mm |
| Rectoscope Diameter | 40 mm | Not applicable - does not
use a rectoscope | Not applicable - does not
use a rectoscope | 40 mm |
| Device Name | PROPOSED
Flex Robotic Colorectal
System
[K162330] | PREDICATE NeoGuide
System [K070622] | REFERENCE
Flex System [K150776] | REFERENCE
Karl Storz Proctoscope/
TEO System [K945209] |
| Access for
Compatible
Instruments | Compatible flexible instruments through accessory channels on the Flex Drive Compatible laparoscopic instruments through the auxiliary port on the Flex Rectoscope | Compatible flexible instrument through instrument channel of the scope | Compatible flexible instruments through accessory channels on the Flex Drive | Compatible laparoscopic instruments through the ports on the rectoscope |
| Scope Rigidity | Flexible / Semi-Rigid
endoscope | Flexible / Semi-Rigid
endoscope | Flexible / Semi-Rigid
endoscope | |
| Scope Overall
Diameter | 28mm (18mm scope + 2,
5mm instrument channels) | 14.5mm | 28mm (18mm scope + 2,
5mm instrument channels) | |
| Scope Working
Diameter | 18mm | 14.5mm | 18mm | |
| Scope Working
Length | 19.2cm (17cm working
length + 2.2cm to traverse
the rectoscope to enter the
patient) | 161 cm (132 cm under
active control) | 17cm | |
| Device Name | PROPOSED
Flex Robotic Colorectal
System
[K162330] | PREDICATE NeoGuide
System [K070622] | REFERENCE
Flex System [K150776] | REFERENCE
Karl Storz Proctoscope/
TEO System [K945209] |
| Advance/retract | Electromechanically aided
with physician controller on
console.
The system is locked in
place and power is
withdrawn from the motors
prior to initiation of a
surgical procedure. | Manual
The links of the endoscope
are locked in a rigid state
prior to initiation of a
surgical procedure. | Electromechanically aided
with physician controller on
console.
The system is locked in
place and power is
withdrawn from the motors
prior to initiation of a
surgical procedure. | |
| Maximum Allowable
Speed | Linear: 22mm/s
Articulation: 22mm/s | Linear: Not applicable.
Directly controlled by the
physician inserting and
withdrawing the device
Articulation: Not published | Linear: 22mm/s
Articulation: 22mm/s | |
| Tip Articulation | 0° - 110° | Unknown – redacted from
K070622 | 0° - 110° | |
| Steering | Electromechanical joystick
controls (the Physician
Controller) on a console aid
steering | Electromechanical joystick
controls on the handle of
the scope aid steering | Electromechanical joystick
controls (the Physician
Controller) on a console aid
steering | |
| Direct Visualization | Yes, during entire
procedure | Yes, during entire
procedure | Yes, during entire
procedure | |
| Multi-Segmented
Endoscope Structure | Yes | Yes | Yes | |
| Device Name | PROPOSED
Flex Robotic Colorectal
System
[K162330] | PREDICATE NeoGuide
System [K070622] | REFERENCE
Flex System [K150776] | REFERENCE
Karl Storz Proctoscope/
TEO System [K945209] |
| | | | | |
| Semi-rigid follow the
leader / guiding
function | Yes | Yes | Yes | |
| Electromechanically
cable driven /
controlled segments | Yes | Yes | Yes | |
| 3D flexible
movements and tip
orientation | Yes | Yes | Yes | |
| Haptic feedback to
user | Based on mechanical scope
limits - Yes
Based on patient anatomy -
No | Based on mechanical scope
limits — No
Based on patient anatomy -
No | Based on mechanical scope
limits - Yes
Based on patient anatomy -
No | |
| Fluid Lumen | Yes | Yes | Yes | |
| Working Channel(s) | Yes 4.7 mm in diameter | Yes, 3.2 mm in diameter | Yes 4.7 mm in diameter | |
| View optics / Optical
Sensor | Lens / Solid State Camera
(CMOS ) | Lens / Solid State Camera
(CCD) | Lens / Solid State Camera
(CMOS) | |
| Optics - Pixels | 1280 x 720 | 768 x 490 | 800 x 800 | |
| Optics - CCD Type | Color | Color | Color | |
| Optics – Field of
View | > 80° (actual measurement
approx.. 86°) | 140° +/- 10° | > 80° (actual measurement
approx.. 86°) | |
| Device Name | PROPOSED
Flex Robotic Colorectal
System
[K162330] | PREDICATE NeoGuide
System [K070622] | REFERENCE
Flex System [K150776] | REFERENCE
Karl Storz Proctoscope/
TEO System [K945209] |
| Optics - Direction of
View | Forward / 0° | Forward | Forward / 0° | |
| Optics - Depth of
Field | 25 - 60 mm | 3 – 80 mm | 25 - 60 mm | |
| Optics - F-stop | 5.6 | 7.2 | 5.6 | |
| Optics - Signal-to-
Noise Ratio | 39 dB | Unknown - not published
or included in K070622 | 39 dB | |
| Optics - Sensitivity | 3300 nV/lux-sec | Unknown - not published
or included in K070622 | 3300 nV/lux-sec | |
| Light Source | LED | LED | LED | |
| Video Image
Processing | Video Data Display | Video Data Display | Video Data Display | |
| Video Display | Standard color video
display | Standard color video
display | Standard color video
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 | Flex Colorectal Drive is
provided Sterile | Endoscope is provided
Clean / Non-Sterile | Flex Scope is provided
Sterile | |
| Device Name | PROPOSED
Flex Robotic Colorectal
System
[K162330] | PREDICATE NeoGuide
System [K070622] | REFERENCE
Flex System [K150776] | REFERENCE
Karl Storz Proctoscope/
TEO System [K945209] |
| Electrical Safety &
EMC | Passed the applicable
electromagnetic compliance
(EMC) and electrical safety
requirements of IEC 60601-
1-2 and IEC 60601-1 | Passed | Passed | |
Table 1 Comparison of Proposed, Predicate, and Reference Devices
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