Who is the manufacturer of Flex Robotic System and Flex Transabdominal Drive?

Medrobotics Corporation filed the 510(k) submission for Flex Robotic System and Flex Transabdominal Drive (K172796).

What is the FDA product code for Flex Robotic System and Flex Transabdominal Drive?

HET. It is classified under 21 CFR 884.1720 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for Flex Robotic System and Flex Transabdominal Drive?

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

What are the predicate devices for Flex Robotic System and Flex Transabdominal Drive?

Olympus LTF-190-10-3D, Endoeye Flex 3D Deflectable Videoscope (K123365).

Who can help prepare an FDA 510(k) submission like Flex Robotic System and Flex Transabdominal Drive?

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

Flex Robotic System and Flex Transabdominal Drive

K172796 · Medrobotics Corporation · HET · Jan 18, 2018 · Obstetrics/Gynecology

Device Facts

Record ID	K172796
Device Name	Flex Robotic System and Flex Transabdominal Drive
Applicant	Medrobotics Corporation
Product Code	HET · Obstetrics/Gynecology
Decision Date	Jan 18, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.1720
Device Class	Class 2

Intended Use

The Medrobotics Flex® Robotic System is intended to provide robot-assisted control of the Flex® Transabdominal Drive. The Flex® Transabdominal Drive is intended to be used with ancillary equipment for endoscopic surgery. The Flex® Transabdominal Drive is indicated to provide robot-assisted visualization within the thoracic and abdominal cavities including female reproductive organs. This instrument must not be used for observation of the heart and must not contact the heart or any area near the heart. This instrument must not contact with any device or therapeutic accessory that contacts the heart or any area near the heart.

Device Story

System comprises Flex Console (user interface/joystick), Flex Cart/Base (positioning/manipulation), and Flex Transabdominal Drive (flexible endoscope with 3D camera). Physician uses console controller to manipulate drive; electromechanical system drives/articulates endoscope inside patient anatomy. Used in hospital setting by physicians for visualization of thoracic/abdominal cavities. Provides benefits of rigid endoscope with computer-assisted control. System is software-controlled; provides 3D visualization via distal camera. Benefits include operator-controlled navigation and visualization of internal structures. Drive is single-use, sterile (EtO); other components are reusable.

Clinical Evidence

Bench testing only. Includes optical performance (resolution, distortion), mechanical/system verification, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and biocompatibility (ISO 10993-1). No clinical data presented.

Technological Characteristics

Flexible/semi-rigid endoscope; 18mm diameter; 320mm length. Electromechanical cable-driven articulation (0°-110°). CMOS sensor (1280x720). LED light source. AC powered. Software-controlled via console joystick. Biocompatible materials. Sterilization: EtO (Drive); cleaning/disinfection (reusable components). Standards: BS ISO 8600-1, IEC 60601-1, IEC 60601-1-2, ISO 10993-1, ISO 11135, AAMI TIR 28.

Indications for Use

Indicated for robot-assisted visualization within thoracic and abdominal cavities, including female reproductive organs, during endoscopic surgery. Contraindicated for use near or in contact with the heart or any device/accessory contacting the heart.

Regulatory Classification

Identification

A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

Predicate Devices

Olympus LTF-190-10-3D, Endoeye Flex 3D Deflectable Videoscope (K123365)

Reference Devices

Flex® Robotic System (Colorectal) (K162330)
Flex® Robotic System (Colorectal) (K172036)

