(125 days)
Olympus LTF-190-10-3D, Endoeye Flex 3D Deflectable Videoscope [K123365]
No
The summary describes a robot-assisted endoscopic system controlled by a physician. It mentions software control and video image processing but does not include any terms or descriptions indicative of AI or ML capabilities, such as learning, adaptation, or data-driven decision making beyond direct physician input.
No.
The device is solely intended for visualization within the thoracic and abdominal cavities during endoscopic surgery and does not provide any therapeutic function.
No
The device is described as providing "robot-assisted visualization" for endoscopic surgery and is used to "achieve appropriate visualization of the target site." Its primary function is to enable visualization during surgical procedures, not to provide a medical diagnosis through analysis of that visualization.
No
The device is described as a system including hardware components such as a console, cart/base, and a transabdominal drive with a camera, in addition to being software-controlled.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide robot-assisted control and visualization within the thoracic and abdominal cavities for endoscopic surgery. This involves direct interaction with the patient's internal anatomy for surgical procedures and visualization.
- Device Description: The device is a robotic system that manipulates a flexible endoscope with a camera for internal visualization. It is introduced into the patient's body.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens outside of the body (in vitro) to provide information about a patient's health. This device operates inside the body (in vivo).
- No Mention of Specimen Analysis: There is no mention of collecting or analyzing biological specimens like blood, urine, tissue samples, etc.
- Focus on Visualization and Manipulation: The primary functions described are visualization and robotic manipulation of an endoscope within the patient.
In summary, the Medrobotics Flex® Robotic System is an in vivo surgical and visualization device, not an in vitro diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
HET
Device Description
The Flex® Robotic System and Flex® Transabdominal Drive make 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 operator-controlled 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and abdominal cavities including female reproductive organs
Indicated Patient Age Range
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
- BS ISO 8600-1:2015, Endoscopes Medical endoscopes and endotherapy devices, Part 1: General requirements
- FDA Guidance Hysteroscopes and Gynecologic Laparoscopes Submission Guidance for a 510(k). Final: March 7, 1996
Key Results: - Resolution / Working Distance: 12.5 lp/mm @ 30mm, 5.5 lp/mm @ 80mm with working distance 30 – 80 mm.
- Distortion:
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
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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)
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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.
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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 | Flex Transabdominal Drive is provided
Sterile – EtO (SAL 10-6) for single
patient use
Flex Camera is provided non-sterile,
reusable and requires cleaning and
sterilization prior to use
The Flex Base, Flex Cart, Stand, and
Flex Console are provided non-sterile
and require cleaning and disinfection
prior to use | The predicate device is provided non-
sterile and requires cleaning and
sterilization prior to use |
| Electrical Safety &
EMC | Complies with EMC standards for
medical electrical equipment in
IEC 60601-1-2 | Complies with EMC standards for
medical electrical equipment in
IEC 60601-1-2 |
6
Comparison of Technological Characteristics
The technological characteristics of the Flex Transabdominal System and the predicate device are compared in detail in the Table below. The minor differences in technological characteristics do not raise different questions of safety or effectiveness, as confirmed by the testing and validation activities described in the submission.
7
8
9
Summary of Non-Clinical Performance Testing
Bench Testing
The Flex® Robotic Transabdominal System has been tested in compliance with relevant sections of:
- A. BS ISO 8600-1:2015, Endoscopes Medical endoscopes and endotherapy devices, Part 1: General requirements
- B. FDA Guidance Hysteroscopes and Gynecologic Laparoscopes Submission Guidance for a 510(k). Final: March 7, 1996
Testing in accordance with the Hysteroscopes and Gynecologic Laparoscopes guidance, included optical performance. Results from this testing are shown in the tables below.
Resolution / Working Distance
| Device Name | Proposed Flex
Transabdominal System | Working
Distance |
|-----------------------------|----------------------------------------|---------------------|
| Image Quality
Resolution | 12.5 lp/mm @ 30mm
5.5 lp/mm @ 80mm | 30 – 80 mm |
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Distortion
| Device Name | Proposed Flex
Transabdominal System |
|-------------|----------------------------------------|
| Distortion |