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.

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.

AI/ML Overview

The provided text describes the Medrobotics Flex Robotic System and Flex Colorectal Drive, focusing on its substantial equivalence to predicate devices. It details various performance tests rather than acceptance criteria for a specific outcome like diagnostic accuracy, as this is a surgical access and visualization device, not a diagnostic one.

However, I can extract and describe the types of studies performed to demonstrate the device's safety and effectiveness, which implicitly satisfy the "acceptance criteria" of being safe and effective for its intended use, as determined by the FDA for 510(k) clearance.

1. Table of Acceptance Criteria and Reported Device Performance

Since this device is for surgical access and visualization rather than providing a diagnostic output, the acceptance criteria are not in the form of sensitivity/specificity or similar metrics. Instead, "acceptance criteria" are demonstrated via various engineering, safety, and functional tests. The reported device performance is that it met these criteria.

Acceptance Criteria Category	Specific Tests/Standards Met	Reported Device Performance
Functional & Performance	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.	Met performance specifications.
Software	Compliance with FDA guidance "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices May 11, 2005" for "moderate level of concern" software. Software verification and validation.	Software was verified and validated and documents prepared per FDA guidance.
Shipping	Per applicable ISTA standards.	Withstood anticipated shipping conditions.
Usability/ Human Factors	Testing in accordance with FDA Guidance Document "Applying Human Factors and Usability Engineering to Medical Devices" (February 3, 2016) and Wiklund's Usability Testing of Medical Devices. Assessed performance by representative end users (surgeons/nurses).	Design meets user requirements and facilitates safe/effective interactions with low risk of user errors.
Biocompatibility	Testing per ANSI/AAMI/ISO/EN 10993-1:2009 and FDA Guidance Document "Use of International Standard ISO 10993-1..." for "external communicating device," contact with "tissue/bone/dentin," and "limited exposure" (≤24 hours).	Patient-contacting portions are biocompatible and nontoxic.
Sterilization (Single Use)	Ethylene oxide (EtO) cycle validated to a sterility assurance level (SAL) of 10^-6, per ANSI/AAMI/ISO 11135-1:2007, ANSI/AAMI/ISO TIR 11135-2:2008, AAMI TIR 28:2009, ANSI/AAMI/ISO/EN 10993-7:2008. Functional testing for shelf life stability.	EtO cycle validated to SAL of 10^-6. Device is stable over labeled shelf life.
Cleaning & Sterilization (Reusable)	Validation of cleaning/sterilization instructions per AAMI TIR12:2010, AAMI TIR30:2011, EN ISO 17664:2004, ANSI/AAMI ST81:2004/(R)2010, ISO TS 15883-5:2005, ANSI/AAMI ST77:2013, ANSI/AAMI ST79:2010, ANSI/AAMI/ISO 14937:2009, ANSI/AAMI/ISO 17665-1:2006, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, ISO 17665-2:2009. Validation of cleaning/disinfection for other reusable components (Base, Cart, Stand, Console, Monitor).	Cleaning/sterilization instructions were validated.
Electrical Safety	Compliance with IEC 60601-1 Ed: 3.1, ANSI/AAMI ES60601-1:2005/(R)2012, IEC 60601-1-6: 2010, IEC 62366: 2007, IEC 60601-1-4: 2000.	Demonstrated electrical safety and compliance.
Electromagnetic Compatibility (EMC)	Compliance with EN 60601-1-2:2007/AC:2010, IEC 60601-1-2 Ed. 3.0, IEC 60601-1-2:2014 (4th Ed.) Table 9 (for cell phones, Wi-Fi, Bluetooth, RFID), ad hoc testing for 125kHz and 13.56MHz RFID, and ESU immunity testing per IEC 60601-2-27:2011.	Device is in compliance with EMC standards.

2. Sample Sizes Used for the Test Set and Data Provenance

Due to the nature of the device (surgical instrument, not diagnostic AI), traditional "test sets" with labeled data are not explicitly mentioned in the context of diagnostic performance. However, human cadaveric specimens were used to test surgical performance.

