(125 days)
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.
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 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Medrobotics Flex® Robotic System and Flex® Transabdominal Drive, guided by your requested information points.
Important Note: The provided document is a 510(k) summary for a medical device. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a novel device's effectiveness through large-scale clinical trials in the same way a drug or a Class III device might. Therefore, many of your requested points (like MRMC studies, training set details for AI, and explicit "acceptance criteria" presented as targets for the device's performance vs. reported performance) are not typically included in this type of submission. The "acceptance criteria" for a 510(k) device are generally that it performs comparably or better than the predicate device in relevant non-clinical tests.
Description of Acceptance Criteria and Study:
The Medrobotics Flex® Robotic System and Flex® Transabdominal Drive (collectively, the Flex® Robotic Transabdominal System) demonstrated substantial equivalence to its predicate device, the Olympus LTF-190-10-3D, Endoeye Flex 3D Deflectable Videoscope [K123365], through a series of non-clinical performance tests. The acceptance criteria are implicitly met by demonstrating that the device performs equivalently or acceptably within established medical device standards and compared to the predicate.
1. A table of acceptance criteria and the reported device performance
As explained, a 510(k) emphasizes substantial equivalence through comparison to a predicate device and adherence to recognized standards. The following table extracts relevant performance characteristics and reported values. Explicit "acceptance criteria" are not given as numerical targets in this document, but rather a demonstration of performance consistent with the predicate and relevant standards.
| Characteristic | Acceptance Criteria (Implied / Comparator) | Reported Device Performance (Flex® Transabdominal System) |
|---|---|---|
| Resolution | Comparable to predicate; meets medical endoscope standards (BS ISO 8600-1) | 12.5 lp/mm @ 30mm; 5.5 lp/mm @ 80mm |
| Working Distance | Meets clinical needs for laparoscopic visualization (implicitly 30-80mm) | 30 – 80 mm |
| Distortion | Acceptable for clear visualization; meets medical endoscope standards (BS ISO 8600-1) | <15% |
| Sterility | Sterility Assurance Level (SAL) of 10⁻⁶ | SAL of 10⁻⁶ (for Flex® Transabdominal Drive, EtO sterilized) |
| Biocompatibility | Compliant with ISO 10993-1 for external communicating devices, limited exposure | Information provided demonstrating compliance |
| Electrical Safety | Complies with IEC 60601-1 and IEC 60601-1-2 standards | Complies with IEC 60601-1 and IEC 60601-1-2 |
| EMC | Complies with IEC 60601-1-2 standards | Complies with IEC 60601-1-2 |
| Software Level | Software classified as "moderate level of concern" | Classified as "moderate level of concern," justification for prior testing reuse provided |
| Mechanical/System | Functional reliability under simulated use conditions | Testing conducted under simulated use conditions |
| Packaging/Shipment | Complies with applicable ISTA standards | Complies with applicable ISTA standards, justification for prior testing reuse provided |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes bench testing, mechanical and system verification testing, software evaluation, ship testing, electrical safety/EMC testing, biocompatibility testing, and sterilization validation. These are non-clinical (laboratory/simulated) studies.
- Sample Size for Test Set: The document does not specify a numerical sample size for individual tests (e.g., how many units were tested for resolution or distortion). It refers to "testing" or "results from this testing," implying sufficient samples were used to meet regulatory requirements for non-clinical validation.
- Data Provenance: The studies are non-clinical, likely conducted at the manufacturer's facilities (Medrobotics Corporation, Raynham, MA 02767) or by contracted testing laboratories. As they are bench tests, "country of origin" of data or "retrospective/prospective" does not apply in the same way it would for clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the provided document. The Flex® Robotic Transabdominal System is a surgical visualization device, not an AI diagnostic tool that requires human expert ground truth for its performance evaluation in this context. The testing described is hardware and software verification against engineering specifications and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used in clinical studies or AI performance evaluations where human interpretation of medical images or data requires a consensus "ground truth." The tests performed here are objective physical and software verifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a robot-assisted surgical visualization system, not an AI-assisted diagnostic tool for image analysis. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable in the context of an AI algorithm assessing medical data. The Flex® Robotic System has software, but it controls the physical endoscope; it does not perform standalone diagnostic assessments akin to an AI algorithm evaluating images. The software itself was assessed for its classification as "moderate level of concern" and its compliance with FDA guidance for software in medical devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests described:
- Resolution, Distortion, Mechanical/System Testing, Electrical Safety, EMC, Ship Testing: The "ground truth" and acceptance criteria are based on engineering specifications, recognized national/international standards (e.g., BS ISO 8600-1, IEC 60601-1, IEC 60601-1-2, ISTA standards), and comparison to the predicate device.
