(29 days)
Not Found
No
The summary describes a robot-assisted flexible scope with computer control for visualization and surgical access. There is no mention of AI, ML, or any features that would typically involve learning algorithms or complex data analysis beyond basic computer-assisted control and visualization. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is used for visualization and surgical site access, and provides channels for instruments, but it does not directly treat a condition. It is an assistive device for surgical procedures.
No
Explanation: The device description clearly states its purpose is for "robot-assisted visualization of and surgical site access to the anus, rectum, and distal colon" and to provide "accessory channels for compatible flexible instruments used in surgery." It is designed for surgical assistance and visualization during procedures, not for diagnosing medical conditions.
No
The device description clearly outlines hardware components like a flexible scope, camera, and accessory channels, indicating it is a physical medical device with software control, not a software-only device.
Based on the provided information, the Medrobotics Flex Robotic System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for robot-assisted control of a flexible scope for visualization and surgical site access to the anus, rectum, and distal colon. This is a surgical and visualization tool used in vivo (within the body).
- Device Description: The description details a flexible scope with a camera and accessory channels for surgical instruments. This aligns with a surgical device, not a device used to examine samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are typically used to diagnose diseases or conditions by testing samples.
Therefore, the Medrobotics Flex Robotic System is a surgical robotic system, not an IVD.
N/A
Intended Use / Indications for Use
The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, recturn and distal colon. The Flex Robotic System is intended for use in adults (≥22 years of age).
The Flex Colorectal Drive is intended for robot-assisted visualization of and surgical site access to the anus, rectum, and distal colon in adults (≥22 years of age). The Flex Colorectal Drive also provides accessory channels for compatible flexible instruments used in surgery.
Product codes
FDF
Device Description
The Medrobotics Flex Robotic System is an operator controlled flexible scope that include the benefits of both a rigid scope and a computer assisted controller. This allows for the Flex Colorectal Drive to be introduced via an operator controlled user interface, easily providing transanal access to the anus, rectum and distal colon. Visualization is provided by a user selectable 2D or 3D HD camera incorporated in distal end of the scope. The Flex Robotic System's scope also provides accessory channels for the use of varied flexible surgical instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anus, rectum, and distal colon
Indicated Patient Age Range
adults (≥22 years of age)
Intended User / Care Setting
Not Found
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)
The Flex Robotic system has been successfully tested for function, performance, and safety as per FDA recognized Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, and Biocompatibility and Toxicity testing of the patient contacting materials to ISO 10993-1. It has been tested and met acceptance criteria per FDA recognized standards for the establishment of labeled shelf life and shipping, and validated for sterility by ETO and Steam to a SAL of 10-6.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 3, 2017
Medrobotics Corporation John D. Bonasera Vice President of Clinical. Regulatory and Ouality Affairs 475 Paramount Drive Raynham, MA 02767
Re: K172036
Trade/Device Name: Medrobotics Flex Robotic System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDF Dated: July 5, 2017 Received: July 5, 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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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.
Charles Viviano -S
For
Beniamin 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) K172036
Device Name Medrobotics Flex Robotic System
Indications for Use (Describe)
The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, recturn and distal colon. The Flex Robotic System is intended for use in adults (≥22 years of age).
The Flex Colorectal Drive is intended for robot-assisted visualization of and surgical site access to the anus, rectum, and distal colon in adults (≥22 years of age). The Flex Colorectal Drive also provides accessory channels for compatible flexible instruments used in surgery.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary Medrobotics Flex Robotic System
| Submitter's Name: | Medrobotics Corporation |
|---|---|
| Submitter's Address: | 475 Paramount Drive |
| Raynham, MA 02767 | |
| Contact Person: | John D. Bonasera |
| Phone Number: | 508-692-6460 |
| Fax Number: | 508-823-1703 |
| Date Prepared: | July 5, 2017 |
| Device Trade Name: | Medrobotics Flex® Robotic System |
| Device Common Name: | Endoscope/Endoscope and Accessories |
| Product Code: | FDF |
| Classification: | The Medrobotics Flex Robotic System is classified as Class II per 21 CFR § |
| 876.1500 | |
| Predicate Device: | Medrobotics Flex Robotic System (K162330) |
| Device Description: | The Medrobotics Flex Robotic System is an operator controlled flexible scope |
| that include the benefits of both a rigid scope and a computer assisted | |
| controller. This allows for the Flex Colorectal Drive to be introduced via an | |
| operator controlled user interface, easily providing transanal access to the | |
| anus, rectum and distal colon. Visualization is provided by a user selectable | |
| 2D or 3D HD camera incorporated in distal end of the scope. The Flex | |
| Robotic System's scope also provides accessory channels for the use of varied | |
| flexible surgical instruments. | |
| Intended Use: | The Medrobotics Flex Robotic System is intended to provide robot-assisted |
| control of the Flex Colorectal Drive during visualization of and surgical site | |
| access to the anus, rectum and distal colon. The Flex Robotic System is | |
| intended for use in adults (≥22 years of age). | |
| The Flex Colorectal Drive is intended for robot-assisted visualization of and | |
| surgical site access to the anus, rectum, and distal colon in adults (≥22 years | |
| of age). The Flex Colorectal Drive also provides accessory channels for | |
| compatible flexible instruments used in surgery. | |
| Performance Data: | The Flex Robotic system has been successfully tested for function, |
| performance, and safety as per FDA recognized Standards: IEC 60601-1, | |
| IEC 60601-1-2, IEC 60601-2-18, and Biocompatibility and Toxicity testing of | |
| the patient contacting materials to ISO 10993-1. It has been tested and met | |
| acceptance criteria per FDA recognized standards for the establishment of | |
| labeled shelf life and shipping, and validated for sterility by ETO and Steam | |
| to a SAL of 10-6. | |
| Substantial Equivalence: | The Medrobotics Flex Robotic System is substantially equivalent to and has |
| the intended use as the predicate device. |