Animal Studies:
- Sample Size: Not explicitly stated as an "N" number for each study. One study compared the Flex Colorectal Drive to a colonoscope control in a porcine model. Two other studies involved "live (porcine) rectal tissue."
- Data Provenance: Porcine (animal) models.
- Retrospective/Prospective: These were prospective animal studies.
Cadaver Study:
- Sample Size: Six human cadaveric specimens.
- Data Provenance: Human cadaveric specimens.
- Retrospective/Prospective: This was a prospective study using cadavers.
Usability/Human Factors Testing:
- Sample Size: "Representative end users (i.e., surgeons and nurses/technicians)." A specific number is not provided.
- Data Provenance: Not specified (presumably from a clinical or simulated environment).
- Retrospective/Prospective: Prospective testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

For the animal and cadaver studies, the "ground truth" related to surgical performance (e.g., successful access, visualization, ability to perform procedures, absence of increased abrasion) was established by the observers/surgeons conducting the study.

Animal and Cadaver Studies: The studies state they were conducted by "the surgeon." While the number of surgeons/experts is not explicitly given (e.g., "three surgeons"), the implication is that qualified surgical personnel were involved in evaluating these outcomes.
Qualifications: "Surgeon" is mentioned, implying relevant medical qualifications. Animal studies were conducted in accordance with Good Laboratory Practice (GLP).

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (like 2+1 or 3+1 consensus) for the animal and cadaver studies. The assessments of performance and outcomes were likely made by the participating surgeons/observers during the studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is described for this device, as it is a surgical access/visualization system and not a diagnostic AI. There is no mention of human readers improving with AI assistance, as the "AI" (robotics) is the primary method of use, not an assistant to human interpretation of images.

6. Standalone Performance Study (Algorithm Only)

The device is a "robot-assisted control" system requiring an operator. Therefore, a standalone (algorithm only without human-in-the-loop performance) study is not applicable or described. The software components underwent verification and validation, but this refers to the software's functionality within the human-operated robotic system, not a standalone diagnostic output.

7. Type of Ground Truth Used

Animal and Cadaver Studies:
- Performance-based Outcomes: Evaluation of successful visualization, surgical access, ability to perform surgical procedures (excision, suturing, bleeding control), maintenance of insufflation, and assessment of tissue abrasion. This could be considered expert assessment/observation of surgical outcomes on models.

8. Sample Size for the Training Set

This document describes a medical device (robot-assisted surgical system) rather than a machine learning or AI model that would typically have a distinct "training set." Therefore, no specific sample size for a training set in the context of an AI model is provided. The development and refinement of the device would be based on engineering principles and iterative testing.

9. How Ground Truth for the Training Set Was Established

As there is no "training set" in the context of an AI model for diagnostic purposes mentioned, this question is not directly applicable. The device's development and validation relied on engineering standards, bench testing, usability testing, and animal/cadaver studies, with "ground truth" for those tests established by direct observation, measurement against specifications, and expert surgical assessment of the device's functionality and safety.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K162330

Device Name Flex Robotic System and Flex Colorectal Drive

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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 DriveRaynham, MA 02767
Contact Person	John D. BonaseraVice President of Clinical, Regulatory, and Quality Affairs
Phone Number	508-692-6460
Fax Number	508-823-1703
Date Prepared	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 alsocompared to the Medrobotics Flex® System, K150776 and theStorz TEO System, K945209. The proposed system is a modifiedversion of the cleared Flex System, K150776. The proposedsystem includes the Flex® Rectoscope, which, like the Storzreference device facilitates access to the colorectal anatomy andallows sealing of the anatomy for insufflation.
Device Description	The Flex® Robotic System and Flex® Colorectal Drive make upthe Flex Robotic Colorectal System. The Flex Robotic Colorectal
	System is an operator-controlled flexible endoscope that providesthe benefits of both a rigid endoscope and a computer assistedcontroller. The Flex Robotic Colorectal System is a software-controlled device. The Flex® Robotic Colorectal System allowsfor the endoscope to be introduced via an operator-controlled userinterface easily providing visualization and access of structures inthe anus, rectum, and distal colon. Visualization is provided by adigital camera attached at the distal end of the endoscope. TheFlex Robotic Colorectal System's endoscope also provides twoaccessory channels for use of varied flexible instruments. TheFlex Robotic Colorectal System is intended for professional useonly in a hospital setting. The Flex Robotic System is providednon-sterile and reusable. The Flex Robotic Colorectal Drive isprovided sterile through EtO sterilization and is intended for singlepatient use. The patient contacting components of the proposedsystem are all composed of biocompatible materials.
Intended Use	The Medrobotics Flex Robotic System is intended to providerobot-assisted control of the Flex Colorectal Drive duringvisualization of and surgical site access to the anus, rectum anddistal colon. The Flex Robotic System is intended for use in adults(≥22 years of age).
	The Flex Colorectal Drive is intended for robot-assistedvisualization of and surgical site access to the anus, rectum, anddistal colon in adults (≥22 years of age). The Flex ColorectalDrive also provides accessory channels for compatible flexibleinstruments used in surgery.
Substantial Equivalence	The Flex® Robotic System and Flex® Colorectal Drive aresubstantially equivalent to the NeoGuide Navigator EndoscopySystem (NeoGuide System). As shown in the comparison table atthe end of this section, the Flex® Robotic System and Flex®Colorectal Drive have very similar functionality and intended useas the predicate device.
Summary of PerformanceTesting	The Flex® Robotic System and Flex® Colorectal Drive have beensubjected to and successfully tested for function, performance, andsafety as per FDA-recognized standards IEC 60601-1 and IEC60601-1-2, and biocompatibility and toxicity of the patientcontacting materials per ISO-10993-1. It has been tested and metacceptance criteria per FDA-recognized standards for theestablishment of shelf life, shipping, and validated for sterility byETO and moist heat to a SAL of 10-6. Processes by which the usermay clean and sterilize certain reusable components have been