- Biocompatibility: Based on compliance with ISO 10993-1 standards.
- Sterilization: Based on validation to a specific sterility assurance level (SAL) of 10⁻⁶ following standards like ISO 11135 and AAMI TIR 28.
There is no "expert consensus," "pathology," or "outcomes data" ground truth referenced for these non-clinical evaluations.
8. The sample size for the training set
This is not applicable. This device is a robotic surgical system, not an AI diagnostic tool trained on a dataset. The software within the device is control software, not a machine learning model that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
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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.
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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 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
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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 DriveRaynham, MA 02767 |
| Contact Person | Linda J. VarrosoDirector 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® TransabdominalDrive |
| 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, “Gynecologiclaparoscope and accessories" |
| Predicate Devices | Olympus LTF-190-10-3D, Endoeye Flex 3D DeflectableVideoscope [K123365] |
| Reference Device | Flex® Robotic System (Colorectal) (K162330 and K172036). Theproposed Flex® Transabdominal System is a modified version ofthe Flex® Colorectal System (K162330 and K172036). The minorchanges between the two systems are intended to make the systemsuitable for the proposed transabdominal visualization indicationfor use. |
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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.
| PROPOSEDFlex® Transabdominal System | PREDICATE DEVICEOlympus Medical Endoeye Flex 3DDeflectable Videoscope[K123365] | |
|---|---|---|
| Indicationsfor Use | ||
| The Medrobotics Flex® Robotic System isintended to provide robot-assisted controlof the Flex® Transabdominal Drive.The Flex® Transabdominal Drive isintended to be used with ancillaryequipment for endoscopy and endoscopicsurgery. The Flex® TransabdominalDrive is indicated to provide robot-assisted visualization within the thoracicand abdominal cavities, including femalereproductive organs.This instrument must not be used forobservation or treatment of the heart andmust not contact the heart or any area nearthe heart. This instrument must not comeinto contact with any device or therapeuticaccessory that contacts the heart or anyarea near the heart. | Indicated to be used with Olympusvideo system center, light source,documentation equipment, 3Dprocessor, monitor, handinstruments, electrosurgical unit andother ancillary equipment forendoscopy and endoscopic surgery.This instrument is indicated for usewithin the thoracic and abdominalcavities including femalereproductive organs.This instrument must not be used forobservation or treatment of the heartand must not contact the heart or anyarea near the heart. This instrumentmust not come into contact with anydevice or therapeutic accessory thatcontacts the heart or any area nearthe heart. | |
| PROPOSEDFlex® Transabdominal System | PREDICATE DEVICEOlympus Medical Endoeye Flex 3D | |
| Deflectable Videoscope[K123365] | ||
| Operating Principles | Cable steered CMOS based videoendoscope using electromechanicalcontrols driven from a console basedcomputer controlled physician handle | Cable steered 3D video endoscopeusing mechanical controls driven fromthe articulation levers in the scopehandle |
| 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 videomonitor 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 |
| OperatingEnvironment -Temperature | 50° – 86° F (10° – 30° C) | 50° – 104° F (10° – 40° C) |
| OperatingEnvironment -Relative Humidity | 15 – 75% relative humidity, non-condensing | 30 – 85% relative humidity, non-condensing |
| OperatingEnvironment – Airpressure | 700 – 1060 hPA | 700 – 1060 hPA |
| Anatomical Access | Scope gains access through a trocar | Scope gains access through a trocar |
| PROPOSEDFlex® Transabdominal System | PREDICATE DEVICEOlympus Medical Endoeye Flex 3DDeflectable 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 withphysician controller on console.The system is locked in place andpower is withdrawn from the motorsprior to initiation of a surgicalprocedure. | Manual |
| MaximumAllowable Speed | Linear: 22 mm/sArticulation: 22 mm/s | Manual |
| Tip Articulation | 0° - 110° | 0° – 100° |
| Steering | Electromechanical joystick controls(the Physician Controller) on a consoleaid steering | Flexible tip is articulated bypushing/pulling steering cables usingthe articulation lever on the scopehandle |
| Direct Visualization | Yes | Yes |
| Multi-SegmentedEndoscopeStructure | Yes | Yes |
| Semi-rigid followthe leader/guidingfunction | Yes | No |
| Electromechanicallycabledriven/controlledsegments | Yes | No |