Related Devices

K152619 — Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) · Prosurg, Inc. · Apr 29, 2016
K050802 — MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS · Intuitive Surgical, Inc. · Jun 29, 2005
K250939 — SIRIUS Endoscope System (PR-SI-1230) · Precision Robotics (Hong Kong) Limited · Aug 29, 2025
K081137 — INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000 · Intuitive Surgical, Inc. · Feb 18, 2009
K202571 — da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories · Intuitive Surgical, Inc. · Nov 12, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol is a stylized image of an eagle, and the text is in blue. There is also the text "yu" on the right side of the image. January 18, 2018 Medrobotics Corporation Linda J. Varroso Director, Regulatory Affairs 475 Paramount Drive Raynham, MA 02767 Re: K172796 Trade/Device Name: Medrobotics Flex® Robotic System and Flex® Transabdominal Drive Regulation Number: 21 CFR§ 884.1720 Regulation Name: Gynecologic Laparoscope and Accessories Regulatory Class: II Product Code: HET Dated: December 21, 2017 Received: December 21, 2017 Dear Linda J. Varroso: 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. Iisting 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 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. 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Image /page/1/Picture/6 description: The image shows the text "Charles Viviano -S" in a large, sans-serif font. The text is black and appears to be centered. The background is a light blue color, with a faint watermark in the background. For 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) K172796 #### Device Name Medrobotics Flex® Robotic System and Flex® Transabdominal Drive Indications for Use (Describe) The Medrobotics Flex® Robotic System is intended to provide robot-assisted control of the Flex® Transabdominal Drive. The Flex® Transabdominal Drive is intended to be used with ancillary equipment for endoscopic surgery. The Flex® Transabdominal Drive is indicated to provide robot-assisted visualization within the thoracic and abdominal cavities including female reproductive organs. This instrument must not be used for observation of the heart and must not contact the heart or any area near the heart. This instrument must not contact with any device or therapeutic accessory that contacts the heart or any area near the heart. X Prescription Use (Part 21 CFR 801 Subpart D) ] Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW * The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # TRADITIONAL 510(K) SUMMARY # Medrobotics Flex® Robotic System and Flex® Transabdominal Drive (K172796) This Summary of the Traditional 510(k) Substantial Equivalence Information is being submitted in accordance with the requirements of 21 C.F.R. § 807.92. All data included in this document is accurate and complete to the best of Medrobotics' knowledge. | Submitter Name | Medrobotics Corporation | |--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter Address | 475 Paramount Drive Raynham, MA 02767 | | Contact Person | Linda J. Varroso Director of Regulatory Affairs | | Phone Number | 508-692-6460 | | Fax Number | 508-823-1703 | | Date Prepared | January 11, 2018 | | Device Trade Name | Medrobotics Flex® Robotic System and Flex® Transabdominal Drive | | Device Common Name | Gynecologic Laparoscope and Accessories | | Product Code | HET, Laparoscope, Gynecologic (And Accessories) | | Classification | Class II pursuant to 21 C.F.R. § 884.1720, “Gynecologic laparoscope and accessories" | | Predicate Devices | Olympus LTF-190-10-3D, Endoeye Flex 3D Deflectable Videoscope [K123365] | | Reference Device | Flex® Robotic System (Colorectal) (K162330 and K172036). The proposed Flex® Transabdominal System is a modified version of the Flex® Colorectal System (K162330 and K172036). The minor changes between the two systems are intended to make the system suitable for the proposed transabdominal visualization indication for use. | {4}------------------------------------------------ # The Flex® Robotic System and Flex® Transabdominal Drive make Device Description up the Flex Robotic Transabdominal System. The system includes three (3) major components: Flex Console; Flex Cart/Base; and Flex Transabdominal Drive with camera. The Flex console is the primary user interface for controlling functionality of the Flex Transabdominal System. The Flex Cart/Base positions and manipulates the Flex Transabdominal Drive. The Flex Camera is a sterile, reusable component that is attached to the Flex Transabdominal Drive. The Flex Transabdominal Drive is attached to the Flex Base and is introduced to the patient through a commercially available trocar. The physician provides input to manipulate the Flex Transabdominal Drive via the Physician Controller located on the Flex Console. The input from the Physician Controller generates the desired motion in the Flex Base resulting in driving and articulation of the endoscope inside the patient's anatomy. Manipulation of available camera controls allows the physician to achieve appropriate visualization of the target site. The Flex® Robotic Transabdominal System is an operatorcontrolled flexible endoscope that provides the benefits of both a rigid endoscope and a computer-assisted controller. The Flex® Robotic Transabdominal System is a software-controlled device. The Flex® Robotic Transabdominal System allows for the endoscope to be introduced via an operator-controlled user interface easily providing visualization of structures in the thoracic and abdominal cavities, including female reproductive organs. Visualization is provided by a 3D camera attached at the distal end of the endoscope. The Flex® Robotic Transabdominal System is intended for professional use only in a hospital setting. The Flex® Robotic System is provided non-sterile and