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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.

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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

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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.

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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

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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.

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Device Name	PROPOSEDFlex Robotic ColorectalSystem[K162330]	PREDICATE NeoGuideSystem [K070622]	REFERENCEFlex System [K150776]	REFERENCEKarl Storz Proctoscope/TEO System [K945209]
Intended Use	For endoscopic access andvisualization of patientanatomy through a naturalorifice.	For endoscopic access andvisualization of patientanatomy through a naturalorifice.	For endoscopic access andvisualization of patientanatomy through a naturalorifice.	For endoscopic access andvisualization of patientanatomy through a naturalorifice.
Indications for Use	The Medrobotics FlexRobotic System is intendedto provide robot-assistedcontrol of the FlexColorectal Drive duringvisualization of and surgicalsite access to the anus,rectum and distal colon.The Flex Robotic System isintended for use in adults(≥22 years of age).The Flex Colorectal Driveis intended for robot-assisted visualization of andsurgical site access to theanus, rectum and distalcolon in adults (≥22 yearsof age). The FlexColorectal Drive alsoprovides accessory channelsfor compatible flexibleinstruments used in surgery.	The NeoGuide EndoscopySystem is intended toprovide visualization anddiagnostic / therapeuticaccess to the adult lowergastrointestinal tract(including, but not limitedto, the anus, rectum,sigmoid colon, colon,cecum and ileocecal valve)for endoscopy andendoscopic surgery.	The Medrobotics FlexSystem is a device that isintended for robot-assistedvisualization and surgicalsite access to theoropharynx, hypopharynx,and larynx in adults (≥ 22years of age). The FlexSystem also providesaccessory channels forcompatible flexibleinstruments used in surgery.	The Karl Storz EndoscopyProctoscopes,Sigmoidoscopes,Accessories, andProctosigmoidoscopyInstruments are manuallyoperated, reusable deviceswhich are designed for useby qualified surgeonsduring gastroenterologicalendoscopic procedures.The instruments aredesigned to facilitate theintroduction or removal ofinstruments, telescopes, andlight duringgastroenterologicalendoscopic surgery.
Device Name	PROPOSEDFlex Robotic ColorectalSystem[K162330]	PREDICATE NeoGuideSystem [K070622]	REFERENCEFlex System [K150776]	REFERENCEKarl Storz Proctoscope/TEO System [K945209]
OperationalPrinciples	Cable steered CMOS basedvideo endoscope usingelectromechanical controlsdriven from a console basedcomputer controlledphysician handle	Cable steered endoscopeusing electromechanicalcontrols on the handle distaltip CCD camera and toolchannels for instrumentbased therapeuticprocedures, valves for airinsufflation, water irrigationand suction.	Cable steered CMOS basedvideo endoscope usingelectromechanical controlsdriven from a console basedcomputer controlledphysician handle
Energy Source	AC powered	AC powered	AC powered
Software	Yes. Software-drivenendoscope.	Yes. Software-drivenendoscope.	Yes. Software-drivenendoscope.
Device Name	PROPOSEDFlex Robotic ColorectalSystem[K162330]	PREDICATE NeoGuideSystem [K070622]	REFERENCEFlex System [K150776]	REFERENCEKarl Storz Proctoscope/TEO System [K945209]
Hardware	Major hardware systemcomponents:- Flex Drive (endoscope)- Flex Console (includingvideo monitor and joystick)- Flex Base- Flex Cart- Flex Camera (with lightsource)- Flex Rectoscope- Instrument Support Arm	Major hardware systemcomponents:- NeoGuide Colonoscope(with integrated camera)- Actuation Control Unit- External Position Sensor- Cart- Colonoscope Support Arm- Isolation Transformer- Video Monitor- Light source/insufflationUnit	Major hardware systemcomponents:- Flex Scope (endoscope),including camera and lightsource- Flex Console (includingvideo monitor and joystick)- Flex Base- Flex Cart- Instrument Support Arm	Major hardware systemcomponents:- Proctoscope- Sigmoidoscope- Accessories- ProctosigmoidoscopyInstruments
OperatingEnvironment -Temperature	50° - 86° F (10° - 30° C)	50° - 104° F (10° - 40° C)	50° - 86° F (10° - 30° C)
OperatingEnvironment -Relative Humidity	15 - 75% relative humidity,non-condensing	30 - 85% relative humidity	15 - 75% relative humidity,non-condensing