| 3D flexiblemovements and tiporientation | Yes | No - rigid body only flexible at thedistal end |
| PROPOSEDFlex® Transabdominal System | PREDICATE DEVICEOlympus Medical Endoeye Flex 3DDeflectable Videoscope[K123365] | |
| Haptic feedback to user | Based on mechanical scope limits – YesBased 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 Xenonlight source 300 watts—5000 lumens |
| Video Image Processing | Video Data Display | Imaging System3D Visualization Unit3D Visualization Unit (3DV-190) |
| Video Display | Standard color video display | Standard color video display |
| PROPOSEDFlex® Transabdominal System | PREDICATE DEVICEOlympus Medical Endoeye Flex 3DDeflectable Videoscope[K123365] | |
| Sterilization | Flex Transabdominal Drive is providedSterile – EtO (SAL 10-6) for singlepatient useFlex Camera is provided non-sterile,reusable and requires cleaning andsterilization prior to useThe Flex Base, Flex Cart, Stand, andFlex Console are provided non-sterileand require cleaning and disinfectionprior to use | The predicate device is provided non-sterile and requires cleaning andsterilization prior to use |
| Electrical Safety &EMC | Complies with EMC standards formedical electrical equipment inIEC 60601-1-2 | Complies with EMC standards formedical electrical equipment inIEC 60601-1-2 |
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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.
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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 FlexTransabdominal System | WorkingDistance |
|---|---|---|
| Image QualityResolution | 12.5 lp/mm @ 30mm5.5 lp/mm @ 80mm | 30 – 80 mm |
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Distortion
| Device Name | Proposed FlexTransabdominal System |
|---|---|
| Distortion | <15% |
Mechanical and System Verification Testing
Mechanical and system verification testing, and Flex Transabdominal Drive Functional Reliability were conducted under simulated use conditions.
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 software as a "moderate level of concern." A justification was provided to support not providing new/additional testing beyond that which was provided to support clearance of the reference device.
Ship Testing
The Flex® Transabdominal System packaging complies with applicable ISTA standards regarding anticipated shipping conditions. A justification was provided to support not providing new/additional testing beyond that which was provided to support clearance of the reference device.
Electrical Safety - Electromagnetic Compatibility Testing
The Flex® Transabdominal System complies with the electrical safety and EMC standards IEC 60601-1, IEC 60601-1-2. A justification was provided to support not providing new/additional testing beyond that which was provided to support clearance of the reference device.
Biocompatibility
The Flex® Transabdominal Drive is the patient-contacting portion of the Flex® Transabdominal 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® Transabdominal Drive is classified as "external communicating device," in contact with "tissue/bone/dentin" and "limited exposure" (≤ 24 hours). Information demonstrating the biocompatibility of the Flex® Transabdominal Drive has been provided. A justification was provided to support not providing new/additional testing beyond that which was provided to support clearance of the reference device.
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Sterilization, Packaging, and Shelf Life for Single Use Flex® Transabdominal Drive
The Flex® Transabdominal Drive is supplied sterile and is a single use device. The Flex® Transabdominal Drive is sterilized via ethylene oxide (EtO). The EtO cycle has been validated to a sterility assurance level (SAL) of 106, in accordance with the following standards:
- ISO 11135:2014. Sterilization of health care products - Ethylene Oxide
- AAMI TIR 28:2016, 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
The Flex® Transabdominal Drive is stable over the labeled shelf life.
Cleaning and Sterilization of Reusable System Components
The Flex Transabdominal System includes a reusable component, the Flex® Camera, which is provided non-sterile. The Flex® Camera is intended to be cleaned and sterilized before each use. The recommended cleaning and sterilization instructions were adopted from the cleared reference device. The Flex® Camera is limited to 10 uses.
The Flex® Transabdominal System also consists of reusable capital equipment supplied nonsterile. 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 recommended cleaning and disinfection instructions were adopted from the cleared reference device.
Conclusion
Based on the performance testing, the Medrobotics Flex® Transabdominal System has been shown to be as safe and effective for its stated intended use as the predicate device to which substantial equivalence is claimed.
§ 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.