reusable. The Flex® Transabdominal 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. The Medrobotics Flex® Robotic System is intended to provide Indications for Use robot-assisted control of the Flex® Transabdominal Drive. The Flex® Transabdominal Drive is intended to be used with ancillary equipment for endoscopy and endoscopic surgery. The Flex® Transabdominal Drive is indicated to provide robot-assisted visualization within the thoracic and abdominal cavities including female reproductive organs. {5}------------------------------------------------ This instrument must not be used for observation or treatment of the heart and must not contact the heart or any area near the heart. This instrument must not come into contact with any device or therapeutic accessory that contacts the heart or any area near the heart. As shown in the comparison table below, the Flex® Transabdominal System and predicate system are both indicated for use in endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs. There are no substantive differences between the proposed and predicate indications for use. | PROPOSED Flex® Transabdominal System | PREDICATE DEVICE Olympus Medical Endoeye Flex 3D Deflectable Videoscope [K123365] | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | | | | The Medrobotics Flex® Robotic System is intended to provide robot-assisted control of the Flex® Transabdominal Drive. The Flex® Transabdominal Drive is intended to be used with ancillary equipment for endoscopy and endoscopic surgery. The Flex® Transabdominal Drive is indicated to provide robot- assisted visualization within the thoracic and abdominal cavities, including female reproductive organs. This instrument must not be used for observation or treatment of the heart and must not contact the heart or any area near the heart. This instrument must not come into contact with any device or therapeutic accessory that contacts the heart or any area near the heart. | Indicated to be used with Olympus video system center, light source, documentation equipment, 3D processor, monitor, hand instruments, electrosurgical unit and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the thoracic and abdominal cavities including female reproductive organs. This instrument must not be used for observation or treatment of the heart and must not contact the heart or any area near the heart. This instrument must not come into contact with any device or therapeutic accessory that contacts the heart or any area near the heart. | | | | PROPOSED Flex® Transabdominal System | PREDICATE DEVICE Olympus Medical Endoeye Flex 3D | | | | Deflectable Videoscope [K123365] | | Operating Principles | Cable steered CMOS based video endoscope using electromechanical controls driven from a console based computer controlled physician handle | Cable steered 3D video endoscope using mechanical controls driven from the articulation levers in the scope handle | | Energy Source | AC powered | AC powered | | Software | Yes. Software-driven endoscope | Yes, but not for driving the endoscope | | Hardware | Major hardware system components: - Flex Drive (endoscope) - Flex Console (including video monitor and joystick) - Flex Base - Flex Cart - Flex Camera (with light source) | Major hardware system components: - Deflectable 3D videoscope - 3D video processor/visualization unit - Evis Exera III Video System Center - Xenon light source | | Operating Environment - Temperature | 50° – 86° F (10° – 30° C) | 50° – 104° F (10° – 40° C) | | Operating Environment - Relative Humidity | 15 – 75% relative humidity, non- condensing | 30 – 85% relative humidity, non- condensing | | Operating Environment – Air pressure | 700 – 1060 hPA | 700 – 1060 hPA | | Anatomical Access | Scope gains access through a trocar | Scope gains access through a trocar | | | PROPOSED Flex® Transabdominal System | PREDICATE DEVICE Olympus Medical Endoeye Flex 3D Deflectable Videoscope [K123365] | | Scope Diameter | 18 mm | 10 mm | | Scope Rigidity | Flexible / Semi-Rigid endoscope | Flexible tip endoscope | | Scope Length | 320 mm | 370 mm | | Advance / Retract | Electro-mechanically 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 | | Maximum Allowable Speed | Linear: 22 mm/s Articulation: 22 mm/s | Manual | | Tip Articulation | 0° - 110° | 0° – 100° | | Steering | Electromechanical joystick controls (the Physician Controller) on a console aid steering | Flexible tip is articulated by pushing/pulling steering cables using the articulation lever on the scope handle | | Direct Visualization | Yes | Yes | | Multi-Segmented Endoscope Structure | Yes | Yes | | Semi-rigid follow the leader/guiding function | Yes | No | | Electromechanically cable driven/controlled segments | Yes | No | | 3D flexible movements and tip orientation | Yes | No - rigid body only flexible at the distal end | | | PROPOSED Flex® Transabdominal System | PREDICATE DEVICE Olympus Medical Endoeye Flex 3D Deflectable Videoscope [K123365] | | Haptic feedback to user | Based on mechanical scope limits – Yes Based on patient anatomy – No | No | | Fluid Lumen | No | No | | Working Channel(s) | No | No | | View Optics/Optical Sensor | Lens/Solid State Camera (CMOS) | Two CCDs | | Optics – Pixels | 1280 x 720 | 1080 x 601 | | Optics – CCD Type | Color | Color | | Optics – Field of View | > 80° | 80° | | Optics – Direction of View | Forward / 0° | Forward / 0° | | Optics – Depth of Field | 25 – 60 mm | 18 – 100 mm | | Light Source | LED | EVIS EXERA III CLV-190 Xenon light source 300 watts—5000 lumens | | Video Image Processing | Video Data Display | Imaging System 3D Visualization Unit 3D Visualization Unit (3DV-190) | | Video Display | Standard color video display | Standard color video display | | | PROPOSED Flex® Transabdominal System | PREDICATE DEVICE Olympus Medical Endoeye Flex 3D Deflectable Videoscope [K123365] | | Sterilization…