OperatingEnvironment - Airpressure	700 - 1060 hPA	700 - 1060 hPA	700 - 1060 hPA
Device Name	PROPOSEDFlex Robotic ColorectalSystem[K162330]	PREDICATE NeoGuideSystem [K070622]	REFERENCEFlex System [K150776]	REFERENCEKarl Storz Proctoscope/TEO System [K945209]
Lubrication	Yes. Lubricate using sterilepetroleum jelly.	Yes. Lubricate usingmedical grade water-solublelubricant.	No.
Insufflation	Insufflation is necessary forprocedure.	Insufflation is necessary forprocedure.	Not applicable. Insufflationnot used in ENTprocedures.	Insufflation is necessary forprocedure.
Insufflationmaintenance	Rectoscope seals theflexible scope and anatomyto maintain insufflation.	Rigid scope exterior is self-sealing against the anus tomaintain insufflation	Not applicable. Insufflationnot used in ENTprocedures.	Rectoscope seals theflexible scope and anatomyto maintain insufflation.
Anatomical Access	Scope gains access throughentry of the FlexRectoscope	No access tools required	Scope gains access throughuse of a retractor	Rigid scope gains entry tothe anatomy through thisrectoscope
	Obturator dilates the anus asthe rectoscope is inserted			Obturator dilates the anus asthe rectoscope is inserted
Device Name	PROPOSEDFlex Robotic ColorectalSystem[K162330]	PREDICATE NeoGuideSystem [K070622]	REFERENCEFlex System [K150776]	REFERENCEKarl Storz Proctoscope/TEO System [K945209]
Rectoscope Ports forCompatibleInstruments	Yes. The system has bothleft (1) and right (1)instrument ports which sealagainst specializedcompatible rigidlaparoscopic instruments tofacilitate two handedsurgery.Also contains a thirdauxiliary port to accept avariety of laparoscopicinstruments.	Not applicable - does notuse a rectoscope	Not applicable - does notuse a rectoscope	Yes. The system has bothleft (1) and right (1)instrument ports which sealagainst specializedcompatible rigidlaparoscopic instruments tofacilitate two handedsurgery.Also contains a thirdauxiliary port to accept avariety of laparoscopicinstruments.
CO2 Port	Yes. 2 leur lock ports toprovide CO2 gas to thesurgical field forinsufflation.	Yes	Not applicable. Insufflationnot used in ENTprocedures.	Yes. 2 leur lock ports toprovide CO2 gas to thesurgical field forinsufflation.
Rectoscope WorkingLength	51.8 mm109 mm	Not applicable - does notuse a rectoscope	Not applicable - does notuse a rectoscope	Ranging from 75 mm to200 mm
Rectoscope Diameter	40 mm	Not applicable - does notuse a rectoscope	Not applicable - does notuse a rectoscope	40 mm
Device Name	PROPOSEDFlex Robotic ColorectalSystem[K162330]	PREDICATE NeoGuideSystem [K070622]	REFERENCEFlex System [K150776]	REFERENCEKarl Storz Proctoscope/TEO System [K945209]
Access forCompatibleInstruments	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-Rigidendoscope	Flexible / Semi-Rigidendoscope	Flexible / Semi-Rigidendoscope
Scope OverallDiameter	28mm (18mm scope + 2,5mm instrument channels)	14.5mm	28mm (18mm scope + 2,5mm instrument channels)
Scope WorkingDiameter	18mm	14.5mm	18mm
Scope WorkingLength	19.2cm (17cm workinglength + 2.2cm to traversethe rectoscope to enter thepatient)	161 cm (132 cm underactive control)	17cm
Device Name	PROPOSEDFlex Robotic ColorectalSystem[K162330]	PREDICATE NeoGuideSystem [K070622]	REFERENCEFlex System [K150776]	REFERENCEKarl Storz Proctoscope/TEO System [K945209]
Advance/retract	Electromechanically aidedwith physician controller onconsole.The system is locked inplace and power iswithdrawn from the motorsprior to initiation of asurgical procedure.	ManualThe links of the endoscopeare locked in a rigid stateprior to initiation of asurgical procedure.	Electromechanically aidedwith physician controller onconsole.The system is locked inplace and power iswithdrawn from the motorsprior to initiation of asurgical procedure.
Maximum AllowableSpeed	Linear: 22mm/sArticulation: 22mm/s	Linear: Not applicable.Directly controlled by thephysician inserting andwithdrawing the deviceArticulation: Not published	Linear: 22mm/sArticulation: 22mm/s
Tip Articulation	0° - 110°	Unknown – redacted fromK070622	0° - 110°
Steering	Electromechanical joystickcontrols (the PhysicianController) on a console aidsteering	Electromechanical joystickcontrols on the handle ofthe scope aid steering	Electromechanical joystickcontrols (the PhysicianController) on a console aidsteering
Direct Visualization	Yes, during entireprocedure	Yes, during entireprocedure	Yes, during entireprocedure
Multi-SegmentedEndoscope Structure	Yes	Yes	Yes
Device Name	PROPOSEDFlex Robotic ColorectalSystem[K162330]	PREDICATE NeoGuideSystem [K070622]	REFERENCEFlex System [K150776]	REFERENCEKarl Storz Proctoscope/TEO System [K945209]

Semi-rigid follow theleader / guidingfunction	Yes	Yes	Yes
Electromechanicallycable driven /controlled segments	Yes	Yes	Yes
3D flexiblemovements and tiporientation	Yes	Yes	Yes
Haptic feedback touser	Based on mechanical scopelimits - YesBased on patient anatomy -No	Based on mechanical scopelimits — NoBased on patient anatomy -No	Based on mechanical scopelimits - YesBased 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 / OpticalSensor	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 ofView	> 80° (actual measurementapprox.. 86°)	140° +/- 10°	> 80° (actual measurementapprox.. 86°)
Device Name	PROPOSEDFlex Robotic ColorectalSystem[K162330]	PREDICATE NeoGuideSystem [K070622]	REFERENCEFlex System [K150776]	REFERENCEKarl Storz Proctoscope/TEO System [K945209]
Optics - Direction ofView	Forward / 0°	Forward	Forward / 0°
Optics - Depth ofField	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 publishedor included in K070622	39 dB
Optics - Sensitivity	3300 nV/lux-sec	Unknown - not publishedor included in K070622	3300 nV/lux-sec
Light Source	LED	LED	LED
Video ImageProcessing	Video Data Display	Video Data Display	Video Data Display
Video Display	Standard color videodisplay	Standard color videodisplay	Standard color videodisplay
Biocompatibility	Patient contacting materialshave been shown to bebiocompatible after testingto ISO 10993	Patient contacting materialshave been shown to bebiocompatible after testingto ISO 10993	Patient contacting materialshave been shown to bebiocompatible after testingto ISO 10993
Sterilization	Flex Colorectal Drive isprovided Sterile	Endoscope is providedClean / Non-Sterile	Flex Scope is providedSterile
Device Name	PROPOSEDFlex Robotic ColorectalSystem[K162330]	PREDICATE NeoGuideSystem [K070622]	REFERENCEFlex System [K150776]	REFERENCEKarl Storz Proctoscope/TEO System [K945209]
Electrical Safety &EMC	Passed the applicableelectromagnetic compliance(EMC) and electrical safetyrequirements of IEC 60601-1-2 and IEC 60601-1	Passed	Passed

Table 1 Comparison of Proposed, Predicate, and Reference Devices

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Regulation Number and Section

§ 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.